NCT04737252: COMPASS

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)

Status unknown NA Last updated 7 November 2023

What this trial tests

NA trial testing Sage (formerly known as COMPASS) in Self-injurious Thoughts and Behaviours in 42 participants. Status unknown.

Timeline

18 January 2021

Primary endpoint
10 August 2023

1 January 2024

Quick facts

Lead sponsor	York University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	42
Start date	18 January 2021
Primary completion	10 August 2023
Estimated completion	1 January 2024
Sites	1 location across Canada

Drugs / interventions tested

• Sage (formerly known as COMPASS)

Conditions studied

• Self-injurious Thoughts and Behaviours — all drugs for Self-injurious Thoughts and Behaviours →
• Borderline Personality Disorder — all drugs for Borderline Personality Disorder →

Sponsor

York University

Who can join

Adults 18 to 70, any sex, with Self-injurious Thoughts and Behaviours or Borderline Personality Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. A case series of sage: a new couple-based intervention for borderline personality disorder.
   Fitzpatrick S, Varma S, Chafe D, Norouzian N, et al · · 2024 · cited 3× · PMID 38212804 · DOI 10.1186/s40479-023-00244-x
2. A pilot and feasibility study of Sage: A couple therapy for borderline personality disorder.
   Fitzpatrick S, Varma S, Traynor J, Earle EA, et al · · 2026 · cited 1× · PMID 40233277 · DOI 10.1080/10503307.2025.2491478
3. Communication Between Individuals With Borderline Personality Disorder and Their Partners.
   Lauzon C, Di Bartolomeo AA, Varma S, Boritz T, et al · · 2025 · PMID 39980084 · DOI 10.1002/pmh.70013