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Development and Initial Testing of a Couple-Based Intervention to Optimize Suicide and Self-Injury Treatment: COMPASS (Connecting, Overcoming, and Moving Past Suicide and Self-Injury) (COMPASS)

Primary Purpose

Self-injurious Thoughts and Behaviours, Borderline Personality Disorder

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Sage (formerly known as COMPASS)
Sponsored by
York University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Self-injurious Thoughts and Behaviours focused on measuring Self-injury Thoughts and Behaviours, Suicide, Non-suicidal Self-injury, Couple Intervention, Emotion Dysregulation, Intimate Relationship Dysfunction, Borderline Personality Disorder

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients have either engaged in 2+ suicidal or non-suicidal self-injurious behaviors in the past two weeks (i.e., chronic and recent SITBs, consistent with previous research evaluating non-suicidal self-injury (Kranzler et al., 2018)), or have severe suicidal ideation as indicated by a score ≥15 on the Beck Scale for Suicidal Ideation (Beck, 1991)
  2. Patients also meet diagnostic criteria for BPD
  3. Patients are between the ages of 18 and 70 years-old
  4. Patients have a romantic partner who is between the ages of 18 and 70 years-old
  5. Patient's romantic partner is willing to participate in the study with them

Exclusion Criteria:

  1. Past-year severe intimate aggression in their relationship such that participants who endorse any severe physical and/or sexual assault behaviors in the past year will be excluded from the study (Monson et al., 2012; Abramowitz et al., 2013), as assessed by the Revised Conflict Tactics Scale, Severe Items Subscale (CTS-2; Straus, Hamby, Boney-McCoy, & Sugarman, 1996)
  2. Either partner has a severe substance use disorder that would interfere with the capacity to attend and participate in this study
  3. Either partner has clinically significant psychotic symptoms or bipolar I disorder (e.g., McMain et al., 2018; McMain et al., 2009)
  4. Either partner has a major cognitive or intellectual impairment that would prevent the individual's ability to attend intervention and participate in the research study
  5. Either partner has illiteracy in English language
  6. Either partner is unable or unwilling to download and use a mobile application on their smart phone to complete daily Ecological Momentary Assessment (EMA) measures
  7. If partners meet inclusion criterion #1, or #2, or meet the self-harm/suicidal behaviour diagnostic criterion for BPD.
  8. If either partner of the couple is unwilling to have assessments and sessions audio or videorecorded
  9. If either partner is currently not residing in Ontario

Sites / Locations

  • York University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sage

Arm Description

Immediately receives 12 sessions of couple intervention aimed to improve self-injury thoughts and behaviours, emotion dysregulation, borderline personality disorder symptoms, and intimate relationship dysfunction.

Outcomes

Primary Outcome Measures

Changes in the frequency and intensity of self-injury thoughts and behaviours from baseline will be examined through ecological momentary assessment.
Change in frequency of self-injury thoughts and behaviours from baseline, as measured by the Suicide Attempt Self-Injury Interview-modified.
Change in severity of suicidal ideation from baseline, as measured by the Beck Scale for Suicidal Ideation.
The Beck Scale for Suicidal Ideation has a minimum possible score of 0, and maximum possible score of 38, wherein higher scores reflect more severe suicidal ideation.
Changes in Borderline Personality Symptom severity from baseline, as measured by the Borderline Symptom List-23.
The Borderline Symptom List-23 has a minimum possible score of 0, and maximum possible score of 92, wherein higher scores reflect more severe borderline personality disorder symptoms.
Changes in Borderline Personality Symptom severity from baseline, as measured by the Zanarini Rating Scale for Borderline Personality Disorder (self-report)
The Zanarini Rating Scale for Borderline Personality Disorder (self-report) has a minimum possible score of 0, and maximum possible score of 36, wherein higher scores reflect more severe borderline personality disorder symptoms.

