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NCT03208855 · ClinicalTrials.gov registry record · NA
Cognitive Behavioral Therapy for Insomnia in Substance Use Disorders
A NA study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- NA
- Development phase
- 28
- Enrollment target
NCT03208855: Completed NA study, sponsored by Johns Hopkins University.
NCT03208855 is a NA study that has completed, run by Johns Hopkins University. The registered enrollment target is 28 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03208855, a NA study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- NA
- Development phase
- 28 participants
- Enrollment target
Study Summary
Substance Use Disorders (SUDs) and insomnia are major public health concerns, and each are independently linked to reduced quality of life, disability, and high healthcare costs. Insomnia, characterized by difficulty initiating or maintaining sleep, or nonrestorative sleep, is prevalent in 10% of the general population and is co-morbid in 70% of patients with SUDs. Primary insomnia and SUDs are chronic, unremitting diseases and have a complex bidirectional relationship. Insomnia symptoms may predate the onset of SUDs and may explain high prevalence of self-treatment. Insomnia may also be a direct effect of intoxication, withdrawal, or abstinence from the substance of abuse. Subjective and objective measures of sleep disruption have been shown in various stages of abuse and recovery. Insomnia is the most well documented predictor of substance use relapse. Treatment specifically targeting chronic insomnia is essential for improved clinical outcomes. Although, chronic insomnia is a well-established, modifiable risk factor, to our knowledge, there are no interdisciplinary residential treatment programs that specifically treat chronic insomnia during acute SUDs treatment. We propose that improved treatment of insomnia as part of a comprehensive reinforcement-based outpatient treatment program will provide an efficient and cost effective opportunity to improve standard outpatient SUD. Converging evidence suggests that prophylactic CBT-I during SUD treatment may have short and long-term efficacy for sleep, and improve attrition. In the proposed study, patients with co-morbid SUDs and insomnia will engage in an 8-week group CBT-I (gCBT-I) program in addition to receiving treatment as usual for SUDs. This study may provide new hope to effectively treat insomnia in SUD and lead to a new standardization of outpatient care. We hypothesize that a CBT-I intervention can be implemented as part of an evidence-based SUD treatment program within a residential facility.
Primary Outcome
Participants in both study arms will record subjective sleep measures via self-report sleep diary. They will also complete the Insomnia Severity Index (ISI)) at both pre-and post-treatment and over 6-month follow-up period.
Interventions
- BEHAVIORAL Cognitive Behavioral Therapy for Insomnia (CBT-I)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2017-07-31 |
| Est. Completion | 2020-10-13 |
| Phase | NA |
What the finished NCT03208855 record still lists
NCT03208855 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Cognitive Behavioral Therapy for Insomnia (CBT-I) is the first listed.
NCT03208855 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03208855 about?
NCT03208855 is a clinical study titled "Cognitive Behavioral Therapy for Insomnia in Substance Use Disorders". Substance Use Disorders (SUDs) and insomnia are major public health concerns, and each are independently linked to reduced quality of life, disability, and high healthcare costs. Insomnia, characterized by difficulty initiating or maintaining sleep, or nonrestorative sleep, is prevalent in 10% of th...
What is the current status of trial NCT03208855?
This trial is currently completed. It is a NA study. The enrollment target is 28 participants. The study started on 2017-07-31. Estimated completion is 2020-10-13.
What interventions are being tested in trial NCT03208855?
The interventions under investigation include: Cognitive Behavioral Therapy for Insomnia (CBT-I) (BEHAVIORAL).
Who is sponsoring clinical trial NCT03208855?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03208855's enrollment target sits among peer trials
28 1704th of 2000 higher than 293 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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