跳至主要内容
临床试验/NCT05674617
NCT05674617招募中不适用

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

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2023年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
48
试验地点
2
主要终点
Retention and adherence rates

研究概览

简要总结

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. 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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Written Exposure Therapy (WET)

Experimental

5 individual therapy sessions of WET via video telehealth

干预措施: Written Exposure Therapy (Behavioral)

PTSD Education Control

Active Comparator

5 individual sessions of PTSD psychoeducation via video telehealth

干预措施: PTSD Education (Behavioral)

结局指标

主要结局

Retention and adherence rates

时间窗: at study completion, approximately 4 years

As a measure of feasibility, the investigators will calculate percent of randomized who attend first 2 sessions.

Number of participants eligible divided by Individuals approached for recruitment

时间窗: Through study completion, an average of 1 year

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)

时间窗: Post-treatment (~7 weeks)

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.

Mean number of sessions attended

时间窗: at study completion, approximately 4 years

A measure of feasibility via adherence.

Treatment dropout percentage

时间窗: at study completion, approximately 4 years

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.

次要结局

  • World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)(Baseline, Post-treatment (~7 weeks), 3-month Follow-up (~19 weeks))
  • Clinician-administered PTSD Scale for DSM-5 (CAPS-5) - Past Month Version(Baseline, Post-treatment (~7 weeks), 3-month Follow-up (~19 weeks))

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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