Clinical trial NCT06135090: Testing a Peer-led Trauma-focused Intervention for Significant Others of Those With BPD
Official title: Development and Initial Testing of a Peer-Led Trauma-Focused Intervention for Significant Others of Individuals With Borderline Personality Disorder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Posttraumatic Stress Disorder
Family Members
Spouses
Keywords: Posttraumatic stress disorder
Borderline personality disorder
Peer-support
Family members
Significant others
Lead sponsor: York University
Sponsor class: OTHER
Collaborators: name: The Sashbear Foundation
First posted: 2023-11-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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).

Detailed description: Borderline Personality Disorder (BPD) is a severe mental illness characterized by intense conflict and instability in interpersonal relationships, emotion dysregulation and inappropriate anger, chronic feelings of emptiness, impulsivity, and self-injury with suicidal or non-suicidal intent. Significant others of people with BPD such as family members, friends, and intimate partners, find self-injury intensely distressing and traumatizing. Perhaps as a result, approximately two thirds of significant others of people with BPD report desiring mental health support for themselves, but not being able to access any. A recent needs assessment conducted by the investigative team involving 157 significant others of people with borderline personality disorder (BPD) suggested that 85.7% of significant others reported having traumatic experiences related to their loved one with BPD and 48.7% exhibited clinically significant posttraumatic stress disorder (PTSD) symptoms. Further, 94.8% of these individuals reported desiring an intervention focused on reducing PTSD symptoms and related phenomena. However, no interventions for significant others focused on trauma currently exist. Therefore, the investigative team collaborated to develop a peer-led, trauma-focused intervention for significant others of people with BPD and emotion dysregulation. The Sashbear Foundation is a non-profit organization that currently delivers over 1000 peer-led groups for significant others of people with BPD and related problems per year focused on education and skills to support those with BPD. The Sashbear Foundation intends to deliver the trauma response program (TRP) that was developed by the investigative team to its network, and members of the investigative team intend to provide training and consultation to members of the Sashbear Foundation regarding the delivery of TRP.

This project involves members of the investigative team providing training/consultation to members of the Sashbear Foundation, regarding the optimal delivery of TRP. It also involves an evaluation of up to the first five TRP administrations that the Sashbear Foundation is delivering. In phase 1 of this project, the investigative team 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. This feedback will be used to refine the TRP manual. Recipients receiving the first TRP group at The Sashbear Foundation will specifically be invited to participate in this research which involves completing measures of PTSD, other mental health and wellness outcomes, and intervention satisfaction. These measures will be administered at baseline, the half-way point, and at the end of the intervention. TRP recipients will also be invited to complete exit interviews at the end of the intervention. Feedback regarding the manual will also be informally-solicited from peer-facilitators throughout intervention delivery, leading to refinement of the intervention.

In phase 2 of this project, the investigative team 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). TRP recipients at The Sashbear Foundation who consent to participate in research procedures will complete measures of PTSD, other mental health and wellness outcomes, and intervention satisfaction. These measures will be administered at baseline, the half-way point, the end of intervention, one month after the end of intervention, and three months after the end of intervention. Phase 1 and Phase 2 TRP peer-facilitators will also be invited to complete exit interviews with the research team following the end of the intervention to capture their experiences administering TRPs.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

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

Primary outcomes:
measure: PTSD Checklist for DSM-5
timeFrame: Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).
Secondary outcomes:
measure: Trauma Related Guilt Inventory (TRGI)
timeFrame: Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).
measure: Generalized Anxiety Disorder 7 (GAD-7)
timeFrame: Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).
measure: Patient Health Questionnaire- 9 (PHQ-9)
timeFrame: Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).
measure: Burden Assessment Scale (BAS)
timeFrame: Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).
measure: Perceived Stress Scale (PSS)
timeFrame: Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).
measure: Experience of Shame Scale
timeFrame: Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).
measure: Brief Coping Orientation to Problems Experienced Inventory (Brief-COPE)
timeFrame: Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).
measure: Difficulties in Regulating Emotion Scale (DERS)
timeFrame: Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).
measure: Single items from the WHOQOL-100
timeFrame: Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).
measure: Dyadic Adjustment Scale - 1 item
timeFrame: Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).
measure: Ineffective Arguing Inventory
timeFrame: Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).
measure: The Family Questionnaire
timeFrame: Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).
measure: Posttraumatic Growth Inventory
timeFrame: Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).
measure: Self Compassion Scale-Short form
timeFrame: Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).
measure: Brief Resilience Scale
timeFrame: Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).
measure: Posttraumatic Cognitions Inventory-self blame subscale
timeFrame: Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).
measure: PANAS-hostility scale
timeFrame: Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).
measure: Client Satisfaction Questionnaire
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: York University
state: Ontario
Study officials:
References: