Augmenting usual care SSRIs with cognitive behavioral therapy for insomnia to improve depression outcomes in youth: Design of a randomized controlled efficacy-effectiveness trial

Abstract

Importance: Extant treatments for youth depression are only modestly effective. Alternative approaches are needed to improve health outcomes. A novel approach to improve depression outcomes is suggested by epidemiological studies finding that insomnia often predates and may contribute to depression risk. We test whether treating insomnia among youth starting a new course of SSRI antidepressants improves depression outcomes. This paper describes our study design.

Design: 2-arm randomized controlled efficacy-effectiveness trial.

Setting: A large non-profit health maintenance organization.

Participants: 165 adolescents aged 12-19 with research-confirmed depression and insomnia diagnoses, starting a new episode of selective serotonin reuptake inhibitor (SSRI) antidepressant treatment prescribed by their usual care provider.

Interventions: Two sleep interventions, each 6-7 sessions, both overlaying "treatment as usual" (TAU) SSRIs: a sleep hygiene (SH) attention control condition, and cognitive-behavioral therapy for insomnia (CBTI).

Conclusions and relevance: If CBT-I improved sleep is shown to improve depression-related outcomes, this may provide an additional, easily tolerated intervention for an important public health target.

Trial registration: clinicaltrials.gov, NCT02290496, https://ichgcp.net/clinical-trials-registry/NCT02290496.

Keywords: Adolescent; Cognitive-behavioral therapy; Depression; Insomnia; Sleep hygiene; Trial.

Conflict of interest statement

Declaration of competing interest Drs. Clarke, Sheppler, Rawlings, Dickerson and Leo report no competing interests. Ms. Firemark reports no competing interests.

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