A Phase 1 interventional study of Trauma Recovery Program (official title TBD) in Posttraumatic Stress Disorder, Family Members and Spouses, sponsored by York University. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by York University · Phase 1, Interventional, and Treatment
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).
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.
2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.
This study's planned enrollment of 60 is below the median of 69 across 2,196 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →York University is the lead sponsor of 51 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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)
See arm description
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).
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).
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).
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).
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).
Perceived Stress Scale (PSS)
This is a 10-item self- report questionnaire that assesses the degree to which individuals perceive life situations as stressful.
Time frame: Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).
Experience of Shame Scale
The is a 25-item self- report questionnaire that assesses feelings of embarrassment, self- consciousness, and shame.
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)
The is a 28-item self- report questionnaire that assesses coping styles in response to hardship.
Time frame: Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).
Difficulties in Regulating Emotion Scale (DERS)
This is a 36-item self- report scale measuring emotion dysregulation.
Time frame: Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).
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
Time frame: Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).
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
Time frame: Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).
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.
Time frame: Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).
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.
Time frame: Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).
Posttraumatic Growth Inventory
This is a 21-item measure that assesses growth and self-improvement that follows a stressful encounter.
Time frame: Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).
Self Compassion Scale-Short form
This is a 12-item self- report questionnaire that assesses one's self- compassion.
Time frame: Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).
Brief Resilience Scale
This is a 5-item self-report measure that assesses the ability to bounce back from stressors.
Time frame: Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).
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
Time frame: Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).
PANAS-hostility scale
Six items measuring past week anger/hostility.
Time frame: Baseline, 3-4 weeks, 7 weeks, 13 weeks (phase 2 only), 17 weeks (phase 2 only).
Client Satisfaction Questionnaire
This is an 8-item scale examining the extent to which people feel satisfied with the program they received
Time frame: 7 weeks
Plan to share: Yes — Data from Phase 2 will be de-identified and posted on an online and public data repository in order to promote integrity of the research and allow other researchers to replicate our findings using this data.
Supporting information: Analytic code
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Jan 2028, 15 months later.
Of 47 non-industry phase 1 interventional studies under Stress Disorders, Post-Traumatic, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 59. This study's planned 15 months is below that.
Counting every sponsor, half of 52 studies reached it within 33 months; a quarter within 17 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Stress Disorders, Post-Traumatic →
York University