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NCT05194930 · ClinicalTrials.gov registry record · NA
Treatments for Insomnia in Veterans With PTSD
A NA study of PTSD and Insomnia, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- NA
- Development phase
- 400
- Enrollment target
- 1
- Study location
NCT05194930: Recruiting NA study of PTSD and Insomnia, sponsored by VA Office of Research and Development.
NCT05194930 is a NA study of PTSD and Insomnia that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 400 participants, above the 299-participant average among 154 other PTSD trials with a reported enrollment target (34% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05194930, a NA study of PTSD and Insomnia, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- NA
- Development phase
- 400 participants
- Enrollment target
- 1
- Study location
Study Summary
This randomized trial will compare a novel treatment, Acceptance of the Behavioral Changes to Treat Insomnia (ABC-I) to Cognitive Behavioral Therapy for Insomnia (CBT-I) among Veterans with comorbid Post-Traumatic Stress Disorder (PTSD) and insomnia disorder. ABC-I combines the behavioral components of CBT-I with components of another behavioral therapy (Acceptance and Commitment Therapy) and has been shown to improve treatment adherence. The study objectives are: 1) to evaluate the benefits of ABC-I in reducing post-traumatic stress disorder (PTSD) symptoms among Veterans with comorbid PTSD and insomnia disorder compared to CBT-I, and 2) to evaluate the effectiveness of ABC-I in improving insomnia symptoms and sleep quality among Veterans with comorbid PTSD and insomnia disorder as compared to CBT-I. Veterans with insomnia and comorbid PTSD who receive care at Sepulveda and West Los Angeles facilities will be recruited for the study. Those who pass an initial eligibility screen will be enrolled and written informed consent will be obtained. A baseline assessment will be completed that includes measures of sleep, PTSD, and quality of life. Veterans who meet all eligibility criteria will be randomly assigned to the ABC-I (n=100) or CBT-I (n=100) treatment. Both treatments will be provided in 5 one-on-one sessions by a trained instructor who is supervised by a behavioral sleep medicine specialist. All randomized participants (n=200) will have 3 follow-up assessments (post-treatment, 3-months, and 6-months after randomization). The follow-up assessments will collect information on PTSD symptoms, insomnia symptoms and sleep quality.
Primary Outcome
The PCL-5 total score will be the main outcome measure for PTSD symptom severity. The PCL-5 is a standardized assessment for PTSD, based on DSM-5. The 20-item scale assesses the presence and severity PTSD symptoms on a 0-4 Likert scale, with a total symptom severity score range from 0-80. A score greater than or equal to 33 is indicative of probable PTSD.
Interventions
- BEHAVIORAL The ABC of Insomnia (Acceptance and the Behavioral Changes to treat Insomnia)
- BEHAVIORAL Cognitive-Behavioral Therapy for Insomnia
Study Locations (1)
California
- VA Greater Los Angeles Healthcare System, Sepulveda, CA - Sepulveda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2022-09-01 |
| Est. Completion | 2026-06-30 |
| Phase | NA |
What NCT05194930 shows while recruiting
NCT05194930 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, above the 299-participant average among 154 other PTSD trials with a reported enrollment target (34% higher).
The record links to 2 conditions, with PTSD appearing as the primary indexed condition, and to 2 interventions - of which The ABC of Insomnia (Acceptance and the Behavioral Changes to treat Insomnia) is the first listed.
NCT05194930 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05194930 about?
NCT05194930 is a clinical study titled "Treatments for Insomnia in Veterans With PTSD". This randomized trial will compare a novel treatment, Acceptance of the Behavioral Changes to Treat Insomnia (ABC-I) to Cognitive Behavioral Therapy for Insomnia (CBT-I) among Veterans with comorbid Post-Traumatic Stress Disorder (PTSD) and insomnia disorder. ABC-I combines the behavioral components...
What is the current status of trial NCT05194930?
This trial is currently recruiting. It is a NA study. The enrollment target is 400 participants. The study started on 2022-09-01. Estimated completion is 2026-06-30.
What conditions does trial NCT05194930 study?
This clinical trial studies the following conditions: PTSD, Insomnia.
What interventions are being tested in trial NCT05194930?
The interventions under investigation include: The ABC of Insomnia (Acceptance and the Behavioral Changes to treat Insomnia) (BEHAVIORAL), Cognitive-Behavioral Therapy for Insomnia (BEHAVIORAL).
Who is sponsoring clinical trial NCT05194930?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05194930 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05194930's enrollment target sits among peer trials
400 12th of 154 higher than 142 of 154 other PTSD trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other PTSD 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.
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