Bipolar Disorder and Family Communication Effects of a Psychoeducational Treatment Program

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1 Page 1 of 19 Journal of Abnormal Psychology November 1999 Vol. 108, No. 4, by the American Psychological Association For personal use only--not for distribution. Bipolar Disorder and Family Communication Effects of a Psychoeducational Treatment Program Teresa L. Simoneau University of Colorado at Boulder David J. Miklowitz University of Colorado at Boulder Jeffrey A. Richards University of Colorado at Boulder Rakhsh a Saleem University of Colorado at Boulder Elizabeth L. George University of Colorado at Boulder ABSTRACT Family psychoeducational programs are efficacious adjuncts to pharmacotherapy for patients with schizophrenic and bipolar disorders, but little is known about what these programs change about families. The authors assessed changes in face-to-face interactional behavior over 1 year among families of bipolar patients who received a 9- month family-focused psychoeducational therapy (FFT; n = 22) or crisis management with naturalistic follow-up (CMNF; n = 22), both administered with maintenance pharmacotherapy. Members of families who received FFT showed more positive nonverbal interactional behavior during a 1-year posttreatment problem-solving assessment than families who received CMNF, although no corresponding decreases were seen in negative interactional behaviors. The positive effect of family treatment on patients' symptom trajectories over 1 year was partially mediated by increases in patients' positive nonverbal interactional behaviors during this same interval. Guest Editors' Note. Jacqueline B. Persons served as the action editor for this article. DJM/LBA This research was supported in part by National Institute of Mental Health Grants MH43931, MH42556, and MH55101; Grant A from the John D. and Catherine T. MacArthur Foundation Network on the Psychobiology of Depression; and by a Faculty Fellowship from the University of Colorado. This study is based on the doctoral dissertation of Teresa L. Simoneau. We thank Kara Allen, Estela Bogaert-Martinez, Barb Dausch, Scott Hake, Aparna Kalbag, Kristin Powell, Natalie Sachs-Ericsson, and Jennifer Wendel for their input. Correspondence may be addressed to Teresa L. Simoneau, who is now at, Rocky Mountain Cancer Centers, 1800 Williams Street, Denver, Colorado, Electronic mail may be sent to teresa.simoneau@usoncology.com Received: September 15, 1998 Revised: April 20, 1999 Accepted: April 21, 1999

2 Page 2 of 19 The development of psychosocial interventions for the major psychiatric disorders has lagged behind comparable research on pharmacological interventions. However, much empirical work on family interventions for schizophrenia has been accomplished in the past 2 decades. Schizophrenia researchers have repeatedly found that family psychoeducational interventions are effective adjuncts to standard neuroleptic regimens in delaying relapses of psychosis and that these interventions successfully bring about reductions in family discord (for reviews, see Goldstein & Miklowitz, 1995 ; Penn & Mueser, 1996 ; but see also Schooler et al., 1997 ). The question of whether similar treatments can be developed and found successful in other recurrent psychiatric disorders, such as bipolar disorder, has only recently become a focus of research. The success of psychoeducational approaches to schizophrenia derives in part from their grounding in basic risk research. The observation that high levels of expressed emotion (EE; critical, hostile, or emotionally overinvolved attitudes among relatives) are predictive of the 9-month to 1-year course of schizophrenia has been repeated cross-nationally and in many different patient subsamples (for a recent review, see Butzlaff & Hooley, 1998 ). The consistency of the EE-outcome relationship has led many to predict that interventions targeting high-ee attitudes, as well as the aversive family interaction patterns with which EE attitudes are correlated (e.g., Miklowitz, Goldstein, Falloon, & Doane, 1984 ; Miklowitz et al., 1989 ), should lead to corresponding improvements in the course of schizophrenia and other psychiatric disorders. Several controlled trials support the contention that family psychoeducational treatment is superior to comparison psychosocial interventions in bringing about reductions in EE (e.g., Hogarty et al., 1986 ; Leff, Kuipers, Berkowitz, Eberlein-Vries, & Sturgeon, 1982 ; Leff, Kuipers, Berkowitz, & Sturgeon, 1985 ; Leff et al., 1989 ; Tarrier et al., 1988 ). Like schizophrenia patients, bipolar patients show recurrent courses of illness and decreases in psychosocial functioning that are only partially alleviated by medication (e.g., Coryell et al., 1993 ; Gelenberg et al., 1989 ; Gitlin, Swendsen, Heller, & Hammen, 1995 ; Maj, Pirozzi, Magliano, & Bartoli, 1998 ). Furthermore, patients with bipolar disorder show levels of family discord (i.e., negative family attitudes [EE] or interactional behaviors) during and following illness episodes that, although not as high as those seen among patients with schizophrenia, predict poor short-term outcomes of the disorder ( Miklowitz, Goldstein, & Nuechterlein, 1995 ; Miklowitz, Goldstein, Nuechterlein, Snyder, & Mintz, 1988 ; O'Connell, Mayo, Flatow, Cuthbertson, & O'Brien, 1991 ; Priebe, Wildgrube, & Muller-Oerlinghausen, 1989 ). Can family interventions ameliorate the clinical course of bipolar disorder when combined with lithium or anticonvulsant regimens? If so, are the mechanisms by which these treatments achieve their effects similar to those observed in treatment studies of schizophrenic patients and their families? A small number of experimental trials support the utility of structured, educationally oriented family interventions for bipolar disorder (for a review, see Craighead, Miklowitz, Vajk, & Frank, 1998 ). Clarkin, Carpenter, Hull, Wilner, and Glick (1998) found that an 11-month psychoeducational intervention with mood-stabilizing medications led to improved global functioning and medication compliance among married bipolar patients when compared with patients treated with medication only ( N = 33). However, Clarkin et al. did not observe improvements in patients' symptoms over this interval. In a nonrandomized pilot trial, Miklowitz and Goldstein (1990) found that a 9-month program of pharmacotherapy and family-focused psychoeducational treatment (FFT), the latter consisting of psychoeducation, communication-enhancement training, and problem-solving skills training, yielded better outcomes (1 of 9 [11%] relapsed in 9 months) than a comparison treatment consisting of

