Sleep To Reduce Incident Depression Effectively (STRIDE)

Henry Ford Health

Status: Completed

Conditions: Major Depressive Disorder; Insomnia, Primary; Rumination

Treatments: Behavioral: face-to-face Cognitive Behavioral Therapy for Insomnia; Behavioral: Sleep Hygiene Education Control; Behavioral: digital Cognitive Behavioral Therapy for Insomnia

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03322774

IRB 11586

Details and patient eligibility

About

This project will assess the effectiveness of a stepped-care model (i.e. digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) followed by face-to-face CBT-I) in improving severity of insomnia and sleep outcomes in an insomnia cohort. This project will also investigate the effectiveness of this stepped-care model in prevention of major depressive disorder, and will test rumination as a mediator of treatment response.

Full description

This project will assess the acute and long-term effectiveness of dCBT-I on Research Domain Criteria (RDoC) sleep parameters: Insomnia Severity Index (ISI), sleep onset latency, and wake after sleep onset in an insomnia cohort including those at elevated risk for depression (e.g. low SES, minority). This will be tested by administering internet-based dCBT-I to people with insomnia and adding face-to-face CBT-I in non-remitters, as well as comparing the RDoC sleep outcomes to an attention control group post-treatment and at 1- and 2-year follow-ups. This study will also determine the acute and long-term effectiveness of face-to-face CBT-I in non-responders to dCBT-I on RDoC sleep outcomes relative to a comparison group post-treatment and at 1- and 2-year follow-ups.

This study will also determine the effects of dCBT-I and CBT-I using a stepped-care model for prevention of major depressive disorder incidence and relapse across 2 years. Specifically, rate of depression of both dCBT-I and CBT-I will be compared to a control group.

This study will also evaluate changes in rumination as a modifiable behavior (post-treatment) that mediates the effect of insomnia treatment on depression risk.

Enrollment: 1,237 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Determination of Insomnia (ISI > 14)
• And no clinically significant depressive symptoms (Quick Inventory of Depressive Symptomatology < 11)

Exclusion criteria

• Age < 18
• Current use of antidepressants for depression
• Bipolar or Seizure disorders
• Known sleep disorders other than insomnia (e.g. obstructive sleep apnea, narcolepsy, restless leg syndrome).
• Current DSM-5 major depressive disorder at baseline.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

---

1,237 participants in 4 patient groups

Attention Control

Sham Comparator group

Description:

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.

Treatment:

Behavioral: Sleep Hygiene Education Control

Stepped Care Model

Experimental group

Description:

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.

Treatment:

Behavioral: digital Cognitive Behavioral Therapy for Insomnia

Behavioral: face-to-face Cognitive Behavioral Therapy for Insomnia

Stepped Care Model Control

Sham Comparator group

Description:

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.

Treatment:

Behavioral: digital Cognitive Behavioral Therapy for Insomnia

Behavioral: Sleep Hygiene Education Control

digital CBT-I

Experimental group

Description:

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.

Treatment:

Behavioral: digital Cognitive Behavioral Therapy for Insomnia