Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06043778

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Schizophrenia Mental Disorders Psychosocial Functioning Schizophrenia Spectrum and Other Psychotic Disorders Schizophrenia and Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Community care for People with Schizophrenia in India (COPSI)

Behavioral

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

mindLAMP Mobile Application

Behavioral

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Other outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

John A Naslund, PhD

CONTACT

[email protected]

617-432-3712

Sponsors and collaborators

Lead sponsor

Harvard Medical School (HMS and HSDM)

Other

Collaborators

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

Registry information

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Sep 21, 2023
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.