3 Page 3 of 19 comparable pharmacotherapy and naturalistic follow-up (14 of 23 [61%] relapsed). Preliminary results from the Colorado Treatment/Outcome Project (CTOP; Miklowitz et al., 1999 ), a randomized, controlled trial of FFT for bipolar patients recovering from an acute mood disorder episode ( N = 101), are consistent with these initial findings. Over a 1-year period of treatment and follow-up, bipolar patients who received FFT and mood-stabilizing medications survived longer in the community without relapsing and showed greater reductions in mood disorder symptoms than patients who received crisis management with naturalistic follow-up (CMNF) and comparable moodstabilizing medications. Two studies examined the effects of psychoeducational family interventions on the emotional attitudes of family members coping with bipolar disorder. In a mixed group of psychotic and major affective patients ( N = 186), Glick, Clarkin, Haas, Spencer, and Chen (1991) found that a brief inpatient family intervention yielded superior effects on symptoms and global functioning than standard hospital care did over a 6- and an 18-month follow-up. The treatment's effects were most pronounced among female patients with bipolar disorder ( Clarkin et al., 1990 ). Although Glick et al. did not measure EE directly, they found that, in their full sample, scores on questionnaire-based measures of negative family attitudes (i.e., rejection of the patient, perceived family burden) improved over the course of follow-up. Honig, Hofman, Rozendaal, and Dingemans (1997) compared a six-session multifamily psychoeducational group ( n = 29) with a waiting list control group ( n = 23) for bipolar patients and their key relatives. Although more relatives changed from high- to low- EE in the psychoeducational treatment group, no data were presented on whether psychoeducation led to different rates of bipolar relapse over time than was observed in the control group. Although their results are promising, none of these studies have examined a major avenue by which family treatments are presumed to be effective: altering family interaction patterns that confer risk in the longitudinal course of mood disorders ( Miklowitz et al., 1988 ; O'Connell et al., 1991 ). In contrast, studies of schizophrenia and the family have documented positive effects of family psychoeducation on family interaction and problem solving (e.g., Doane, Goldstein, Miklowitz, and Falloon, 1986 ). We report here on the effects of a 9-month program of FFT on the verbal and nonverbal interactional patterns of bipolar patients and their relatives, as measured during problemsolving interactions conducted before the initiation of psychosocial treatment and again after 1 year of treatment and follow-up. We examined a subsample of patients and families ( n = 44) from the CTOP who had received either FFT or CMNF and who had completed both family interactional assessments. We used the Category System for Partner Interactions (KPI; Hahlweg, Reisner et al., 1984 ) to quantify the affective tone of family interactions, as reflected in the verbal and nonverbal behavior of the patient and his or her relatives. The KPI has been found to be a reliable measure of the different ways in which high- and low-ee families interact during the highly stressful postepisode period, whether the index disorder is schizophrenia or bipolar illness ( Hahlweg et al., 1989 ; Hooley, 1986 ; Simoneau, Miklowitz, & Saleem, 1998 ). The sensitivity of the KPI to changes in communication has also been demonstrated in studies of distressed and nondistressed couples undergoing marital therapy ( Hahlweg, Reisner, et al., 1984 ; Hahlweg, Revenstorf, & Schindler, 1984 ). Because the major emphasis of FFT is on the teaching of communication skills, we predicted that, following treatment, patients and relatives in FFT would have higher scores on measures of positive verbal and nonverbal interactional behavior (e.g., KPI positive solution-focused statements, selfdisclosures, or agreements; positive facial expressions) and, possibly, lower scores on measures of negative verbal and nonverbal behavior (e.g., KPI criticisms, disagreements, or self-justifications;

4 Page 4 of 19 negative facial expressions) than those in CMNF. We investigated whether these treatment effects on family interactional behavior remained significant after covarying the effects of family EE attitudes (high vs. low). Finally, we investigated whether the effects of family treatment on the symptomatic course of bipolar disorder were mediated by improvements in family interactional patterns. Participants Recruitment. Method By means of a randomized design, the CTOP compared the efficacy of FFT and CMNF, both administered with standard mood-stabilizing medications for bipolar disorder. Both treatments were conducted over a 9-month period; patients were clinically monitored over 2 years, with research follow-up interviews at 3, 6, 9, 12, 18, and 24 months after study entry. This article reports on the results from the first year of treatment and research follow-up of 79 patients (of a final sample of 101), who entered the CTOP between January 1990 and July Weekly screening of inpatient charts identified potential participants for the larger treatment study. Recruitment efforts focused on four sites in the Denver, Colorado, area: (a) the University of Colorado Health Sciences Center, (b) Centennial Peaks Hospital, (c) Boulder Community Hospital, and (d) Boulder County Mental Health Center's Cedar House, a nonacute transitional living residence. Most of the patients ( n = 74) required hospitalization for treatment of their index episode. Five patients were referred to the project by community psychiatrists during or shortly after an acute outpatient episode. Inclusionary criteria. Participants met the following criteria: (a) a research diagnosis of Diagnostic and Statistical Manual of Mental Disorders (DSM III R, 3rd ed., rev.; American Psychiatric Association, 1987 ) bipolar disorder, manic, mixed, or depressed phase, in the 3 months leading up to and including the month of study entry; (b) age between 18 and 60 years; (c) no evidence of organic central nervous system disorder or mental retardation; (d) no evidence of significant drug or alcohol abuse or dependence in the 6 months before the acute episode; (e) living with or in significant contact with key relative(s) for a minimum of 1 of the 3 months prior to study entry; (f) the willingness to commit to a regime of mood-stabilizing medications; and (g) the willingness and ability to give written informed consent to participate. Diagnosis. Study personnel verified patient diagnoses through a diagnostic interview, the Structured Clinical Interview for the DSM III R, Patient Version (SCID P; Spitzer, Williams, Gibbon, & First, 1988 ). The SCID P was administered within 1 month after the onset of the acute illness episode. Training on the SCID P involved didactic training sessions, ratings of standardized SCID P videotapes, and ongoing individual supervision until raters reached adequate reliability with a criterion rater. After training, interrater reliability for SCID P items (each rated on a 0, 1, or 2 scale) averaged 0.71 ( Cohen's [1960] kappa; p <.001, calculated on a minimum of 7 interviews per rater) across six interviewers. Randomization to treatments.