Secondary Outcome Measures

Change in severity of depression from baseline, as measured by the Patient Health Questionnaire-9.
The Patient Health Questionnaire-9 has a minimum possible score of 0 and a maximum possible score of 27, wherein higher scores reflect higher severity of depression.
Changes is emotion dysregulation from baseline, as measured by The Difficulties in Emotion Regulation Scale (DERS).
The Difficulties in Emotion Regulation scale has a minimum possible score of 36, and maximum possible score of 180, wherein higher scores reflect greater emotion dysregulation.
Changes in one's report of their partner's emotion dysregulation from baseline, as measured by the Difficulties in Emotion Regulation Scale - Partner Version (DERS-Partner).
The Difficulties in Emotion Regulation Scale - Partner has a minimum possible score of 8, and maximum possible score of 40, wherein higher scores reflect more severe emotion dysregulation reported of one's partner.
Changes in severity of conflict from baseline, as measured by the Ineffective Arguing Inventory.
The Ineffective Arguing Inventory has a minimum possible score of 8, and a maximum possible score of 40, wherein higher scores indicate decreased satisfaction with the style of arguing in a relationship.

Full Information

First Posted
December 17, 2020
Last Updated
January 24, 2023
Sponsor
York University
Collaborators
Toronto Metropolitan University
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1. Study Identification

