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

13 maart 2022 bijgewerkt door: Nadine Kaslow, PhD, Emory University
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) .

Studie Overzicht

Toestand

Beëindigd

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

456

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Georgia
      • Atlanta, Georgia, Verenigde Staten, 30322
        • Grady Health System (non-CRN)

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 64 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Compassion meditation (CM)
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.
Gedragsmatig: 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.
Actieve vergelijker: Support group (SG)
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.
Gedragsmatig: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Beck Scale for Suicide Ideation (BSS) score
Tijdsspanne: Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Beck Depression Inventory II (BDI-II) score
Tijdsspanne: Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
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)
Change in Experience of Shame Scale (ESS) score
Tijdsspanne: Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
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)
Change in Levels of Self-Criticism Scale (LOSC) score
Tijdsspanne: Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
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)
Change in Social Support Behaviors Scale (SSB) score
Tijdsspanne: Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
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)
Change in Self-Compassion Scale (SCS) score
Tijdsspanne: Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
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)
Change in Five Facet Mindfulness Questionnaire (FFMQ) score
Tijdsspanne: Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
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)
Change in Behavior Monitoring Form (BMF) score
Tijdsspanne: Weekly during participation in the study up to 3 months
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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Emory University

Onderzoekers

  • Hoofdonderzoeker: Nadine Kaslow, PhD, Emory University

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

13 mei 2010

Primaire voltooiing (Werkelijk)

7 maart 2020

Studie voltooiing (Werkelijk)

22 oktober 2021

Studieregistratiedata

Eerst ingediend

7 maart 2018

Eerst ingediend dat voldeed aan de QC-criteria

7 maart 2018

Eerst geplaatst (Werkelijk)

13 maart 2018

Updates van studierecords

Laatste update geplaatst (Werkelijk)

29 maart 2022

Laatste update ingediend die voldeed aan QC-criteria

13 maart 2022

Laatst geverifieerd

1 maart 2022

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • IRB00038057

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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