Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06135090
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-18
First Post:
2023-11-06
Brief Title:
Testing a Peer-led Trauma-focused Intervention for Significant Others of Those With BPD
Sponsor:
York University
Organization:
York University
Study Overview
Official Title:
Development and Initial Testing of a Peer-Led Trauma-Focused Intervention for Significant Others of Individuals With Borderline Personality Disorder
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 857 of significant others reported having traumatic experiences related to their loved one with BPD and 487 exhibited clinically significant posttraumatic stress disorder PTSD symptoms Further 948 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 trainingconsultation 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
This project involves members of the investigative team providing trainingconsultation 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None