5 Page 5 of 19 After completing all pretreatment assessments (detailed below), families were randomly assigned to receive FFT or CMNF. A 2:1 randomization schedule, based on a random number table, assigned 53 of 79 families to CMNF with pharmacotherapy and 26 to FFT with pharmacotherapy. More families were assigned to CMNF than FFT because a secondary purpose of the study was to examine socioenvironmental risk variables (such as EE) in predicting the 1- and 2-year course of bipolar disorder under conditions of standard pharmacotherapy and routine community care (the CMNF condition). Of the 79 patients, 16 (20%) dropped out of the study before completing the pretreatment family interactional assessments. An additional 19 patients/families completed a pretreatment family interactional assessment but failed to complete a 1-year posttreatment interactional assessment. Therefore, 44 patients and their family members ( N =52) were available for this study. Failure to complete the 1-year interactional assessment was more common in the CMNF than in the FFT condition (see the Results section). Of the 44 families who completed the pretreatment and 1-year assessments, 22 were assigned to FFT and 22 to CMNF. Most of the patients were young ( M = 34 years, SD = 9) and well educated ( M = 13.8 years of schooling, SD = 2.2; see Table 1 ). Although some patients were experiencing their first bipolar episode ( n = 8, 14%), most of the patients had been ill for some time (mean number of prior episodes = 4.0, SD = 3.3). As would be expected from the random assignment to treatments, there were no significant pretreatment differences between the 22 FFT participants and the 22 CMNF participants on patients' age, sex, socioeconomic status, years of education, type of family (parental, spousal, or other), age at onset of bipolar illness, years since the illness onset, number of months the patient was ill, or number of prior hospitalizations (for all, p >.10). Procedure: Treatment Protocols Pharmacologic treatment. On entering the study, all patient participants were referred to community psychiatrists for medication management. Psychiatrists prescribed standard mood-regulating medications: lithium ( n = 25), anticonvulsants (carbamazepine or divalproex sodium, n = 10), or combinations of lithium carbonate and anticonvulsants ( n = 8). Patients were also given adjunctive antidepressant, antipsychotic, or anxiolytic agents as needed. In one case, an antipsychotic agent alone was used to stabilize the patient's mood. No attempt was made to manipulate the patients' drug regimes for the purposes of the study. Patients in the FFT and CMNF conditions did not differ on the frequency of prescriptions for lithium, anticonvulsants, the combination of lithium plus anticonvulsants, or whether they were prescribed neither of these types of medications, at either the first pretreatment month, χ 2 (3, N = 44) = 4.82, p >.10, or at the 12-month posttreatment follow-up, χ 2 (3, N = 44) = 3.22, p >.10. As a further check on the relative complexity of pharmacotherapy regimens, we calculated a treatment intensity score ( Ellicott, Hammen, Gitlin, Brown, & Jamison, 1990 ; Gitlin et al., 1995 ; Keller, 1988 ), which ranged from 0 ( no medications ) to 4 ( high intensity regimen ). Patients who were on higher dosages of lithium, anticonvulsants, or antipsychotics, or who were on combinations of mood-stabilizing medications, received higher scores on the scale. When available, lithium blood levels were used to rate lithium intensity instead of dosages. There were no differences between patients in the FFT group and the CMNF group on treatment intensity scores during the first pretreatment month, F (1, 42) = 0.50, p >.10, or at the time of the 1-year posttreatment assessment, F (1, 42) = 1.65, p >.10.

6 Page 6 of 19 Compliance with medications was also assessed during each follow-up interview. For each prescribed mood-stabilizing medication, patients were asked to recount any instances in which they missed prescribed dosages or any suggestions by others that they were not complying during the follow-up interval. Serum blood levels, if obtained during the interval, were used to supplement patients' selfreport data (serum lithium ion levels of mmol/l were considered indicative of compliance). Raters who were unaware of patients' psychosocial treatment assignments made a single 3-point rating (1= complete compliance, 2= partial compliance, and 3= full noncompliance ; Keck et al., 1998 ) for each follow-up interval, using all available compliance data. Patients assigned to FFT and CMNF did not differ in their mean compliance ratings during the first pretreatment month, F (1, 40) = 1.76, p >.10 (compliance data were missing for 2 patients) or at the 12-month posttreatment assessment, F (1, 40) = 0.6, p >.10. Psychosocial treatment conditions. Family-focused psychoeducational therapy ( Miklowitz & Goldstein, 1997 ) is similar in structure to the behavioral family therapy model of Liberman, Wallace, Falloon, and Vaughn (1981) and Falloon, Boyd, and McGill (1984). In the CTOP study, FFT was administered in 21 outpatient sessions of home-based family therapy over 9 months (12 weekly sessions, 6 biweekly sessions, and 3 monthly sessions). Family sessions involved the patient and his or her close relatives (parents, siblings, or spouse). There were three major components to the therapy: psychoeducation (didactic information about the nature, symptoms, prognosis, etiology, and treatment of bipolar disorder); communicationenhancement training (training in active listening, delivering positive and negative verbal feedback, and requesting changes in the behavior of other family members); and problem-solving skills training (identifying and defining problems, generating and evaluating solutions, and implementing solutions). Modeling and behavioral rehearsal, in the form of role-plays and homework assignments, helped assure that patients and family members generalized the communication and problem-solving skills to the home setting. Families in this study who received FFT completed an average of 20 sessions ( SD = 2.8). Family treatment was conducted by two cotherapists, typically a trained FFT therapist and a trainee. The same therapists provided the entire treatment for a given family. The clinicians were master's or doctoral level psychologists ( N = 19) who had undergone a 2-year FFT training and certification procedure. The clinicians received weekly individual and group supervision throughout the course of the study to ensure adherence to the FFT manual. Therapy sessions were audiotaped, and random sessions were reviewed by the principal investigator (David J. Miklowitz). Additional supervision was given when therapists were not adequately adhering to the FFT model. Case management with naturalistic follow-up also lasted for 9 months and consisted of two sessions of home-based family education that covered topics such as the etiology of bipolar disorder (using a stress-vulnerability model), the importance of medication, how the family could be helpful to the patient, and relapse intervention procedures. CMNF clinicians also provided participants with crisis intervention (supportive problem solving) as needed, in the form of telephone counseling or, in some cases, individual support sessions. Patients were contacted by CMNF clinicians at least once per month. The CMNF clinician also helped arrange emergency services for the patient (e.g., hospitalization, psychiatric sessions) when needed.

