Evidence map›Paper›PMID 34330334›Full record

ArticlePilot and feasibility studies2021

Posttraumatic stress disorder intervention for people with severe mental illness in a low-income country primary care setting: a randomized feasibility trial protocol.

Lauren C Ng, Eyerusalem Getachew Serba, Benyam W Dubale, Abebaw Fekadu, Charlotte Hanlon

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Pilot and feasibility studies, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04385498 (Posttraumatic Stress Disorder Intervention for People With Severe Mental Illness in Low- and Middle-Income Country Primary Care Settings), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.1field-weighted citation impact, top 22% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04385498 nacompletednot on this mapstarted 2023, after this paper: background citation

Posttraumatic Stress Disorder Intervention for People With Severe Mental Illness in Low- and Middle-Income Country Primary Care Settings

TypeinterventionalSponsorUniversity of California, Los AngelesRan2023 to 2023Enrolled14ConditionsPTSDArmsBREATHE Intervention, Waitlist Treatment as Usual
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 10 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 5 institutions in 4 countries.

Lauren C NgDepartment of Psychology, University of California Los Angeles, Los Angeles, CA, USA. Laurenng@ucla.edu.ORCID http://orcid.org/0000-0001-5988-008X
Eyerusalem Getachew SerbaDepartment of Psychiatry, School of Medicine, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.
Benyam W DubaleDepartment of Psychiatry, School of Medicine, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.
Abebaw FekaduDepartment of Psychiatry, School of Medicine, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.
Charlotte HanlonCentre for Innovative Drug Development and Therapeutic Trials for Africa (CDT-Africa), School of Medicine, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.
Addis Ababa University · ETBrighton and Sussex Medical School · GBKing's College London · GBUniversity of California, Los Angeles · USUniversity of Toronto · CA

Funding

Posttraumatic Stress Disorder Intervention for People with Severe Mental Illness in Low- and Middle-Income Country Primary Care SettingsK23MH110601 · NIMH · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI NG, LAUREN CHRISTINA · 2016 to 2021
$1.0M
Medical Research Council MR/M025470/1NIH HHS 5K23MH110601-04NIMH NIH HHS K23 MH110601
6 · The paper itself

Abstract

backgroundIn 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.

methodsSpecifically, 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: 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 registrationRegistered with ClinicalTrials.gov (NCT04385498) first posted May 13

Indexed as

Global mental healthInterventionPrimary carePsychosisPTSDTask-sharing

Identifiers

PMID34330334
PMCPMC8323310
OpenAlexW3123496345

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.