Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Task Sharing for the Care of Severe Mental Disorders in a Low-income Country: a Randomised, Controlled Non-inferiority Trial
Brief Summary: Task sharing mental health care through integration of mental health into primary health care (PHC) is advocated as a means of narrowing the treatment gap for mental disorders in low-income countries. In Ethiopia, it is estimated that only around 10% of people with severe mental disorders (SMDs) ever receive evidence-based treatment for their condition, largely due to scarcity of specialist mental health services. A task-sharing model of mental health care in PHC would be more affordable and accessible to the majority of persons with SMD who do not currently receive evidence-based mental health care. Furthermore, task sharing mental health care with PHC is about to be scaled up in Ethiopia in line with the National Mental Health Strategy. However, the effectiveness of the task sharing model of mental health care for people with SMD has not been evaluated systematically in a low-income country. In this study we propose to investigate non-inferiority of a task sharing model of mental health care in PHC compared to a less accessible, but more specialist, psychiatric nurse-led model of care. The specialist model of care has been demonstrated to be acceptable and associated with improved clinical outcomes for persons with SMD engaged in the service in Ethiopia thus making this an appropriate comparison model against which to evaluate non-inferiority of the task sharing model.


Options:
A: Arm Label: Routine health education; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Routine health education | Arm Label: Nutrition education package; Type: EXPERIMENTAL; Interventions: Behavioral: Nutrition education, Behavioral: Routine health education | Intervention Type: BEHAVIORAL; Name: Nutrition education; Assigned to Arm(s): Nutrition education package | Intervention Type: BEHAVIORAL; Name: Routine health education; Assigned to Arm(s): Nutrition education package, Routine health education
B: Arm Label: Integrated mental health in primary care; Type: EXPERIMENTAL; Interventions: Behavioral: Integrated mental health in primary care | Arm Label: Psychiatric nurse-led specialist care; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Psychiatric nurse-led specialist care | Intervention Type: BEHAVIORAL; Name: Integrated mental health in primary care; Assigned to Arm(s): Integrated mental health in primary care | Intervention Type: BEHAVIORAL; Name: Psychiatric nurse-led specialist care; Assigned to Arm(s): Psychiatric nurse-led specialist care
C: Arm Label: Training of VHVs in iCCM; Type: EXPERIMENTAL; Interventions: Other: Training of VHVs in iCCM | Intervention Type: OTHER; Name: Training of VHVs in iCCM; Assigned to Arm(s): Training of VHVs in iCCM
D: Arm Label: Current protocol; Type: ACTIVE_COMPARATOR; Interventions: Other: Current protocol | Arm Label: Integrated Protocol; Type: EXPERIMENTAL; Interventions: Other: Integrated Protocol | Intervention Type: OTHER; Name: Integrated Protocol; Assigned to Arm(s): Integrated Protocol | Intervention Type: OTHER; Name: Current protocol; Assigned to Arm(s): Current protocol

Answer: B