Augmenting Cognitive Processing Therapy With a Peer Led Support Intervention to Improve Well-Being: A Sustainable and Scalable Model for Enhancing PTSD Recovery in Vulnerable Populations
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Clinician assessed PTSD Symptoms
研究概览
简要总结
Posttraumatic stress disorder (PTSD) can have significant impairment on aspects of mental well-being (MWB) including functioning, loneliness, physical health, and quality of life. There are several evidence-based treatments (EBPs) effective in treating PTSD such as Cognitive Processing Therapy (CPT) which is a specific type of cognitive behavioral therapy that has been proven effective in reducing symptoms of PTSD. However, there are several barriers (e.g., lack of providers, waitlists, costs, stigma, disabilities that complicate travel) that can prevent someone from engaging with these treatments. Recently, a self-help version of CPT was created to help address these barriers; but little research has been conducted to test its efficacy. Further, less is know about how a peer support program may augment improvements from participating in an EBP. The Women Veteran Network (WoVeN), a peer support program designed for women veterans, has a manualized 8-week program that directly targets MWB. It has been found to help foster belongingness and connectedness, particularly in those suffering from PTSD and depression.
The present study aims to establish the feasibility, acceptability and tolerability of a scalable, sustainable, and effective treatment option for trauma survivors with subthreshold or full PTSD. The overarching goal is to understand the effectiveness of a self-help version of an EBP (either alone or in combination with a peer support program) in reducing PTSD symptoms while also helping improve mental well-being, reduce barriers, and increase access to quality care within health disparity populations.
详细描述
The design for this study is a three-arm, randomized, controlled clinical trial (RCT) with a national sample of women veterans who suffer from PTSD. Participants will be recruited from WoVeN and from the women veteran population. Treatment conditions will be 1.) self-help CPT only (shCPT), 2.) concurrent WoVeN + self-help CPT (BOTH), or 3.) referral + treatment as usual (TAU). All treatments must be completed within 10 weeks. Ninety women will be randomized in a 1:1:1 ratio across the three treatment conditions. Patient participants will be asked to complete three major assessments (baseline, post-treatment, three month follow up) that consist of a structured interview and questionnaire. These major assessment will take ~2.5 hours to complete. Participants will also be asked to complete weekly surveys that will help monitor ongoing progress engagement with the intervention. Before the RCT launches, an open trial involving 6 women will pilot the BOTH condition. Information gathered from this will be used to refine the study before recruiting more women.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Identifies as a woman
- •Has served in the United States military
- •A full or subthreshold (meets criteria for 2 out of 4 of the symptom clusters for PTSD) Post Traumatic Stress Disorder (PTSD) diagnosis
- •Able to read English well enough to complete study questionnaires
排除标准
- •Clinician judgment that the participant is not appropriate for self-help level of care for PTSD (i.e., recent psychiatric hospitalization, requires detox, volatile, active suicidality)
- •Current psychosis or unstable bipolar disorder (determined during baseline interview as described in screening and enrollment procedures)
- •Must not have participated in a WoVeN group within the last year
- •Must not be receiving an evidenced-based therapy for PTSD at the time of the screening
研究组 & 干预措施
Treatment as Usual (TAU)
Participants randomized to this arm will receive TAU.
干预措施: Treatment as Usual (Other)
Self-Help Cognitive Processing Therapy (shCPT)
Participants randomized to this arm will receive Cognitive Processing Therapy (CPT) and a self- help book.
干预措施: Self-Help Cognitive Processing Therapy (Behavioral)
Women Veterans Network (WoVeN) + self-help CPT (BOTH)
Participants randomized to this arm will receive Cognitive Processing Therapy by trained peer leaders from the Women Veterans Network (WoVeN).
干预措施: Self-Help Cognitive Processing Therapy (Behavioral)
Women Veterans Network (WoVeN) + self-help CPT (BOTH)
Participants randomized to this arm will receive Cognitive Processing Therapy by trained peer leaders from the Women Veterans Network (WoVeN).
干预措施: Women Veterans Network (WoVeN) (Behavioral)
结局指标
主要结局
Clinician assessed PTSD Symptoms
时间窗: Pre intervention- baseline, Post intervention- 10 weeks, Follow-up- 28 weeks
This outcome will be assessed with the Clinician-Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Illnesses (DSM-5) (CAPS-5). It obtains information about frequency and intensity for the 20 PTSD symptoms using a 5-point ordinal scale from 0 (absent) to 4 (extreme/incapacitating), based on the patient's frequency and intensity of the symptom. The final score is a total severity score that can range from 0 to 80 with higher scores indicating more severe PTSD symptoms.
次要结局
- Belongingness(Pre intervention- baseline, Post intervention- 10 weeks, Follow-up- 28 weeks)
- Trauma Related Cognitions(Pre intervention- baseline, Post intervention- 10 weeks, Follow-up- 28 weeks)
- Self reported depression(Pre intervention- baseline, Post intervention- 10 weeks, Follow-up- 28 weeks)
- Mental well being(Pre intervention- baseline, Post intervention- 10 weeks, Follow-up- 28 weeks)
- Self reported PTSD(Pre intervention- baseline, Post intervention- 10 weeks, Follow-up- 28 weeks)
- Belongingness(Pre intervention- baseline, Post intervention- 10 weeks, Follow-up- 28 weeks)
- Trauma Related Cognitions(Pre intervention- baseline, Post intervention- 10 weeks, Follow-up- 28 weeks)