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

Boston University

Status: Begins enrollment this month

Conditions: Posttraumatic Stress Disorder; Depression

Treatments: Other: Treatment as Usual; Behavioral: Women Veterans Network (WoVeN); Behavioral: Self-Help Cognitive Processing Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07250061

H-46292

1R34MH138605-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

Self-Help Cognitive Processing Therapy (shCPT)

Experimental group

Description:

Participants randomized to this arm will receive Cognitive Processing Therapy (CPT) and a self- help book.

Treatment:

Behavioral: Self-Help Cognitive Processing Therapy

Women Veterans Network (WoVeN) + self-help CPT (BOTH)

Experimental group

Description:

Participants randomized to this arm will receive Cognitive Processing Therapy by trained peer leaders from the Women Veterans Network (WoVeN).

Treatment:

Behavioral: Self-Help Cognitive Processing Therapy

Behavioral: Women Veterans Network (WoVeN)

Treatment as Usual (TAU)

Active Comparator group

Description:

Participants randomized to this arm will receive TAU.

Treatment:

Other: Treatment as Usual