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PTSD Treatment for Veterans With Serious Mental Illness to Improve Functional Outcomes

Primary Purpose

Stress Disorders, Post-Traumatic; Mental Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Written Exposure Therapy
PTSD Education
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 Stress Disorders, Post-Traumatic; Mental Disorders focused on measuring Stress Disorders, Post-Traumatic, Mental Disorders, Culturally responsive assessment

Eligibility Criteria

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

Inclusion Criteria: enrolled in outpatient mental health services within the VAMHCS (including general outpatient Mental Health Clinic (MHC), Psychosocial Rehabilitation and Recovery Centers (PRRCs), Mental Health Intensive Case Management (MHICM), and PTSD Clinical Teams (PCTs)) diagnosis of PTSD as confirmed by assessment with the Clinician-administered PTSD Scale for DSM-5 (CAPS-5) past month version SMI diagnosis as defined by VHA Directive 1160 (i.e., psychotic spectrum or bipolar disorders) as confirmed by the medical record regular telephone access Exclusion Criteria: are engaging in moderate-to-severe substance use that would impact their ability to participate and/or would require a higher level of care already engaged in trauma-focused EBP for PTSD (e.g., WET, CPT, PE, or EMDR) or completed an EBP for PTSD within the past 6 months

Sites / Locations

  • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Written Exposure Therapy (WET)

PTSD Education Control

Arm Description

5 individual therapy sessions of WET via video telehealth

5 individual sessions of PTSD psychoeducation via video telehealth

Outcomes

Primary Outcome Measures

Number of participants eligible divided by Individuals approached for recruitment
As a measure of feasibility, the investigators will evaluate recruitment and suitability of eligibility criteria by calculating number eligible participants (e.g., those that passed screening) divided by number potential participants that were approached for recruitment.
Client Satisfaction Questionnaire (CSQ-8)
Acceptability Full measure title: Client Satisfaction Questionnaire (CSQ-8) Minimum score: 8 Maximum score: 32 Score interpretation: Greater scores indicate greater client satisfaction. Citation: Attkisson, C. C., & Greenfield, T. K. (1994). Client Satisfaction Questionnaire-8 and Service Satisfaction Scale-30. In M. E. Maruish (Ed.), The use of psychological testing for treatment planning and outcome assessment (p. 402-420). Hillsdale, NJ, US: Lawrence Erlbaum Associates, Inc.
Retention and adherence rates
As a measure of feasibility, the investigators will calculate percent of randomized who attend first 2 sessions.
Mean number of sessions attended
A measure of feasibility via adherence.
Treatment dropout percentage
As a measure of feasibility, the investigators will calculate treatment dropout percentage based on the number who dropped out prior to completing treatment divided by the number who engaged.

Secondary Outcome Measures

Clinician-administered PTSD Scale for DSM-5 (CAPS-5) - Past Month Version
PTSD symptom improvement Full measure title: Clinician-administered PTSD Scale for DSM-5 (CAPS-5) - Past Month Version Minimum score: 0 Maximum score: 80 Score interpretation: Greater scores indicate greater severity of PTSD symptoms. Citation: Weathers, F. W., Blake, D. D., Schnurr, P. P., et al. (2013). The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Available online from the National Center for PTSD.
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
Health-related functioning Full measure title: World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) Minimum score: 0 Maximum score: 100 Score interpretation: Greater scores indicate greater disability and/or functional impairments. Citation: Ustun, T., Chatterji, S., Kostanjsek, N., et al. (2010). Developing the World Health Organization Disability Assessment Schedule 2.0. Bulletin of the World Health Organization, 88(11), 815-823.

Full Information

First Posted
December 2, 2022
Last Updated
October 18, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05674617
Brief Title
PTSD Treatment for Veterans With Serious Mental Illness to Improve Functional Outcomes
Official Title
PTSD Treatment for Veterans With Serious Mental Illness to Improve Functional Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
March 31, 2027 (Anticipated)
Study Completion Date
March 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
Yes

