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An Effectiveness-implementation Hybrid Cluster Randomized Controlled Trial to Evaluate Add-on Online Mental Health
Gajanan Ganapati Sabhahit1, Nileswar Das2, Ranjitha Ramachandraiah1
1Dept. of Psychiatry, National Institute of Mental Health and Neuro Sciences (NIMHANS), Bengaluru, Karnataka, India.
Background:
Building capacity in primary mental healthcare supports effective task-shifting and sharing. Using technology in this context offers convenience and scalability.
Methods:
We describe the methodology of a novel effectiveness-implementation hybrid randomized controlled trial to evaluate the effect of an add-on online mental health training (OMHT) program for primary care doctors (PCDs) on their management of commonly prevalent psychiatric disorders. The comparator was training as usual (TAU).Nine (9) taluks of Tumkur District in Karnataka state were divided into study (SG) and control group (CG) clusters through randomization (SG-6; CG-3). TAU: an annual, in-person training program for 2 days on identifying and treating commonly prevalent psychiatric disorders in the community. was received by all PCDs across the district. An add-on OMHT (12 hours of digital training followed by supportive handholding through Collaborative Video Consultations for 3 months) was provided to the PCDs in SG. Primary outcomes included comparison of diagnostic concordance, treatment concordance, and combined concordance (diagnosis and treatment) between the assessors (research psychiatrists) and PCDs. Secondary outcomes were comparison of (a) short-term clinical outcomes of patients with psychiatric disorders treated by PCDs using standardized scales, (b) implementation questionnaire having a bearing on integrating mental health into primary healthcare delivery systems and (c) procurement pattern of psychiatric medications at Primary Health Centers (PHC) across three phases: 4 months pre-training, training (4 months) and 4 months post training.
Results:
The results of this trial are described separately in other articles.
Conclusions:
The trial's results shed light on the utility of online training methods for PCDs to hone their skills in primary care psychiatry. It would also provide insights into the implementation barriers and facilitators for capacity-building programs, as well as their translation into clinical practice.
Registration:
Clinical Trials Registry of India (CTRI/2024/02/062906).
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