Peer-led Trauma Recovery Program for Post-Traumatic Stress Disorder

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: York University

Disqualifiers: Suicidal behavior, Elevated BPD symptoms

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new peer-led program to help individuals cope with trauma related to having a loved one with borderline personality disorder (BPD). The Trauma Recovery Program is not therapy but a group support experience where participants learn to manage trauma-related beliefs and reactions. It is designed for those who have already completed the Family Connections program at The Sashbear Foundation. Participants should have experienced trauma due to their loved one's BPD. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to experience this innovative support program.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators for guidance.

What prior data suggests that this program is safe?

Research shows that trauma-focused treatments can help people with PTSD feel better and experience fewer symptoms. Many studies have found that participants often report improvements after these treatments. The specific Trauma Recovery Program (TRP) in this trial is new but builds on proven methods like cognitive processing therapy and cognitive behavioral conjoint therapy. These methods are generally well-received and have been shown to help people manage trauma-related symptoms. As this trial is in its early stages, the researchers are still learning about the full safety of the TRP. However, because it uses established therapeutic approaches, it could be a promising and safe option for participants. ^{1 2 3 4}

Why are researchers excited about this trial?

Researchers are excited about the Trauma Recovery Program because it offers a fresh approach to helping family members of people with borderline personality disorder (BPD) and emotion dysregulation who are experiencing PTSD. Unlike traditional therapies, which often require direct psychotherapy, this program is peer-led and operates as a support model, making it more accessible for participants. By focusing on cognitive processing therapy and cognitive behavioral conjoint therapy principles, it empowers individuals to learn and practice skills for challenging trauma-related beliefs, potentially leading to significant improvements in their trauma recovery journey. This peer-driven format not only fosters a supportive community but also encourages personal growth through shared experiences and collaborative learning.

What evidence suggests that this Trauma Recovery Program is effective for post-traumatic stress symptoms?

Research has shown that trauma-focused treatments can greatly reduce symptoms of post-traumatic stress disorder (PTSD). One study found that intensive therapy sessions conducted remotely effectively lessened PTSD symptoms. Another review highlighted improvements in current methods for managing trauma symptoms, supporting the success of new programs. In this trial, the Trauma Recovery Program, a peer-led group initiative, incorporates concepts from cognitive processing therapy to help change beliefs that hinder recovery. This approach, distinct from traditional therapy, aids participants in understanding and managing their reactions to trauma. It may be particularly beneficial for those affected by a loved one's borderline personality disorder. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for family members or significant others who have experienced trauma related to a loved one with Borderline Personality Disorder (BPD). Participants must have completed the Family Connections program at Sashbear and not engaged in self-harm or shown elevated BPD symptoms within the last year.

Inclusion Criteria

I have completed the Family Connections program at Sashbear for BPD.

You have experienced a traumatic event related to a loved one with BPD or related issues that still affects you.

Exclusion Criteria

Engagement in suicidal or self-injurious behaviour in the past year

I have symptoms of borderline personality disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Initial TRP Delivery and Feedback

Evaluation of the first delivery of the Trauma Response Program (TRP) at The Sashbear Foundation, including feedback from peer-facilitators and recipients.

7 weeks

3 visits (in-person or virtual)

Phase 2: Efficacy and Safety Evaluation

Evaluation of the efficacy, acceptability, and safety of the next two to four TRPs delivered at The Sashbear Foundation.

17 weeks

5 visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with measures taken at one and three months post-intervention.

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Trauma Recovery Program

Trial Overview The study tests a peer-led Trauma Recovery Program developed for those affected by someone with BPD. It involves feedback collection, efficacy evaluation, and safety assessment of the program delivered through The Sashbear Foundation.

How Is the Trial Designed?

Group I: Trauma Recovery Program (official title TBD) Experimental Treatment 1 Intervention

The trauma recovery program (TRP) is a seven-session, peer-led, group program for family members/significant others of people with borderline personality disorder (BPD) and emotion dysregulation. It draws on principles of cognitive processing therapy for PTSD and cognitive behavioural conjoint therapy for PTSD to target PTSD symptoms in these individuals that are related to having a loved one with BPD or emotion dysregulation. As a peer-support model, it is not a psychotherapy. The TRP involves learning about common reactions to trauma and learning methods of challenging trauma-related beliefs that inhibit trauma recovery. Group members are asked to practice exercises outside of sessions that focus on challenging beliefs that fall into several key trauma-related themes.

Who Is Running the Clinical Trial?

York University

Lead Sponsor

Trials

64

Recruited

521,000+

The Sashbear Foundation

Collaborator

Trials

3

Recruited

610+

Published Research Related to This Trial

In a study involving 291 adults with PTSD and/or substance use disorders, peer providers delivered the Seeking Safety (SS) program with similar effectiveness to licensed clinicians, showing non-inferiority in reducing PTSD symptoms and improving coping skills.