5. Study Description

Brief Summary
PTSD is common among Veterans with serious mental illness (SMI). Co-occurring PTSD and SMI lead to poorer mental health and physical functioning than either diagnosis alone and is a critical obstacle to rehabilitation and recovery. Despite known high prevalence rates of PTSD in SMI populations as well as disparities in prevalence and treatment use for Black, Indigenous, and other people of color (BIPOC), little research has been done to: a) evaluate leading treatments for PTSD in individuals with SMI, and b) develop culturally responsive methods to integrate with PTSD treatments for SMI Veterans. This study aims to address research and clinical gaps by: a) testing the feasibility and acceptability of Written Exposure Therapy (WET), a VA evidence-based psychotherapy for PTSD in Veterans with SMI, and b) incorporating culturally responsive assessment methods. Results from this study will inform whether WET and culturally responsive assessment are feasible to implement, acceptable to Veterans with SMI, and worth examining in standard or optimized form in a larger clinical trial.
Detailed Description
Project Background: PTSD is prevalent among Veterans and others with serious mental illness (SMI), contributing to substantial mental and physical health impairments. Written Exposure Therapy (WET) is a new evidence-based practice for PTSD that may have special clinical utility for Veterans with SMI and PTSD. However, such Veterans have been largely excluded from PTSD clinical trials, and no WET trials to date have focused on an SMI population. Further, there are significant race and ethnicity disparities in PTSD and SMI prevalence and treatment, even in Veterans Health Administration. For instance, persistence and chronicity of SMI and PTSD are higher for Black, Indigenous, and other people of color (BIPOC) underlining the need for PTSD EBPs to be delivered in culturally responsive ways. Project Objectives: The proposed CDA-2 research will address research and clinical gaps by integrating culturally responsive assessment methods and testing the feasibility and acceptability of WET among Veterans with SMI and PTSD. The first step of this research will focus on administering culturally responsive assessments and WET to Veterans with PTSD and SMI in a training trial (n = 10), including qualitative interviews exploring participants' experiences with and views of these instruments and WET. The second step will involve completing a small randomized controlled trial of WET to examine feasibility, acceptability, and fidelity of WET, and to preliminarily explore changes to clinical outcomes and functioning among 48 Veterans randomized to WET (n = 32) vs. a PTSD psychoeducation control intervention (n = 16). We will assess rates of recruitment, initial intervention engagement, and session attendance (feasibility); Veteran satisfaction with WET (acceptability); and preliminarily explore response to WET. The final step of this research will involve conducting a process evaluation to consider ways to optimize WET for future clinical trials to improve functional recovery for Veterans with SMI. This evaluation will synthesize information from: 1) WET interventionist notes and 2) qualitative interviews with a subset of Veterans in the WET condition (n = 15). Project Methods: This project will include: 1) delivering WET with the CFI during a training trial followed by qualitative interviews with Veterans with PTSD and SMI; 2) completing a randomized control trial (RCT) with 48 Veteran participants, monitoring fidelity, feasibility, and acceptability; and 3) studying Veterans' experiences of WET and culturally responsive assessment methods through qualitative interviews. The investigators will measure functional outcomes during the RCT at baseline, post-treatment and 3-month follow-up using clinician-rated and self-report questionnaires for preliminary exploratory analysis, preparatory to a future full RCT if WET proves promising.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic; Mental Disorders
Keywords
Stress Disorders, Post-Traumatic, Mental Disorders, Culturally responsive assessment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trial (RCT)
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Written Exposure Therapy (WET)
Arm Type
Experimental
Arm Description
5 individual therapy sessions of WET via video telehealth
Arm Title
PTSD Education Control
Arm Type
Active Comparator
Arm Description
5 individual sessions of PTSD psychoeducation via video telehealth
Intervention Type
Behavioral
Intervention Name(s)
Written Exposure Therapy
Other Intervention Name(s)
WET
Intervention Description
WET will be conducted in accordance with the Written Exposure Therapy for PTSD: A Brief Treatment Approach for Mental Health Professionals Manual and the VA evidence-based practice (EBP) rollout training.
Intervention Type
Behavioral
Intervention Name(s)
PTSD Education
Intervention Description
