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

NCT07250061 | Not Yet Recruiting

• 2 other identifiers: H-462921R34MH138605-01A1
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Posttraumatic Stress Disorder; Depression

Keywords

Mental well being; Self help cognitive processing therapy; Peer support program; Quality of life; Loneliness; Women Veterans Network

Outcome Measures

Primary Outcomes (1)

• Clinician assessed PTSD Symptoms

  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.

  Pre intervention- baseline, Post intervention- 10 weeks, Follow-up- 28 weeks

Secondary Outcomes (5)

• 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

Study Arms (3)

Self-Help Cognitive Processing Therapy (shCPT)

EXPERIMENTAL

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

Behavioral: Self-Help Cognitive Processing Therapy

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

EXPERIMENTAL

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

Behavioral: Self-Help Cognitive Processing Therapy; Behavioral: Women Veterans Network (WoVeN)

Treatment as Usual (TAU)

ACTIVE COMPARATOR

Participants randomized to this arm will receive TAU.

Other: Treatment as Usual

Interventions

Self-Help Cognitive Processing Therapy BEHAVIORAL

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

Also known as: shCPT

Self-Help Cognitive Processing Therapy (shCPT); Women Veterans Network (WoVeN) + self-help CPT (BOTH)

Women Veterans Network (WoVeN) BEHAVIORAL

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.

Also known as: BOTH

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

Treatment as Usual OTHER

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.

Also known as: TAU

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University: lead
• National Institute of Mental Health (NIMH): collaborator

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression; Psychological Well-Being

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Personal Satisfaction

Study Officials

• Tara E Galovski, PhD

  BUCA School of Medicine, Psychiatry and VA Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tara E Galovski, PhD

CONTACT

(857) 364-4129; Tara.Galovski@va.gov

Lauren Mcsweeney, PhD

CONTACT

(617) 480-0429; Lauren.Mcsweeney@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A three-arm, randomized, controlled clinical trial will be conducted with a national sample of women veterans who suffer from PTSD.

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 26, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share