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Table 1 Pilot study objectives

From: Reducing stigma among healthcare providers to improve mental health services (RESHAPE): protocol for a pilot cluster randomized controlled trial of a stigma reduction intervention for training primary healthcare workers in Nepal

Domains Research questions Hypotheses Methods Participants
1-1. Feasibility and acceptability of intervention Do mental health expert trainers, primary care trainees, and mental health service users find it acceptable for trained mental health service users to participate as co-facilitators in training and supervision? Key stakeholders will find participation of trained mental health service users acceptable. Qualitative interviews with mental health expert trainers, primary care trainees, trained mental health service users, and research staff
Process notes from trainings and supervision sessions
Mental health expert trainers, primary care trainees, trained mental health service users, research staff
1-2. Fidelity and contamination of intervention Can fidelity be feasibly and reliably assessed? What degree of fidelity to RESHAPE is achievable? Can contamination be captured through fidelity and other assessments? Fidelity can be feasibly and reliably assessed with a structured tool, which will also inform assessment of contamination Use of fidelity assessment tool by research staff; target is fidelity of 75% of items on the fidelity checklist
Qualitative interviews with mental health expert trainers, primary care trainees, trained mental health service users, and research staff
Process notes and videos from trainings and supervision sessions
Mental health expert trainers, primary care trainees, trained mental health service users, research staff
1-3. Randomization Are there biases in the randomization procedure for primary care workers or patients? How could randomization be adjusted based on contamination findings? Simple randomization will be adequate Tabulation of descriptive summaries for baseline characteristics comparing the two groups
Trainee demographics (educational/professional qualifications, age, gender, prior mental health exposure, years of experience)
Health facility log book review for patient demographics (age, gender, disorder, number of visits)
Primary care trainees and patients
1-4. Recruitment and retention Can adequate numbers of mental health service users be recruited, trained, and retained to serve as facilitators? Can adequate numbers of primary care workers and patients be recruited and retained for outcome analyses? Mental health service users can be trained and retained throughout to sustain ongoing social engagement throughout the study. Primary care workers and patients will need to be over-recruited to account for population mobility, loss to follow-up, and professional transfers. Process outputs: mental health service users (number trained, number participating in training, number participating in supervision), target is 50% service user retention; primary care worker trainees (number available in facilities, number at trainings, number at supervision sessions; number completing assessments), target is 66% health workers completion of assessment at 16 months; patients (number attending facilities, number of sessions received, number consenting, number completing assessments), target is 66% patient completion of 6-month follow-up assessment
Qualitative interviews with primary care trainees, trained mental health service users, patients, and research staff
Primary care trainees, trained mental health service users, patients, research staff
1-5. Acceptability, feasibility, and validity of measures Are the assessment tools feasible to administer and understand for primary care workers and patients at the planned intervals? Is there expected inter-instrument validity? The measures will demonstrate adequate acceptability, feasibility, and validity for subsequent trials. Tool completion rate, time for completion, number of missing items; target is fewer than 15% missing items on measures
Correlations among instruments
Cognitive interviewing for transcultural validity
Primary care trainees, patients, and research staff
1-6. Instrument statistical characteristics in cluster design What is the between and within cluster variance for outcome measures? Clustering of outcomes within health facilities supports need for cluster randomized design Statistical analyses of outcome measures Primary care trainees, patients
1-7. Ethics and safety of trial Does the research pose harm to primary care workers, patients, or mental health service users, facilitators and are these harms adequately prevented, documented, and addressed? A subsequent larger scale trial can be conducted using the ethical and safety standards piloted Qualitative interviews
Process evaluation notes
Documentation of adverse events and serious adverse events
Primary care trainees, patients, mental health expert trainers, mental health service users, and research staff
1-8. Assess the change in primary care worker attitudes, knowledge, and clinical competency Do primary care workers’ knowledge, attitudes, and competence improve? Primary care workers in the RESHAPE intervention arm will show improvement in outcomes Outcome assessment pre- and post-training, plus 4- and 16-month follow-up Primary care trainees
1-9. Assess the change in patient stigma-related barriers to care, functioning, and symptoms Do patients’ experiences of stigma, functioning, and depression symptoms improve? Patients in the RESHAPE intervention arm will show improvement in outcomes Pre-treatment assessment plus 6-month follow-up Patients