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

Phase I Interventional Posttraumatic Stress Disorder Family Members Spouses

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Trauma Recovery Program (official title TBD).
Who it may be relevant to
Registry conditions: Posttraumatic Stress Disorder, Family Members, Spouses. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • PTSD Checklist for DSM-5 [Time frame: Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).]
Secondary outcome measures (12)
  • Trauma Related Guilt Inventory (TRGI) [Time frame: Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).]
  • Generalized Anxiety Disorder 7 (GAD-7) [Time frame: Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).]
  • Patient Health Questionnaire- 9 (PHQ-9) [Time frame: Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).]
  • Burden Assessment Scale (BAS) [Time frame: Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).]
  • Perceived Stress Scale (PSS) [Time frame: Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).]
  • Experience of Shame Scale [Time frame: Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).]
  • Brief Coping Orientation to Problems Experienced Inventory (Brief-COPE) [Time frame: Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).]
  • Difficulties in Regulating Emotion Scale (DERS) [Time frame: Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).]
  • Single items from the WHOQOL-100 [Time frame: Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).]
  • Dyadic Adjustment Scale - 1 item [Time frame: Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).]
  • Ineffective Arguing Inventory [Time frame: Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).]
  • The Family Questionnaire [Time frame: Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • York University — Toronto

Identifiers

NCT: NCT06135090 · 4054

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