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Cognitive Behavioral Therapy
Cognitive Behavioral Therapy for Insomnia (STRIDE Trial)
N/A
Waitlist Available
Led By Christopher L Drake, PhD
Research Sponsored by Henry Ford Health System
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 days
Treatment Varies
Follow Up 3 days
Awards & highlights
STRIDE Trial Summary
This trial will test whether a digital cognitive behavioral therapy for insomnia followed by a face-to-face CBT-I is more effective in improving insomnia and sleep outcomes than just the digital therapy alone.
Who is the study for?
This trial is for adults with insomnia but without major depression (no severe depressive symptoms and not currently on antidepressants). It's not for those under 18, or with other sleep disorders like sleep apnea, narcolepsy, restless legs syndrome, bipolar disorder, or seizure disorders.Check my eligibility
What is being tested?
The study tests a two-step treatment for insomnia: starting with digital Cognitive Behavioral Therapy (dCBT-I), followed by face-to-face CBT-I if needed. It also looks at whether this approach can prevent major depression and explores the role of rumination in how well the treatment works.See study design
What are the potential side effects?
While specific side effects are not listed for these therapies, common issues might include temporary discomfort from changing sleep habits or discussing personal thoughts during therapy sessions.
STRIDE Trial Timeline
Screening ~ 3 days1 visit
Treatment ~ Varies
Follow Up ~ 3 days1 visit
Screening ~ 3 days
Treatment ~ Varies
Follow Up ~3 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Effectiveness of Stepped Care model of dCBT-I/CBT-I for insomnia remission.
Mediation of Depression Prevention by Reducing Rumination (Nocturnal rumination)
Preventing major depressive disorder development with dCBT-I/CBT-I stepped care treatment for insomnia.
Secondary outcome measures
Mediation of Depression Prevention by Reducing Rumination (Depressive rumination)
Mediation of Depression Prevention by Reducing Rumination (Transdiagnostic)
Mediation of Depression Prevention by Reducing Rumination (Worry)
+4 moreSTRIDE Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: digital CBT-IExperimental Treatment1 Intervention
This group receives digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) through the third party program, "Sleepio." Treatment includes weekly sessions of CBT-I administered over the internet in hour-long video sessions. Daily sleep diaries are recorded online for individual tailoring of treatment.
Group II: Stepped Care ModelExperimental Treatment2 Interventions
This group receives digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) through the third party program, "Sleepio." Following initial treatment with dCBT-I, individuals who do not experience remission of their insomnia will begin treatment with face-to-face Cognitive Behavioral Therapy for Insomnia with a trained staff member in behavioral sleep medicine.
Group III: Attention ControlPlacebo Group1 Intervention
This group receives sleep hygiene education, which serves as a credible control intervention to digital cognitive behavioral therapy for insomnia (dCBT-I). This intervention mimics the web-based patient contact inherent in dCBT-I but is inert with respect to sleep outcomes.
Group IV: Stepped Care Model ControlPlacebo Group2 Interventions
This group receives digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) through the third party program, "Sleepio." Following initial treatment with dCBT-I, individuals who do not experience remission of their insomnia will receive sleep hygiene education, serving as a credible control intervention for comparison to the Stepped Care Model.
Find a Location
Who is running the clinical trial?
University of MichiganOTHER
1,799 Previous Clinical Trials
6,377,401 Total Patients Enrolled
68 Trials studying Depression
69,123 Patients Enrolled for Depression
Henry Ford Health SystemLead Sponsor
300 Previous Clinical Trials
2,098,645 Total Patients Enrolled
8 Trials studying Depression
4,438 Patients Enrolled for Depression
Big Health Inc.Industry Sponsor
11 Previous Clinical Trials
138,094 Total Patients Enrolled
1 Trials studying Depression
248 Patients Enrolled for Depression
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with major depression.I am currently taking antidepressants for depression.You have no clinically significant depressive symptoms.You have insomnia (ISI > 14).I have a sleep disorder other than insomnia.I am under 18 years old.I have been diagnosed with bipolar disorder or a seizure disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Attention Control
- Group 2: Stepped Care Model
- Group 3: digital CBT-I
- Group 4: Stepped Care Model Control
Awards:
This trial has 0 awards, including: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: You will receive the treatment for 3 null
- Follow Ups: You may be asked to continue sharing information regarding the trial for 3 Months after you stop receiving the treatment.
Depression Patient Testimony for trial: Trial Name: NCT03322774 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants still being accepted into this study?
"Yes, according to clinicaltrials.gov this research study is still seeking participants. This trial was first made available on the 9th of March 2018 and most recently revised on the 7th of February 2022."
Answered by AI
What are the ambitions of this exploration?
"The primary aim of this clinical trial, which will be evaluated over the course of 1 and 2 years post randomization, is to assess the efficiency of dCBT-I/CBT-I for insomnia relief. The secondary objectives comprise ascertaining if race plays a role in depression prevention with stepped care treatment (self reported by patients), determining the mediation of depression avoidance through reducing rumination on a transdiagnostic level (as determined by Perseverative Thinking Questionnaire scores ranging from 15 - 75) and examining whether depressive rumination can mediate such prevention as established via Rumination Response Scale scores between 22 - 88)."
Answered by AI
What is the sample size of this experiment?
"Affirmative. The records posted to clinicaltrials.gov show that this medical research, which was originally published on March 9th 2018, is currently enrolling volunteers. An estimated 1000 patients are being sought from 1 particular healthcare centre."
Answered by AI
Who else is applying?
What state do they live in?
Michigan
Florida
What site did they apply to?
Henry Ford Medical Center - Columbus
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
2
3+
What questions have other patients asked about this trial?
Would my travel cost be paid? What medication’s are involved? Will I be doing this all online?
PatientReceived 2+ prior treatments
Why did patients apply to this trial?
I am on medication now and it definitely is not doing any good. I've tried many drugs to help depression and I'm medication resistant.
PatientReceived no prior treatments
I'm interested because I have been on other medications and they didn't fit my needs.
PatientReceived 2+ prior treatments
I’ve struggled with depression as have members of my family. I’m tired of the fatigue and anxiety from it.
PatientReceived 2+ prior treatments
I have tried several medication’s that didn’t seem to work completely for me. So interested To know what the trial is about. What is success rates you have had so far. And if I am eligible, how I can be of service and not only learn from this trial but help others in the meantime. I am detail oriented, conscientious, committed and I have a good follow through. I take Clinical Trial’s very seriously. I recently left my job this past Friday so I have time on my hands to commit to the project. Thank you for your consideration.
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Email
Phone Call
Most responsive sites:
- Henry Ford Medical Center - Columbus: < 24 hours
Average response time
- < 1 Day
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