The 5-session PTSD psychoeducation and skills protocol we will be utilizing for our PTSD education control condition was developed by PTSD clinical team (PCT) clinicians at the Washington DC VA Medical Center as a group protocol for Veterans admitted to the PCT and who were on the waitlist for individual therapy with an EBP for PTSD. The "PTSD 101" protocol consists of psychoeducation on topics related to PTSD symptoms and an introduction to PTSD-related coping skills. Its duration and structure will be similar to WET (5 weekly individual 50-minute sessions). To parallel the time an attention given in individual WET sessions more closely, participants will quietly review any written materials or videos that are a part of the manualized curriculum for 30 minutes of the session, bookended by a 10-minute check-in with their provider on symptoms and introduction to new materials at the start of session and another 10-minute debrief of reviewed materials at the end of session.
Primary Outcome Measure Information:
Title
Number of participants eligible divided by Individuals approached for recruitment
Description
As a measure of feasibility, the investigators will evaluate recruitment and suitability of eligibility criteria by calculating number eligible participants (e.g., those that passed screening) divided by number potential participants that were approached for recruitment.
Time Frame
Through study completion, an average of 1 year
Title
Client Satisfaction Questionnaire (CSQ-8)
Description
Acceptability Full measure title: Client Satisfaction Questionnaire (CSQ-8) Minimum score: 8 Maximum score: 32 Score interpretation: Greater scores indicate greater client satisfaction. Citation: Attkisson, C. C., & Greenfield, T. K. (1994). Client Satisfaction Questionnaire-8 and Service Satisfaction Scale-30. In M. E. Maruish (Ed.), The use of psychological testing for treatment planning and outcome assessment (p. 402-420). Hillsdale, NJ, US: Lawrence Erlbaum Associates, Inc.
Time Frame
Post-treatment (~7 weeks)
Title
Retention and adherence rates
Description
As a measure of feasibility, the investigators will calculate percent of randomized who attend first 2 sessions.
Time Frame
at study completion, approximately 4 years
Title
Mean number of sessions attended
Description
A measure of feasibility via adherence.
Time Frame
at study completion, approximately 4 years
Title
Treatment dropout percentage
Description
As a measure of feasibility, the investigators will calculate treatment dropout percentage based on the number who dropped out prior to completing treatment divided by the number who engaged.
Time Frame
at study completion, approximately 4 years
Secondary Outcome Measure Information:
Title
Clinician-administered PTSD Scale for DSM-5 (CAPS-5) - Past Month Version
Description
PTSD symptom improvement Full measure title: Clinician-administered PTSD Scale for DSM-5 (CAPS-5) - Past Month Version Minimum score: 0 Maximum score: 80 Score interpretation: Greater scores indicate greater severity of PTSD symptoms. Citation: Weathers, F. W., Blake, D. D., Schnurr, P. P., et al. (2013). The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Available online from the National Center for PTSD.
Time Frame
Baseline, Post-treatment (~7 weeks), 3-month Follow-up (~19 weeks)
Title
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
Description
Health-related functioning Full measure title: World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) Minimum score: 0 Maximum score: 100 Score interpretation: Greater scores indicate greater disability and/or functional impairments. Citation: Ustun, T., Chatterji, S., Kostanjsek, N., et al. (2010). Developing the World Health Organization Disability Assessment Schedule 2.0. Bulletin of the World Health Organization, 88(11), 815-823.
Time Frame
Baseline, Post-treatment (~7 weeks), 3-month Follow-up (~19 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: enrolled in outpatient mental health services within the VAMHCS (including general outpatient Mental Health Clinic (MHC), Psychosocial Rehabilitation and Recovery Centers (PRRCs), Mental Health Intensive Case Management (MHICM), and PTSD Clinical Teams (PCTs)) diagnosis of PTSD as confirmed by assessment with the Clinician-administered PTSD Scale for DSM-5 (CAPS-5) past month version SMI diagnosis as defined by VHA Directive 1160 (i.e., psychotic spectrum or bipolar disorders) as confirmed by the medical record regular telephone access Exclusion Criteria: are engaging in moderate-to-severe substance use that would impact their ability to participate and/or would require a higher level of care already engaged in trauma-focused EBP for PTSD (e.g., WET, CPT, PE, or EMDR) or completed an EBP for PTSD within the past 6 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mary K Howell, PhD
Phone
(410) 605-7000
Email
Mary.Howell@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Amy L Drapalski, PhD
Phone
(410) 637-1855
Email
amy.drapalski@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary K Howell, PhD
Organizational Affiliation
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frederick M Ivey, PhD
Phone
410-605-7000
Ext
56510
Email
Frederick.Ivey@va.gov
First Name & Middle Initial & Last Name & Degree
Natalie V Dugger, BS
Phone
(410) 605-7000
Ext
56407
Email
Natalie.Dugger@va.gov
First Name & Middle Initial & Last Name & Degree
Mary K Howell, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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PTSD Treatment for Veterans With Serious Mental Illness to Improve Functional Outcomes

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