Testing a Peer-led Trauma-focused Intervention for Significant Others of Those With BPD

NCT06135090 | Unknown Phase 1 DMC

• 1 other identifier: 4054
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This project involves developing and piloting a peer-led intervention focused on posttraumatic stress symptoms for the family members and significant others of people with borderline personality disorder. The project involves collaborating with The Sashbear Foundation who will be delivering the trauma response program (TRP) that was developed by the investigative team to its network. In phase 1 of this project, the investigators will evaluate the first delivery of the TRP at The Sashbear Foundation and solicit feedback from peer-facilitators and recipients who consent to research participation. In phase 2 of this project, the investigators will evaluate the efficacy, acceptability, and safety of the delivery of the next two to four TRPs delivered at The Sashbear Foundation consisting of up to approximately 10 group members (maximum number of TRP recipient research participants in phase 2 is 40).

Conditions

Posttraumatic Stress Disorder; Family Members; Spouses

Keywords

Posttraumatic stress disorder; Borderline personality disorder; Peer-support; Family members; Significant others

Outcome Measures

Primary Outcomes (1)

• PTSD Checklist for DSM-5

  This 20-item measure assesses post-traumatic stress symptoms

  Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).

Secondary Outcomes (18)

• Trauma Related Guilt Inventory (TRGI)

  Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).

• Generalized Anxiety Disorder 7 (GAD-7)

  Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).

• Patient Health Questionnaire- 9 (PHQ-9)

  Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).

• Burden Assessment Scale (BAS)

  Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).

• Perceived Stress Scale (PSS)

  Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).

Study Arms (1)

Trauma Recovery Program (official title TBD)

EXPERIMENTAL

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.

Behavioral: Trauma Recovery Program (official title TBD)

Interventions

Trauma Recovery Program (official title TBD) BEHAVIORAL

See arm description

Trauma Recovery Program (official title TBD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-identify as having experienced a trauma related to their loved one with BPD or related problems that impacts them
• Has previously received the Family Connections program at Sashbear (i.e., a peer-led intervention that teaches family members skills for managing their relationships with their loved one with BPD and related problems)

You may not qualify if:

• Engagement in suicidal or self-injurious behaviour in the past year
• Elevated BPD symptoms

Sponsors & Collaborators

• York University: lead
• The Sashbear Foundation: collaborator

Study Sites (1)

York University

Toronto, Ontario, M9A 3C8, Canada

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Personality Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: This is a single arm, uncontrolled design. Thus, no masking to intervention allocation is possible.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 18, 2023
• Study Start: February 1, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE

Locations

CA (1)