Self-Help Treatment for Insomnia: a Randomized Controlled Trial

Transcription

1 INSOMNIA Self-Help Treatment for Insomnia: a Randomized Controlled Trial Charles M. Morin, PhD; Simon Beaulieu-Bonneau, MPs; Mélanie LeBlanc, MPs; Josée Savard, PhD Université Laval, Québec, Canada Study Objectives: Insomnia is a prevalent health complaint that often remains untreated. Several interventions are efficacious but they are not widely available. This study evaluated the efficacy of a self-help behavioral intervention for insomnia. Design: The study used a 2 (conditions; self-help treatment, no treatment control) 3 (assessments; pretreatment, posttreatment, 6-month followup) mixed factorial design. Setting: This study was part of a larger epidemiologic study conducted with a randomly selected sample of 2001 adults of the province of Quebec in Canada. Participants: One-hundred ninety-two adults (n = 127 women, 65 men; mean age, 46 years) with insomnia, selected from a larger communitybased epidemiologic sample, were randomly assigned to self-help treatment (n = 96) or no-treatment control (n = 96). Interventions: The self-help intervention included 6 educational booklets mailed weekly to participants and providing information about insomnia, healthy sleep practices, and behavioral sleep scheduling and cognitive strategies. Measurements and Results: Participants completed sleep diaries and questionnaires at pretreatment, posttreatment, and 6-month follow-up. Significant but modest improvements were obtained on subjective sleep parameters for treatment but not control participants. Treated participants averaged nightly gains of 21 minutes of sleep and a reduction of 20 minutes of wakefulness, with a corresponding increase of 4% in sleep efficiency. Improvements were also obtained on measures of insomnia severity (Insomnia Severity Index) and of sleep quality (Pittsburgh Sleep Quality Index), and those changes were maintained at follow-up. Conclusions: A self-help behavioral intervention was effective in alleviating a broad range of insomnia symptomatology in a community sample. Self-help may be a promising approach to make effective intervention more widely available. Keywords: Insomnia, sleep, sleep disorder, self-help, behavioral, treatment, intervention Citation: Morin CM; Beaulieu-Bonneau S; LeBlanc M et al. Self-help treatment for insomnia: A randomized controlled trial. SLEEP 2005;28(10): efficacy. Behavioral and educational interventions about healthy sleep practices and sleep scheduling represent a promising alternative approach to drugs for treating insomnia. There is increasing evidence that such nonpharmacologic interventions produce reliable and durable sleep improvements, with minimal adverse effects; are well accepted by consumers; and may actually be more cost effective than pharmacotherapy on a long-term basis However, such interventions for insomnia are still relatively unknown and underused by health-care practitioners.16 Important barriers to a more widespread use include the lack of information and poor dissemination of such interventions, the time and efforts required to implement behavioral changes, and their limited availability in the health-care system.16 There is a need to validate more readily accessible interventions in order to reach more individuals with insomnia, and self-help approaches represent a promising alternative to traditional practitioner-guided treatments. Several studies have evaluated the impact of self-help or minimal interventions for insomnia,17-23 using audiotape,20 videotape,22 television and radio,21 and the Internet23 as the main treatment mediums, along with complementary written material. Despite some variations in content across studies, the core components of most self-help interventions include (1) educational materials about sleep, insomnia, and good sleep hygiene practices; (2) behavioral recommendations about sleep scheduling; (3) relaxation; and (4) psychological methods for changing beliefs and attitudes about sleep. Overall, results from these studies have shown significant improvement in several sleep variables for self-help treatment conditions compared with control groups, with changes well maintained at 3-19,20 and 6-month follow-ups.18 One study found that self-help treatment with weekly telephone consultations yielded improvements comparable with those obtained with therapistguided individual or group treatment.18 Several variables were INTRODUCTION INSOMNIA IS A HIGHLY PREVALENT SLEEP COMPLAINT, WITH ABOUT ONE THIRD OF THE ADULT POPULATION REPORTING OCCASIONAL SLEEP DIFFICULTIES1 and 6% to 10% meeting criteria for an insomnia disorder.2-4 Insomnia is more frequent among women and the elderly, and it is often associated with comorbid medical or psychological conditions. Persistent insomnia also carries a significant burden for both the individual (eg, impaired daytime functioning, reduced quality of life, depression) and society (eg, health-care costs, reduced productivity).5,6 Despite the high prevalence and burden of insomnia, only a minority of individuals with sleep disturbances receive treatment. The first line of treatment usually involves self-medication with herbal or dietary supplements, over-the-counter sleep aids, or alcohol, although the risks and benefits of those products are not well documented.2,7-10 When professional help is sought, it is usually with a general practitioner, and a prescribed hypnotic medication is often the only proposed recommendation. Although sleep medications are efficacious for short-term use, their long-term use is associated with risks of adverse effects, tolerance, and dependence. In addition, there is very limited evidence of long-term Disclosure Statement This was not an industry supported study. Drs. Morin, Savard, Mr. BeaulieuBonneau, and Ms. LeBlanc have indicated no financial conflicts of interest. Submitted for publication February 2005 Accepted for publication May 2005 Address correspondence to: Charles M. Morin, PhD, École de psychologie, Université Laval, Québec, Canada, G1K 7P4; Tel: (418) ; Fax: (418) ; cmorin@psy.ulaval.ca 1319 Self-Help Treatment for Insomnia Morin et al