7 Page 7 of 19 Procedure: Assessment Instruments Expressed emotion ratings. For this study, EE was viewed as an important moderating variable in evaluating the success or failure of the FFT or CMNF treatments. The Camberwell Family-EE Interview (CFI; Vaughn & Leff, 1976 ) was administered to significant relatives (parents, spouses, or siblings) while patients were still hospitalized for their index episode or while they were being stabilized pharmacologically on an outpatient basis (on average, 10.7 days, SD = 13.2 days, after the SCID P interview). The CFI is a semistructured interview that focuses on the relative's reactions to the patient's behavior and symptoms, particularly during the three months prior to the acute episode. From audiotapes of the CFI, trained EE raters coded the number of critical comments expressed by each relative and made qualitative judgments of hostility (personalized or generalized criticism) and emotional overinvolvement (overprotective, overconcerned, or self-sacrificing attitudes or behaviors). The criteria used to classify a relative as high EE were (a) six or more criticisms, (b) the presence of hostility, and/or (c) ratings of 4 ( moderately high ) or 5 ( high ) on emotional overinvolvement ( Vaughn & Leff, 1976 ). A family was considered high EE ( n = 14, 32%) if (a) the sole relative in a single parent or spousal family was rated high EE or (b) one or both of the relatives in a dual-relative household were rated high EE. Otherwise, the family was considered low EE ( n = 30, 68%). The mean number of criticisms during the pretreatment CFI assessment was 3.2 ( SD = 2.8), and the mean emotional overinvolvement rating was 1.6 ( SD = 1.3); 3 relatives were rated as hostile. Following completion of an EE rating workshop, the two CFI raters had attained interrater agreement levels of.80 or higher (using the phi coefficient) with a criterion rater for judgments of high- versus low-ee status. A second interrater reliability assessment was undertaken during the course of the study using 10 randomly selected audiotapes of CFI interviews from this sample. Intraclass correlations ( Bartko & Carpenter, 1976 ) between the two trained CFI raters were.82 ( p <.001) for critical comments,.93 ( p <.0001) for hostility ratings, and.80 ( p =.001) for emotional overinvolvement. Relatives from 41 of the 44 families who were interviewed at the pretreatment point agreed to be reinterviewed at the end of the year of treatment and follow-up. Relatives who did not agree to be reinterviewed had all been assigned to FFT. Posttreatment CFI tapes were rated for EE by the same raters who had coded the pretreatment interviews, and the raters had remained unaware of participants' treatment assignments. At the 1-year point, 31 families were rated low-ee (76%) and 10 were rated high-ee (24%). The EE status of the family remained the same in 29 of the 41 cases (24 remained low-ee and 5 remained high-ee); 7 families changed from high- to low-ee, and 5 families changed from low- to high-ee. There were no differences between the FFT and CMNF families in the frequency with which families changed their EE status, χ 2 (3, N = 41) = 0.49, p >.10. Family interactional assessment. The main hypotheses of this study concerned changes in family communication as a result of a family intervention. Families participated in two laboratory-based problem-solving assessments: a pretreatment assessment conducted after resolution of the patient's index episode (on average, 45 days [ SD = 47 days] after discharge from the hospital, if one had occurred; and, on average, 26.3 days [ SD = 31.8 days] after the CFI assessment) and a follow-up assessment conducted an average of 12 months after the pretreatment assessment ( SD = 3 months).

8 Page 8 of 19 All assessments were conducted in a research laboratory in the psychology department at the University of Colorado at Boulder. To generate family discussions, research staff members first identified two family conflict issues during individual interviews with patients and their relatives. The patient or relative verbalized the content of and their feelings about each issue while being audiotaped (e.g., "You're so quiet. It makes me feel excluded from your life."). Then, the relative or patient to whom the issue was directed responded to the issue on the same audiotape, recorded contiguously (e.g., "Sometimes I'm so depressed I don't feel like talking."). To initiate the family discussions, the experimenter played the audiotape of one of the problem topics (i.e., a participant's statement of the problem and the target person's response) to the patient and his or her relative(s). The family or couple was then left alone for 10 min to discuss and try to resolve the problem. The same procedure was followed for the second family problem. All discussions were audio- and videotaped. The order of presentation of the problem stimuli (patient- vs. relativegenerated problem) was counterbalanced across families. The same procedures were undertaken for the pretreatment and 1-year assessments. Interactional Coding System. We assessed verbal and nonverbal communication behaviors of patients and their family members using the KPI, an interactional coding system for dyadic or triadic interactions. The system is composed of 29 verbal codes, which fall into three broad categories of positive (statements of selfdisclosure, acceptance, agreement, or suggesting positive solutions to a problem), negative (statements of criticism, justification, disagreement, or suggesting negative solutions to a problem), and neutral (problem description, metacommunication, rest category, or listening) behaviors (for definitions and examples of the KPI codes, see Hahlweg, Reisner, et al., 1984 ). The unit of measurement for the KPI is a statement (or several statements) of similar content, by a single speaker, that meets criteria for one of the 29 categories of verbal expression. Raters first determine whether the statement is positive, negative, or neutral and then apply the verbal code that best fits within the respective category. KPI codes are assigned to patients' and relatives' statements in alternating fashion. Each coding unit also receives a nonverbal code. Hierarchical decision rules are used to determine the affective tone of the nonverbal behaviors that accompany the verbal behaviors. Facial expressions are assessed first. If the facial expression is neither positive nor negative, then voice tone is assessed. If voice tone is neither positive nor negative, then body movements are assessed. If a positive or negative code is not assigned after all three hierarchical levels are assessed, then a neutral code is assigned. Teresa L. Simoneau learned the KPI system by reading its manual and by rating sample videotapes and transcripts. She then served as the criterion rater and trained two undergraduate psychology students on the use of the KPI system. To ease the coding process, coding units were marked on the transcripts of the two 10-min family problem-solving interactions. Next, raters watched each videotaped interaction and used transcripts to assign a verbal and nonverbal KPI code to each unit of speech. The trained KPI raters were unaware of the treatment status of each family during the coding process. To minimize bias from prior exposure to a family's interactions, the rater who coded the pretreatment interaction for a family was different from the rater who coded that family's 1-year posttreatment interaction.