At 6 months, both peer-led and clinician-led groups experienced significant decreases in PTSD symptoms and increases in coping skills, suggesting that peer-delivered interventions could enhance access to mental health treatment, especially in underserved areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Peer-Delivered Trauma Treatment in a Rural Community: A Randomized Non-inferiority Trial. Crisanti, AS., Murray-Krezan, C., Reno, J., et al.[2020]

In a study of 172 patients with PTSD at a trauma center, those with private insurance, a high school diploma or higher, and more severe PTSD symptoms were more likely to participate in Trauma Recovery Services (TRS) programming, which aims to reduce PTSD symptoms and improve patient satisfaction.

Patients living further away from the TRS location were less likely to participate, suggesting that reducing travel distance could enhance participation in psychosocial programs for PTSD recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors influencing participation in psychosocial programming among orthopaedic trauma patients with PTSD. Furdock, RJ., Feldman, B., Sinkler, M., et al.[2022]

A pilot study involving 18 participants with probable PTSD showed that peer-delivered cognitive-behavioral therapy was feasible and highly acceptable, with participants reporting high satisfaction with the intervention.

The study found significant improvements in PTSD symptoms, as well as reductions in depressive, anxiety, and general stress symptoms, suggesting that peer support could effectively enhance access to mental health care in low-resource settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer delivery of a brief cognitive-behavioral treatment for posttraumatic stress disorder: A hybrid effectiveness-implementation pilot study. Smith, AM., Stewart, K., Baul, T., et al.[2023]

A pilot study evaluated a peer-led version of the Seeking Safety (SS) program for 18 women with co-occurring substance use disorder (SUD) and trauma-related issues, showing significant improvements in trauma symptoms, mental health, and coping skills.

Participants reported high satisfaction with the peer-led SS approach, indicating its potential as an effective intervention for those facing both SUD and trauma-related challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer-led seeking safety: results of a pilot outcome study with relevance to public health. Najavits, LM., Hamilton, N., Miller, N., et al.[2018]

The PTSD Recovery Program, which includes group therapy alongside individual therapy and medication, was effectively used to treat PTSD in 18 refugees over 10 weekly sessions, showing positive outcomes based on pre- and post-intervention questionnaires.

Qualitative data from participants indicated symptom improvement, and providers reported high satisfaction with the program, supporting its efficacy as an adjunctive treatment for PTSD in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a Veterans Affairs Posttraumatic Stress Disorder Group Therapy Program With Refugees. Haefner, J., Abedi, M., Morgan, S., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11504181/

The effectiveness of a remote intensive trauma-focused ... The results of this study demonstrate that a remote intensive trauma-focused treatment was effective in reducing PTSD symptoms and secondary outcomes.

2. ptsd.va.gov ptsd.va.gov/professional/articles/article-pdf/id1549479.pdf

Comparing the effectiveness of VA residential PTSD treatment ... Many MST survivors report exposure to other traumatic experiences, such as pre- and post-military interpersonal trauma and combat exposure (Creech and Orchowski ...

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A Review of PTSD and Current Treatment Strategies - PMC Current treatment strategies for control of trauma-associated symptoms of Post Traumatic Stress Disorder (PTSD) have recently been updated.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0272735824001557

Towards an understanding of readiness for trauma ... In this review we build a conceptual case for readiness for TFT. We use qualitative research exploring PTSD treatment service users' and providers' experiences.

5. bmjopen.bmj.com bmjopen.bmj.com/content/12/3/e051079

Interventions to treat post-traumatic stress disorder (PTSD) ... The goals of this study are to identify and analyse interventions that aim to treat post-traumatic stress disorder (PTSD) and complex PTSD in people who are ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10914157/

Implementation of a Stepped Care Program to Address ... Annually, over 600,000 adults served in US trauma centers (≥20%) develop posttraumatic stress disorder (PTSD) and/or depression in the first ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6624844/

Conceptualization, Assessment, and Treatment of ... Evidence indicates that the prevalence of posttraumatic stress disorder (PTSD) is substantially higher among first responders than the general population.

8. ptsd.va.gov ptsd.va.gov/professional/treat/cooccurring/ptsd_physical_health.asp

Trauma, PTSD, and Physical Health - PTSD: National ... Several studies have shown improvements in self-reported health symptoms following trauma-focused treatment for PTSD (e.g. 37-39) and on functioning (40,41).

9. research.va.gov research.va.gov/topics/ptsd.cfm

Posttraumatic Stress Disorder (PTSD) After the treatment, 91% of participants showed a significant reduction in their PTSD symptoms. top. ➤Other PTSD treatments. Present-centered therapy—Present- ...