DEPRESSION-FOCUSED INTERVENTION FOR PREGNANT SMOKERS 1. Supplemental Material For Online Use Only

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1 DEPRESSION-FOCUSED INTERVENTION FOR PREGNANT SMOKERS 1 Supplemental Material For Online Use Only Effects of an Intensive Depression-Focused Intervention for Smoking Cessation in Pregnancy

2 DEPRESSION-FOCUSED INTERVENTION FOR PREGNANT SMOKERS 2 Treatment Fidelity The CBASP intervention was delivered by one of 5 Ph.D. level clinical psychologist postdoctoral fellows with zero to two years of post-degree experience. The HW intervention was delivered by the same Ph.D. level therapists, who delivered 49% of all HW sessions, and an additional 2 masters-level counselors with one to four years of post-degree experience, who delivered 51% of all HW sessions. CBASP therapists spent approximately 120 hours in training that included reading material, viewing videotaped CBASP sessions, role play and completion of 2 to 3 pilot cases. HW therapists spent approximately 40 hours in training that included reading materials, role play, viewing videotaped HW sessions, and completion of 2 to 3 pilot cases. The CBASP and HW supervisors viewed the majority of pilot case treatment sessions and rated therapists for adherence and competence and provided supervisory feedback. Before seeing study patients, CBASP and HW therapists were expected to achieve an overall competence rating of 3 (sufficient delivery) or 4 (good delivery) on the last 3 sessions of two of the pilot cases. Therapists followed treatment manuals in delivering both conditions. All treatment sessions were videotaped. The CBASP supervisor rated one randomly identified CBASP session a week for each therapist. The supervisor provided weekly supervision and feedback to CBASP therapists. Comparable assessments were carried out each week on two randomly selected HW sessions from two different therapists. Ratings were completed by an outside consultant who was a Ph.D. level clinical psychologist with experience in providing smoking cessation interventions, who was trained in the provision of ratings by the primary HW supervisor. Bi-monthly HW supervision was provided to the two masters-level HW therapists by two of the postdoctoral study therapists who achieved consistently high competence ratings of their delivery of HW.

3 DEPRESSION-FOCUSED INTERVENTION FOR PREGNANT SMOKERS 3 In line with recommendations presented by Waltz and colleagues.(waltz, Addis, Koerner, & Jacobson, 1993), adherence rating scales were constructed to include therapist behaviors that were outlined in the HW and CBASP treatment manuals. To ensure that the CBASP and HW treatments could be distinguished from each other, adherence ratings scales also included proscribed (prohibited) therapist behaviors. Therapists adherence was rated by indicating whether indicated interventions and proscribed behaviors were performed or not performed. Therapist behaviors were divided into four categories: a) essential and unique in the CBASP condition this category included each of the SA steps, CBASP interventions involving use of the therapeutic relationship, and assignment and discussion of CBASP homework. In the HW condition, this category included involving participants in choosing an HW topic, review of the association between the module content and smoking or stress, and didactic presentation of the module content. Fifty percent of CBASP therapist behaviors fell in this category versus 25% of HW therapist behaviors. The primary cause for the difference between groups was that HW therapists were allowed to spend up to 50% of therapist contact time chatting, an acceptable but not necessary therapist behavior (see item D below), while chatting was proscribed in the CBASP condition. b) essential but not unique for both the HW and CBASP conditions, this category included the behavioral and motivational smoking cessation counseling interventions and treatment termination procedures. Forty-nine percent of CBASP therapist behaviors fell in this category versus 58% of HW therapist behaviors. Differences between treatment groups were not significant; c) acceptable but not necessary for the CBASP condition this included therapist self disclosure. For the HW condition this included chit chat for less than 50% of total contact time and therapist self-disclosure. Less than 1% of CBASP therapist

4 DEPRESSION-FOCUSED INTERVENTION FOR PREGNANT SMOKERS 4 behaviors fell in this category versus 15% of HW therapist behaviors, and d) proscribed for the CBASP condition this included discussion of HW topics, discussion of clinical issues outside the CBASP scope, and off-topic general discussion ( chit chat ). For HW this included use of any CBASP intervention technique, lengthy follow-up of previous HW topics, HW homework, creation of a plan for implementing HW topics to address problems in participants everyday lives, discussion of clinical issues outside the HW scope, practice of behavioral techniques such as role-play, discussion of issues in the therapeutic relationship and chit chat for greater than 50% of contact time. Less than 1% of CBASP therapist behaviors fell in this category versus 1% of HW therapist behaviors. Global competence scales were constructed to rate overall level of therapist skill in delivering the behavioral and motivational smoking cessation treatment component, and the CBASP and HW treatment components. CBASP and HW therapists were also rated for competence in providing nonspecific therapeutic factors including rapport, control of session, tolerance of negative affect, empathy, and effective listening. There were no differences in competence between the HW and CBASP groups. Mean competence ratings for behavioral and motivational smoking cessation counseling on a scale of 1 (does not attempt intervention) to 4 (good use of behavioral counseling and motivational enhancement) were 3.9 (SD = 0.4) for CBASP and 3.8 (SD = 0.4) for HW. On the same 4 point scale, mean global CBASP competence ratings were 3.8 (SD = 0.5) and mean global HW competence ratings were 3.9 (SD = 0.4). Competence in provision of nonspecific factors was similar across treatment groups and ranged from 3.7 (SD = 0.7) for control of session to 4.3 (SD = 0.6) for effective listening. Participants completed a total of 1,052 CBASP therapy sessions, of which 97 (9.2%) were rated by the primary CBASP rater. Of those sessions that were reviewed by the CBASP

