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

Suicidal Ideation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03463980
• Other study ID #: IRB00038057
• Status: Terminated
• Phase: N/A
• Start date: May 13, 2010
• Est. completion date: October 22, 2021

Study information

• Verified date: March 2022
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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) .

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 456
• Est. completion date: October 22, 2021
• Est. primary completion date: March 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Suicidal Ideation

Intervention

Behavioral:
• Compassion meditation (CM)
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.
• Support group (SG)
SG session: 90 minutes to talk about current concerns and to receive support and guidance from other group members and the leaders.

Locations

Country	Name	City	State
United States	Grady Health System (non-CRN)	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
Secondary	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."	Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
Secondary	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."	Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
Secondary	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.	Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
Secondary	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.	Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
Secondary	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.	Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
Secondary	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.	Weekly during participation in the study up to 3 months