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NCT01987089 · ClinicalTrials.gov registry record · NA
The Efficacy of CBT-I in Alcoholics & Its Effects on Remission & Relapse
A NA study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 63
- Enrollment target
NCT01987089: Completed NA study, sponsored by VA Office of Research and Development.
NCT01987089 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 63 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01987089, a NA study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 63 participants
- Enrollment target
Study Summary
Insomnia is a highly prevalent disorder in those recovering from alcoholism. It has been associated with anxiety and depressive symptoms, as well as an increased risk of relapse back to the drinking. Cognitive Behavioral Therapy for Insomnia (CBT-I), a non-pharmacologic approach is the recommended standard of care for insomnia. Some preliminary studies have shown that CBT-I may be efficacious for insomnia during recovery. The current study proposes to use a standard 8-week CBT-I to treat the insomnia with a post-treatment follow-up at 3- and 6-months (after treatment). Further, it will evaluate if an improvement in the insomnia is associated with an improvement in the underling alcoholism and the daytime functioning. On an exploratory basis, the association of a first-degree family history of alcoholism with the insomnia severity and treatment response will also be evaluated.
Primary Outcome
Insomnia Severity Index (ISI): This 7-item (0-4 Likert scales) measure yields a total score of 28. The norms for the scale are as follows: 0-7 represents no clinically significant insomnia; 8-14 represents sub threshold insomnia; 15-21 represents clinical insomnia (moderate severity); 21-28 represents clinical insomnia (severe). The scale provides a measure of severity of insomnia (overall), a measure of insomnia subtype, a measure of the diurnal effects of insomnia, and a measure of sleep "sati
Interventions
- BEHAVIORAL Cognitive Behavioral Therapy for Insomnia (CBT-I)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2014-08-15 |
| Est. Completion | 2020-03-30 |
| Phase | NA |
What the finished NCT01987089 record still lists
NCT01987089 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Cognitive Behavioral Therapy for Insomnia (CBT-I) is the first listed.
NCT01987089 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01987089 about?
NCT01987089 is a clinical study titled "The Efficacy of CBT-I in Alcoholics & Its Effects on Remission & Relapse". Insomnia is a highly prevalent disorder in those recovering from alcoholism. It has been associated with anxiety and depressive symptoms, as well as an increased risk of relapse back to the drinking. Cognitive Behavioral Therapy for Insomnia (CBT-I), a non-pharmacologic approach is the recommended ...
What is the current status of trial NCT01987089?
This trial is currently completed. It is a NA study. The enrollment target is 63 participants. The study started on 2014-08-15. Estimated completion is 2020-03-30.
What interventions are being tested in trial NCT01987089?
The interventions under investigation include: Cognitive Behavioral Therapy for Insomnia (CBT-I) (BEHAVIORAL).
Who is sponsoring clinical trial NCT01987089?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01987089's enrollment target sits among peer trials
63 1157th of 2000 higher than 844 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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