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NCT05683132 · ClinicalTrials.gov registry record · NA

Treatments in Women Veterans With Insomnia and PTSD

A NA study of PTSD and Insomnia, sponsored by VA Office of Research and Development.

Recruiting
Registry status
NA
Development phase
100
Enrollment target
1
Study location

NCT05683132: Recruiting NA study of PTSD and Insomnia, sponsored by VA Office of Research and Development.

NCT05683132 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 100 participants, below the 301-participant average among 154 other PTSD trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05683132, 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
100 participants
Enrollment target
1
Study location

Study Summary

This pilot trial will compare trauma-informed Cognitive Behavioral Therapy for Insomnia (CBT-I) to a psychoeducational intervention in women Veterans with comorbid insomnia and posttraumatic stress disorder (PTSD). The CBT-I intervention includes trauma-informed adaptations to an insomnia treatment and the psychoeducational intervention is modeled after usual care in a VA Women's Mental Health Clinic. The study objectives are to: 1) Iteratively refine the structure and materials of trauma-informed CBT-I in preparation for a pilot trial, 2) Pilot test the effects of trauma-informed CBT-I on PTSD treatment readiness and engagement in a sample of women Veterans, and 3) Examine potential mechanisms underlying variations in PTSD treatment readiness and engagement over time among women Veterans. Women 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 PTSD treatment readiness, perceived barriers to PTSD treatment, and sleep and mental health symptoms. Then Veterans who meet all eligibility criteria will be randomly assigned to trauma-informed CBT-I (n=25) or the psychoeducational intervention (n=25). 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=50) will have 2 follow-up assessments (post-treatment and 3-months). The follow-up assessments will collect information on PTSD treatment readiness, perceived barriers to PTSD treatment, and sleep and mental health symptoms. Chart reviews will be conducted 6-months post-treatment to assess number of PTSD treatment appointments attended (treatment engagement measure). Qualitative interviews will be conducted to identify mechanisms underlying PTSD tr

Primary Outcome

The problem-specific URICA (psychotherapy version) is a 32-item questionnaire that assesses respondent's readiness to change at entrance to treatment. The URICA includes 4 subscales measuring the stages of change: Precontemplation (P), Contemplation (C), Action (A), and Maintenance (M). To obtain a readiness to change score, first sum items from each subscale and divide by 7 to get the mean for each subscale. One item from each subscale is omitted for the subscale mean calculations for the 32-it

Interventions

  • BEHAVIORAL Trauma-Informed CBT-I
  • BEHAVIORAL PTSD Psychoeducation

Study Locations (1)

California

  • VA Greater Los Angeles Healthcare System, West Los Angeles, CA - West Los Angeles

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2023-06-01
Est. Completion 2028-12-31
Phase NA
VA Office of Research and Development

1,668 total trials

What NCT05683132 shows while recruiting

NCT05683132 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 301-participant average among 154 other PTSD trials with a reported enrollment target (67% lower).

The record links to 3 conditions, with PTSD appearing as the primary indexed condition, and to 2 interventions - of which Trauma-Informed CBT-I is the first listed.

NCT05683132 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT05683132 about?

NCT05683132 is a clinical study titled "Treatments in Women Veterans With Insomnia and PTSD". This pilot trial will compare trauma-informed Cognitive Behavioral Therapy for Insomnia (CBT-I) to a psychoeducational intervention in women Veterans with comorbid insomnia and posttraumatic stress disorder (PTSD). The CBT-I intervention includes trauma-informed adaptations to an insomnia treatment ...

What is the current status of trial NCT05683132?

This trial is currently recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2023-06-01. Estimated completion is 2028-12-31.

What conditions does trial NCT05683132 study?

This clinical trial studies the following conditions: PTSD, Insomnia, Women Veterans.

What interventions are being tested in trial NCT05683132?

The interventions under investigation include: Trauma-Informed CBT-I (BEHAVIORAL), PTSD Psychoeducation (BEHAVIORAL).

Who is sponsoring clinical trial NCT05683132?

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 NCT05683132 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for PTSD

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 NCT05683132's enrollment target sits among peer trials

100 62nd of 154 higher than 89 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05683132, the US trial registry maintained by the National Library of Medicine. NCT05683132 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.