2 found to moderate treatment outcomes. For example, 1 study 17 found that treatment response was greater for younger persons relative to older ones, and another suggested that medication users obtained fewer benefits compared with nonusers. 20 Two studies showed that therapist guidance enhanced sleep improvements compared with self help-only conditions. 19,22 Despite these promising results, additional research is needed to further validate self-help interventions and to increase their applicability to a larger population. Indeed, all but 1 of the previous self-help studies 21 have recruited participants through media advertisements, introducing an important selection bias by reaching only those individuals who were willing to seek help and participate in a research study. Also, selection criteria were, for the most part, fairly restrictive, leading to an overrepresentation of individuals with severe and persistent insomnia, often without any significant medical or psychological condition, or utilization of medication. Yet, there is a significant number of people with insomnia who present with comorbidity, take medication to alleviate their symptoms, or both, without necessarily fulfilling all the diagnostic criteria for an insomnia syndrome. These individuals may still experience sleep difficulties severe enough to benefit from a self-help intervention, and they may actually represent a greater proportion of those seen in clinical practice than do those previously recruited for clinical trials. The objective of this study was to evaluate the efficacy of a minimal self-help behavioral intervention for insomnia, with a community-based sample of people presenting a broad range of insomnia symptomatology severity. METHODS Study Context and Sample Selection This treatment study was part of a larger epidemiologic study conducted with a randomly selected sample of 2001 adults who were French-speaking residents of the province of Quebec. 2 The larger study began with a telephone survey, and selection of the sample involved 2 procedures: (1) random digit dialing method, which generates geographically stratified phone numbers (including unlisted, confidential, cell-phone, and fax) and (2) the Kish method, 24 which was used to identify the individual to be interviewed in each household. These methods ensure that the sample is representative of the target population. At the conclusion of the telephone interview, participants were asked if they wanted to take part in the longitudinal phase of the study, which involved completion of 4 postal evaluations over a 24-month period. The first 1 was conducted one month after the telephone interview. The remaining 3 evaluations took part, respectively, 6, 12, and 24 months after the first 1. Questionnaires included in those evaluations were about sleep, physical and mental health, quality of life, anxiety, depression, personality, and stress management. Following each assessment (telephone survey, postal evaluations), participants were classified in 1 of 3 groups according to their sleep status: good sleepers, insomnia symptoms, and insomnia syndrome. The classification used an algorithm based on a combination of insomnia diagnostic criteria from the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition 4 and the International Classification of Diseases, 10 th Edition (ICD- 10), 25 and on the utilization of sleep-promoting products. Responses from a sleep survey and from the Insomnia Severity Index (ISI) 26 and the Pittsburgh Sleep Quality Index (PSQI) 27 were used to evaluate the presence or absence of the criteria. The 3 sleep-status subgroups were defined as follows. Insomnia syndrome: Participants in this subgroup presented all the diagnostic criteria for insomnia: (1) complaint of poor sleep quality or dissatisfaction regarding sleep; (2) symptoms of initial, maintenance, or late insomnia at least 3 nights per week; (3) presence of psychological distress or daytime impairment related to sleep difficulties; and (4) presence of the sleep difficulties for at least 1 month. If medication (prescribed or over-the-counter) was used as a sleep-promoting agent at least 3 nights per week, participants were automatically classified in the insomnia syndrome subgroup regardless of their sleep profile. Insomnia symptoms: Participants classified in this subgroup presented definite symptoms of insomnia (initial, maintenance, or late insomnia) at least 3 nights per week, without fulfilling all the insomnia diagnostic criteria (eg, dissatisfaction, daytime consequences, or duration). Also included in this subgroup were individuals dissatisfied with their sleep quality but without any insomnia symptom. Good sleepers: These participants were satisfied with their sleep, did not report any insomnia symptom, and