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

Posttraumatic Stress Disorder Clinical Trial

Official title:

Development and Initial Testing of a Peer-Led Trauma-Focused Intervention for Significant Others of Individuals With Borderline Personality Disorder

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06135090
• Other study ID #: 4054
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: February 1, 2024
• Est. completion date: January 1, 2026

Study information

• Verified date: November 2023
• Source: York University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Family Members
• Personality Disorders
• Posttraumatic Stress Disorder
• Spouses
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Trauma Recovery Program (official title TBD)
See arm description

Locations

Country	Name	City	State
Canada	York University	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
York University	The Sashbear Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Trauma Related Guilt Inventory (TRGI)	This is a 32-item self- report measure that is designed to measure guilt experienced as a result of a traumatic event. It is composed of three subscales including guilt cognitions, distress, and global guilt.	Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).
Secondary	Generalized Anxiety Disorder 7 (GAD-7)	This is a 7-item self-report scale that assesses anxiety with excellent psychometric properties.	Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).
Secondary	Patient Health Questionnaire- 9 (PHQ-9)	This is a 9-item self-report questionnaire that assesses depression.	Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).
Secondary	Burden Assessment Scale (BAS)	This is a 19-item self- report questionnaire that assesses burden in caregivers of individuals with a close other with serious mental illness.	Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).
Secondary	Perceived Stress Scale (PSS)	This is a 10-item self- report questionnaire that assesses the degree to which individuals perceive life situations as stressful.	Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).
Secondary	Experience of Shame Scale	The is a 25-item self- report questionnaire that assesses feelings of embarrassment, self- consciousness, and shame.	Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).
Secondary	Brief Coping Orientation to Problems Experienced Inventory (Brief-COPE)	The is a 28-item self- report questionnaire that assesses coping styles in response to hardship.	Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).
Secondary	Difficulties in Regulating Emotion Scale (DERS)	This is a 36-item self- report scale measuring emotion dysregulation.	Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).
Secondary	Single items from the WHOQOL-100	3 items from the 100-item self-report questionnaire will be used to measure perceived health, work functioning, and quality of life	Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).
Secondary	Dyadic Adjustment Scale - 1 item	1 item from this self- report measure will be used to assess satisfaction with the relationship with one's close other with BPD/emotion dysregulation	Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).
Secondary	Ineffective Arguing Inventory	This is an 8-item self- report measure that assesses the quality of arguments between the individual in the study and their close other with BPD/emotion dysregulation.	Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).
Secondary	The Family Questionnaire	This is a 20-item measure that assesses expressed emotion in the context of having a close other with serious mental illness.	Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).
Secondary	Posttraumatic Growth Inventory	This is a 21-item measure that assesses growth and self-improvement that follows a stressful encounter.	Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).
Secondary	Self Compassion Scale-Short form	This is a 12-item self- report questionnaire that assesses one's self- compassion.	Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).
Secondary	Brief Resilience Scale	This is a 5-item self-report measure that assesses the ability to bounce back from stressors.	Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).
Secondary	Posttraumatic Cognitions Inventory-self blame subscale	This is a 5-item subscale that examines the extent to which people feel self- blame for traumatic experiences	Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).
Secondary	PANAS-hostility scale	Six items measuring past week anger/hostility.	Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).
Secondary	Client Satisfaction Questionnaire	This is an 8-item scale examining the extent to which people feel satisfied with the program they received	7 weeks