Digital CBT for Insomnia and Depression

Depression Clinical Trial

Official title:

Optimizing Digital Behavioral Treatment for Co-occurring Insomnia and Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05456607
• Other study ID #: STUDY00007379
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: September 30, 2027

Study information

• Verified date: May 2024
• Source: University of Rochester
• Contact: Wilfred Pigeon, PhD
• Phone: (585) 275-2900
• Email: wilfred_pigeon[@]urmc.rochester.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Although efficacious behavioral treatments like cognitive behavioral therapy for insomnia (CBT-I) and for depression (CBT-D) exist for insomnia and depression disorders, their impact on co-occurring symptoms can be modest and residual symptoms often remain. In addition, scalable versions of these interventions (like computer accessible or phone app versions) are needed for U.S. military Veterans who lack access to first-line interventions because of rural or other resource-limited environments. Finally, little is known about heterogeneity of treatment effects; that is, variation in which interventions are best for which individuals. This comparative effectiveness trial is designed to develop an an individualized intervention rule to match the right digital intervention to the right person with co-occurring insomnia and depression.

The study will use digital versions of CBT-I and CBT-D found to be efficacious for their intended target. A total of 1,500 participants who are Veterans with both insomnia and depression will be randomized with equal allocation to five study arms: two single interventions (CBT-I or CBT-D); two sequenced interventions (CBT-I+D or CBT-D+I); and a mood monitoring condition that will serve as the control group. Assessments occur at baseline, mid-treatment, post-treatment, at 3-month and 6-month follow-ups. The primary endpoint will be remission of both depression and insomnia at 3 months following the 12 week intervention period. All study activity will be conducted remotely including recruitment, treatment delivery and assessments, so that participants can be recruited nationwide.

The study will estimate average treatment effects on insomnia and depression remission at 3-months post-treatment (primary outcome) and 6-month maintenance of remission as well as treatment response. Significantly higher remission and response rates for sequenced rather than single interventions and lowest for the mood monitoring control condition are expected. Because variation in which interventions are best for which individuals are expected, study investigators will develop and evaluate an individualized intervention rule to determine an optimal approach for each participant in promoting 3-month remission of both disorders. A cutting-edge ensemble machine learning method will be used to do this. In a companion, subsequent trial with a new cohort of 800 participants, the investigators will evaluate whether assigning participants to a treatment condition via the individualized intervention rule is superior to simple randomization that does not consider individual factors in the treatment decision. This subsequent trial will be registered as a separate clinical trial, but will refer back to this current trial.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: September 30, 2027
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• English-speaking

• U.S. Military Veterans

• endorse depression (Patient Health Questionnaire-depression score > 10)

• endorse insomnia (Insomnia Severity Index score > 10).

Exclusion Criteria are limited in accordance with real world effectiveness trials, but will include:

• 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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Cognitive 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.
• Cognitive 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.
• Mood 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

Country	Name	City	State
United States	University of Rochester Sleep Research Laboratory	Rochester	New York

Sponsors (5)

Lead Sponsor	Collaborator
University of Rochester	Harvard University, United States Department of Defense, University of California, Irvine, University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dual Remission of Depression and Insomnia	The proportion of participants achieving dual remission in each study arm with Depression Remission defined as a total score of < 5 on the Patient Health Questionnaire (PHQ-9) and Insomnia Remission defined as a total score of < 8 on the Insomnia Severity Index (ISI).	3 Months post-treatment
Secondary	Depression Response	The proportion of participants achieving a Depression treatment response defined as a = 5 point reduction in the total PHQ-9 score	3 Months post treatment
Secondary	Insomnia Response	The proportion of participants achieving an Insomnia treatment response defined as a = 8 point reduction in the total ISI score	3 Months post treatment