did not use sleep-promoting products more than twice per week. Participants A total of 2001 participants completed the telephone interview, and 1467 of those (73.3%) accepted to take part in the longitudinal study. Of this number, 105 (7.2%) were excluded because they reported the presence of a sleep disorder other than insomnia, the only major exclusion criterion of the mother study. The first postal evaluation was mailed to 1362 participants. Of this number, 589 (43.2%) were randomly selected from the insomnia symptoms and syndrome subgroups (based on the telephone-interview assessment) and invited to participate in the treatment study. Of those, 333 participants expressed interest, and 221 returned the completed pretreatment measures. Inclusion criteria were (1) being aged 18 years and older, (2) being French-speaking residents of the province of Quebec, and (3) meeting insomnia symptoms or syndrome criteria at the telephone-interview assessment. Exclusion criteria were (1) working on a night shift (n = 19) and (2) reporting a diagnosed sleep disorder other than insomnia (n = 10). This last element was assessed by the question: Have you ever been diagnosed by a health-care professional with 1 of the following sleep disorders (insomnia, sleep apnea, hypersomnia, restless legs, periodic leg movements other?) Figure 1 illustrates participant flow in the study protocol. The final sample included 192 participants (32.6% of those who were invited to participate) who were randomly assigned to a self-help treatment or to a no-treatment control condition. A blind coding system provided by an independent person (biostatistician) was used for the randomization. There were 3 assessment periods: pretreatment, posttreatment, and a 6-month follow-up. The study used a 2 (condition, between-groups factor) 3 (assessments, within-group factor) mixed factorial design. For each evaluation point, all data available were analyzed according to an intent-to-treat paradigm. There were 20 dropouts at posttreatment and 25 at follow-up. Dropout rates were higher for the treatment than for the control group at posttreatment (13.5% vs 7.3%) and follow-up (15.6% vs 10.4%), but these differences were not significant (P >.05). Regarding the inclusion criterion for insomnia (criterion Self-Help Treatment for Insomnia Morin et al

3 96 Assigned to Self-Help Treatment Condition 83 Completed Posttreatment Assessment 81 Completed 6-Month Follow-up above), participants had to meet this criterion based on data obtained from the telephone interview. However, since the treatment study began about 6 months after the telephone interview, some participants experienced a change in their sleep status during that interval. Indeed, comparisons of telephone and postal evaluations revealed that about 50% of individuals had a different sleep status based on the algorithm previously described, including 32.8% of participants (n = 63) who were considered good sleepers at the baseline assessment of the treatment study. They were still randomly assigned and kept in the study because of the documented variability in the sleep patterns of individuals with insomnia and also because we were interested in evaluating whether treatment might prevent recurrence among those individuals who had experienced sleep difficulties in the recent past. Measures Sleep Diary 589 Assessed for Eligibility 397 Excluded 19 Working on a Night Shift 10 With Primary Sleep Disorder 1 Enrolling for Another Person 256 Declined to Enroll 111 Not Returning Baseline Measures 192 Randomized Figure 1 Participant Flow in the Study 96 Assigned to No-Treatment Control Condition 89 Completed Posttreatment Assessment 86 Completed 6-Month Follow-up Participants had to complete sleep diaries during 2 consecutive weeks for each evaluation period. The sleep diary 26 is the most commonly used self-monitoring tool and outcome measure in insomnia research. 28 The sleep diary is completed upon arising in the morning and includes entries for documenting napping, utilization of sleep aids, bedtime, lights-off time, sleep-onset latency, number and duration of awakenings during the night, number of times getting up during the night, wake-up time, rising time, feeling at awakening, and sleep quality. The latter 2 questions are answered on a 5-point Likert scale. Several sleep parameters can be derived from these data: sleep-onset latency, corresponding to the time taken to fall asleep after lights-off time; wake after sleeponset, which is the summation of the duration of all the awakenings between sleep onset and final wake-up time; early morning awakening, defined as the time awake between the last awakening and the rising time; total wake time, which is the summation of sleep-onset latency, wake after sleep onset, and early morning awakening; time spent in bed, defined as the difference between lights-off time and rising time; total sleep time, computed by subtracting total wake time from time spent in bed; sleep efficiency, which is the ratio of total sleep time divided by time spent in bed, multiplied by 100; and sleep quality, computed by calculating the average of the feeling at awakening and sleep-quality questions. Insomnia Severity Index The ISI 26 is a 7-item questionnaire assessing the severity of (1) sleep-onset, (2) sleep-maintenance, and (3) early morning awakening problems; (4) satisfaction regarding sleep; (5) perceived interference of sleep difficulties with daytime functioning; (6) noticeability of sleep problems by others; and (7) distress caused by the sleep difficulties. A 5-point Likert scale (0 = not at all, 4 = extremely) is used to rate each of these items, yielding to a total score ranging from 0 to 28. A higher score indicates more severe insomnia, within 4 severity categories: absence of insomnia (0-7), subthreshold insomnia symptoms (8-14), moderate insomnia (15-21), severe insomnia (22-28). The ISI has adequate psychometric properties and is sensitive to measure treatment outcome. 