RecruitingNot ApplicableNCT05456607

Digital CBT for Insomnia and Depression

Optimizing Digital Behavioral Treatment for Co-occurring Insomnia and Depression


Sponsor

University of Rochester

Enrollment

1,200 participants

Start Date

May 1, 2023

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a digital (app-based) CBT program that addresses both insomnia and depression at the same time in U.S. military veterans. **You may be eligible if...** - You are a U.S. military veteran - You are English-speaking - You are experiencing both depression (PHQ score above 10) and insomnia (ISI score above 10) **You may NOT be eligible if...** - You are pregnant - You have a history of bipolar disorder or psychosis - You currently take antipsychotic medications or mood stabilizers like lithium - You have active thoughts of suicide with a specific plan or intent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALCognitive Behavioral Therapy for Insomnia

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.

BEHAVIORALCognitive Behavioral Therapy for Depression

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.

BEHAVIORALMood Monitoring

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)

University of Rochester Sleep Research Laboratory

Rochester, New York, United States

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NCT05456607


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