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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.
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Who is running the clinical trial?
University of MichiganOTHER
1,810 Previous Clinical Trials
6,383,868 Total Patients Enrolled
68 Trials studying Depression
69,113 Patients Enrolled for Depression
Henry Ford Health SystemLead Sponsor
304 Previous Clinical Trials
2,103,195 Total Patients Enrolled
9 Trials studying Depression
4,938 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
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