29 The French version of the questionnaire was used in this study. 30 This version has good internal consistency, test-retest reliability, and convergent validity (r = 0.65 when correlated with the sleep diary). Pittsburgh Sleep Quality Index The PSQI 27 is a 19-item questionnaire evaluating sleep quality and disturbances over a 1-month time interval. The first 4 items are open questions, whereas items 5 to 19 are rated on a 4-point Likert scale. Individual item scores yield 7 components: (1) subjective sleep quality, (2) sleep latency, (3) sleep duration, (4) habitual sleep efficiency, (5) sleep disturbances, (6) utilization of sleeping medication, and (7) daytime dysfunction. A total score, ranging from 0 to 21, is obtained by adding the 7 component scores. A score higher than 5 suggests poor sleep quality. Psychometric properties of the PSQI are adequate, with an insomnia diagnostic sensitivity of 89.6% and specificity of 86.5%. The validated French version, which has adequate psychometric properties, was used in this study. 30 Beck Depression Inventory II The Beck Depression Inventory II (BDI-II) is a commonly used questionnaire for the assessment of depressive symptoms. The French version was used in this study. 31 Its psychometric properties are well established. It contains 21 items rating depressive symptoms experienced during the past 2 weeks on a 4-point Likert scale. A total score is derived, ranging from 0 to 63, with a higher score suggesting a higher depressive symptomatology. State-Trait Anxiety Inventory The State-Trait Anxiety Inventory (STAI) 32 is a 2-part instrument assessing State (actual) and Trait (more stable trait) anxiety. Only the State part (STAI-State) was used in the present study; it includes 20 items rated on a 4-point Likert scale (1 = not at all, 4 = a lot). Participants have to answer how they relate to the statements at that precise moment. Psychometric properties of the STAI are well documented. 32 The validated French-Canadian adaptation was used in the present study. 33 Treatment Expectations, Evaluation, and Compliance A homemade questionnaire was designed to evaluate treatment expectations and satisfaction with the treatment materials. Compliance was also evaluated globally as the percentage (0%-100%) of the treatment booklet the participant reported having read. In 1321 Self-Help Treatment for Insomnia Morin et al

4 addition, there were questions asking how often (0 = never; 4 = always) participants complied with the following recommendations: (1) completing a daily sleep diary, (2) complying with a sleep window (restriction of time in bed), (3) reserving 1 hour for unwinding before bedtime, (4) going to bed only when sleepy, (5) leaving the bedroom when unable to fall asleep, (6) keeping a regular rising time, (7) reserving the bedroom for sleep, and (8) napping. Because these recommendations were introduced only in the second treatment booklet, compliance was measured from weeks 2 to 6. A global compliance percentage was obtained from the means of the weekly compliance scores. Two different methods were used to deal with missing data, including a conservative approach counting a missing questionnaire as a 0% compliance rate and a standard approach computing compliance percentages based only on available data. Self-Help Treatment The intervention consisted of 6 psychoeducational booklets, each covering a different core component of insomnia therapy. The booklets were mailed weekly over a 6-week period. Their content was similar to those used by Mimeault and Morin, 19 which were adapted from 6 chapters of the self-help book Relief From Insomnia. 34 Each booklet had approximately 15 pages and included case examples to illustrate the behavioral procedures and their rationale. The core component of each booklet included: (1) basic information about sleep and insomnia and about the selfmanagement approach; (2) sleep-scheduling strategies: going to bed only when sleepy, getting out of bed when unable to sleep, arising at the same time every morning, using the bed and bedroom for sleep only, restricting time in bed to the actual amount of sleep and, avoiding naps; (3) information about the risks and benefits of sleep aids and optional guidelines to reduce their usage among chronic users; (4) psychological guidelines to alter faulty beliefs and attitudes about sleeplessness; (5) basic sleep-hygiene principles about factors that may impede (eg, caffeine) or promote (eg, exercise) sleep; and (6) relapse prevention and maintenance of gains. 