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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
Study Summary
This trial will test whether treating insomnia first, then depression, is better than treating depression first, or treating either one alone. It will also try to find out if there's a difference in how well different people respond to different treatments.
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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dual Remission of Depression and Insomnia
Secondary outcome measures
Mental Depression
Insomnia Response
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
~1800
Cognitive Behavioral Therapy for Depression
2011
N/A
~130
Find a Location
Who is running the clinical trial?
University of RochesterLead Sponsor
840 Previous Clinical Trials
532,750 Total Patients Enrolled
24 Trials studying Depression
7,284 Patients Enrolled for Depression
United States Department of DefenseFED
865 Previous Clinical Trials
326,199 Total Patients Enrolled
9 Trials studying Depression
1,834 Patients Enrolled for Depression
University of South FloridaOTHER
413 Previous Clinical Trials
186,767 Total Patients Enrolled
17 Trials studying Depression
3,784 Patients Enrolled for Depression
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking anti-psychotic medications or mood stabilizers like lithium.I have severe insomnia.I have severe insomnia.You have a high score for depression on a questionnaire called the Patient Health Questionnaire.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Single Insomnia Treatment
- Group 3: Single Depression Treatment
- Group 4: Sequenced Depression and Insomnia Treatment
- Group 5: Sequenced Insomnia and Depression Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Depression Patient Testimony for trial: Trial Name: NCT05456607 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any openings available for this investigation?
"Unfortunately, this medical trial has closed its recruitment process. Initially posted on January 1st 2023 and last adjusted on July 8th 2022, the study is no longer looking for participants. However, 1497 other trials remain open to applicants at present time."
Answered by AI
Who else is applying?
What state do they live in?
New York
What site did they apply to?
University of Rochester Sleep Research Laboratory
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
Tried/failed many medications for both depression and insomnia and hope to learn how to manage these more effectively.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
How long are screening visits?
PatientReceived 1 prior treatment
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