- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03463980
Compassion Meditation and ReliefLink App for Suicidal, Low-Income, African Americans
13 marzo 2022 aggiornato da: 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) .
Panoramica dello studio
Stato
Terminato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
456
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
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Georgia
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Atlanta, Georgia, Stati Uniti, 30322
- Grady Health System (non-CRN)
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 64 anni (Adulto)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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Comparatore attivo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change in Beck Scale for Suicide Ideation (BSS) score
Lasso di tempo: 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 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change in Beck Depression Inventory II (BDI-II) score
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Nadine Kaslow, PhD, Emory University
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
13 maggio 2010
Completamento primario (Effettivo)
7 marzo 2020
Completamento dello studio (Effettivo)
22 ottobre 2021
Date di iscrizione allo studio
Primo inviato
7 marzo 2018
Primo inviato che soddisfa i criteri di controllo qualità
7 marzo 2018
Primo Inserito (Effettivo)
13 marzo 2018
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
29 marzo 2022
Ultimo aggiornamento inviato che soddisfa i criteri QC
13 marzo 2022
Ultimo verificato
1 marzo 2022
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IRB00038057
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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