Posttraumatic Stress DisorderNCT07250061
Self-Help Cognitive Processing Therapy (CPT)/Women Veterans Network (WoVeN) Study
A study testing Self-Help Cognitive Processing Therapy, Women Veterans Network (WoVeN) and Treatment as Usual in people with Posttraumatic Stress Disorder and Depression, run by Boston University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Posttraumatic Stress Disorder, Depression
- What is being tested?
- Self-Help Cognitive Processing Therapy, Women Veterans Network (WoVeN) and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2026to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fully online study
Boston, Massachusetts, 02118
Tara E Galovski, PhD, 857-364-4129, Tara.Galovski@va.gov
About this 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
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.
Read the 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.
- Conditions
- Posttraumatic Stress Disorder, Depression
- Being tested
- Self-Help Cognitive Processing Therapy, Women Veterans Network (WoVeN), Treatment as Usual
- Keywords
- Mental well being, Self help cognitive processing therapy, Peer support program, Quality of life, Loneliness, Women Veterans Network
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Help Cognitive Processing TherapyBehavioural
Also called shCPT
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
Women Veterans Network (WoVeN)Behavioural
Also called BOTH
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.
Treatment as UsualOther
Also called TAU
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.
| Study group | Role | What they receive |
|---|---|---|
| Self-Help Cognitive Processing Therapy (shCPT) | Experimental | Participants randomized to this arm will receive Cognitive Processing Therapy (CPT) and a self- help book. Receives: 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). Receives: 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. Receives: Other: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre intervention- baseline, Post intervention- 10 weeks, Follow-up- 28 weeks
Secondary outcomes (5)
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.
Measured: Pre intervention- baseline, Post intervention- 10 weeks, Follow-up- 28 weeks
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.
Measured: Pre intervention- baseline, Post intervention- 10 weeks, Follow-up- 28 weeks
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.
Measured: Pre intervention- baseline, Post intervention- 10 weeks, Follow-up- 28 weeks
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
Measured: Pre intervention- baseline, Post intervention- 10 weeks, Follow-up- 28 weeks
Trauma Related Cognitions
This outcome will be assessed with the Posttraumatic Cognitions Inventory - 9 item (PTCI-9) which is a 33 item assessment of trauma-related thoughts and beliefs. The assessment yields 3 subscales, negative thoughts of self, negative thoughts about the world, and self-blame. Higher total scores and subscale scores indicate a greater endorsement of negative post-traumatic cognitions.
Measured: Pre intervention- baseline, Post intervention- 10 weeks, Follow-up- 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start5 Mar 2026
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A three-arm, randomized, controlled clinical trial will be conducted with a national sample of women veterans who suffer from PTSD.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Tara E Galovski, PhD, Principal investigator, BUCA School of Medicine, Psychiatry and VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07250061
- Sponsor's protocol ID
- H-46292
- Other IDs
- 1R34MH138605-01A1
- Status last verified
- May 2026
- First submitted
- 18 Nov 2025
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07250061
- Acronym / sponsor ID
- H-46292
- Conditions
- Posttraumatic Stress Disorder, Depression
- Keywords
- Mental well being, Self help cognitive processing therapy, Peer support program, Quality of life, Loneliness, Women Veterans Network
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 5 Mar 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A three-arm, randomized, controlled clinical trial will be conducted with a national sample of women veterans who suffer from PTSD.
| Arm | Type | Receives |
|---|---|---|
| Self-Help Cognitive Processing Therapy (shCPT) | Experimental | Behavioral: Self-Help Cognitive Processing TherapyParticipants randomized to this arm will receive Cognitive Processing Therapy (CPT) and a self- help book. |
| Women Veterans Network (WoVeN) + self-help CPT (BOTH) | Experimental | Behavioral: Self-Help Cognitive Processing Therapy, Behavioral: Women Veterans Network (WoVeN)Participants randomized to this arm will receive Cognitive Processing Therapy by trained peer leaders from the Women Veterans Network (WoVeN). |
| Treatment as Usual (TAU) | Active comparator | Other: Treatment as UsualParticipants randomized to this arm will receive TAU. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Help Cognitive Processing TherapyAlso: shCPTParticipants 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 | Behavioural | Self-Help Cognitive Processing Therapy (shCPT), Women Veterans Network (WoVeN) + self-help CPT (BOTH) |
| Women Veterans Network (WoVeN)Also: BOTHParticipants 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. | Behavioural | Women Veterans Network (WoVeN) + self-help CPT (BOTH) |
| Treatment as UsualAlso: TAUParticipants 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. | Other | Treatment as Usual (TAU) |
Primary outcome
Clinician assessed PTSD Symptoms
Time frame: Pre intervention- baseline, Post intervention- 10 weeks, Follow-up- 28 weeks
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tara E Galovski, PhD principal investigator
BUCA School of Medicine, Psychiatry and VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Help Cognitive Processing Therapy, Women Veterans Network (WoVeN) and Treatment as Usual in people with Posttraumatic Stress Disorder and Depression, run by Boston University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tara E Galovski, PhD ((857) 364-4129, Tara.Galovski@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician assessed PTSD Symptoms (time frame: Pre intervention- baseline, Post intervention- 10 weeks, Follow-up- 28 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.