Digital CBT for Insomnia and Depression
Optimizing Digital Behavioral Treatment for Co-occurring Insomnia and Depression
University of Rochester
1,500 participants
May 1, 2023
INTERVENTIONAL
Conditions
Summary
This study has two primary objectives, each of which addresses critical clinical and research gaps for individuals who have co-occurring insomnia and depression. The first objective is to address whether sequential treatment of insomnia and depression is superior to a single treatment for either depression or for insomnia, and if so, which treatment sequence is optimal. The second objective is to determine if there are heterogeneity of treatment effects; that is, variation in which interventions are best for which individuals, and if so, to develop and individualized intervention rule to better match individuals with the treatment that is most likely to lead to the best outcomes. A large randomized trial will be conducted to meet these objectives.
Eligibility
Inclusion Criteria4
- English-speaking
- U.S. Military Veterans
- endorse depression (Patient Health Questionnaire-depression score \> 10)
- endorse insomnia (Insomnia Severity Index score \> 10).
Exclusion Criteria5
- pregnancy
- history of bipolar disorder
- history of psychosis
- current use of anti-psychotic medications or mood stabilizers (e.g., lithium)
- current suicidal ideation with active intent
Interventions
Cognitive Behavioral Therapy for Insomnia consists of the standard features of this well-established insomnia treatment that will be delivered in this study via a mobile optimized web app. Participants also have access to an intervention coach/guide as needed.
Cognitive Behavioral Therapy for Depression consists of the standard features of this well-established depression treatment that will be delivered in this study via a mobile optimized web app. Participants also have access to an intervention coach/guide as needed.
The mood monitoring intervention is based on mood tracking principles in broader mood management interventions, but without any psychoeducational content or cognitive-behavioral exercises. Instead, participants will get access to a mobile optimized web app that allows users to enter their mood, tag related events, and view trends over time to raise awareness of how activities influence certain mood states.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05456607