A two-phase, prescriptive comparative effectiveness study to optimize the treatment of co-occurring insomnia and depression with digital interventions

Abstract

BackgroundInsomnia and depression frequently co-occur. Significant barriers preclude a majority of patients from receiving first line treatments for both disorders in a sequential treatment episode. Although digital versions of cognitive behavioral therapy for insomnia (CBTI) and for depression (CBTD) hold some promise to meet demand, especially when paired with human support, it is unknown whether heterogeneity of treatment effects exist, such that some patients would be optimally treated with single or sequential interventions. ObjectiveDescribe the protocol for a two-phase, prescriptive comparative effectiveness study to develop and evaluate an individualized intervention rule (IIR) for prescribing the optimal digital treament of co-occurring insomnia and depression. MethodsThe proposed sample size is 2300 U.S. military veterans with insomnia and depression recruited nationally (Phase 1 = 1500; Phase 2 = 800). In each phase, the primary endpoint will be remission of both depression and insomnia 3 months following a 12-week intervention period. Phase 1 is a 5-arm randomized trial: two single digital interventions (CBT-I or CBT-D); two sequenced interventions (CBT-I + D or CBT-D + I); and a mood monitoring control condition. A cutting-edge ensemble machine learning method will be used to develop the IIR. Phase 2 will evaluate the IIR by randomizing participants with equal allocation to either the IIR predicted optimal intervention for that individual or by randomization to one the four CBT interventions. ResultsStudy procedures are ongoing. Results will be reported in future manuscripts. ConclusionThe study will generate evidence on the optimal scalable approach to treat co-occurring insomnia and depression.