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

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

	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

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

ISSN: 2055-5784