9 Page 9 of 19 Using a random selection of 10 family problem-solving interactions, we assessed interrater reliability using intraclass correlations. Correlations between trained rater criterion rater pairs for the verbal and nonverbal categories were as follows: positive verbal behavior, M =.94; negative verbal behavior, M =.84 (range.80 to.91); positive nonverbal behavior, M =.78 (range.77 to.79); and negative nonverbal behavior, M =.68 (range.67 to.68); for all, p < Patient symptoms. Research personnel evaluated patients' symptomatic status every 3 months during the first study year. After the first year, patients were followed for an additional year with face-to-face assessments of symptomatology conducted every 6 months. All patients continued to receive pharmacotherapy with their community psychiatrists, and study personnel continued to provide case management (face-toface sessions or telephone contacts) as needed, during the second year of the study. The primary measure of patients' symptoms in the CTOP study was the Schedule for Affective Disorders and Schizophrenia Change Version (SADS C; Spitzer & Endicott, 1978 ). Trained outcome assessors administered the SADS C to patients in FFT and CMNF at the time of the initial SCID P interview, during the pretreatment family interactional assessment (one month after study entry), and at the scheduled follow-up assessments (3, 6, 9, 12, 18, and 24 months). The SADS C is a structured interview for assessing the severity of depressive, manic, and psychotic symptoms. Reliability for the SADS C was calculated across 11 study raters, who each coded a minimum of 10 randomly selected interview audiotapes. Intraclass correlations averaged.92 ( SD =.08) for depression items,.81 ( SD =.11) for mania items, and.81 ( SD =.10) for psychosis items (for all, p <.001). Data Reduction and Analyses Results We evaluated changes in family interactional behavior over the 1-year period of treatment and follow-up using analyses of covariance (ANCOVAs). Treatment group (FFT vs. CMNF) served as the independent variable, and KPI scores from the 1-year interactions served as dependent variables, with pretreatment KPI scores covaried. We also examined the explanatory effects of pharmacotherapy regimes and family EE (at pretreatment and 1-year) in predicting KPI scores at the 1-year assessment. Finally, we examined a pathway from treatment group to changes in patients' interactional behavior to improvements in patients' mood disorder symptoms over the year of treatment. To reduce the number of between-groups (FFT vs. CMNF) comparisons, we created total family positive and negative KPI scores for the various verbal and nonverbal behaviors identified by the KPI system. A total positive KPI score for families consisted of the total amount of positive verbal and nonverbal KPI behaviors displayed by patients and relatives, summed across the two 10-min interactions. This positive score consisted of (a) verbal statements of self-disclosure, acceptance, agreement, and positive solutions to problems and (b) positive nonverbal behaviors such as smiles, head nods, a warm voice tone, or an open body posture. A total family negative KPI score was constructed in a similar manner and consisted of (a) verbal statements of criticism, justifications, disagreement, and negative solutions to problems and (b) nonverbal behaviors such as a disinterested expression, an angry voice tone, or a tense body posture. Scores were further decomposed into total

10 Page 10 of 19 verbal and total nonverbal positive and negative KPI scores. We did not compare the treatment groups on the frequency of neutral behaviors (e.g., simple descriptions of problems) because we had no specific hypotheses about changes in these behaviors after treatment. Data were analyzed at the family level (i.e., total positive and negative verbal and nonverbal KPI scores summed across patients and relatives) and at the individual level (i.e., patients and relatives separately) because we suspected that patients and relatives might have different responses to family or crisis management treatment. We adjusted the amount of positive and negative behavior displayed by families during the 1-year assessment by controlling for family KPI behavior during the pretreatment period. This adjustment was possible because the same relatives participated in the pretreatment and 1-year interactional assessments. Thus, each family served as its own control. There were 8 dual-relative families, 6 of whom were assigned to FFT. To calculate total KPI scores in the dual-relative families, we summed the two relatives' (e.g., mother and father) KPI scores and added them to the patients' scores. In single-relative families, the total family KPI scores consisted of the sum of the individual relative's scores and the patient's scores. 1 Dual-relative families had a higher number of total family (patient plus relatives) verbal KPI codes over the two pretreatment 10- min interactions than single-relative families, F (1, 42) = 9.23, p <.01. However, dual-relative families did not differ from single-relative families in their total amount of positive, t (1, 42) =.54, p >.10, or negative, t (1, 42) = 1.13, p >.10, verbal KPI behavior. Analysis of Attrition Effects There was differential attrition in the two treatment conditions. Of the original 79 cases (26 FFT, 53 CMNF), 15 participants assigned to CMNF and 1 assigned to FFT dropped out before the pretreatment family interactional assessment could be completed. Furthermore, 16 of the 19 families who did complete the pretreatment interactional assessment but who failed to complete the 1-year family assessment were in the CMNF condition, χ 2 (2, N = 79) = 13.49, p <.001. The families who did not complete the 1-year family assessment ( n = 19) did not differ from those who completed the 1-year assessment ( n = 44) on pretreatment levels of EE criticism, t (1, 61) = 1.05, p >.10; EE hostility, χ 2 (1, N = 63) = 1.24, p >.10; EE emotional overinvolvement ratings, t (1, 61) = 1.47, p >.10; pretreatment total family positive KPI scores, F (1, 55) = 0.05, p >.10; or pretreatment total family negative KPI scores, F (1, 55) = 0.74, p >.10 (pretreatment KPI coding was available on only 13 of the 19 families who did not complete the 1-year family assessment). In addition, there were no differences between the participants who did and did not complete the 1-year assessments on a number of demographic and illness variables, including patients' age, sex, socioeconomic status, years of education, type of family (parental, spousal, or other), age at onset of bipolar illness, years since the illness onset, or number of prior hospitalizations (for all, p >.10). Changes in Communication Behaviors There were no differences between families from the two treatment groups in the total amount of positive, F (1, 42) = 0.31, p >.10, or negative, F (1, 42) = 0.66, p >.10, verbal and nonverbal KPI behavior displayed during the pretreatment interactional assessment. However, at the 1-year reassessment (see Table 2 ), families who received FFT displayed more total positive KPI behavior than did families of patients who received CMNF, once pretreatment positive KPI scores were covaried, F (2, 41) = 5.15, p <.05. Both patients and relatives contributed to this group difference in positive behaviors at the 1-year assessment, F (2, 41) = 6.10, p <.02 for patients, and F (2, 41) = 3.15, p <.10 for relatives.

