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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

Must not have

Age < 18

Current use of antidepressants for depression

Timeline

Screening 3 days

Treatment Varies

Follow Up 3 days

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

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I am currently taking antidepressants for depression.

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I have been diagnosed with bipolar disorder or a seizure disorder.

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I have a sleep disorder other than insomnia.

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I have been diagnosed with major depression.

Timeline

Screening ~ 3 days1 visit

Treatment ~ Varies

Follow Up ~ 3 days1 visit

Screening ~ 3 days

Treatment ~ Varies

Follow Up ~3 days

This trial's timeline: 3 days for screening, Varies for treatment, and 3 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 more

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.

0 / 5Eligibility criteria met