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

NCT03463980 | Terminated DMC

• 1 other identifier: IRB00038057
• Study Type: interventional
• Target: 456
• Locations: 1 country
• Sites: 1

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) .

Conditions

Suicidal Ideation

Keywords

Meditation; African American; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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.

  Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)

Secondary Outcomes (7)

• Change in Beck Depression Inventory II (BDI-II) score

  Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)

• Change in Experience of Shame Scale (ESS) score

  Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)

• Change in Levels of Self-Criticism Scale (LOSC) score

  Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)

• Change in Social Support Behaviors Scale (SSB) score

  Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)

• Change in Self-Compassion Scale (SCS) score

  Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)

Study Arms (2)

Compassion meditation (CM)

EXPERIMENTAL

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.

Behavioral: Compassion meditation (CM)

Support group (SG)

ACTIVE COMPARATOR

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.

Behavioral: Support group (SG)

Interventions

Compassion meditation (CM) BEHAVIORAL

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.

Compassion meditation (CM)

Support group (SG) BEHAVIORAL

SG session: 90 minutes to talk about current concerns and to receive support and guidance from other group members and the leaders.

Support group (SG)

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• significant cognitive impairments (MMSE \< 22)
• active psychosis (diagnosed based on Psychotic Screen (PS))
• imminently life-threatening medical condition

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Grady Health System (non-CRN)

Atlanta, Georgia, 30322, United States

Location

Related Publications (2)

• 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.

  PMID: 33884617 DERIVED

• 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.

  PMID: 33677832 DERIVED

MeSH Terms

Conditions

Suicidal Ideation

Interventions

Self-Help Groups

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Officials

• Nadine Kaslow, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & Chief Psychologist

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: March 13, 2018
• Study Start: May 13, 2010
• Primary Completion: March 7, 2020
• Study Completion: October 22, 2021
• Last Updated: March 29, 2022

Record last verified: 2022-03

Locations

US (1)