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Digital CBT for Insomnia and Depression

N/A
Recruiting
Led By Wilfred Pigeon, PhD
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months post treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial uses online therapy programs to help Veterans with both sleep and mood problems. It focuses on those who have limited access to traditional therapy. The therapies work by teaching skills to change negative thoughts and behaviors affecting sleep and mood.

Who is the study for?
This trial is for U.S. military veterans who speak English and are experiencing both insomnia and depression, with scores indicating moderate to severe symptoms on standard questionnaires. It's not open to pregnant individuals, those with a history of bipolar disorder or psychosis, current users of antipsychotic medications or mood stabilizers like lithium, or anyone currently having suicidal thoughts with intent.
What is being tested?
The study is testing whether treating insomnia and depression one after the other works better than just treating one condition. It also aims to find out which treatment sequence might be best and if treatments should vary based on individual differences. Participants will receive digital Cognitive Behavioral Therapy (CBT) tailored either for insomnia or depression along with mood monitoring.
What are the potential side effects?
Since this trial involves non-pharmaceutical interventions like digital CBT and mood monitoring, typical drug side effects aren't expected. However, participants may experience emotional discomfort as they address their sleep disorders and depressive symptoms during therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dual Remission of Depression and Insomnia
Secondary study objectives
Mental Depression
Insomnia Response

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: Single Insomnia TreatmentExperimental Treatment1 Intervention
Cognitive-behavioral therapy for insomnia delivered in a self-managed online format (computer or phone app) with access to a coach. Duration of access for 12 weeks.
Group II: Single Depression TreatmentExperimental Treatment1 Intervention
Cognitive-behavioral therapy for depression delivered in a self-managed online format (computer or phone app) with access to a coach. Duration of access for 12 weeks.
Group III: Sequenced Insomnia and Depression TreatmentExperimental Treatment2 Interventions
Cognitive-behavioral therapy for insomnia followed by cognitive-behavioral therapy for depression each delivered in a self-managed online format (computer or phone app) with access to a coach. Duration of access to the insomnia treatment only for 4 weeks after which the access to the depression treatment is also made available. Total duration of access for 12 weeks.
Group IV: Sequenced Depression and Insomnia TreatmentExperimental Treatment2 Interventions
Cognitive-behavioral therapy for depression followed by cognitive-behavioral therapy for insomnia each delivered in a self-managed online format (computer or phone app) with access to a coach. Duration of access to the depression treatment only for 4 weeks after which the access to the insomnia treatment is also made available. Total duration of access for 12 weeks.
Group V: ControlActive Control1 Intervention
Online Mood Monitoring for 12 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Behavioral Therapy for Insomnia
2013
Completed Phase 3
~1750
Cognitive Behavioral Therapy for Depression
2011
N/A
~130

Find a Location

Who is running the clinical trial?

University of RochesterLead Sponsor
872 Previous Clinical Trials
548,597 Total Patients Enrolled
24 Trials studying Depression
7,284 Patients Enrolled for Depression
United States Department of DefenseFED
917 Previous Clinical Trials
333,199 Total Patients Enrolled
9 Trials studying Depression
1,834 Patients Enrolled for Depression
University of South FloridaOTHER
427 Previous Clinical Trials
191,131 Total Patients Enrolled
17 Trials studying Depression
3,784 Patients Enrolled for Depression
Harvard UniversityOTHER
233 Previous Clinical Trials
472,431 Total Patients Enrolled
26 Trials studying Depression
6,394 Patients Enrolled for Depression
University of California, IrvineOTHER
566 Previous Clinical Trials
1,931,548 Total Patients Enrolled
8 Trials studying Depression
5,434 Patients Enrolled for Depression
Wilfred Pigeon, PhDPrincipal InvestigatorUniversity of Rochester
1 Previous Clinical Trials
48 Total Patients Enrolled

Media Library

Cognitive Behavioral Therapy for Depression Clinical Trial Eligibility Overview. Trial Name: NCT05456607 — N/A
Depression Research Study Groups: Control, Single Insomnia Treatment, Single Depression Treatment, Sequenced Depression and Insomnia Treatment, Sequenced Insomnia and Depression Treatment
Depression Clinical Trial 2023: Cognitive Behavioral Therapy for Depression Highlights & Side Effects. Trial Name: NCT05456607 — N/A
Cognitive Behavioral Therapy for Depression 2023 Treatment Timeline for Medical Study. Trial Name: NCT05456607 — N/A
Depression Patient Testimony for trial: Trial Name: NCT05456607 — N/A
~581 spots leftby Dec 2025
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