Self-Help Cognitive Processing Therapy (CPT)/Women Veterans Network (WoVeN) Study

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Behavioral Self-Help Cognitive Processing Therapy
  Participants will be given a copy of the CPT self-help book that guides the trauma survivor through the same CPT protocol that is typically delivered by a therapist but supplemented with significant additional guidance and suggestions to aid the survivor in their journey toward recovery. This 10-week program also provides links to educational videos, fillable worksheets, and resources for the individual if they would like to seek additional care
• Behavioral Women Veterans Network (WoVeN)
  Participants will complete the CPT self-help book while also enrolled in a WoVeN group. WoVeN is a national, peer support network with groups led by women veterans, for women veterans. During this 8-week program, Peer Leaders who are trained by national experts in the WoVeN curriculum conduct weekly groups. Groups consist of approximately 4-8 women veterans, each lasting about 90 minutes, and focus on relevant themes such as life transitions, balance, hope, connections, trust, and esteem.
• Other Treatment as Usual
  Participants will receive psychoeducation about PTSD and different treatment options using the materials developed by the VA National Center for PTSD. They will also be provided with a referral list with guidance and suggestions and assistance in navigating the list and the referral process. All interventions must be completed within 10 weeks.

Primary outcome measures

• Clinician assessed PTSD Symptoms [Time frame: Pre intervention- baseline, Post intervention- 10 weeks, Follow-up- 28 weeks]

Secondary outcome measures (5)

• Self reported depression [Time frame: Pre intervention- baseline, Post intervention- 10 weeks, Follow-up- 28 weeks]
• Mental well being [Time frame: Pre intervention- baseline, Post intervention- 10 weeks, Follow-up- 28 weeks]
• Self reported PTSD [Time frame: Pre intervention- baseline, Post intervention- 10 weeks, Follow-up- 28 weeks]
• Belongingness [Time frame: Pre intervention- baseline, Post intervention- 10 weeks, Follow-up- 28 weeks]
• Trauma Related Cognitions [Time frame: Pre intervention- baseline, Post intervention- 10 weeks, Follow-up- 28 weeks]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Fully online study — Boston

Identifiers

NCT: NCT07250061 · H-46292 · 1R34MH138605-01A1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