Novi, Michigan 48377

  • Rumination

Purpose:

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.


Study summary:

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.


Criteria:

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.


NCT ID:

NCT03322774


Primary Contact:

Principal Investigator
Christopher L Drake, PhD
Henry Ford Health System

Cynthia Fellman-Couture, PhD
Phone: 248-344-7362
Email: cfellma1@hfhs.org


Backup Contact:

Email: csagong1@hfhs.org
Chaewon Sagong, BA
Phone: 2483442409


Location Contact:

Novi, Michigan 48377
United States

Cynthia Fellman-Couture, PhD
Phone: 248-344-7362
Email: cfellma1@hfhs.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 28, 2022

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