- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03463980
Compassion Meditation and ReliefLink App for Suicidal, Low-Income, African Americans
March 13, 2022 updated by: Nadine Kaslow, PhD, Emory University
The purpose of this study is to conduct a pilot randomized controlled trial (RCT) with low-income, suicidal African American women and men that compares the relative effectiveness of compassion meditation (CM) versus a support group (SG) .
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to conduct a pilot randomized controlled trial (RCT) with low-income, suicidal African American women and men that compares the relative effectiveness of compassion meditation (CM) versus a support group (SG) for (1) reducing psychological distress (suicidal ideation, depressive symptoms, and shame); (2) bolstering interpersonal connectedness; and (3) enhancing self-compassion and mindfulness.
It is hypothesized that at post-intervention and follow-up, compared to individuals in the SG, those in the CM intervention will endorse less psychological distress (suicidal ideation, depressive symptoms, and shame), more interpersonal connectedness, and greater levels of self-compassion and mindfulness.
Study Type
Interventional
Enrollment (Actual)
456
Phase
- 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 Locations
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Georgia
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Atlanta, Georgia, United States, 30322
- Grady Health System (non-CRN)
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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
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- self-identify as African American or Black
- speak English
- present to medical and psychiatric emergency rooms at Grady Health System following a suicide attempt
- moderate level of intent associated with the attempt (SSI >= 8 required)
- Mini Mental State Exam (MMSE) score > 22
Exclusion Criteria:
- significant cognitive impairments (MMSE < 22)
- active psychosis (diagnosed based on Psychotic Screen (PS))
- imminently life-threatening medical condition
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Compassion meditation (CM)
The CM participants will attend six weekly sessions (each 120 minute), and will be video and/or audiotaped.
Each weekly CM session will entail a 30 minute check-in regarding the participants' levels of suicidal ideation, as well as a discussion of current life stress and weekly meditation practice; a 30 minute didactic session that will describe the meditative technique introduced during the week; and a 30 minute guided meditation session.
Participants will be encouraged to meditate at least 30 minutes a day and will be asked to track their daily meditation time and bring in their tracking sheet to each session.
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CM session: 30 minute check-in regarding the participants' levels of suicidal ideation, as well as a discussion of current life stress and weekly meditation practice; a 30 minute didactic session that will describe the meditative technique introduced during the week; and a 30 minute guided meditation session.
Participants are also encouraged to meditate at least 30 minutes a day.
|
Active Comparator: Support group (SG)
SG participants will attend six weekly sessions, 90 minutes in length.
It will be unstructured.
Participants will use this time to talk about current concerns and to receive support and guidance from other group members and the leaders.
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SG session: 90 minutes to talk about current concerns and to receive support and guidance from other group members and the leaders.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Beck Scale for Suicide Ideation (BSS) score
Time Frame: Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
|
The BSS is a self-report 19-item scale preceded by five screening items.
The BSS and its screening items are intended to assess a patient's thoughts, plans and intent to commit suicide.
All 24 items are rated on a three-point scale (0 to 2) total scores could range from 0 to 48.
No specific cut-off scores exist to classify severity or guide patient management.
Increasing scores reflect greater suicide risk, and any positive response merits investigation.
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Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Beck Depression Inventory II (BDI-II) score
Time Frame: Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
|
The BDI is a self-report 21-item scale used to assess the current severity of depression.
Each item is rated on a four-point scale (0 to 3) with possible total scores ranging from 0 to 63. Scores provide a measure of the severity of self-reported depression: 0 -9 minimal, 10 -16 mild, 17-29 moderate, and 30 - 63 severe.
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Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
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Change in Experience of Shame Scale (ESS) score
Time Frame: Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
|
The Experiences of Shame Scale (ESS) is a 25 item inventory that measures the experience of shame about a variety of areas including shame about one's body, personal habits, manner with others, personal ability, whether one has said or done something wrong (e.g.
"Have you felt ashamed of any of your personal habits?") over the past month.. Participants are asked to answer questions on a 4 point Likert scale from "not at all" to "very much."
|
Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
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Change in Levels of Self-Criticism Scale (LOSC) score
Time Frame: Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
|
The Levels of Self-Criticism Scale (LOSC), which has 22 items assessing comparative self-criticism and internalized self-criticism, will be used to measure the level of self-criticism.
The LOSC measures both comparative self-criticism (e.g.
"I fear that if people get to know me too well, they will not respect me.") and internalized self-criticism (e.g.
"Failure is a very painful experience for me.").
Participants are asked to rate each item on a 7 point Likert scale from "not at all" to "very well."
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Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
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Change in Social Support Behaviors Scale (SSB) score
Time Frame: Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
|
is interpersonal connectedness.
It will be evaluated using the 45 item Social Support Behaviors Scale (SSB), which includes five modes of social support separately for family and friends and these subscale have been confirmed with a multi-ethnic sample.
Respondents rate, on a scale of 1 to 5: 1- no one would provide the support, to 5 - most (family/friends) would do this.
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Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
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Change in Self-Compassion Scale (SCS) score
Time Frame: Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
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particularly relevant to the focus of the intervention, namely self-compassion and mindfulness.
The 26-item Self-Compassion Scale (SCS) includes six domains of self-compassion: self-kindness, self-judgment, common humanity, isolation, mindfulness, and over-identified.
Scores on the SCS are correlated with lower levels of depression and anxiety and better life satisfaction.
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Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
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Change in Five Facet Mindfulness Questionnaire (FFMQ) score
Time Frame: Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
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The Five Facet Mindfulness Questionnaire (FFMQ) will be used to assess five elements of mindfulness, observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience.
The measure includes 39-items that are rated on a 1 to 5 point Likert-type scale assessing five facets.
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Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
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Change in Behavior Monitoring Form (BMF) score
Time Frame: Weekly during participation in the study up to 3 months
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The Behavior Monitoring Form (BMF) assesses suicidal behavior (levels of hopelessness, depressive feelings, stress, suicidal thoughts, suicidal actions) in the prior week; items are rated on a 5 point scale.
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Weekly during participation in the study up to 3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nadine Kaslow, PhD, Emory 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
- Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Interventions for self-harm in children and adolescents. Cochrane Database Syst Rev. 2021 Mar 7;3(3):CD013667. doi: 10.1002/14651858.CD013667.pub2.
- Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
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)
May 13, 2010
Primary Completion (Actual)
March 7, 2020
Study Completion (Actual)
October 22, 2021
Study Registration Dates
First Submitted
March 7, 2018
First Submitted That Met QC Criteria
March 7, 2018
First Posted (Actual)
March 13, 2018
Study Record Updates
Last Update Posted (Actual)
March 29, 2022
Last Update Submitted That Met QC Criteria
March 13, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00038057
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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