What side effects are associated with this type of intervention?

Common treatments for Borderline Personality Disorder (BPD) that target emotion dysregulation and intimate relationship dysfunction include Dialectical Behavior Therapy (DBT), Mentalization-Based Therapy (MBT), and Transference-Focused Therapy (TFT). DBT can sometimes lead to emotional distress during the initial stages as patients confront difficult emotions. MBT may cause temporary increases in anxiety as patients learn to observe and interpret their mental states. TFT can evoke intense emotional reactions due to the exploration of deep-seated issues. Pharmacotherapy, often used to manage specific symptoms, can have side effects such as weight gain, sedation, and metabolic changes when using mood stabilizers or low-dose antipsychotics. It is important for patients to discuss these potential side effects with their healthcare provider to tailor the treatment plan to their needs.

What prior FDA approvals exist?

There are no FDA-approved medications specifically for Borderline Personality Disorder (BPD). However, treatments often target symptom domains such as emotion dysregulation and impulsive-behavioral dyscontrol. Medications like mood stabilizers and low-dose antipsychotics are suggested for affective dysregulation, while mood stabilizers are preferred for impulsivity. Fluoxetine has shown efficacy in reducing anger, a component of emotion dysregulation in BPD. The Sage trial aims to address both emotion dysregulation and intimate relationship dysfunction, areas not specifically targeted by current FDA-approved treatments.

What other types of research exist?

Promising novel alternatives to Sage for BPD patients in 2024 include: 1) Dialectical Behavior Therapy (DBT) with a focus on emotion regulation and interpersonal effectiveness, 2) Mentalization-Based Treatment (MBT) which enhances understanding of self and others' mental states, 3) Transference-Focused Psychotherapy (TFP) that addresses relationship patterns and emotional regulation, and 4) Systems Training for Emotional Predictability and Problem Solving (STEPPS) which combines skills training with group therapy to improve emotional and interpersonal functioning.

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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 only at baseline (pre-intervention), half-way through intervention, immediately after the intervention, and three months after the intervention (phase 3 only).

Awards & highlights

No Placebo-Only Group

Summary

This trial tests Sage, a program for people with borderline personality disorder (BPD) and their partners. Sage aims to reduce self-injurious thoughts and behaviors by addressing emotional and relationship issues together. The program includes creating safety plans, managing emotions, and improving relationship dynamics. The goal is to make treatment more effective and accessible for those with BPD.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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).

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

Changes in Borderline Personality Symptom severity from baseline, as measured by the Zanarini Rating Scale for Borderline Personality Disorder (self-report)

Secondary study objectives

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.

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Other study objectives

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 emotional reactivity from baseline, as measured by the Emotional Reactivity.

Changes in one's report of their partner's suicidal ideation from baseline, as measured by the suicide Behaviours Questionnaire-Revised - Partner Report.

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Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Borderline Personality Disorder (BPD) such as Dialectical Behavior Therapy (DBT), schema-focused therapy, and mentalization-based therapy target core issues like emotion dysregulation and intimate relationship dysfunction. DBT combines cognitive-behavioral techniques with mindfulness to help manage intense emotions and reduce self-injurious behaviors. Schema-focused therapy aims to change deeply ingrained maladaptive patterns of thinking and behavior. Mentalization-based therapy helps patients understand and interpret their own and others' mental states, improving emotional regulation and interpersonal relationships. These treatments are crucial for BPD patients as they address the root causes of emotional instability and relationship difficulties, which are often the underlying factors driving self-injurious thoughts and behaviors.

Short Imagery Rescripting Intervention to Treat Emotionally Dysregulated Behavior in Borderline Personality Disorder: An Exploratory Study.