Posttraumatic stress disorder intervention for people with severe mental illness in a low-income country primary care setting: a randomized feasibility trial protocol.
Global mental health
Intervention
PTSD
Primary care
Psychosis
Task-sharing
Journal
Pilot and feasibility studies
ISSN: 2055-5784
Titre abrégé: Pilot Feasibility Stud
Pays: England
ID NLM: 101676536
Informations de publication
Date de publication:
30 Jul 2021
30 Jul 2021
Historique:
received:
11
01
2021
accepted:
09
07
2021
entrez:
31
7
2021
pubmed:
1
8
2021
medline:
1
8
2021
Statut:
epublish
Résumé
In this protocol, we outline a mixed-methods randomized feasibility trial of Brief Relaxation, Education and Trauma Healing (BREATHE) Ethiopia. BREATHE Ethiopia is a culturally and contextually adapted intervention for PTSD in participants with severe mental illness. BREATHE Ethiopia maps onto the World Health Organization's guidelines for posttraumatic stress disorder (PTSD) treatment in low- and middle-income country primary care settings. Specifically, this study includes a non-randomized pre-pilot (n = 5) and a randomized feasibility trial comparing BREATHE Ethiopia to Treatment as Usual (n = 40) to assess trial procedures, acceptability, and feasibility of intervention delivery, and investigate potential effectiveness and implementation. In a process evaluation, we will collect data that will be critical for a future fully randomized controlled trial, including the numbers of participants who are eligible, who consent, who engage in treatment, and who complete the assessments, as well as the feasibility and acceptability of assessments and the intervention. Qualitative data on facilitators and barriers to intervention delivery and quantitative data on provider fidelity to the intervention and participant and provider satisfaction will also be collected. Quantitative assessments at baseline, post-treatment, 1-month follow-up, and 3-month follow-up will assess change in mental health symptoms and functional impairment and hypothesized intervention mechanisms, including knowledge about PTSD, stigma, trauma-related cognitions, and physiological arousal. Findings from this study will inform a future fully-powered randomized controlled trial, and if found to be effective, the intervention has the potential to be integrated into mental healthcare scale-up efforts in other low-resource settings. Registered with ClinicalTrials.gov (NCT04385498) first posted May 13
Sections du résumé
BACKGROUND
BACKGROUND
In this protocol, we outline a mixed-methods randomized feasibility trial of Brief Relaxation, Education and Trauma Healing (BREATHE) Ethiopia. BREATHE Ethiopia is a culturally and contextually adapted intervention for PTSD in participants with severe mental illness. BREATHE Ethiopia maps onto the World Health Organization's guidelines for posttraumatic stress disorder (PTSD) treatment in low- and middle-income country primary care settings.
METHODS
METHODS
Specifically, this study includes a non-randomized pre-pilot (n = 5) and a randomized feasibility trial comparing BREATHE Ethiopia to Treatment as Usual (n = 40) to assess trial procedures, acceptability, and feasibility of intervention delivery, and investigate potential effectiveness and implementation. In a process evaluation, we will collect data that will be critical for a future fully randomized controlled trial, including the numbers of participants who are eligible, who consent, who engage in treatment, and who complete the assessments, as well as the feasibility and acceptability of assessments and the intervention. Qualitative data on facilitators and barriers to intervention delivery and quantitative data on provider fidelity to the intervention and participant and provider satisfaction will also be collected. Quantitative assessments at baseline, post-treatment, 1-month follow-up, and 3-month follow-up will assess change in mental health symptoms and functional impairment and hypothesized intervention mechanisms, including knowledge about PTSD, stigma, trauma-related cognitions, and physiological arousal.
DISCUSSION
CONCLUSIONS
Findings from this study will inform a future fully-powered randomized controlled trial, and if found to be effective, the intervention has the potential to be integrated into mental healthcare scale-up efforts in other low-resource settings.
TRIAL REGISTRATION
BACKGROUND
Registered with ClinicalTrials.gov (NCT04385498) first posted May 13
Identifiants
pubmed: 34330334
doi: 10.1186/s40814-021-00883-3
pii: 10.1186/s40814-021-00883-3
pmc: PMC8323310
doi:
Banques de données
ClinicalTrials.gov
['NCT04385498']
Types de publication
Journal Article
Langues
eng
Pagination
149Subventions
Organisme : NIMH NIH HHS
ID : K23 MH110601
Pays : United States
Organisme : Medical Research Council
ID : MR/M025470/1
Pays : United Kingdom
Organisme : NIH HHS
ID : 5K23MH110601-04
Pays : United States
Informations de copyright
© 2021. The Author(s).
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