11 Page 11 of 19 Separate analyses for verbal and nonverbal KPI behaviors showed that families from the two treatment groups differed in the amount of positive nonverbal behavior, F (1, 41) = 5.47, p <.05, but not of positive verbal behavior, F (1, 41) = 2.49, p >.10, at the 1-year assessment, although differences in positive verbal behavior were in the expected direction. The significant group differences in positive nonverbal behavior after treatment characterized patient participants, F (1, 41) = 7.83, p <.01, and to a lesser extent, relatives, F (1, 41) = 2.93, p <.10. There were no differences between families who received FFT and those who received CMNF in total negative verbal and nonverbal behavior at the 1-year family interaction, F (1, 41) = 0.05, p >.10, once negative KPI verbal and nonverbal behaviors during the pretreatment interactional assessment were covaried. The total amount of negative family KPI behavior at the 1-year assessment was strongly accounted for by the amount of negative KPI behavior observed during the pretreatment assessment, F (1, 41) = 15.95, p <.001. Effects of Symptom Status and Pharmacotherapy Regimes We investigated whether the symptomatic status of patients could account for posttreatment differences in interactional behavior between the FFT and CMNF groups. For example, if patients in the FFT group were more hypomanic or less depressed than those in CMNF at the time of the 1-year assessment, we might observe more positively toned family interactions in the former group. We did not have a measure of patients' mood states on the day of the laboratory interactional assessments. However, we had collected data on patients' symptomatic states (using the SADS C) over the 3- month period leading up to and including the 1-year family assessment. When pretreatment positive family KPI scores and total scores from this SADS C assessment were covaried, the difference between the FFT and CMNF families on total positive (verbal plus nonverbal) family KPI scores remained significant, F (1, 40) = 4.34, p <.05. Second, we reasoned that patients who were more symptomatic at the time of the 1-year interactional assessment would also be on more complex medication regimens or perhaps might be less compliant with these regimes. When medication treatment intensity scores (see the Method section) at the time of the 1-year assessment and pretreatment positive family KPI scores were covaried, the difference between FFT and CMNF groups on posttreatment positive family KPI scores remained significant, F (1, 40) = 5.39, p <.05. Furthermore, there remained a significant main effect of treatment group when we included as covariates (a) mean pharmacotherapy intensity scores calculated over the full year of treatment and follow-up, F (1, 40) = 7.55, p <.01, and (b) mean medication compliance scores over the year of treatment and follow-up, F (1, 40) = 5.99, p <.02. Family Communication and EE In a previous examination of pretreatment data from this sample, we found that family EE status was closely associated with the amount of negative KPI behavior shown by families during the pretreatment interactional task ( Simoneau et al., 1998 ). Specifically, high-ee relatives expressed more negative KPI statements than low-ee relatives, whereas patients from high-ee families were more nonverbally negative and less nonverbally positive than patients from low-ee families. Because EE is an important predictor of family interactional behavior among the families of bipolar patients, we reasoned that it might also moderate the effects of family treatment on positive and negative KPI communication behaviors. We conducted two-way ANCOVAs, with treatment group and family EE status (high vs. low) as the independent variables, 1-year family KPI scores as the dependent

12 Page 12 of 19 variables, and pretreatment family KPI interactional behaviors as covariates. Pretreatment family EE status was unrelated to total family positive, F (1, 39) = 0.02, p >.10, or negative, F (1, 39) = 0.79, p >.10, KPI behaviors during problem-solving interactions at the 1-year family assessment. In addition, there was no interaction between the pretreatment EE status and treatment group in predicting posttreatment positive, F (1, 39) = 0.66, p >.10, or negative, F (1, 39) = 0.42, p >.10, family KPI behaviors. Family EE status assessed at 1-year was related to total family positive verbal and nonverbal interactional behavior during the 1-year assessment, F (1, 36) = 6.14, p <.05 (1-year EE data were missing on 3 families). However, the main effect of treatment condition on 1-year total family positive KPI scores remained significant when covarying family EE status at 1 year, F (1, 36) = 4.10, p =.05. Thus, treatment condition and EE independently contributed to the variance in positive family interactional behavior during the 1-year assessment. Family Treatment and Patients' Symptomatic Outcomes One of our core hypotheses was that family treatment would positively affect the symptomatic course of bipolar illness through improving the emotional tone of the family's ongoing face-to-face interactions. Because the effects of FFT were most pronounced on patients' positive nonverbal KPI behaviors, we examined in a multiple regression model whether improvements in these behaviors (calculated as a posttreatment pretreatment difference score) mediated any observed relationships between treatment condition and patients' symptomatic improvements. The dependent variable was a slope of SADS C total affective symptom scores (the sum of all mania and depression mood disorder items) obtained at intake into the study (the acute episode), at the pretreatment family laboratory assessment, and at 3-, 6-, 9- and 12-month follow-ups. More negative slope scores indicated greater clinical improvement from intake into the study until the end of the year of treatment. The simple relationship between treatment condition and the SADS C slope scores was significant, β =.32, t (1, 42) = 2.2, p <.05; R 2 =.10, suggesting that patients in FFT showed greater improvements in mood disorder symptoms over the year of treatment than patients in CMNF showed. The simple relationship between treatment condition and patients' positive nonverbal difference (posttreatment pretreatment) scores was also significant, β =.31, t (1, 42) = 2.10, p <.05; R 2 =.095. Finally, the simple relationship between patients' positive nonverbal difference scores and the slope of mood disorder symptom scores over 1 year was significant, β =.36, t (1, 42) = 2.51, p <.02; R 2 =.13. Patients who became more nonverbally positive over the year of treatment showed greater symptomatic improvements (i.e., more negative slope of symptom scores). In a model in which treatment condition and patients' nonverbal change scores were entered as predictors of symptom slopes (see Figure 1 ), treatment condition lost its predictive strength, β =.23, t (1, 41) = 1.56, p =.13, whereas patients' positive nonverbal difference scores continued to predict patients' symptoms, to an extent that approached but did not reach statistical significance, β =.29, t (1, 41) = 1.95, p =.058. The overall model with both predictors included was statistically reliable, F (2, 41) = 4.48, p <.02; R 2 =.18. Thus, there was partial evidence for a mediational model in which FFT predicted improvements in patients' nonverbal engagement in interactions with spouses or parents, which in turn predicted the degree of symptomatic improvement in patients during the year of treatment.

