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Suicidal IdeationNCT03463980

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

A study testing Compassion meditation (CM) and Support group (SG) in people with Suicidal Ideation, run by Emory University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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) . Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Suicidal Ideation
What is being tested?
Compassion meditation (CM) and Support group (SG)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
456 participants
Where
1 siteUnited States
Study dates
13 May 2010to 22 Oct 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Grady Health System (non-CRN)

    Atlanta, Georgia, 30322

Other trials in United States

About this study

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) .

Read the 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.

Being tested
Compassion meditation (CM), Support group (SG)
Keywords
Meditation, African American, Randomized controlled trial
Medical subject headings
Suicidal Ideation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Compassion meditation (CM)Behavioural

    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)Behavioural

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

Study groups in NCT03463980
Study groupRoleWhat they receive
Compassion meditation (CM)ExperimentalThe 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.
Receives: Behavioral: Compassion meditation (CM)
Support group (SG)Active comparatorSG 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.
Receives: Behavioral: Support group (SG)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (7)

  1. 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.

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

  2. 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."

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

  3. 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."

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

    Measured: Weekly during participation in the study up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2018
  2. Study start13 May 2010
  3. Primary completion7 Mar 2020
  4. Study completion22 Oct 2021

Why it 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.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
456 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03463980
Sponsor's protocol ID
IRB00038057
Status last verified
Mar 2022
First submitted
7 Mar 2018
Last updated
29 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 33884617

  • 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.

    PubMed 33677832

Questions about this trial

What is this clinical trial studying?

A study testing Compassion meditation (CM) and Support group (SG) in people with Suicidal Ideation, run by Emory University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: 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.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03463980, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.

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