Posttraumatic stress disorder intervention for people with severe mental illness in a low-income country primary care setting: a randomized feasibility trial protocol
Bibliographic record
Abstract
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: 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: 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: , 2020; https://www.clinicaltrials.gov/ct2/show/NCT04385498?term=ethiopia&cond=PTSD&draw=2&rank=1 .
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.051 | 0.033 |
| Meta-epidemiology (narrow) | 0.004 | 0.003 |
| Meta-epidemiology (broad) | 0.005 | 0.004 |
| Bibliometrics | 0.003 | 0.003 |
| Science and technology studies | 0.005 | 0.003 |
| Scholarly communication | 0.004 | 0.004 |
| Open science | 0.004 | 0.003 |
| Research integrity | 0.006 | 0.006 |
| Insufficient payload (model declined to judge) | 0.062 | 0.010 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".