13 Page 13 of 19 Discussion This study examined changes in the face-to-face verbal and nonverbal interactional behavior of bipolar patients and their family members following a 9-month family psychoeducational program (FFT). Bipolar patients with a recent, acute episode of their disorder were randomly assigned to receive FFT with pharmacological maintenance or CMNF, a crisis management intervention, also delivered with pharmacotherapy. Prior to treatment, there were no differences between the two treatment groups in the amount of positive and negative verbal and nonverbal behavior displayed by families (patients and their parents, spouse, or siblings) during laboratory problem-solving interactions. However, patients and relatives who received FFT showed a greater amount of positive interactional behavior following the year of treatment and follow-up than did patients and relatives in the CMNF condition, even when pretreatment levels of these behaviors were statistically controlled. A primary goal of FFT is to foster a greater acceptance of the syndrome of bipolar disorder among participants through the process of psychoeducation ( Miklowitz & Goldstein, 1997 ). FFT also uses a skills training model to enhance communication and problem-solving proficiency. Therapists emphasize the importance of clear and constructive verbal communication and nonverbal engagement (e.g., maintaining good eye contact, communicating appreciation through facial gestures). Thus, it is perhaps not surprising that patients and relatives who participated in FFT displayed more positive interactional behavior after treatment than untreated families did. Participants showed significant improvements in nonverbal but not verbal interactional behavior after family treatment. It may be that verbal communication patterns are more habitual in families and more difficult to modify through behavioral modeling or rehearsal, or that they change more slowly than the corresponding nonverbal behaviors. Gottman, Coan, Carrere, and Swanson (1998) have argued that couples who receive behavioral marital interventions generally do not adopt the types of verbal listening skills that are taught in these treatments (i.e., paraphrasing, validating feelings, summarizing feelings). However, they did find that among untreated, happy, stable couples, nonverbal listening behaviors (e.g., making eye contact) were more frequently displayed than were verbal listening behaviors. The most dramatic increases in positive nonverbal behaviors were seen among patients, and there was a direct relationship between increases in patients' nonverbal behavior and greater symptom improvement among these patients during the year of treatment. Moreover, there was evidence for a partial mediation model, in which increases in patients' positive nonverbal behaviors helped explain the relationships observed between participation in family treatment and the 1-year mood disorder outcomes of patients. Our results may suggest the importance of nonverbal engagement with others as an index of health or mood stability in this population. Possibly, promoting the use of nonverbal affiliative behaviors (e.g., making eye contact, leaning toward family members when speaking) should be a goal of psychoeducational interventions that are initiated with bipolar patients during the postepisode period. However, because of the design of the study, we could not fully disentangle whether family treatment led to improvements in patients' nonverbal interactional behaviors and, subsequently, improvement in patients' symptoms, or whether patients' symptomatic improvements led to more positively toned interactions between these patients and their relatives. Multiple, repeated assessments of family interactional behavior and, simultaneously, of patients' symptoms, would have made it possible to more fully address this issue. It is notable that, following treatment with FFT, relatives and patients did not show a decrease in

14 Page 14 of 19 negative communication behaviors. In fact, negative interactional behaviors were quite stable from the pretreatment to the 1-year assessments. Although negative behaviors are not directly targeted for change in the FFT model, our assumption had been that negative behaviors (e.g., criticisms of other family members) would be replaced by positive behaviors (e.g., statements of acceptance) or more adaptive communication skills (e.g., self-disclosures of feelings) after treatment. In contrast to our results, Doane, Goldstein, Miklowitz, and Falloon (1986) were able to detect reductions in the negative affective style behavior (e.g., criticisms of the patient; intrusive, "mind-reading" statements) of the relatives of schizophrenic patients only 3 months after the families began receiving behavioral family treatment, when compared with relatives whose offspring received individual supportive therapy and medication. A greater increase in positive problem-solving behavior was also noted in the family treatment group. Our failure to replicate Doane et al.'s (1986) findings regarding changes in negative interactional behavior may have occurred for any of several reasons. First, when observed in face-to-face interactions during the posthospital period, the parents of schizophrenic patients appear to be more verbally intrusive and critical toward their schizophrenic offspring and more likely to distance themselves nonverbally (e.g., lean away) from the patient, than the parents of bipolar patients ( Miklowitz et al., 1995 ; Simoneau, Miklowitz, Goldstein, Nuechterlein, & Richards, 1996 ). Because they may start from a higher pretreatment level of negativity, the families of schizophrenic patients may show greater improvements in levels of negative affective communication after family treatment than the families of bipolar patients. Second, the families in Doane et al.'s (1986) study were in the middle of the behavioral family treatment when they were assessed for changes in interactional behavior, which may have created certain demand characteristics on the families to show how much they had learned. The 3-month reassessments also took place when the behavioral treatment was most intense (weekly sessions), whereas in the present study we assessed families after treatment was completed. It remains to be seen whether longer-term decreases in negative interactional behavior or increases in positive interactional behavior can be accomplished through psychosocial treatment, or whether families or couples resume their earlier styles of responding after treatment is withdrawn. Our results regarding the effects of psychoeducational treatment on family interactional behaviors are consistent with the developing literature suggesting that positive and negative affect are not simply opposite ends of a continuum. Watson and others ( Feldman, 1995 ; Larsen & Diener, 1992 ; Watson & Clark, 1997 ; Watson & Tellegen, 1985 ) have argued for a two-factor model of emotion in which positive and negative affect are both unipolar dimensions. In this model, one end of each dimension represents high emotional arousal and the opposite end an absence of arousal or affective involvement. Furthermore, each dimension may be differentially correlated with various domains of individual or family functioning. For example, in the aforementioned study by Gottman et al. (1998), positive affect was the only predictor of marital stability and happiness in a 6-year follow-up of couples with stable marriages. Negative affect (i.e., anger, negative reciprocity) did not distinguish between stable and unstable marriages or happily or unhappily married couples. The results of both our study and Gottman et al.'s study underline the importance of considering positive and negative emotional expression separately in high-risk or intervention studies involving families or couples. This study had several limitations. First, only a subset of the patients (44 of 79, or 56%) and their family members completed their study-based treatments and the pretreatment and 1-year family interactional assessments. Moreover, it was more common for participants in the CMNF condition to drop out than for participants in the FFT condition. Beyond pharmacological management, CMNF

