03352nas a2200301   4500000000100000008004100001260004400042653003300086653005700119653001800176653003100194100001600225700001300241700001100254700001800265700001600283700001200299700001200311700001800323700001300341700001300354700001400367245013500381856007700516490000700593520243600600022001403036       2022                            d  bSpringer Science and Business Media LLC10aPsychiatry and Mental health10aPublic Health, Environmental and Occupational Health10aHealth Policy10aPshychiatric Mental Health1 aMukherjee A1 aDaniel M1 aKaur A1 aDevarapalli S1 aKallakuri S1 aEssue B1 aRaman U1 aThornicroft G1 aSaxena S1 aPeiris D1 aMaulik PK00aOperational challenges in the pre-intervention phase of a mental health trial in rural India: reflections from SMART Mental Health  uhttps://ijmhs.biomedcentral.com/track/pdf/10.1186/s13033-022-00549-4.pdf0 v163 a<p>Background</p>

<p>Availability of mental health services in low- and middle-income countries is largely concentrated in tertiary care with limited resources and scarcity of trained professionals at the primary care level. SMART Mental Health is a strategy that combines a community anti-stigma campaign with a primary health care workforce strengthening initiative, using electronic decision support with the goal of better identifying and supporting people with common mental disorders in India.</p>

<p>Methods</p>

<p>We describe the challenges faced and lessons learnt during the pre-intervention phase of SMART Mental Health cluster Randomised Controlled Trial. Pre-intervention phase includes preliminary activities for setting-up the trial and research activities prior to delivery of the intervention. Field notes from project site visit, project team meetings and detailed follow-up discussions with members of the project team were used to document operational challenges and strategies adopted to overcome them. The socio-ecological model was used as the analytical framework to organise the findings.</p>

<p>Results</p>

<p>Key challenges included delays in government approvals, addressing community health worker needs, and building trust in the community. These were addressed through continuous communication, leveraging support of relevant stakeholders, and addressing concerns of community health workers and community. Issues related to use of digital platform for data collection were addressed by a dedicated technical support team. The COVID-19 pandemic and political unrest led to significant and unexpected challenges requiring important adaptations to successfully implement the project.</p>

<p>Conclusion</p>

<p>Setting up of this trial has posed challenges at a combination of community, health system and broader socio-political levels. Successful mitigating strategies to overcome these challenges must be innovative, timely and flexibly delivered according to local context. Systematic ongoing documentation of field-level challenges and subsequent adaptations can help optimise implementation processes and support high quality trials. Trial registration: The trial is registered with Clinical Trials Registry India (CTRI/2018/08/015355). Registered on 16th August 2018. http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=23254&amp;EncHid=&amp;userName=CTRI/2018/08/015355</p>
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