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Sage Intervention for Self-Harm and Suicide (COMPASS Trial)

N/A

Waitlist Available

Led By Dr. Skye Fitzpatrick, PhD

Research Sponsored by York University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up it will be administered daily (three times per day) for five weeks throughout the intervention; from baseline to post intervention

Awards & highlights

COMPASS Trial Summary

This trial is studying a new treatment for self-injurious thoughts and behaviors (SITBs), including suicide, thinking about suicide, and self-injury without intent to die, which are major public health crises. The treatment, called "Sage," is delivered conjointly to individuals with SITBs and their intimate partners, and targets both emotion dysregulation and intimate relationship dysfunction to reduce SITBs and related symptoms.

Who is the study for?

This trial is for adults aged 18-70 with Borderline Personality Disorder (BPD) who have recently engaged in self-harm or experienced severe suicidal thoughts. Participants must have a romantic partner willing to join the study, and both must be able to use a smartphone app for daily assessments.Check my eligibility

What is being tested?

The intervention being tested is Sage, aimed at reducing self-injurious thoughts and behaviors (SITBs) in individuals with BPD by addressing emotion dysregulation and relationship issues through sessions with their partners. The treatment will be delivered via videoconferencing.See study design

What are the potential side effects?

As this is a psychological intervention focusing on therapy rather than medication, traditional side effects are not applicable. However, participants may experience emotional discomfort or distress during the process.

COMPASS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ it will be administered daily (three times per day) for five weeks throughout the intervention; from baseline to post intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~it will be administered daily (three times per day) for five weeks throughout the intervention; from baseline to post intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and it will be administered daily (three times per day) for five weeks throughout the intervention; from baseline to post intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Suicide attempt

Change in severity of suicidal ideation from baseline, as measured by the Beck Scale for Suicidal Ideation.

Changes in Borderline Personality Symptom severity from baseline, as measured by the Borderline Symptom List-23.

+2 more

Secondary outcome measures

Change in severity of depression from baseline, as measured by the Patient Health Questionnaire-9.

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).

Changes in severity of conflict from baseline, as measured by the Ineffective Arguing Inventory.

+1 more

Other outcome measures

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).

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.

Changes in addiction severity from baseline, as measured by the Addiction Severity Index.

+11 more

COMPASS Trial Design

1Treatment groups

Experimental Treatment

Group I: SageExperimental Treatment1 Intervention

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Ryerson UniversityOTHER

76 Previous Clinical Trials

7,857 Total Patients Enrolled

1 Trials studying Borderline Personality Disorder

33 Patients Enrolled for Borderline Personality Disorder

York UniversityLead Sponsor

58 Previous Clinical Trials

17,434 Total Patients Enrolled

2 Trials studying Borderline Personality Disorder

93 Patients Enrolled for Borderline Personality Disorder

Toronto Metropolitan UniversityOTHER

83 Previous Clinical Trials

10,875 Total Patients Enrolled

1 Trials studying Borderline Personality Disorder

33 Patients Enrolled for Borderline Personality Disorder

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?

Florida

Alberta

How old are they?

18 - 65

What site did they apply to?

York University

What portion of applicants met pre-screening criteria?

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

I've been contending with BPD for all my life, and every moment of every day is an exercise in learning how to mediate my emotions and learning to distinguish the disorder from me, which is a pointless exercise to a certain degree. I have been on and off psychotherapy and antidepressants and nothing has really worked so far. Being part of a novel clinical therapeutic trial would not only give me a shot at learning and being able to live with this disorder better but it would do the same for people with BPD the world over.

PatientReceived 1 prior treatment

Recent research and studies

Clinical Psychology ReviewJournal

The Borderline Interpersonal-affective Systems (BIAS) Model: Extending Understanding of the Interpersonal Context of Borderline Personality Disorder

Fitzpatrick, Skye, Rachel E. Liebman, and Candice M. Monson. 2021. “The Borderline Interpersonal-affective Systems (BIAS) Model: Extending Understanding of the Interpersonal Context of Borderline Personality Disorder”. Clinical Psychology Review. Elsevier BV. doi:10.1016/j.cpr.2021.101983.

Personality Disorders: Theory, Research, and TreatmentJournal

Optimizing Borderline Personality Disorder Treatment by Incorporating Significant Others: A Review and Synthesis.

Fitzpatrick, Skye, Anne C. Wagner, and Candice M. Monson. 2019. “Optimizing Borderline Personality Disorder Treatment by Incorporating Significant Others: A Review and Synthesis.”. Personality Disorders: Theory, Research, and Treatment. American Psychological Association (APA). doi:10.1037/per0000328.

clinicaltrials.govStudy

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)

Skye Fitzpatrick 2021. "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. https://clinicaltrials.gov/ct2/show/NCT04737252.