Unique Protocol Identification Number
NCT04737252
Brief Title
Development and Initial Testing of a Couple-Based Intervention to Optimize Suicide and Self-Injury Treatment: COMPASS (Connecting, Overcoming, and Moving Past Suicide and Self-Injury)
Acronym
COMPASS
Official Title
Development and Initial Testing of a Couple-Based Intervention to Optimize Suicide and Self-Injury Treatment: COMPASS (Connecting, Overcoming, and Moving Past Suicide and Self-Injury)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 18, 2021 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
July 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
York University
Collaborators
Toronto Metropolitan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Self-injurious thoughts and behaviors (SITBs), including suicide, thinking about suicide, and self-injury without intent to die, are major public health crises, with variably effective, and sometimes long and expensive, interventions. SITBs are particularly common in borderline personality disorder (BPD). Moreover, people with BPD often cannot access SITB treatment, drop out of them, and may lose their improvements after them. Reducing SITBs in BPD requires innovative interventions that have greater impact and are faster to deliver. SITBs are particularly influenced by emotion dysregulation (i.e., intense, negative emotion and difficulties changing it) and intimate relationship dysfunction, but leading evidence-based SITB interventions typically focus on the former, while neglecting the latter. For other mental health problems, couple treatments result in comparable or better individual outcomes relative to individually-delivered treatments, with added benefits of enhanced intimate relationship functioning. SITB treatment outcomes in BPD could likely be expedited and optimized with a couple intervention that targets emotion dysregulation in a relational context and intimate relationship dysfunction. This project aims to develop, refine, and test a brief SITB intervention delivered conjointly to individuals with BPD and SITBs (i.e., "patients") and their intimate partners (i.e., "partners")- Sage (formerly known as COMPASS (Connecting, Overcoming, and Moving Past Suicide and Self- injury))- that targets both emotion dysregulation and intimate relationship dysfunction to reduce SITBs and BPD symptoms in the short- and long-term. Prior to formal testing in an uncontrolled trial, it is important to solicit preliminary data regarding the clarity, accessibility, safety, tolerability, and efficacy of Sage. This project involves 3 Phases: translating Sage outlines into a manual (Phase 1); refining Sage (Phase 2); and an uncontrolled pilot trial of Sage (Phase 3). In Phase 1, the three stages of Sage will be manualized to focus on (1) developing a conjoint safety plan to reduce SITB risk, (2) reducing emotion dysregulation and intimate relationship dysfunction, and (3) changing patterns that maintain SITBs. In Phase 2, Sage will be delivered to 5-10 patients with BPD and SITBs and their partners (i.e., 5-10 couples) who will provide feedback about whether Sage is clear, helpful, and useable. This feedback will be used to refine the Sage manual. In Phase 3, the investigators will test whether Sage is safe, initially efficacious, and feasible by administering it to 15-20 patients with BPD and SITB and their partners (i.e., 15-20 couples). The investigators will examine whether Sage results in changes in SITBs and BPD symptoms in patients with BPD and SITBs, and SITB risk factors (e.g., emotion dysregulation and intimate relationship dysfunction) in both patients and partners. These outcomes will be measured multiple times per day during treatment using participant's smartphones (i.e., ecological momentary assessment), and interviews/questionnaires administered at the beginning, middle, end, and at 3 months after the intervention. The investigators predict that Sage will reduce SITBs and BPD symptoms in the patient with BPD and SITBs and improve emotion dysregulation and intimate relationship dysfunction in both patients with BPD and SITBs and their partners. This study offers a novel SITB and BPD treatment that directly targets SITBs, BPD symptoms, and the factors that drive them. Its short duration broadens the accessibility of BPD and SITB interventions with the potential to contribute to reducing SITBs and BPD symptoms on a large scale. During this period of social distancing due to COVID-19, Sage will be delivered remotely via secure videoconferencing (Zoom Healthcare). As social distancing restrictions lift, Sage will be delivered in the laboratory.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Self-injurious Thoughts and Behaviours, Borderline Personality Disorder
Keywords
Self-injury Thoughts and Behaviours, Suicide, Non-suicidal Self-injury, Couple Intervention, Emotion Dysregulation, Intimate Relationship Dysfunction, Borderline Personality Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Uncontrolled pilot trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sage
Arm Type
Experimental
Arm Description
Immediately receives 12 sessions of couple intervention aimed to improve self-injury thoughts and behaviours, emotion dysregulation, borderline personality disorder symptoms, and intimate relationship dysfunction.
Intervention Type
Behavioral
Intervention Name(s)
Sage (formerly known as COMPASS)
Intervention Description
Sage is a remote 12 session intervention for couples wherein one individual has Borderline Personality Disorder (BPD) and engages in self-injury thoughts and behaviours. The intervention consists of elements of Cognitive Behavioural Conjoint Therapy (CBCT) and has been adapted for this population. Couples will meet remotely with a clinician (registered psychologists and/or graduate level clinicians) for 8-12 sessions via Zoom Healthcare. The primary outcomes are self-injury thoughts and behaviours (as measured by the Suicide Attempt and Self-Injury Interview-modified, and the Beck Scale for Suicidal Ideation and ecological momentary assessment) and borderline personality disorder symptoms (as measured by the Borderline Symptom List-23).
Primary Outcome Measure Information:
Title
Changes in the frequency and intensity of self-injury thoughts and behaviours from baseline will be examined through ecological momentary assessment.
Time Frame
It will be administered daily (three times per day) for five weeks throughout the intervention; from baseline to post intervention
Title
