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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months post-treatment

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

~1930

Cognitive Behavioral Therapy for Depression

2011