Brief Behavioral Therapy for Refractory Insomnia in Residual Depression: An Assessor-Blind, Randomized Controlled Trial

Objective: Insomnia often persists despite pharmacotherapy in depression and represents an obstacle to its full remission. This study aimed to investigate the added value of brief behavioral therapy for insomnia over treatment as usual (TAU) for residual depression and refractory insomnia.

Method: Thirty-seven outpatients (mean age of 50.5 years) were randomly assigned to TAU alone or TAU plus brief behavioral therapy for insomnia, consisting of 4 weekly 1-hour individual sessions. The Insomnia Severity Index (ISI) scores (primary outcome), sleep parameters, and GRID-Hamilton Depression Rating Scale (GRID-HAMD) scores were assessed by blind raters and remission rates for both insomnia and depression were collected at 4- and 8-week follow-ups. The patients were recruited from February 18, 2008, to April 9, 2009.

Results: Brief behavioral therapy for insomnia plus TAU resulted in significantly lower ISI scores than TAU alone at 8 weeks (P < .0005). The sleep efficiency for the combination was also significantly better than that for TAU alone (P = .015). Significant differences were observed in favor of the combination group on both the total GRID-HAMD scores (P = .013) and the GRID-HAMD scores after removing the 3 sleep items (P = .008). The combination treatment produced higher rates of remission than TAU alone, both in terms of insomnia (50% vs 0%), with a number needed to treat (NNT) of 2 (95% CI, 1-4), and in terms of depression (50% vs 6%), with an NNT of 2 (95% CI, 1-5).

Conclusions: In patients with residual depression and treatment refractory insomnia, adding brief behavioral therapy for insomnia to usual clinical care produced statistically significant and clinically substantive added benefits.

Trial Registration: clinicaltrials.gov Identifier: NCT00610259

J Clin Psychiatry

Submitted: March 21, 2010; accepted June 14, 2010.

Online ahead of print: March 8, 2011 (doi:10.4088/JCP.10m06130gry).

Corresponding author: Norio Watanabe, MD, PhD, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601 Japan ([email protected]).