Change in frequency of self-injury thoughts and behaviours from baseline, as measured by the Suicide Attempt Self-Injury Interview-modified.
Time Frame
It will be administered only at baseline (pre-intervention), half-way through intervention, immediately after the intervention, and three months after the intervention (Phase 3 only).
Title
Change in severity of suicidal ideation from baseline, as measured by the Beck Scale for Suicidal Ideation.
Description
The Beck Scale for Suicidal Ideation has a minimum possible score of 0, and maximum possible score of 38, wherein higher scores reflect more severe suicidal ideation.
Time Frame
It will be administered only at baseline (pre-intervention), half-way through intervention, immediately after the intervention, and three months after the intervention (Phase 3 only).
Title
Changes in Borderline Personality Symptom severity from baseline, as measured by the Borderline Symptom List-23.
Description
The Borderline Symptom List-23 has a minimum possible score of 0, and maximum possible score of 92, wherein higher scores reflect more severe borderline personality disorder symptoms.
Time Frame
It will be administered only at baseline (pre-intervention), half-way through intervention, immediately after the intervention, and three months after the intervention (Phase 3 only).
Title
Changes in Borderline Personality Symptom severity from baseline, as measured by the Zanarini Rating Scale for Borderline Personality Disorder (self-report)
Description
The Zanarini Rating Scale for Borderline Personality Disorder (self-report) has a minimum possible score of 0, and maximum possible score of 36, wherein higher scores reflect more severe borderline personality disorder symptoms.
Time Frame
It will be administered only at baseline (pre-intervention), half-way through intervention, immediately after the intervention, and three months after the intervention (Phase 3 only).
Secondary Outcome Measure Information:
Title
Change in severity of depression from baseline, as measured by the Patient Health Questionnaire-9.
Description
The Patient Health Questionnaire-9 has a minimum possible score of 0 and a maximum possible score of 27, wherein higher scores reflect higher severity of depression.
Time Frame
It will be administered only at baseline (pre-intervention), half-way through intervention, immediately after the intervention, and three months after the intervention (Phase 3 only).
Title
Changes is emotion dysregulation from baseline, as measured by The Difficulties in Emotion Regulation Scale (DERS).
Description
The Difficulties in Emotion Regulation scale has a minimum possible score of 36, and maximum possible score of 180, wherein higher scores reflect greater emotion dysregulation.
Time Frame
It will be administered only at baseline (pre-intervention), half-way through intervention, immediately after the intervention, and three months after the intervention (Phase 3 only).
Title
Changes in one's report of their partner's emotion dysregulation from baseline, as measured by the Difficulties in Emotion Regulation Scale - Partner Version (DERS-Partner).
Description
The Difficulties in Emotion Regulation Scale - Partner has a minimum possible score of 8, and maximum possible score of 40, wherein higher scores reflect more severe emotion dysregulation reported of one's partner.
Time Frame
It will be administered only at baseline (pre-intervention), half-way through intervention, immediately after the intervention, and three months after the intervention (Phase 3 only).
Title
Changes in severity of conflict from baseline, as measured by the Ineffective Arguing Inventory.
Description
The Ineffective Arguing Inventory has a minimum possible score of 8, and a maximum possible score of 40, wherein higher scores indicate decreased satisfaction with the style of arguing in a relationship.
Time Frame
It will be administered only at baseline (pre-intervention), half-way through intervention, immediately after the intervention, and three months after the intervention (Phase 3 only).
Other Pre-specified Outcome Measures:
Title
Changes in participants psychiatric and medical treatments (e.g., medication, day treatment programs) from baseline, measured by The Mental Health Utilization Interview-Modified.
Time Frame
It will be administered only at baseline (pre-intervention) and immediately after the intervention.
Title
Changes in relationship satisfaction from baseline, as measured by mean change from baseline on the Couples Satisfaction Index.
Description
The Couples Satisfaction Index has a minimum possible score of 0, and a maximum possible score of 161, wherein higher scores reflect higher levels of relationship satisfaction.
Time Frame
It will be administered only at baseline (pre-intervention), half-way through intervention, immediately after the intervention, and three months after the intervention (Phase 3 only).
Title
Changes in severity of Anxiety from baseline, as measured by Generalized Anxiety Disorder-7.
Description
The Generalized Anxiety Disorder-7 has a minimum possible score of 0 and maximum possible score of 21, wherein higher scores reflect more severe levels of anxiety.
Time Frame
It will be administered only at baseline (pre-intervention), half-way through intervention, immediately after the intervention, and three months after the intervention (Phase 3 only).
Title
Changes in Posttraumatic Stress Disorder severity from baseline, as measured by the Post-Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5).
Description
The Post-Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) has a minimum possible score of 0 and a maximum possible score of 80, wherein higher scores reflect more severe posttraumatic stress disorder symptomatology.
Time Frame
It will be administered only half-way through intervention, immediately after the intervention, and three months after the intervention (Phase 3 only).
Title
Changes in one's report of their partner's Borderline Personality Symptoms severity from baseline, as measured by the Borderline Symptom List-23 - Partner Report.
Time Frame
It will be administered only at baseline (pre-intervention), half-way through intervention, immediately after the intervention, and three months after the intervention (Phase 3 only).
Title
Changes in suicidal ideation severity from baseline, as measured by the Suicide Behaviours Questionnaire-Revised.
Description
The Suicide Behaviours Questionnaire-Revised has a minimum possible score of 3, and a maximum possible score of 18, wherein higher scores indicate more severe suicidal ideation.
