Compassion Meditation and ReliefLink App for Suicidal, Low-Income, African Americans
13. mars 2022 oppdatert av: 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) .
Studieoversikt
Status
Avsluttet
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Intervensjonell
Registrering (Faktiske)
456
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Georgia
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Atlanta, Georgia, Forente stater, 30322
- Grady Health System (non-CRN)
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 64 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
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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.
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Aktiv komparator: 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.
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SG session: 90 minutes to talk about current concerns and to receive support and guidance from other group members and the leaders.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Beck Scale for Suicide Ideation (BSS) score
Tidsramme: 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.
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Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Beck Depression Inventory II (BDI-II) score
Tidsramme: 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.
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Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
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Change in Experience of Shame Scale (ESS) score
Tidsramme: Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
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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."
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Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
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Change in Levels of Self-Criticism Scale (LOSC) score
Tidsramme: Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
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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."
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Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
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Change in Social Support Behaviors Scale (SSB) score
Tidsramme: 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.
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Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
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Change in Self-Compassion Scale (SCS) score
Tidsramme: Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
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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.
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Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
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Change in Five Facet Mindfulness Questionnaire (FFMQ) score
Tidsramme: Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
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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.
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Pre-intervention - baseline (T1), post-intervention - at completion of 6 weekly sessions (T2), and at 6 week follow-up (T3)
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Change in Behavior Monitoring Form (BMF) score
Tidsramme: Weekly during participation in the study up to 3 months
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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.
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Weekly during participation in the study up to 3 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Nadine Kaslow, PhD, Emory University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
13. mai 2010
Primær fullføring (Faktiske)
7. mars 2020
Studiet fullført (Faktiske)
22. oktober 2021
Datoer for studieregistrering
Først innsendt
7. mars 2018
Først innsendt som oppfylte QC-kriteriene
7. mars 2018
Først lagt ut (Faktiske)
13. mars 2018
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
29. mars 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. mars 2022
Sist bekreftet
1. mars 2022
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IRB00038057
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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