Cognitive Behavioral Therapy for Patients with Primary Insomnia or Insomnia Associated Predominantly with Mixed Psychiatric Disorders: a Randomized Clinical Trial

Objective: This study was conducted to evaluate the efficacy of cognitive behavioral therapy (CBT) against a sleep hygiene education control therapy in patients with primary or comorbid insomnia. Design and Setting: Randomized, parallel-group, clinical trial conducted at a single Veterans Affairs medical center, with recruitment from March 2001 to June 2005. Participants: Eighty-one adults (n = 11 women; mean age, 54.2 years) with chronic primary (n = 40) or comorbid insomnia associated predominantly with mixed psychiatric disorders (n = 41). Interventions: Patients, screened via structured interviews and diagnostic polysomnography, were randomly assigned to receive CBT (sleep education, stimulus control, and time-in-bed restrictions, 20 patients with primary and 21 with comorbid insomnia), or sleep hygiene (SH: education about aspects of lifestyle and the bedroom environment that affect sleep; 20 patients with primary and 20 with comorbid insomnia). Outpatient treatment included 4 biweekly sessions with a post-treatment assessment and a follow-up conducted at 6 months. Measures and Results: Participants completed actigraphy and sleep diaries for 2 weeks prior to therapy, during a 2-week posttreatment assessment, and during 2 weeks at follow-up. They also completed questionnaires measuring global insomnia symptoms, general sleep quality, and sleep-disruptive beliefs before treatment, immediately following treatment, and at the follow-up time point. Consistent with previous studies, CBT outperformed sleep hygiene across several study outcome measures for the sample as a whole. Statistical analyses showed no significant 3-way interaction of treatment group, time, and insomnia type for any of the sleep or questionnaire measures, suggesting the benefits of CBT over sleep hygiene were comparable for patients with primary insomnia and comorbid insomnia. Moreover, only 1 of several indexes of clinically notable improvement suggested a significantly better response to CBT by patients with primary insomnia, as compared with those with comorbid insomnia. Conclusions: A fixed 4-session dose of CBT produced similar benefits for patients with primary and those with comorbid insomnia across most measures examined. Thus, CBT appears to be a viable psychological insomnia therapy both for those with primary insomnia and for groups composed mainly of patients with insomnia and nonpsychotic psychiatric conditions.