26,34 Participants were instructed to thoroughly read the treatment material and apply the recommended procedures. They were also instructed to complete the daily sleep diary included in each booklet to ensure that the restriction of time in bed was implemented properly. A toll-free telephone line was available for participants who needed additional information or guidance in understanding and implementing treatment recommendations. However, most questions received via the telephone line dealt with the logistic of the study rather than with treatment per se. Procedure Several demographic and clinical data about participants were collected in the first postal evaluation of the longitudinal study, 4 months prior to the pretreatment assessment of the present study. Pretreatment measures included 2 weeks of sleep diary, as well as a package of questionnaires, including the ISI, PSQI, BDI-II, STAI-State, and the questionnaire about treatment expectations, evaluation, and compliance. The same measures were mailed with the last booklet for posttreatment assessment, so that all outcomes measures were obtained within a 6- to 8-week interval from baseline assessment. Follow-up assessment was conducted 6 months later. Participants in both treatment and control groups who completed and returned the measures on time received a $25 monetary compensation for each evaluation. Throughout the duration of the study, there were no other contacts between the investigators and the participants. Statistical Analyses For all analyses, the α level of significance was set at.05. χ 2 Tests, t tests, and 1-way analyses of variance (ANOVAs) were conducted to evaluate pretreatment group equivalency (for conditions and for sleep-status subgroups). To evaluate treatment efficacy, mixed model analyses, with 1 between-groups factor (treatment condition: treatment, control) and 1 within-group factor (assessments: pretreatment, posttreatment, follow-up) were conducted and followed by simple-effects tests when the interaction was significant. The dependent variables were grouped in 2 subsets: (1) sleep-diary variables, ie, sleep-onset latency, wake after sleep onset, early morning awakening, total wake time, total sleep time, sleep efficiency, sleep quality, and weekly frequency of utilization of sleep aid (ie, prescribed and over-the-counter products) and (2) ancillary measures, ie, total scores of ISI, PSQI, STAI-State, and BDI-II. Effect sizes for the pretreatment to posttreatment differences were computed for both conditions with the Powpal software 35 based on t tests from simple effects. However, since this program computes only independent t tests, all effect-size estimates were divided by 2 to obtain accurate estimates for paired samples. Changes in sleep status (good sleepers, insomnia symptoms, insomnia syndrome) were examined to assess the clinical significance of sleep improvements. The McNemar test was used to determine if Pearson χ 2 reached significance, meaning that the distribution changed over time. Finally, compliance was correlated with changes on sleep parameters. RESULTS Demographic and Clinical Characteristics of the Sample Descriptive data of demographic and clinical variables are summarized in Table 1. The sample included 192 participants (127 women; 65 men) with a mean age of 46.0 years (SD = 14.8; range, 18-77). Most participants were married (53.1%) and fulltime workers (52.6%). Of all participants, 19.3% reported having used prescribed medication in the last 12 months, and 4.2% were regular users (> 3 nights/week) at the initial assessment. Mean insomnia duration was 7.85 years (SD = 10.24), and 48.4% of participants presented with mixed sleep-onset and maintenance insomnia. The χ 2 and t test analyses performed on demographic and clinical variables showed no significant difference between the treatment and control groups. The same analyses were conducted for dependent variables derived from sleep diaries and ancillary measures. For all variables, except for wake after sleep onset, which was significantly higher in the treatment group, t 190 = -2.10, P =.04, both conditions were equivalent at pretreatment. Sleep Status Subgroups Means and SD of selected sleep parameters for the 3 subgroups are shown in Table 2. As stated earlier, while all participants met criteria for insomnia symptoms (n = 71) or insomnia syndrome (n = 121) at the telephone interview, the sleep status of several participants changed from the initial telephone assessment to the 1322 Self-Help Treatment for Insomnia Morin et al

5 Table 1 Demographic and Clinical Characteristics of the Study Participants Mean (SD) Treatment Control Total n = 96 n = 96 N = 192 age, y (15.39) (14.25) (14.79) Sex Women Men Education, y Marital status Married/Common-law Single Divorced/Separated Widowed Main occupation Working full-time Working part-time Student Retired Other Annual family income, in 1000 $Can < > Utilization of prescribed medication, /wk None < > Use of over-the-counter or natural products, /wk None < > Mean (SD) insomnia 7.70 (9.90) 8.02 (10.67) 7.85 (10.24) duration, y* Insomnia subtype Initial Middle Terminal Mixed Data are presented as percentages unless otherwise noted. Percentages do not necessarily add up to 100% due to missing data. *Means and SD are calculated on participants who reported a duration of insomnia of more than 0 months (n = 140). Table 2 Pretreatment Sleep Variables for the Sleep Status Subgroups Sleep variables Good Insomnia Insomnia Sleepers Symptoms Syndrome n = 63 n = 81 n = 48 Total wake time, (28.06) (38.75) (53.31) min Total sleep time, (56.60) (51.70) (75.30) min Sleep efficiency, % (5.50) (7.12) (10.87) Sleep quality, 3.59 (.65) 3.35 (.62) 3.00 (.56) 1-5 rating ISI score 6.63 (4.12) 9.72 (3.86) (4.30) PSQI score 4.35 (1.75) 6.17 (2.01) 9.67 (3.26) Data are presented as mean (SD). All means in the same row differ at P <.05. ISI refers to Insomnia Severity