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

NCT07250061 · Boston University
In plain English

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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
About this study
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.
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
Study design
Enrollment target: 100 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-03-05
Estimated completion: 2028-03
Last updated: 2026-05-27
Interventions
Behavioral: Self-Help Cognitive Processing TherapyBehavioral: Women Veterans Network (WoVeN)Other: Treatment as Usual
Primary outcomes
  • Clinician assessed PTSD Symptoms (Pre intervention- baseline, Post intervention- 10 weeks, Follow-up- 28 weeks)
Sponsor
Boston University · other
With: National Institute of Mental Health (NIMH)
Contacts & investigators
ContactTara E Galovski, PhD · contact · Tara.Galovski@va.gov · (857) 364-4129
ContactLauren Mcsweeney, PhD · contact · Lauren.Mcsweeney@va.gov · (617) 480-0429
InvestigatorTara E Galovski, PhD · principal_investigator, BUCA School of Medicine, Psychiatry and VA Medical Center
All locations (1)
Fully online studyRecruiting
Boston, Massachusetts, United States
Self-Help Cognitive Processing Therapy (CPT)/Women Veterans Network (WoVeN) Study · TrialPath