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Augmenting usual care SSRIs with cognitive behavioral therapy for insomnia to improve depression outcomes in youth: Design of a randomized controlled efficacy-effectiveness trial.
- Source :
-
Contemporary clinical trials [Contemp Clin Trials] 2020 Apr; Vol. 91, pp. 105967. Date of Electronic Publication: 2020 Feb 28. - Publication Year :
- 2020
-
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.<br />Design: 2-arm randomized controlled efficacy-effectiveness trial.<br />Setting: A large non-profit health maintenance organization.<br />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.<br />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).<br />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.<br />Trial Registration: clinicaltrials.gov, NCT02290496, https://clinicaltrials.gov/ct2/show/NCT02290496.<br />Competing Interests: Declaration of competing interest Drs. Clarke, Sheppler, Rawlings, Dickerson and Leo report no competing interests. Ms. Firemark reports no competing interests.<br /> (Copyright © 2020 Elsevier Inc. All rights reserved.)
- Subjects :
- Adolescent
Child
Female
Humans
Male
Young Adult
Parents
Research Design
Sleep Hygiene
Trauma Severity Indices
Randomized Controlled Trials as Topic
Cognitive Behavioral Therapy methods
Depression etiology
Depression prevention & control
Selective Serotonin Reuptake Inhibitors administration & dosage
Selective Serotonin Reuptake Inhibitors adverse effects
Selective Serotonin Reuptake Inhibitors therapeutic use
Sleep Initiation and Maintenance Disorders complications
Sleep Initiation and Maintenance Disorders therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1559-2030
- Volume :
- 91
- Database :
- MEDLINE
- Journal :
- Contemporary clinical trials
- Publication Type :
- Academic Journal
- Accession number :
- 32114185
- Full Text :
- https://doi.org/10.1016/j.cct.2020.105967