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Compassion Meditation and ReliefLink App for Suicidal, Low-Income, African Americans

Primary Purpose

Suicidal Ideation

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Compassion meditation (CM)
Support group (SG)
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicidal Ideation focused on measuring Meditation, African American, Randomized controlled trial

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Grady Health System (non-CRN)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Compassion meditation (CM)

Support group (SG)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Beck Scale for Suicide Ideation (BSS) score
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.

Secondary Outcome Measures

Change in Beck Depression Inventory II (BDI-II) score
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.
Change in Experience of Shame Scale (ESS) score
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."
Change in Levels of Self-Criticism Scale (LOSC) score
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."
Change in Social Support Behaviors Scale (SSB) score
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.
Change in Self-Compassion Scale (SCS) score
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.
Change in Five Facet Mindfulness Questionnaire (FFMQ) score
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.
Change in Behavior Monitoring Form (BMF) score
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.

Full Information

First Posted
March 7, 2018
Last Updated
March 13, 2022
Sponsor
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT03463980
Brief Title
Compassion Meditation and ReliefLink App for Suicidal, Low-Income, African Americans
Official Title
Compassion Meditation and ReliefLink App for Suicidal, Low-Income, African Americans
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated during the pandemic as data collection could not be completed any further, and personnel changes did not allow for completion. At the time of termination, enough data was collected for a publication, all benchmarks were met.
Study Start Date
May 13, 2010 (Actual)
Primary Completion Date
March 7, 2020 (Actual)
Study Completion Date
October 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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) .
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation
Keywords
Meditation, African American, Randomized controlled trial

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
456 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Compassion meditation (CM)
Arm Type
Experimental
Arm Description
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.
Arm Title
Support group (SG)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Compassion meditation (CM)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Support group (SG)
Intervention Description
SG session: 90 minutes to talk about current concerns and to receive support and guidance from other group members and the leaders.
Primary Outcome Measure Information:
Title
Change in Beck Scale for Suicide Ideation (BSS) score
Description
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.
Time Frame
Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
Secondary Outcome Measure Information:
Title
Change in Beck Depression Inventory II (BDI-II) score
Description
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.
Time Frame
Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
Title
Change in Experience of Shame Scale (ESS) score
Description
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."
Time Frame
Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
Title
Change in Levels of Self-Criticism Scale (LOSC) score
Description
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."
Time Frame
Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
Title
Change in Social Support Behaviors Scale (SSB) score
Description
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.
Time Frame
Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
Title
Change in Self-Compassion Scale (SCS) score
Description
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.
Time Frame
Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
Title
Change in Five Facet Mindfulness Questionnaire (FFMQ) score
Description
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.
Time Frame
Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
Title
Change in Behavior Monitoring Form (BMF) score
Description
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.
Time Frame
Weekly during participation in the study up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadine Kaslow, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grady Health System (non-CRN)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33884617
Citation
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.
Results Reference
derived
PubMed Identifier
33677832
Citation
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.
Results Reference
derived

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Compassion Meditation and ReliefLink App for Suicidal, Low-Income, African Americans

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