Time Frame
It will be administered only at baseline (pre-intervention), half-way through intervention, immediately after the intervention, and three months after the intervention (Phase 3 only).
Title
Changes in one's report of their partner's suicidal ideation from baseline, as measured by the suicide Behaviours Questionnaire-Revised - Partner Report.
Description
The Suicide Behaviours Questionnaire-Revised - Partner Report has a minimum possible score of 3, and a maximum possible score of 18, wherein higher scores indicate more severe suicidal ideation reported of their partner.
Time Frame
It will be administered only at baseline (pre-intervention), half-way through intervention, immediately after the intervention, and three months after the intervention (Phase 3 only).
Title
Changes in emotional reactivity from baseline, as measured by the Emotional Reactivity.
Description
The Emotional Reactivity Scale has a minimum possible score of 0, and a maximum possible score of 84, wherein higher scores reflect greater emotional reactivity.
Time Frame
It will be administered only at baseline (pre-intervention), half-way through intervention, immediately after the intervention, and three months after the intervention (Phase 3 only).
Title
Changes in affect from baseline, as measured by the Positive and Negative Affect Schedule-Modified.
Time Frame
It will be administered only at baseline (pre-intervention), half-way through intervention, immediately after the intervention, and three months after the intervention (Phase 3 only).
Title
Changes in addiction severity from baseline, as measured by the Addiction Severity Index.
Time Frame
It will be administered only at baseline (pre-intervention), half-way through intervention, immediately after the intervention, and three months after the intervention (Phase 3 only).
Title
Changes in Work, Health, and Life Quality from baseline, as measured by 3 one-item self-report measurements that assess work functioning, perceived health status, and overall quality of life.
Time Frame
It will be administered only at baseline (pre-intervention), half-way through intervention, immediately after the intervention, and three months after the intervention (Phase 3 only).
Title
Changes in shame from baseline, as measured by the Experience of Shame Scale.
Description
The Experience of Shame Scale has a minimum possible score of 25, and a maximum possible score of 100, wherein higher scores reflect higher levels of shame.
Time Frame
It will be administered only at baseline (pre-intervention), half-way through intervention, immediately after the intervention, and three months after the intervention (Phase 3 only).
Title
Frequency of Emergency Department Visits and Hospitalizations with change measured as mean change from baseline.
Time Frame
It will be administered only at baseline (pre-intervention), half-way through intervention, immediately after the intervention, and three months after the intervention (Phase 3 only).
Title
Client satisfaction with the intervention as measured by the Client Satisfaction Questionnaire.
Description
The Client Satisfaction Questionnaire has a minimum possible score of 8, and a maximum possible score of 32, wherein higher scores reflect greater satisfaction with the intervention.
Time Frame
It will be administered only immediately after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients have either engaged in 2+ suicidal or non-suicidal self-injurious behaviors in the past two weeks (i.e., chronic and recent SITBs, consistent with previous research evaluating non-suicidal self-injury (Kranzler et al., 2018)), or have severe suicidal ideation as indicated by a score ≥15 on the Beck Scale for Suicidal Ideation (Beck, 1991) Patients also meet diagnostic criteria for BPD Patients are between the ages of 18 and 70 years-old Patients have a romantic partner who is between the ages of 18 and 70 years-old Patient's romantic partner is willing to participate in the study with them Exclusion Criteria: Past-year severe intimate aggression in their relationship such that participants who endorse any severe physical and/or sexual assault behaviors in the past year will be excluded from the study (Monson et al., 2012; Abramowitz et al., 2013), as assessed by the Revised Conflict Tactics Scale, Severe Items Subscale (CTS-2; Straus, Hamby, Boney-McCoy, & Sugarman, 1996) Either partner has a severe substance use disorder that would interfere with the capacity to attend and participate in this study Either partner has clinically significant psychotic symptoms or bipolar I disorder (e.g., McMain et al., 2018; McMain et al., 2009) Either partner has a major cognitive or intellectual impairment that would prevent the individual's ability to attend intervention and participate in the research study Either partner has illiteracy in English language Either partner is unable or unwilling to download and use a mobile application on their smart phone to complete daily Ecological Momentary Assessment (EMA) measures If partners meet inclusion criterion #1, or #2, or meet the self-harm/suicidal behaviour diagnostic criterion for BPD. If either partner of the couple is unwilling to have assessments and sessions audio or videorecorded If either partner is currently not residing in Ontario
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Skye Fitzpatrick, PhD
Organizational Affiliation
York University
Official's Role
Principal Investigator
Facility Information:
Facility Name
York University
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3J 1P3
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30714800
Citation
Fitzpatrick S, Wagner AC, Monson CM. Optimizing borderline personality disorder treatment by incorporating significant others: A review and synthesis. Personal Disord. 2019 Jul;10(4):297-308. doi: 10.1037/per0000328. Epub 2019 Feb 4.
Results Reference
background
PubMed Identifier
33517245
Citation
Fitzpatrick S, Liebman RE, Monson CM. The borderline interpersonal-affective systems (BIAS) model: Extending understanding of the interpersonal context of borderline personality disorder. Clin Psychol Rev. 2021 Jan 24;84:101983. doi: 10.1016/j.cpr.2021.101983. Online ahead of print.
Results Reference
background

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Development and Initial Testing of a Couple-Based Intervention to Optimize Suicide and Self-Injury Treatment: COMPASS (Connecting, Overcoming, and Moving Past Suicide and Self-Injury)

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