Self-injurious Thoughts and BehavioursCOMPASSNCT04737252
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)
A study testing Sage (formerly known as COMPASS) in people with Self-injurious Thoughts and Behaviours and Borderline Personality Disorder, run by York University at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Self-injurious Thoughts and Behaviours, Borderline Personality Disorder
- What is being tested?
- Sage (formerly known as COMPASS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- 18 Jan 2021to 10 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Sage (formerly known as COMPASS)
- Keywords
- Self-injury Thoughts and Behaviours, Suicide, Non-suicidal Self-injury, Couple Intervention, Emotion Dysregulation, Intimate Relationship Dysfunction, Borderline Personality Disorder
- Medical subject headings
- Behavior, Borderline Personality Disorder, Suicide, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sage (formerly known as COMPASS)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Sage | Experimental | 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. Receives: Behavioral: Sage (formerly known as COMPASS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the frequency and intensity of self-injury thoughts and behaviours from baseline will be examined through ecological momentary assessment.
Measured: It will be administered daily (three times per day) for five weeks throughout the intervention; from baseline to post intervention
Change in frequency of self-injury thoughts and behaviours from baseline, as measured by the Suicide Attempt Self-Injury Interview-modified.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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 (4)
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start18 Jan 2021
- Primary completion10 Aug 2023
- Study completion10 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Self-injurious Thoughts and BehavioursStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Uncontrolled pilot trial
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- York University
- Sponsor type
- University, hospital or other
- Collaborators
- Toronto Metropolitan University
- Responsible party
- Principal investigator, Skye Fitzpatrick, York University
- Investigators
- Dr. Skye Fitzpatrick, PhD, Principal investigator, York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04737252
- Sponsor's protocol ID
- PRG-0-057-19
- Acronym
- COMPASS
- Status last verified
- Feb 2025
- First submitted
- 17 Dec 2020
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30714800Fitzpatrick 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.
PubMed 33517245Fitzpatrick S, Varma S, Traynor J, Earle EA, Vanstone R, Fulham L, Goenka K, Blumberg MJ, Wyatt L, Siegel AN, Di Bartolomeo AA, Norouzian N, Burdo J, Ennis N, Carney A, Luxor O, Sankar R, Monson C, Liebman R. A pilot and feasibility study of Sage: A couple therapy for borderline personality disorder. Psychother Res. 2026 Mar;36(3):455-470. doi: 10.1080/10503307.2025.2491478. Epub 2025 Apr 15.
PubMed 40233277Fitzpatrick S, Varma S, Chafe D, Norouzian N, Traynor J, Goss S, Earle E, Di Bartolomeo A, Siegel A, Fulham L, Monson CM, Liebman RE. A case series of sage: a new couple-based intervention for borderline personality disorder. Borderline Personal Disord Emot Dysregul. 2024 Jan 12;11(1):1. doi: 10.1186/s40479-023-00244-x.
PubMed 38212804
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04737252
- Acronym / sponsor ID
- COMPASS / PRG-0-057-19
- Keywords
- Self-injury Thoughts and Behaviours, Suicide, Non-suicidal Self-injury, Couple Intervention, Emotion Dysregulation, Intimate Relationship Dysfunction, Borderline Personality Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- York UniversityUniversity, hospital or other
- Collaborators
- Toronto Metropolitan University
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 10 Aug 2023 (actual)
- Study completion
- 10 Aug 2023 (actual)
- First posted
- 3 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Uncontrolled pilot trial
| Arm | Type | Receives |
|---|---|---|
| Sage | Experimental | Behavioral: Sage (formerly known as COMPASS)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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sage (formerly known as COMPASS)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). | Behavioural | Sage |
Primary outcome
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
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).
Change in severity of suicidal ideation from baseline, as measured by the Beck Scale for 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).
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.
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).
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)
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).
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.
4 secondary outcomes
Change in severity of depression from baseline, as measured by the Patient Health Questionnaire-9.
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).
Changes is emotion dysregulation from baseline, as measured by The Difficulties in Emotion Regulation Scale (DERS).
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).
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).
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).
Changes in severity of conflict from baseline, as measured by the Ineffective Arguing Inventory.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Background: PubMed 30714800Fitzpatrick 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.
- Background: PubMed 33517245Fitzpatrick 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.
- Derived from this study: PubMed 40233277Fitzpatrick S, Varma S, Traynor J, Earle EA, Vanstone R, Fulham L, Goenka K, Blumberg MJ, Wyatt L, Siegel AN, Di Bartolomeo AA, Norouzian N, Burdo J, Ennis N, Carney A, Luxor O, Sankar R, Monson C, Liebman R. A pilot and feasibility study of Sage: A couple therapy for borderline personality disorder. Psychother Res. 2026 Mar;36(3):455-470. doi: 10.1080/10503307.2025.2491478. Epub 2025 Apr 15.
- Derived from this study: PubMed 38212804Fitzpatrick S, Varma S, Chafe D, Norouzian N, Traynor J, Goss S, Earle E, Di Bartolomeo A, Siegel A, Fulham L, Monson CM, Liebman RE. A case series of sage: a new couple-based intervention for borderline personality disorder. Borderline Personal Disord Emot Dysregul. 2024 Jan 12;11(1):1. doi: 10.1186/s40479-023-00244-x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Skye Fitzpatrick, PhD principal investigator
York University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sage (formerly known as COMPASS) in people with Self-injurious Thoughts and Behaviours and Borderline Personality Disorder, run by York University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04737252, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.