Clinical trial NCT03463980: 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
Overall status: TERMINATED
Phase: NA
Conditions: Suicidal Ideation
Keywords: Meditation
African American
Randomized controlled trial
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2018-03-13
Enrollment: 456
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in Beck Scale for Suicide Ideation (BSS) score
timeFrame: Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
Secondary outcomes:
measure: Change in Beck Depression Inventory II (BDI-II) score
timeFrame: Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
measure: Change in Experience of Shame Scale (ESS) score
timeFrame: Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
measure: Change in Levels of Self-Criticism Scale (LOSC) score
timeFrame: Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
measure: Change in Social Support Behaviors Scale (SSB) score
timeFrame: Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
measure: Change in Self-Compassion Scale (SCS) score
timeFrame: Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
measure: Change in Five Facet Mindfulness Questionnaire (FFMQ) score
timeFrame: Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
measure: Change in Behavior Monitoring Form (BMF) score
timeFrame: Weekly during participation in the study up to 3 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Health System (non-CRN)
state: Georgia
Study officials:
affiliation: Emory University
name: Nadine Kaslow, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.