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Table 4 Schedule of enrollment, interventions, and assessments for RESHAPE

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

  Study period
Primary healthcare workers (direct beneficiaries)—trained to deliver mental health services
  Cluster allocation Enrollment Post-allocation Close-out
Time point -t 1 t 0 t 1 t 2 t 3 t 4 t 5 t 6
Enrollment  
 Allocation X        
 Eligibility screen   X       
 Informed consent   X       
Interventions  
 PRIME training and supervision (TAU)    ←−−−−−−−−−−−−−−−−−−−−−−−−−−→  
 RESHAPE training and supervision    ←−−−−−−−−−−−−−−−−−−−−−−−−−−→  
Assessments  
 mhGAP knowledge    X X X X   
 mhGAP attitudes    X X X X   
 Social Distance    X X X X   
 Implicit Assoc. Test    X X X X   
 Health worker—ENACT    X X X X   
 Qualitative interviews    X X X    X
Patients (indirect beneficiaries)—patients treated by TAU or RESHAPE-trained primary healthcare workers
  Cluster Allocation   Post-allocation Close-out
Time point** -t 1   t 1 t 2 t 3 t 4 t 5 t 6
Enrollment  
 Allocation X        
 Eligibility screen       X   
 Informed consent       X   
Interventions  
 mhGAP + HAP/CAP        ← − →  
Assessments  
Patient—BACE        X X
Patient—WHODAS        X X
Patient—PHQ-9        X X
Patient—AUDIT        X X
Patient—ENACT        X X
Qualitative interviews         X
  1. Note: All health facility clusters are allocated are -t1. Primary healthcare workers are assigned to Training As Usual (TAU) or RESHAPE trainings based on the health facility in which they work. Primary healthcare workers are enrolled and consents at t0. Primary healthcare workers are administered assessment batteries immediately prior to training at t1. They then participate in training and subsequent supervision for the duration of the research study. There is an immediate post-training assessment at t2, followed by a 4-month (t3) and 16-month (t5) assessment. Close-out qualitative interviews are conducted with a subset of primary healthcare workers at t6. Patients are enrolled with TAU or RESHAPE-trained primary healthcare workers according to the allocation of their local healthcare facility. They all receive mhGAP and HAP/CAP interventions. Patient enrollment occurs at approximately 18 months after primary healthcare workers are trained. Patients are assessed at treatment initiation (t5) and 6 months later at study close-out (t6). Close-out qualitative interviews are conducted with a subset of patients at t6