Digital cognitive behavioral therapy for insomnia and depression in veterans
Optimizing Digital Behavioral Treatment for Co-occurring Insomnia and Depression
This study tests whether a new online therapy can help veterans with both insomnia and depression feel better by trying different treatment combinations.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Rochester Academic / other |
| Locations | 1 site (Rochester, New York) |
| Trial ID | NCT05456607 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of sequential treatment for insomnia and depression in U.S. military veterans. It will compare the outcomes of single interventions for either condition against combined treatments, while also exploring individual variations in treatment response. A total of 1,500 participants will be randomized into five groups, including two single interventions, two sequenced interventions, and a control group. The primary goal is to achieve remission of both conditions within three months following a 12-week intervention period.
Who should consider this trial
Good fit: Ideal candidates for this study are English-speaking U.S. military veterans who experience both insomnia and depression.
Not a fit: Patients with a history of bipolar disorder, psychosis, or current suicidal ideation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide tailored digital interventions that significantly improve the management of insomnia and depression in veterans.
How similar studies have performed: Other studies have shown promise in using digital cognitive behavioral therapy for mental health conditions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Rochester, New York
- University of Rochester Sleep Research Laboratory — Rochester, New York, United States (Recruiting)
Study contacts
- Principal investigator: Wilfred Pigeon, PhD — University of Rochester
- Study coordinator: Wilfred Pigeon, PhD
- Email: wilfred_pigeon@urmc.rochester.edu
- Phone: (585) 275-2900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.