5 DEPRESSION-FOCUSED INTERVENTION FOR PREGNANT SMOKERS 5 primary rater, 8 (8%) were also reviewed by a trained secondary rater. Participants completed a total of 1,056 HW sessions, of which 104 (9.8%) were rated by the primary HW rater. Of these sessions, 10 (9%) were reviewed by a trained secondary rater. Statistical agreement of competence ratings between raters were compared and resulted in an overall Cohen s kappa (k)(landis & Koch, 1977) of 0.93 (95% CI= ), suggesting a high degree of agreement between raters. Participants attended an average of 8 (SD = 2.8) total therapy sessions of approximately 58 minutes (S D= 10.1) in length, with no significant differences in therapy dose between treatment groups. Seventy-eight percent of the sample completed at least 7 therapy sessions, 74% completed at least 8 therapy sessions, and 70% completed at least 9 therapy sessions. There were no between-group differences in treatment session attendance.

6 DEPRESSION-FOCUSED INTERVENTION FOR PREGNANT SMOKERS 6 Table 1 Adherence and Competence Measures Variable CBASP Mean (SD)/ freq w/in group (%) n = 128 HW Mean (SD)/ freq w/in group (%) n = 129 Total Mean (SD)/ freq (%) N = 257 Total Therapy Visits Attended 8.2 (2.8) 8.2 (2.8) 8.2 (2.8) Completed Therapy Visits (%) 7 or more 100 (78) 100 (78) 200 (78) 8 or more 97 (76) 94 (73) 191 (74) 9 or more 90 (70) 89 (69) 179 (70) Total Therapy Minutes Per Session 55.9 (11.1) 58.8 (8.9) 57.7 (10.1) Minutes in Behavioral Counseling Per Session 16.7 (7.5) 18.1 (7.6) 17.4 (7.6) Minutes in Other Counseling Per Session 39.9 (10.7) 40.8 (10.2) 40.4 (10.4) Total Sessions Rated by Primary Rater Total Sessions Rated by Secondary Rater (%) 8 (8) 10 (9) 18 (8) Global Competence Ratings (scale 1-4) Behavioral Counseling 3.9 (0.4) 3.8 (0.4) 3.8 (0.4) Other Counseling 3.8 (0.5) 3.9 (0.4) 3.9 (0.4) Non-Specific Factors Competence Ratings (scale 1-5) Rapport 4.2 (0.6) 4.1 (0.4) 4.2 (0.5) Therapist Control of Session 3.8 (0.5) 3.7 (0.7) 3.7 (0.6) Tolerance of Negative Affect 4.1 (0.5) 4.0 (0.3) 4.0 (0.4) Empathy 4.1 (0.6) 4.0 (0.2) 4.1 (0.5) Effective Listening 4.3 (0.6) 4.1 (0.3) 4.2 (0.5)

7 DEPRESSION-FOCUSED INTERVENTION FOR PREGNANT SMOKERS 7 Figure 1. Treatment by baseline CES-D by visit interaction for predicted CES-D scores, graphed by quartile, with baseline CES-D as covariate in the model. Raw baseline CES- D score within each quartile averaged: I (M=5.53, SD=2.87); II (M=13.11, SD=2.06); III (M=21.16, SD=3.44); and IV (M=35.08, SD=5.07). (a) CES-D Total Score HW, Q1 CBASP, Q1 Treatment Week Phone Call Months PP Time Point (b) CES-D Total Score HW, Q2 CBASP, Q2 Treatment Week Phone Call Months PP Time Point

8 DEPRESSION-FOCUSED INTERVENTION FOR PREGNANT SMOKERS 8 (c) CES-D Total Score HW, Q3 CBASP, Q3 Treatment Week Phone Call Months PP Time Point (d) CES-D Total Score HW, Q4 CBASP, Q4 Treatment Week Phone Call Months PP Time Point

9 DEPRESSION-FOCUSED INTERVENTION FOR PREGNANT SMOKERS 9 Figure 2. Treatment by visit interaction for predicted CES-D scores, with baseline CES-D as covariate in the model HW CBASP 12 CES-D Total Score Visit

10 DEPRESSION-FOCUSED INTERVENTION FOR PREGNANT SMOKERS 10 References Landis, J. R. & Koch, G. G. (1977). The measurement of observer agreement for categorical data. Biometrics, 33, Waltz, J., Addis, M. E., Koerner, K., & Jacobson, N. S. (1993). Testing the integrity of a psychotherapy protocol: Assessment of adherence and competence. Journal of Consulting and Clinical Psychology, 61,