Dose-response effects of cognitive-behavioral insomnia therapy: a randomized clinical trial.

SUBJECT OBJECTIVE: To determine the optimal number of therapist-guided Cognitive-Behavioral Insomnia Therapy (CBT) sessions required for treating primary sleep-maintenance insomnia. DESIGN AND SETTING: Randomized, parallel-group, clinical trial at a single academic medical center. Outpatient treatment lasted 8 weeks with final follow-up conducted at 6 months. PARTICIPANTS: 86 adults (43 women; mean age 55.4 +/- 9.7 years) with primary sleep-maintenance insomnia (nightly mean wake time after sleep onset [WASO] = 93.4 +/- 44.5 minutes). INTERVENTIONS: One (week 1), 2 (weeks 1 and 5), 4 (biweekly), or 8 (weekly) individual CBT sessions scheduled over an 8-week treatment phase, compared with an 8-week no-treatment waiting period (WL). MEASUREMENT: Sleep diary and actigraphy measures of total sleep time, onset latency, WASO, total wake time, and sleep efficiency, as well as questionnaire measures of global insomnia symptoms, sleep related self-efficacy, and mood. RESULTS: Statistical tests of subjective/objective sleep measures favored the 1- and 4-session CBT doses over the other CBT doses and WL control. However, comparisons of pretreatment data with data acquired at the 6-month follow-up showed only the 4-session group showed significant long-term improvements in objective wake time and sleep efficiency measures. Additionally, 58.3% of the patients receiving 4 CBT sessions met criteria for clinically significant improvement by the end of treatment compared to 43.8% of those receiving 1 CBT session, 22.2% of those provided 2 sessions, 35.3% of those receiving 8 sessions, and 9.1% of those in the control condition. CONCLUSION: Findings suggest that 4 individual, biweekly sessions represents the optimal dosing for the CBT intervention tested. Additional dose-response studies are warranted to test CBT models that contain additional treatment components or are delivered via group therapy.

Duke Scholars

Author Rodney Allan Radtke Neurology, Epilepsy and Sleep

Author Cynthia Jan Coffman Biostatistics & Bioinformatics, Division of Biostatistics