Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06458933
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-05-23
Brief Title:
Sage A Couple Intervention for Borderline Personality Disorder
Sponsor:
York University
Organization:
York University
Study Overview
Official Title:
A Randomized Controlled Trial Testing Sage A Couple Intervention for Borderline Personality Disorder
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
Borderline personality disorder BPD is a life-threatening costly public health crisis affecting 1-3 of North Americans with 10 dying by suicide and annual healthcare costs of 63k Canadian Dollarspatient Further people with BPDs intimate relationships are highly disrupted and their partners report elevated mental health problems but little access to treatment Existing BPD treatments are resource-heavy inaccessible and 47 of people with BPD do not respond to them These treatments also neglect relationship problems and intimate partners mental health concerns even though they are thought to play a key role in BPD maintenance BPD interventions may produce stronger quicker and more durable outcomes if they incorporated partners to target both the emotional and relationship core of BPD Moreover incorporating partners into interventions may improve relationship outcomes and partner mental health without added resource investments
Accordingly members of our team developed Sage Named after a plant that thrives in relationship with its ecosystem Sage is a brief 12-session conjoint intervention for people with BPD and their intimate partners that targets BPD relationship conflict and partner mental health Our recent uncontrolled trial provides preliminary support for its efficacy
As a next step in testing Sage it is critical to utilize a Randomized Controlled Trial RCT design to identify if Sage is more efficacious than standard care that these couples typically receive supportive individual psychotherapy SIP for people with BPD and their partners The investigators propose to conduct the first RCT of Sage for couples wherein one member has BPD The study will examine if Sage is more efficacious than SIP in improving BPD symptoms primary outcome as well as relationship conflict and partner mental health secondary outcomes as well as a range of other outcomes from pre- to post-intervention and post-intervention to follow-up It will also investigate factors that influence treatment response BPD severity and related problems
Up to 152 couples wherein one member has BPD will be randomized to receive Sage or SIP Gold-standard measures of primary secondary and exploratory outcomes will be administered at baseline mid-intervention post-intervention and a one-month three- month and six-month follow-up
Accordingly members of our team developed Sage Named after a plant that thrives in relationship with its ecosystem Sage is a brief 12-session conjoint intervention for people with BPD and their intimate partners that targets BPD relationship conflict and partner mental health Our recent uncontrolled trial provides preliminary support for its efficacy
As a next step in testing Sage it is critical to utilize a Randomized Controlled Trial RCT design to identify if Sage is more efficacious than standard care that these couples typically receive supportive individual psychotherapy SIP for people with BPD and their partners The investigators propose to conduct the first RCT of Sage for couples wherein one member has BPD The study will examine if Sage is more efficacious than SIP in improving BPD symptoms primary outcome as well as relationship conflict and partner mental health secondary outcomes as well as a range of other outcomes from pre- to post-intervention and post-intervention to follow-up It will also investigate factors that influence treatment response BPD severity and related problems
Up to 152 couples wherein one member has BPD will be randomized to receive Sage or SIP Gold-standard measures of primary secondary and exploratory outcomes will be administered at baseline mid-intervention post-intervention and a one-month three- month and six-month follow-up
Detailed Description:
None
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