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) (COMPASS)

November 6, 2023 updated by: Skye Fitzpatrick, York University
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M3J 1P3
        • York University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sage
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.
Behavioral: 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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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).
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.
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.
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.
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)
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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
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.
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).
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.
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).
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.
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).
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.
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 Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in participants psychiatric and medical treatments (e.g., medication, day treatment programs) from baseline, measured by The Mental Health Utilization Interview-Modified.
Time Frame: It will be administered only at baseline (pre-intervention) and immediately after the intervention.
It will be administered only at baseline (pre-intervention) and immediately after the intervention.
Changes in relationship satisfaction from baseline, as measured by mean change from baseline on the Couples Satisfaction Index.
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 Couples Satisfaction Index has a minimum possible score of 0, and a maximum possible score of 161, wherein higher scores reflect higher levels of relationship satisfaction.
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 Anxiety from baseline, as measured by Generalized Anxiety Disorder-7.
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 Generalized Anxiety Disorder-7 has a minimum possible score of 0 and maximum possible score of 21, wherein higher scores reflect more severe levels of anxiety.
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 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).
Time Frame: It will be administered only half-way through intervention, immediately after the intervention, and three months after the intervention (Phase 3 only).
The Post-Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) has a minimum possible score of 0 and a maximum possible score of 80, wherein higher scores reflect more severe posttraumatic stress disorder symptomatology.
It will be administered only 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 Borderline Personality Symptoms severity from baseline, as measured by the Borderline Symptom List-23 - Partner 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).
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 suicidal ideation severity from baseline, as measured by the Suicide Behaviours Questionnaire-Revised.
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 Suicide Behaviours Questionnaire-Revised has a minimum possible score of 3, and a maximum possible score of 18, wherein higher scores indicate more severe suicidal ideation.
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 suicidal ideation from baseline, as measured by the suicide Behaviours Questionnaire-Revised - Partner 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 Suicide Behaviours Questionnaire-Revised - Partner Report has a minimum possible score of 3, and a maximum possible score of 18, wherein higher scores indicate more severe suicidal ideation reported of their partner.
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 emotional reactivity from baseline, as measured by the Emotional Reactivity.
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 Emotional Reactivity Scale has a minimum possible score of 0, and a maximum possible score of 84, wherein higher scores reflect greater emotional reactivity.
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 affect from baseline, as measured by the Positive and Negative Affect Schedule-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).
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 addiction severity from baseline, as measured by the Addiction Severity Index.
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).
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 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.
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).
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 shame from baseline, as measured by the Experience of Shame Scale.
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 Experience of Shame Scale has a minimum possible score of 25, and a maximum possible score of 100, wherein higher scores reflect higher levels of shame.
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).
Frequency of Emergency Department Visits and Hospitalizations with change measured as mean change from baseline.
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).
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).
Client satisfaction with the intervention as measured by the Client Satisfaction Questionnaire.
Time Frame: It will be administered only immediately after the intervention
The Client Satisfaction Questionnaire has a minimum possible score of 8, and a maximum possible score of 32, wherein higher scores reflect greater satisfaction with the intervention.
It will be administered only immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
York University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Toronto Metropolitan University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dr. Skye Fitzpatrick, PhD, York University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 18, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 10, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 17, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 3, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRG-0-057-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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