Greg Clarke1, Christina R Sheppler2, Alison J Firemark3, Andreea M Rawlings4, John F Dickerson5, Michael C Leo6. 1. Kaiser Permanente Northwest, Center for Health Research, 3800 N Interstate Ave, Portland, OR 97227, USA. Electronic address: Greg.Clarke@kpchr.org. 2. Kaiser Permanente Northwest, Center for Health Research, 3800 N Interstate Ave, Portland, OR 97227, USA. Electronic address: Christina.R.Sheppler@kpchr.org. 3. Kaiser Permanente Northwest, Center for Health Research, 3800 N Interstate Ave, Portland, OR 97227, USA. Electronic address: Alison.J.Firemark@kpchr.org. 4. Kaiser Permanente Northwest, Center for Health Research, 3800 N Interstate Ave, Portland, OR 97227, USA. Electronic address: Andreea.M.Rawlings@kpchr.org. 5. Kaiser Permanente Northwest, Center for Health Research, 3800 N Interstate Ave, Portland, OR 97227, USA. Electronic address: John.F.Dickerson@kpchr.org. 6. Kaiser Permanente Northwest, Center for Health Research, 3800 N Interstate Ave, Portland, OR 97227, USA. Electronic address: Michael.C.Leo@kpchr.org.
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://clinicaltrials.gov/ct2/show/NCT02290496.
RCT Entities:
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://clinicaltrials.gov/ct2/show/NCT02290496.