Index; PSQI, Pittsburgh Sleep Quality Index. baseline evaluation. Of the 192 participants, 63 were considered good sleepers (treatment, n = 28; control, n = 35), 81 were in the insomnia symptoms subgroup (treatment, n = 40; control, n = 41), and 48 were classified as insomnia syndrome (treatment, n = 28; control, n = 20). The distribution of participants from the sleep-status subgroups was equivalent in the treatment and control conditions. One-way ANOVAs and posthoc comparisons revealed that the 3 subgroups were significantly different from each other on baseline levels of total wake time, total sleep time, sleep efficiency, sleep quality, and ISI and PSQI scores. For all variables, good sleepers had better sleep parameters than did individuals with insomnia symptoms, who in turn slept better than the insomnia syndrome subgroup. Treatment Efficacy Sleep Diary Variables Means and 95% confidence intervals for each condition on sleep-diary variables at each assessment period are shown in Table 3. No significant group effect was found. There was a significant time effect for 5 of the 8 variables: wake after sleep onset, F 2,335 = 7.98, P <.001, total wake time, F 2,329 = 9.57, P <.001, total sleep time, F 2,328 = 6.87, P =.001, sleep efficiency, F 2,327 = 12.23, P <.001, and sleep quality, F 2,331 = 5.10, P =.007. A significant group time interaction was found for wake after sleep onset, F 2,335 = 5.92, P =.003, total wake time, F 2,329 = 18.69, P <.001, total sleep time, F 2,328 = 5.57, P =.034, and sleep efficiency, F 2,327 = 9.92, P <.001. No significant interaction effect was obtained for sleep-onset latency, early morning awakening, sleep quality, and weekly frequency of utilization of sleep aid. For variables with a significant interaction effect, simple effects analyses revealed significant differences for the treatment group between pretreatment and posttreatment, and between pretreatment and follow-up (for all tests, P <.001), whereas the control group did not change across assessments. The significant differences were all in the expected direction, with sleep improvements occurring for the treatment group. Ancillary Measures Means and 95% confidence intervals for each condition on ancillary measures at each assessment period are shown in Table 4. Mixed-model analyses showed no significant group effect; however, a significant time effect was obtained for all 4 ancillary measures: ISI score, F 2,337 = 16.04, P <.001, PSQI score, F 2,342 = 4.10, P =.017, STAI-State score, F 2,358 = 13.83, P <.001, and BDI-II score, F 2,355 = 8.55, P <.001. A significant group time interaction effect was found for the ISI, F 2,337 = 4.06, P =.018, and PSQI, F 2,342 = 7.98, P <.001, but not for the STAI-State and the BDI-II. Simple-effects tests for the ISI and PSQI scores revealed significant changes for the treatment group between pretreatment and posttreatment and between pretreatment and 1323 Self-Help Treatment for Insomnia Morin et al

6 Table 3 Sleep Diary Variables Condition Pretreatment Posttreatment 6-Month Follow-up Effect size Sleep-onset latency, min Treatment ( ) ( ) ( ).16 Control ( ) ( ) ( ).02 Wake after sleep-onset, min Treatment ( ) ( ) ( ).26 Control ( ) ( ) ( ).04 Early morning awakening, min Treatment ( ) ( ) ( ).15 Control ( ) ( ) ( ).01 Total wake time, min Treatment ( ) ( ) ( ).30 Control ( ) ( ) ( ).03 Total sleep time, min Treatment ( ) ( ) ( ).23 Control ( ) ( ) ( ).05 Sleep efficiency, % Treatment ( ) ( ) ( ).33 Control ( ) ( ) ( ).04 Sleep quality, on a scale of 1-5 Treatment 3.32 ( ) 3.48 ( ) 3.36 ( ).15 Control 3.36 ( ) 3.46 ( ) 3.43 ( ).10 Weekly frequency of utilization of sleep aid, 0-7 nights Treatment.88 ( ).60 ( ).58 ( ).10 Control.90 ( ).83 ( ).86 ( ).03 Data are presented as means (95% confidence intervals). Effect sizes were computed for the difference between pretreatment and posttreatment (Cohen s d). Table 4 Ancillary Measures Condition Pretreatment Posttreatment 6-Month Follow-up Effect size Insomnia Severity Index Treatment 9.63 ( ) 8.08 ( ) 7.02 ( ).19 Control 9.70 ( ) 9.33 ( ) 8.81 ( ).05 Pittsburgh Sleep Quality Index Treatment 6.58 ( ) 5.38 ( ) 5.28 ( ).21 Control 6.31 ( ) 6.62 ( ) 6.44 ( ).06 Beck Depression Inventory Treatment ( ) 6.67 ( ) ( ).16 Control 9.50 ( ) 6.80 ( ) 8.78 ( ).13 State Trait Anxiety Inventory-State Treatment ( ) ( ) ( ).18 Control ( ) ( ) ( ).17 Data are presented as means (95% confidence intervals). Effect sizes were computed for the difference between pretreatment and posttreatment (Cohen s d). follow-up (P values <.001). The 2 groups were significantly different at follow-up (P values <.02), with treatment showing lower scores than control subjects. Moreover, there were significant differences in ISI scores for the treatment group between posttreatment and follow-up (P =.021) and in PSQI scores between the 2 conditions at posttreatment (P =.007). The differences for sleep-related parameters (ISI, PSQI) were in the expected direction, with sleep improvements occurring for the treatment group from pretreatment to posttreatment and from posttreatment to follow-up. Anxiety (STAI-State) and depression (BDI-II) scores decreased between pretreatment and posttreatment but came back to the pretreatment levels at follow-up for both conditions. Effect Sizes Effect sizes were calculated for simple-effects tests to compare the time effect from pretreatment to posttreatment between the 2 conditions. They are shown in Tables 3 and 4. For the 8 parameters derived from the sleep diary, effect sizes ranged from Cohen s d =.10 (weekly frequency of utilization of sleep aid) to d =.33 (sleep efficiency) for the treatment group and from d =.01 (early morning awakening) to d =.10 (sleep quality) for the control group. Four effect sizes were greater than 0.20 for the treatment group, which is above the typical cut-off score for defining a small effect, compared with none for the control group. For the sleep-related ancillary measures (ISI, PSQI), the same pattern was observed with effect sizes for treatment being 1324 Self-Help Treatment for Insomnia Morin et al

