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

February 10, 2026 updated by: John A. Naslund, Harvard Medical School (HMS and HSDM)
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Schizophrenia is one of the leading causes of disability due to mental disorders in low-income and middle-income countries (LMICs), such as India, with this burden disproportionately impacting lower income individuals who primarily access health care services through publicly run facilities. In 2017, it was estimated that there were over 3.5 million people in India living with schizophrenia, with an increasing prevalence of schizophrenia observed from 1990 to 2017 as the population ages and disease burden shifts to chronic conditions experienced in adulthood. Importantly, the burden of disability due to schizophrenia is often underestimated as many epidemiological studies do not adequately account for the added burden of chronic medical conditions, such as hypertension, heart disease, and diabetes that disproportionately impact individuals living with schizophrenia. Globally, the dramatically reduced life expectancy observed among individuals living with schizophrenia is largely due to preventable and treatable medical conditions. Recent epidemiological studies in India have further observed a mortality rate among individuals living with schizophrenia that is twice the rate observed in the general population, with calls for greater efforts to address this significant health disparity. In addition to recognizing the need to address the alarming care gap, where in India it is estimated that upwards of 75% of individuals living with schizophrenia do not have access to essential mental health care, urgent attention is also needed towards responding to the medical and physical health needs of this vulnerable patient population. Psychosocial interventions, focused on rehabilitation and skill-building, engaging in social activities, managing mental health symptoms, and promoting recovery and community reintegration, hold potential to reduce disability and improve mental health and functioning for individuals living with schizophrenia. Furthermore, building on recent compelling evidence from higher-income countries, community-based programs could be augmented with additional content aimed at addressing risk factors for early mortality, such as lifestyle behaviors, tobacco use, and management of co-occurring chronic medical conditions. Therefore, our study seeks to evaluate the use of a digital platform for supporting the clinical effectiveness and integration of task shared delivery of the evidence-based COPSI (Community care for People with Schizophrenia in India) program in primary care. We will build on important preliminary work led by project collaborators to support our aims to evaluate whether a novel digital platform can enhance the clinical effectiveness (Aim 1) and the integration (Aim 2) of an evidence-based psychosocial rehabilitation intervention for patients with schizophrenia in primary care settings in India.

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Major visual impairment or inability to operate a smartphone
  • Cognitive impairment or diagnosis of dementia
  • Planning to move out of the study area in the next 12 months
  • Does not speak Hindi or Kannada

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: COPSI plus mindLAMP
Participants allocated to this arm will be enrolled in COPSI and also have access to the mindLAMP mobile application. mindLAMP's materials will be available on demand for participants use.
Behavioral: Community care for People with Schizophrenia in India (COPSI)
This intervention is designed to promote collaboration between the person with schizophrenia, their caregivers and the treatment team to deliver a flexible, individualized, and needs-based intervention. The COPSI intervention will be delivered by Community Health Officers in three phases: intensive engagement (0-3 months), stabilization phase (4-7 months), and maintenance phase (8-12).
Other Names:
  • Psychosocial rehabilitation intervention
Behavioral: mindLAMP Mobile Application
Participants in COPSI plus mindLAMP arm will have access to COPSI and the mindLAMP mobile application. mindLAMP has already been co-developed and culturally adapted by patients, family members, and clinicians at both Indian sites. Materials (articles, videos, web links, audio files, etc.) will be available on-demand and can be accessed by patients at any time. Community Health Officers will also schedule content to specific participants to promote engagement.
Active Comparator: COPSI
Participants allocated to this arm will be enrolled in COPSI alone. COPSI is delivered in three phases: 1) intensive engagement (0-3 months), including six to eight home visits by Community Health Officers; 2) stabilization phase (4-7 months) with sessions delivered once every 15 days; 3) and maintenance phase (8-12) with sessions delivered once a month.
Behavioral: Community care for People with Schizophrenia in India (COPSI)
This intervention is designed to promote collaboration between the person with schizophrenia, their caregivers and the treatment team to deliver a flexible, individualized, and needs-based intervention. The COPSI intervention will be delivered by Community Health Officers in three phases: intensive engagement (0-3 months), stabilization phase (4-7 months), and maintenance phase (8-12).
Other Names:
  • Psychosocial rehabilitation intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Indian Disability Evaluation and Assessment Scale (IDEAS)
Time Frame: Baseline, 6 months, and 12 months
- 4-domain self-report measure detecting the level of disability in psychiatric patients in India which generates a global score of severity of disability (0-20) with increasing scores indicating more severe disabilities
Baseline, 6 months, and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive and Negative Syndrome Scale (PANSS)
Time Frame: Baseline, 6 months, and 12 months
30-item self-report measure of positive and negative symptoms and general psychopathology
Baseline, 6 months, and 12 months
Generalized Anxiety Disorder Assessment-7 (GAD-7)
Time Frame: Baseline, 6 months, and 12 months
7-item self-report measure of anxiety symptom severity based on DSM-5 criteria
Baseline, 6 months, and 12 months
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: Baseline, 6 months, and 12 months
9-item self-report measure of depression severity based on DSM-5 criteria
Baseline, 6 months, and 12 months
Clinical Global Impression-Schizophrenia (CGI-SCH) Scale
Time Frame: Baseline, 6 months, and 12 months
7-item self-report measure of severity of schizophrenia, each component of the CGI-SCH is waited separately and does not yield a global score
Baseline, 6 months, and 12 months
Brief Assessment of Cognition in Schizophrenia (BACS)
Time Frame: Baseline, 6 months, and 12 months
Newly developed instrument to assess aspects of cognition in patients with schizophrenia
Baseline, 6 months, and 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pittsburgh Sleep Questionnaire Index (PSQI)
Time Frame: Baseline, 6 months, and 12 months
19-item self-report measure of sleep quality for patients with psychiatric disorders
Baseline, 6 months, and 12 months
EuroQol-5D (EQ5D)
Time Frame: Baseline, 6 months, and 12 months
25-item self-report standardized measure of health status and quality of life to provide a generic measure of health for clinical appraisal
Baseline, 6 months, and 12 months
Social Functioning Scale (SFS)
Time Frame: Baseline, 6 months, and 12 months
A measure with 7 subscales used to assess functioning in patients with psychosis
Baseline, 6 months, and 12 months
Framingham Risk Score
Time Frame: Baseline, 6 months, and 12 months
A measure used to assess cardiovascular risk using quantitative information to aid in targeting lower risk factors
Baseline, 6 months, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harvard Medical School (HMS and HSDM)

Collaborators

Sangath
Beth Israel Deaconess Medical Center
National Institute of Mental Health and Neuro Sciences, India
All India Institute of Medical Sciences, Bhopal

Investigators

  • Principal Investigator: John A Naslund, PhD, Harvard Medical School (HMS and HSDM)
  • Principal Investigator: John Torous, MD, Beth Israel Deaconess Medical Center
  • Principal Investigator: Narayana Manjunatha, MD, MBBS, National Institute of Mental Health and Neuro Sciences, India

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

March 31, 2029

Study Completion (Estimated)

March 31, 2029

Study Registration Dates

First Submitted

September 12, 2023

First Submitted That Met QC Criteria

September 12, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH133230 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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