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Treatments in Women Veterans With Insomnia and PTSD

Primary Purpose

Insomnia, PTSD, Women Veterans

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trauma-Informed CBT-I
PTSD Psychoeducation
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Insomnia Disorder, Posttraumatic Stress Disorder, Women's Health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Community-dwelling women Veterans aged 18 years and older Received care from VAGLAHS in the prior year Have symptoms of PTSD Have symptoms of insomnia Exclusion Criteria: 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 Cognitive Behavioral Therapy for Insomnia (CBT-I) treatment Previously completed >3 sessions of PTSD treatment (Cognitive Processing Therapy and/or Prolonged Exposure) Pregnant or pregnant within 6 months of study Untreated 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

Sites / Locations

  • VA Greater Los Angeles Healthcare System, West Los Angeles, CARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Trauma-Informed CBT-I

PTSD Psychoeducation

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
Frequency of PTSD Treatment Appointments
A structured medical record review will be performed 3 months post-treatment to obtain information on utilization of VA healthcare services. 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.
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.
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.
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. 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.

Secondary Outcome Measures

Full Information

First Posted
December 21, 2022
Last Updated
June 2, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05683132
Brief Title
Treatments in Women Veterans With Insomnia and PTSD
Official Title
Increasing PTSD Treatment Engagement in Women Veterans: Role of CBT for Insomnia (CDA 20-227)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Posttraumatic stress disorder (PTSD) is the most common psychiatric service-connected condition among women Veterans, yet many women Veterans do not receive evidence-based psychotherapies for PTSD. PTSD and insomnia disorder are highly comorbid in women Veterans and research suggests that insomnia is a risk factor for PTSD development and severity, while healthy sleep is associated with improved mood, daytime functioning, enhanced learning, and increased emotion regulation. Addressing insomnia symptoms in women Veterans may offer an early point of intervention to reduce insomnia and some PTSD symptoms, while also providing a novel approach to improve patient engagement in PTSD treatments. No previous studies have examined the impact of trauma-informed Cognitive Behavioral Therapy for insomnia (CBT-I) on sleep and psychiatric symptoms among women Veterans with comorbid insomnia disorder and PTSD. This pilot trial will compare trauma-informed CBT-I to a psychoeducational intervention in women Veterans with comorbid insomnia and 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. The first 5 eligible participants will receive trauma-informed CBT-I and provide feedback to guide intervention refinement. 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. A chart review will be conducted 6-months post-treatment to assess number of PTSD treatment appointments attended (i.e., treatment engagement measure). Qualitative interviews (n=20) will be conducted with pilot completers and non-completers to identifying other facilitators of and barriers to PTSD treatment engagement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, PTSD, Women Veterans
Keywords
Insomnia Disorder, Posttraumatic Stress Disorder, Women's Health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Trauma-Informed CBT-I
Arm Type
Experimental
Arm Description
This intervention includes trauma-informed adaptations to standard treatment for insomnia, CBT-I
Arm Title
PTSD Psychoeducation
Arm Type
Active Comparator
Arm Description
This intervention includes psychoeducation about PTSD symptoms modeled after usual care in a VA Women's Health Clinic.
Intervention Type
Behavioral
Intervention Name(s)
Trauma-Informed CBT-I
Intervention Description
5 individual sessions incorporating behavioral and cognitive therapy components and trauma-informed adaptations with a trained instructor.
Intervention Type
Behavioral
Intervention Name(s)
PTSD Psychoeducation
Intervention Description
5 individual sessions incorporating psychoeducation about PTSD symptoms with a trained instructor.
Primary Outcome Measure Information:
Title
University of Rhode Island Change Assessment Scale (URICA)
Description
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.
Time Frame
Post-Treatment (approximately 1 week after last intervention session)
Title
Readiness for Psychotherapy Index (RPI)
Description
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.
Time Frame
Post-Treatment (approximately 1 week after last intervention session)
Title
Frequency of PTSD Treatment Appointments
Description
A structured medical record review will be performed 3 months post-treatment to obtain information on utilization of VA healthcare services. 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.
Time Frame
3-month Follow-up (approximately 12 weeks after last intervention session)
Title
University of Rhode Island Change Assessment Scale (URICA)
Description
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.
Time Frame
3-month Follow-up (approximately 12 weeks after last intervention session)
Title
Readiness for Psychotherapy Index (RPI)
Description
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.
Time Frame
3-month Follow-up (approximately 12 weeks after last intervention session)
Title
Frequency of PTSD Treatment Appointments
Description
A structured medical record review will be performed 6 months post-treatment to obtain information on utilization of VA healthcare services. 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.
Time Frame
6-month Follow-up (approximately 24 weeks after last intervention session)

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only women Veterans will be eligible for the study.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Community-dwelling women Veterans aged 18 years and older Received care from VAGLAHS in the prior year Have symptoms of PTSD Have symptoms of insomnia Exclusion Criteria: 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 Cognitive Behavioral Therapy for Insomnia (CBT-I) treatment Previously completed >3 sessions of PTSD treatment (Cognitive Processing Therapy and/or Prolonged Exposure) Pregnant or pregnant within 6 months of study Untreated 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael K Ong, MD PhD
Phone
(310) 478-3711
Ext
42345
Email
Michael.Ong2@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Scott E Krahl, PhD MA BA
Phone
(818) 895-5861
Email
scott.krahl@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gwendolyn C Carlson, PhD
Organizational Affiliation
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
City
West Los Angeles
State/Province
California
ZIP/Postal Code
90073-1003
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taigy T Gooding, DrPH
Phone
310-478-3711
Ext
36025
Email
Taigy.Gooding@va.gov
First Name & Middle Initial & Last Name & Degree
Irma Gvilia, PhD MS
Phone
(818) 891-7711
Ext
38024
Email
Irma.Gvilia@va.gov
First Name & Middle Initial & Last Name & Degree
Gwendolyn C Carlson, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Treatments in Women Veterans With Insomnia and PTSD

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