Testing a Peer-led Trauma-focused Intervention for Significant Others of Those With BPD
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorYork University
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Engagement in suicidal or self-injurious behaviour in the past year
Elevated BPD symptoms
Trial design
Design model
Single group
Treatments tested in this trial
Trauma Recovery Program (official title TBD)
BehavioralSee arm description
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Trauma Recovery Program (official title TBD)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
PTSD Checklist for DSM-5
This 20-item measure assesses post-traumatic stress symptoms
Time frame
Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).Secondary outcomes
1
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.
Time frame
Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).2
Generalized Anxiety Disorder 7 (GAD-7)
This is a 7-item self-report scale that assesses anxiety with excellent psychometric properties.
Time frame
Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).3
Patient Health Questionnaire- 9 (PHQ-9)
This is a 9-item self-report questionnaire that assesses depression.
Time frame
Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).4
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.
Time frame
Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).Sponsors and contacts
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York University
Lead sponsor
The Sashbear Foundation
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: