Clinical trial NCT04737252: 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)
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: York University
Sponsor class: OTHER
Collaborators: name: Toronto Metropolitan University
First posted: 2021-02-03
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Uncontrolled pilot trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in the frequency and intensity of self-injury thoughts and behaviours from baseline will be examined through ecological momentary assessment.
timeFrame: It will be administered daily (three times per day) for five weeks throughout the intervention; from baseline to post intervention
measure: Change in frequency of self-injury thoughts and behaviours from baseline, as measured by the Suicide Attempt Self-Injury Interview-modified.
timeFrame: 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).
measure: Change in severity of suicidal ideation from baseline, as measured by the Beck Scale for Suicidal Ideation.
timeFrame: 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).
measure: Changes in Borderline Personality Symptom severity from baseline, as measured by the Borderline Symptom List-23.
timeFrame: 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).
measure: Changes in Borderline Personality Symptom severity from baseline, as measured by the Zanarini Rating Scale for Borderline Personality Disorder (self-report)
timeFrame: 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 outcomes:
measure: Change in severity of depression from baseline, as measured by the Patient Health Questionnaire-9.
timeFrame: 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).
measure: Changes is emotion dysregulation from baseline, as measured by The Difficulties in Emotion Regulation Scale (DERS).
timeFrame: 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).
measure: 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).
timeFrame: 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).
measure: Changes in severity of conflict from baseline, as measured by the Ineffective Arguing Inventory.
timeFrame: 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 outcomes:
measure: Changes in participants psychiatric and medical treatments (e.g., medication, day treatment programs) from baseline, measured by The Mental Health Utilization Interview-Modified.
timeFrame: It will be administered only at baseline (pre-intervention) and immediately after the intervention.
measure: Changes in relationship satisfaction from baseline, as measured by mean change from baseline on the Couples Satisfaction Index.
timeFrame: 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).
measure: Changes in severity of Anxiety from baseline, as measured by Generalized Anxiety Disorder-7.
timeFrame: 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).
measure: 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).
timeFrame: It will be administered only half-way through intervention, immediately after the intervention, and three months after the intervention (Phase 3 only).
measure: 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.
timeFrame: 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).
measure: Changes in suicidal ideation severity from baseline, as measured by the Suicide Behaviours Questionnaire-Revised.
timeFrame: 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).
measure: Changes in one's report of their partner's suicidal ideation from baseline, as measured by the suicide Behaviours Questionnaire-Revised - Partner Report.
timeFrame: 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).
measure: Changes in emotional reactivity from baseline, as measured by the Emotional Reactivity.
timeFrame: 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).
measure: Changes in affect from baseline, as measured by the Positive and Negative Affect Schedule-Modified.
timeFrame: 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).
measure: Changes in addiction severity from baseline, as measured by the Addiction Severity Index.
timeFrame: 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).
measure: 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.
timeFrame: 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).
measure: Changes in shame from baseline, as measured by the Experience of Shame Scale.
timeFrame: 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).
measure: Frequency of Emergency Department Visits and Hospitalizations with change measured as mean change from baseline.
timeFrame: 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).
measure: Client satisfaction with the intervention as measured by the Client Satisfaction Questionnaire.
timeFrame: It will be administered only immediately after the intervention
Locations:
city: Toronto
country: Canada
facility: York University
state: Ontario
Study officials:
affiliation: York University
name: Dr. Skye Fitzpatrick, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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 Mar;84:101983. doi: 10.1016/j.cpr.2021.101983. Epub 2021 Jan 24.