7 % Pretreatment (n=96) Posttreatment (n=80) greater than those of the control group. Both conditions produced small and equivalent effect sizes for the BDI-II and STAI-State (d =.13 to d =.18). Treatment Response Among Different Sleep Subgroups Mixed-model analyses using sleep-status subgroup as an additional factor were computed to examine whether treatment response varied as a function of insomnia severity (ie, sleep-status subgroups). There was no significant interaction between sleep status (good sleepers, insomnia symptoms, insomnia syndrome), conditions (treatment, control), and assessment (pretreatment, posttreatment, follow-up) on any of the dependent sleep variables. As expected, however, there was evidence that, within the treatment condition, participants with an insomnia syndrome showed greater improvement rates (eg, +6.2% on sleep efficiency) relative to participants in the insomnia symptoms (+3.7%) and good sleepers (+2.2%) subgroups. Clinical Significance Six-month Follow-up (n=78) Figure 2 shows the percentages of participants in each sleep subgroup (good sleepers, insomnia symptoms, insomnia syndrome) for the 3 assessment phases. To assess the clinical significance of changes observed with treatment, the number of participants falling in each subgroup from pretreatment to posttreatment and from posttreatment to follow-up was computed for the treatment and control groups separately. Only the data from participants who completed both assessments were used for these comparisons. According to the McNemar test, the sleep-status distribution changed significantly from pretreatment to posttreatment for the treatment group, χ 2 (4, N = 80) = 20.44, P =.001, but not for the control group, χ 2 (4, N = 87) = 27.34, P =.349. The majority of the participants were classified in the same subgroup at both assessments, ie, 51.3% (41 out of 80) in the treatment group and 52.9% (46 out of 87) in the control group. There were more treated than control participants (37.5% vs 27.6%) whose sleep status changed in the improved direction from baseline to posttreatment. From posttreatment to followup, the distribution of sleep status remained unchanged for both conditions Pretreatment (n=96) Assessments Posttreatment (n=87) Six-month Follow-up (n=85) Insomnia syndrome Insomnia symptoms Good sleepers Figure 2 Percentages of participants in each sleep subgroup across assessment phases Treatment Evaluation When asked to judge which booklet was the most useful, 45.8% of treated participants found the second booklet, which described behavioral scheduling strategies, to be the most useful, whereas 34.4% considered the fourth booklet, about cognitive restructuring, the most useful. The first component presenting general information about sleep, insomnia, and the self-help approach was found most useful by 30.2%, sleep hygiene by 21.9%, relapse prevention by 10.4%, and information about medication by 7.3%. Twelve participants reported using the optional tapering program in the third treatment booklet, but only 1 completed the program at posttreatment while 2 had abandoned it. Finally, no significant differences were found among the 6 booklets with regard to their general quality. Treatment Compliance Depending on the treatment week, between 20 and 33 of the 96 treated participants failed to return at least 1 of the compliance questionnaires, and 13 participants (13.5%) did not return any of the 6 questionnaires. Twenty-six participants (27.1%) reported to have read all booklets completely, while 51 (53.1%) read all booklets partially. For each individual booklet, between 61 (booklet #4) and 75 (booklet #1) participants partially read the material. These descriptive results suggest that a significant proportion of participants did not completely read the material and, therefore, could not comply diligently with the treatment recommendations. Before calculating percentages for global compliance, the 5 weekly compliance scores (weeks 2 to 6) were compared to determine if there was a time effect over the course of treatment. Because no time effect was obtained, global compliance percentages were computed for the 5 weekly scores combined. Mean conservative compliance estimate for all booklets was 43.1% (SD = 27.0%; range, 0%-95%), and mean standard compliance estimate was 61.8% (SD = 12.6%; range, 31.3%-95.0%), suggesting that the true compliance rate fell between those 2 scores. Compliance ratings for treatment procedures were particularly low for 2 of them, namely establishing a sleep window (conservative, 27.3%; standard, 40.0%) and leaving the bedroom when unable to fall asleep (conservative, 16.4%; standard, 23.3%). Finally, global compliance scores were correlated with changes in sleep efficiency from pretreatment to posttreatment to determine if there was a relationship between the 2 variables. Pearson correlation coefficients