100 Participants NeededMy employer runs this trial

Self-Help Cognitive Processing Therapy for Post-Traumatic Stress Disorder

TE
LM
Overseen ByLauren Mcsweeney, PhD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Boston University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a self-help version of Cognitive Processing Therapy (CPT) can effectively reduce PTSD symptoms in women who have served in the U.S. military. The study will also explore whether combining this self-help approach with a peer support program called the Women Veterans Network (WoVeN) enhances its benefits. Participants will join one of three groups: self-help CPT alone, self-help CPT with WoVeN, or treatment as usual. Women veterans diagnosed with full or subthreshold PTSD who can read English may be eligible. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve PTSD treatments for women veterans.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, you cannot be receiving an evidence-based therapy for PTSD at the time of screening.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Past research has shown that Cognitive Processing Therapy (CPT) effectively reduces PTSD symptoms. Participants who received CPT reported improvements in PTSD, depression, and anxiety, with these benefits often lasting a year or more after treatment. Importantly, CPT is generally manageable, with few serious side effects reported.

For the self-help version of CPT being tested, specific information is limited. However, since it is based on the same principles as traditional CPT, it is expected to be similarly safe. The self-help format may also reduce costs and the need for therapist visits, making it more accessible.

The Women Veterans Network (WoVeN) aims to support mental well-being. Although limited safety data exists on combining WoVeN with self-help CPT, WoVeN itself fosters a sense of belonging and connection, particularly for women with PTSD. This peer support program is considered safe and can enhance the benefits of self-help CPT.

Overall, both treatments are based on well-established methods, suggesting they are likely safe and manageable.12345

Why are researchers excited about this trial?

Researchers are excited about Self-Help Cognitive Processing Therapy (shCPT) because it empowers individuals with PTSD to take charge of their own healing process using a self-guided approach. Unlike traditional treatments that require clinician-led sessions, shCPT provides participants with a self-help book, enabling them to engage with therapy at their own pace and convenience. This method can increase accessibility and reduce barriers to treatment, especially for those who may not have easy access to regular therapy sessions. Additionally, the involvement of trained peer leaders from the Women Veterans Network (WoVeN) in one of the trial arms adds a supportive community element that can enhance the therapeutic experience and potentially improve outcomes.

What evidence suggests that this trial's treatments could be effective for PTSD?

Research has shown that Cognitive Processing Therapy (CPT) can reduce PTSD symptoms, with many patients experiencing significant improvements. In this trial, participants may receive a self-help version of CPT, designed for individual use. Another group will receive CPT combined with support from the Women Veterans Network (WoVeN), a peer support program that helps women veterans feel connected and supported. This combination might improve PTSD symptoms and mental well-being by addressing both personal and community needs. However, further research is needed to confirm the effectiveness of these self-help approaches.12356

Who Is on the Research Team?

TE

Tara E Galovski, PhD

Principal Investigator

BUCA School of Medicine, Psychiatry and VA Medical Center

Are You a Good Fit for This Trial?

This trial is for women who have served in the U.S. military, can read English, and have either full or partial PTSD. Participants must be able to complete study questionnaires.

Inclusion Criteria

I identify as a woman.
I have served in the United States military.
I have been diagnosed with full or partial PTSD.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Open Trial

An open trial involving 6 women will pilot the BOTH condition to refine the study

Not specified

Treatment

Participants receive either self-help CPT, WoVeN + self-help CPT, or treatment as usual

10 weeks
Weekly surveys

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 weeks
3 major assessments (baseline, post-treatment, three month follow-up)

What Are the Treatments Tested in This Trial?

Interventions

  • Self-Help Cognitive Processing Therapy
  • Women Veterans Network (WoVeN)

Trial Overview

The study compares a self-help version of Cognitive Processing Therapy (CPT), a peer support program called WoVeN, and usual care to see which best helps women veterans with PTSD or depression improve their mental well-being.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: Women Veterans Network (WoVeN) + self-help CPT (BOTH)Experimental Treatment2 Interventions
Group II: Self-Help Cognitive Processing Therapy (shCPT)Experimental Treatment1 Intervention
Group III: Treatment as Usual (TAU)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston University

Lead Sponsor

Trials
494
Recruited
9,998,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

Citations

Cognitive Processing Therapy for PTSD

Those participants who received CPT demonstrated significantly more improvement in PTSD symptoms, depression, anxiety, guilt and social adjustment. Forty ...

Effectiveness of Cognitive Processing Therapy for PTSD in ...

This study provides promising data on the outcomes associated with a modified CPT protocol for treating PTSD in a high need but under-treated SMI population.

Comparison of Prolonged Exposure vs Cognitive Processing ...

Prolonged exposure was more effective than cognitive processing therapy for reducing PTSD symptoms, but the difference between treatments did not reach the ...

Cognitive behavioral therapy (CBT) for adult posttraumatic ...

A multisite randomized controlled effectiveness trial of cognitive processing therapy for military-related posttraumatic stress disorder. Journal of Anxiety ...

Cognitive Processing Therapy Versus Prolonged Exposure ...

This study will evaluate the effectiveness of cognitive processing therapy versus prolonged exposure therapy in treating women with post-traumatic stress ...

State of the Science of Cognitive Processing Therapy

CPT prioritizes thoughts about the trauma itself, and the second half of CPT attends to more generalized beliefs about self and others around themes of safety, ...