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NCT06043778Not yet recruiting

Digital Implementation Support to Achieve Uptake and Integration of Task-Shared Care for Schizophrenia in Primary Care in India

Source: ClinicalTrials.gov · Last updated 10 Jul 2026

Brief summary (registry, in English)

Schizophrenia represents a significant contributor to the global burden of disease, with this burden disproportionately impacting low- and middle-income countries (LMICs). In India, the burden due to schizophrenia is further exacerbated by low access to effective psychosocial interventions aimed at promoting recovery, rehabilitation, and community tenure, as well as inadequate attention to managing co-occurring chronic medical conditions that result in significantly reduced life expectancy among those living with schizophrenia compared to the general population. A major driver of these alarming gaps in access to care for persons with schizophrenia in India is the limited capacity within primary care settings aimed at addressing the complex co-occurring mental health, physical health, and functional needs of this patient population. There now exists strong evidence demonstrating that community programs delivered in primary care and leveraging psychosocial interventions combined with linkage to specialty psychiatric services are effective for supporting treatment and recovery of schizophrenia in low-resource settings. We will leverage our existing collaboration and robust research infrastructure in both rural and urban settings in Madhya Pradesh and Karnataka, India to conduct a hybrid type 1 effectiveness-implementation trial to evaluate whether the use of a digital platform offers added clinical benefit and can support integration of this task shared care for schizophrenia into routine primary care settings. We will address the following aims: 1) evaluate whether the use of the mindLAMP digital platform can enhance the clinical effectiveness of task-shared community-based psychosocial rehabilitation (COPSI) for individuals with schizophrenia, and 2) determine whether the addition of mindLAMP to the delivery of the COPSI program has an impact on implementation metrics when compared to delivery of COPSI alone.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
240 (estimated)
First submitted
12 Sept 2023
Start date
1 Oct 2026
Primary completion date
31 Mar 2029
Lead sponsor
Harvard Medical School (HMS and HSDM)
NCT number
NCT06043778

What you commit to

  • Study type: Interventional
  • Planned participants: 240
  • From 1 Oct 2026 to the primary completion date, 31 Mar 2029
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Major visual impairment or inability to operate a smartphone
  • Cognitive impairment or diagnosis of dementia

Other

  • Planning to move out of the study area in the next 12 months
  • Does not speak Hindi or Kannada

Who the study is looking for

  • Primary diagnosis of schizophrenia per IDC-10 diagnostic criteria for research and an illness duration of greater than 12 months and overall moderate level of severity on the CGI-SCH scale
  • At least one risk factor for early mortality (e.g. hypertension, diabetes, dyslipidemia, etc)
  • Willingness to stay in the study area during the trial period
  • Ability to operate a smartphone

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.