were not significant for either the conservative compliance estimate, r(77) = -.06, P =.63, or the standard estimate, r(67) =.01, P =.92. DISCUSSION The findings suggest that a self-help behavioral intervention is effective in alleviating insomnia. Treated participants improved on all the main sleep parameters, including subjective sleep quality, whereas control subjects did not. Changes were well maintained at the 6-month follow-up, suggesting that self-help treatment can produce durable sleep improvements. Although statistically significant results were obtained for most outcome variables, the clinical magnitude of improvements was fairly modest, as evidenced by an average increase of 21 minutes of sleep, a reduction of 20 minutes in wakefulness, and a corresponding increase of 1325 Self-Help Treatment for Insomnia Morin et al

8 4% in sleep efficiency. These results are consistent with those found in previous selfhelp intervention studies. The magnitude of changes was greater in some of the past studies 19,21,23 than those reported here, but no study used as minimal an intervention as the one used in the current study. Moreover, effect sizes in the present study were higher for treated subjects than for controls, with 4 sleep parameters exceeding what is typically considered a small effect size (ie, d = 0.2), 36 compared with none for the control group. Despite this slight advantage for self-help treatment, such an improvement rate is smaller than that obtained with therapist-guided intervention. 11 These smaller gains may be due to the milder insomnia severity 37 and less-potent intervention in the current study. These results suggest a note of caution in that self-help treatment may not be indicated or recommended for all patients with insomnia. An important objective of this study was to simulate a typical minimal intervention received by individuals who would buy a self-help book about behavioral treatment for insomnia. Because we were interested in maximizing generalizability, selection criteria were liberal, which yielded a heterogeneous sample ranging from individuals with relatively normal sleep to participants with an insomnia syndrome, some of whom may have presented with significant medical or psychiatric comorbidity. While this might partly explain the smaller improvement rates, it may also be more representative of the wide range of insomnia severity in the general population and among those seeking treatment. In addition, despite a floor effect in treatment response among those with very mild insomnia, one could argue that these individuals may be better prepared to face future episodes of insomnia. Additional longitudinal research would be useful to evaluate whether such a large community-based self-help or educational sleep intervention may prevent the development of more-severe insomnia among atrisk individuals. Assessment of treatment compliance revealed that only 27.1% of the treated participants reported reading all the materials, whereas compliance rates with the main treatment procedures were estimated to be between 43.1% and 61.8%. Although comparisons with previous studies are difficult because few studies have evaluated this issue, a meta-analysis of self-help treatment 38 found that effect sizes of studies reporting 75% to 100% compliance were more than 3 times greater than those studies reporting less than 75% compliance. It is plausible then that additional social support, feedback, and reinforcement throughout the intervention, perhaps through telephone consultations, could improve both compliance and outcomes. Additional research is needed to validate this hypothesis. Participants rated all 6 booklets as of equal quality, and the booklet about the behavioral sleep-scheduling strategies (sleep restriction, stimulus control) was considered the most useful by 45.8% of the treatment group. Interestingly, compliance was particularly low for the sleep-restriction procedure, a procedure that has been found to be the best predictor of sleep improvement in 2 39, 40 previous studies. There are several limitations to this study. First, as in most self-help treatment studies, outcomes were based on self-reported data. Although polysomnographic data could have yielded more objective and reliable data, such an assessment is not readily available and does not fit well with a minimal intervention paradigm. Second, because there was no independent rating of treatment compliance, it is difficult to determine to what extent outcome was moderated by compliance, efficacy, or both. Third, while the liberal inclusion criteria may have yielded a more representative sample, it is probable that some participants included in the study presented with comorbid disorders (sleep, medical, psychiatric conditions), which may have attenuated the true impact of this self-help intervention. A more systematic evaluation of those comorbid conditions would have been useful to examine moderating factors of outcome. The present findings suggest that a minimal intervention can be helpful in alleviating insomnia in a heterogeneous community-based sample. Although professional and therapist guidance may be necessary in patients with severe insomnia and comorbid medical or psychiatric conditions, such professional support is not always readily available. Self-help interventions are more widely available and may prove to be more cost effective in the long term. 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