Treatments in Women Veterans With Insomnia and PTSD

NCT05683132 | Recruiting

• 1 other identifier: CDX 22-009
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 treatment engagement.

Conditions

PTSD; Women Veterans; Insomnia

Keywords

Insomnia Disorder; Posttraumatic Stress Disorder; Women's Health

Outcome Measures

Primary Outcomes (5)

• University of Rhode Island Change Assessment Scale (URICA)

  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-item version of the URICA (items 4, 9, 20, and 31). Then sum the means from the Contemplation, Action, and Maintenance subscales and subtract the Precontemplation mean (C + A + M - PC = Readiness). Scores range from -2 to 14. Higher scores will indicate greater readiness.

  Post-Treatment (approximately 1 week after last intervention session)

• Readiness for Psychotherapy Index (RPI)

  The RPI is a 20-item questionnaire that assesses respondent's readiness to engage in psychotherapy. The RPI consists of 4 subscales including: disinterest, perseverance, openness, and distress. To obtain a readiness score, sum items from each subscale. Then sum the scores from the perseverance, openness, and distress subscales and subtract the disinterest subscale score (Perseverance + Openness + Distress - Disinterest = Readiness). Scores range from -10 to 70. Higher scores will indicate greater readiness.

  Post-Treatment (approximately 1 week after last intervention session)

• University of Rhode Island Change Assessment Scale (URICA)

  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-item version of the URICA (items 4, 9, 20, and 31). Then sum the means from the Contemplation, Action, and Maintenance subscales and subtract the Precontemplation mean (C + A + M - PC = Readiness). Scores range from -2 to 14. Higher scores will indicate greater readiness.

  3-month Follow-up (approximately 90 days after last intervention session)

• Readiness for Psychotherapy Index (RPI)

  The RPI is a 20-item questionnaire that assesses respondent's readiness to engage in psychotherapy. The RPI consists of 4 subscales including: disinterest, perseverance, openness, and distress. To obtain a readiness score, sum items from each subscale. Then sum the scores from the perseverance, openness, and distress subscales and subtract the disinterest subscale score (Perseverance + Openness + Distress - Disinterest = Readiness). Scores range from -10 to 70. Higher scores will indicate greater readiness.

  3-month Follow-up (approximately 90 days after last intervention session)

• Frequency of PTSD Treatment Appointments

  A structured medical record review will be performed 6 months post-treatment to obtain information on utilization of VA healthcare services during the time period between the last intervention session and 180 days after the last intervention session. Reviews will identify the presence and frequency of mental health appointments with evidence-based practice (EBP) health codes and/or Cognitive Processing Therapy (CPT) and Prolonged Exposure (PE) note templates, which are psychotherapies to treat PTSD. Attendance will be measured as a count, ranging from 0 to an unlimited value. Higher counts will indicate greater engagement in PTSD treatment.

  6-month Follow-up (180 days after last intervention session)

Study Arms (2)

Trauma-Informed CBT-I

EXPERIMENTAL

This intervention includes trauma-informed adaptations to standard treatment for insomnia, CBT-I

Behavioral: Trauma-Informed CBT-I

PTSD Psychoeducation

ACTIVE COMPARATOR

This intervention includes psychoeducation about PTSD symptoms modeled after usual care in a VA Women's Health Clinic.

Behavioral: PTSD Psychoeducation

Interventions

Trauma-Informed CBT-I BEHAVIORAL

5 individual sessions incorporating behavioral and cognitive therapy components and trauma-informed adaptations with a trained instructor.

Trauma-Informed CBT-I

PTSD Psychoeducation BEHAVIORAL

5 individual sessions incorporating psychoeducation about PTSD symptoms with a trained instructor.

PTSD Psychoeducation

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only women Veterans will be eligible for the study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Community-dwelling women Veterans aged 18 years and older
• Received care from VAGLAHS
• Have symptoms of PTSD
• Have symptoms of insomnia

You may not qualify if:

• Reported health or emotional problems, or use of drugs or alcohol that would make it difficult for them to participate in this study
• Too ill to engage in the study procedures
• Unable to self-consent to participate
• Previously engaged in \>1 session of Cognitive Behavioral Therapy for Insomnia (CBT-I) treatment
• Previously engaged in \>1 session of PTSD psychoeducational group offered in VAGLAHS Women's Health Clinic
• Previously completed \>3 sessions of PTSD treatment (e.g., Cognitive Processing Therapy, Prolonged Exposure, and/or Eye Movement Desensitization and Reprocessing )
• Pregnant or pregnant within 6 months of study
• Untreated moderate to severe obstructive sleep apnea diagnosis as evidenced by Apnea Hypopnea Index (AHI) in chart and/or screens that indicate high risk
• Unstable housing
• Inability to read, write, and communicate in English
• Unstable medical or psychiatric disorders (which is a contraindication for behavioral treatment of insomnia)
• Remission of PTSD or insomnia symptoms

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

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

West Los Angeles, California, 90073-1003, United States

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Officials

• Gwendolyn C Carlson, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gwendolyn C Carlson, PhD

CONTACT

(818) 891-7711; Gwendolyn.Carlson@va.gov

Michael K Ong, MD PhD

CONTACT

(310) 478-3711; Michael.Ong2@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded from group assignment and the treatment content. Participants will be blinded to the content of the treatment arm to which they are not assigned.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: January 12, 2023
• Study Start: June 1, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)