15 Page 15 of 19 provided only limited family education and case management, which may have provided an inadequate incentive for the participants to continue with the research follow-ups or family assessments. We have also observed that some bipolar patients and relatives agree to a psychosocial protocol in the midst of a crisis (i.e., during a hospitalization), but later see no need for the treatment once patients' symptoms begin to remit. Possibly, psychosocial treatments should be initiated during the height of the acute episode, when the motivation for outpatient treatment and follow-up may be highest among patients and their family members. We found no evidence that families who dropped out of the study were of lower conflict, or had less severely ill patient family members, than those who remained in the study. Families who dropped out did not have more positive or negative interactional styles or lower rates of EE during the pretreatment period than those who continued, and the patients in these families did not have more prior hospitalizations for bipolar disorder. Nonetheless, because of the problem of attrition, we cannot conclude that our results generalize to the larger population of bipolar patients and families who are eligible for psychosocial treatment protocols. Another limitation of the study was our failure to assess patients' mood states on the day of the pretreatment or 1-year family interactional assessments. Although we assessed patients' manic and depressive symptoms during the months leading up to and including the interactional assessments, these symptom measures do not fully characterize the day-to-day mood fluctuations of bipolar patients. Future investigations should include contemporaneous measures of mood states in both patient and family member participants to determine the degree to which these states affect the emotional tone of family interactions. The generalizability of the results is limited by two other issues. First, bipolar patients who have spouses or who are in close contact with family members represent only a portion of the total sample of bipolar patients. Many bipolar patients are unmarried, divorced, or alienated from their families due to the strain the symptoms of the illness can place on relationships. Second, even though the families generated the problems to be discussed during the family interactions, laboratory-based interactional assessments may or may not generate behavior samples that reflect a family's communication habits in the home setting. Because we compared a relatively intensive family treatment to a no-psychotherapy comparison group, we cannot address the "more is better" argument that it is simply the amount of therapist contact, rather than the type of contact, that brings about improvements in family communication over a 1-year course of treatment. It is indeed possible that some of the same treatment effects observed in this study could have been achieved with individual psychotherapy (in combination with medication maintenance) of comparable duration and frequency. Finally, this was a laboratory-based study, and it is unclear whether the same results would have been obtained in a community-based study with randomly selected therapists, different pharmacotherapy protocols, or a broader sample of patients. Clearly, psychosocial treatment research with bipolar patients is in its infancy, and both efficacy and effectiveness studies that address these issues are warranted. References American Psychiatric Association (1987). Diagnostic and statistical manual of mental disorders ((3rd ed., rev.). Washington, DC: Author) Bartko, J. J. & Carpenter, W. T. (1976). On the methods and theory of reliability. Journal of Nervous

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18 Page 18 of 19 W. A., Kane, J. M., Ninan, P. T., Frances, A., Jacobs, M., Lieberman, J. A., Mance, R., Simpson, G. M. & Woerner, M. G. (1997). Relapse and rehospitalization during maintenance treatment of schizophrenia: The effects of dose reduction and family treatment. Archives of General Psychiatry, 54, Simoneau, T. L., Miklowitz, D. J., Goldstein, M. J., Nuechterlein, K. H. & Richards, J. A. (1996). Nonverbal interactional behavior in the families of persons with schizophrenic and bipolar disorders. Family Process, 35, Simoneau, T. L., Miklowitz, D. J. & Saleem, R. (1998). Expressed emotion and interactional patterns in the families of bipolar patients. Journal of Abnormal Psychology, 107, Spitzer, R. L. & Endicott, J. (1978). Schedule for affective disorders and schizophrenia change version. (New York: State Psychiatric Institute) Spitzer, R. L., Williams, J. B., Gibbon, M. & First, M. B. (1988). Instruction manual for the Structured Clinical Interview for DSM III R. (New York: State Psychiatric Institute, Biometrics Research) Tarrier, N., Barrowclough, C., Vaughn, C., Bamrah, J. S., Porceddu, K., Watts, S. & Freeman, H. (1988). The community management of schizophrenia: A controlled trial of a behavioural intervention with families to reduce relapse. British Journal of Psychiatry, 153, Vaughn, C. E. & Leff, J. P. (1976). The influence of family and social factors on the course of psychiatric illness. British Journal of Psychiatry, 129, Watson, D. & Clark, L. A. (1997). Measurement and mismeasurement of mood: Recurrent and emergent issues. Journal of Personality Assessment, 68, Watson, D. & Tellegen, A. (1985). Toward a consensual structure of mood. Psychological Bulletin, 98, Watt, N. F. (1976). Two-factor index of social position: Amherst modification. (Unpublished manuscript) 1 Consistent with our prior work on family interaction in bipolar disorder ( Miklowitz et al., 1995 ), we chose to sum rather than average the relatives' scores in dual-relative families. If the codes had been averaged, the total KPI scores for the dual-relative families would have had twice as many patients' codes as relatives' codes. This discrepancy would have occurred because the KPI system requires that the user apply a patient code in between each relative's code in a continuous stream of interaction. Thus, the patients' KPI scores would have had an inordinate amount of influence on the total family KPI scores. Demographic and Illness Characteristics of 44 Patients With Bipolar Disorder