Self-Help Cognitive Processing Therapy (CPT)/Women Veterans Network (WoVeN) Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorBoston University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Self-Help Cognitive Processing Therapy
BehavioralParticipants 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
Women Veterans Network (WoVeN)
BehavioralParticipants 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.
Treatment as Usual
Other interventionParticipants 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.
Treatment groups
100 Participants
are divided into 3 treatment groupsGroup A: Self-Help Cognitive Processing Therapy (shCPT)Experimental treatment 1 intervention
Group B: Women Veterans Network (WoVeN) + self-help CPT (BOTH)Experimental treatment 2 interventions
Group C: Treatment as Usual (TAU)Active comparator 1 intervention
Trial outcomes
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.
Time frame
Pre intervention- baseline, Post intervention- 10 weeks, Follow-up- 28 weeksSecondary outcomes
1
Self reported depression
This outcome will be assessed with the Patient Health Questionnaire-9 (PHQ-9) which is a a 9-item brief assessment of current depressive symptoms using a 4-point Likert scale from 0 (not at all) to 3 (nearly every day). The final score is a total severity score that can range from 0 to 27 with higher scores indicating more severe depression symptoms.
Time frame
Pre intervention- baseline, Post intervention- 10 weeks, Follow-up- 28 weeks2
Mental well being
This outcome will be assessed with the Ryff's Psychological Well-Being Scale which is a 42 item self-report assessment that measures 6 aspects of well-being and happiness including autonomy, environmental mastery, personal growth, positive relationships with others, purpose in life, and self-acceptance on a Likert scale from 1 (strongly agree) to 7 (strongly disagree). A higher score on a subscale indicates a greater degree of well-being in that area.
Time frame
Pre intervention- baseline, Post intervention- 10 weeks, Follow-up- 28 weeks3
Self reported PTSD
This outcome will be assessed with the PTSD Checklist -DSM-5 (PCL-5), a 20-item assessment of the respondent's reactions to a potentially traumatic experience, according to the DSM-5 symptom criteria for PTSD. The PCL-5 uses a 5-point Likert scale from 0 (not at all) to 4 (extremely). This results in a total symptom severity score ranging from 0 to 80, with higher scores indicating more severe symptoms.
Time frame
Pre intervention- baseline, Post intervention- 10 weeks, Follow-up- 28 weeks4
Belongingness
This outcome will be assessed with the The General Belongingness Scale (GBS) a 12-item scale that assesses general feelings of belonging on a Likert scale of 1= strongly disagree to 7= strongly agree. Six items are included on the acceptance/inclusion subscale and the other six load onto the rejection/exclusion subscale. The total score ranges from 12 to 84, with higher scores indicating a greater sense of belonging
Time frame
Pre intervention- baseline, Post intervention- 10 weeks, Follow-up- 28 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Boston University
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov