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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHarvard Medical School (HMS and HSDM)

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

  • 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.

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: COPSI plus mindLAMPExperimental treatment 2 interventions
Group B: COPSIActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Indian Disability Evaluation and Assessment Scale (IDEAS)

\- 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

Time frame
Baseline, 6 months, and 12 months

Secondary outcomes

1

Positive and Negative Syndrome Scale (PANSS)

30-item self-report measure of positive and negative symptoms and general psychopathology

Time frame
Baseline, 6 months, and 12 months
2

Generalized Anxiety Disorder Assessment-7 (GAD-7)

7-item self-report measure of anxiety symptom severity based on DSM-5 criteria

Time frame
Baseline, 6 months, and 12 months
3

Patient Health Questionnaire-9 (PHQ-9)

9-item self-report measure of depression severity based on DSM-5 criteria

Time frame
Baseline, 6 months, and 12 months
4

Clinical Global Impression-Schizophrenia (CGI-SCH) Scale

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

Time frame
Baseline, 6 months, and 12 months

Other outcomes

1

Pittsburgh Sleep Questionnaire Index (PSQI)

19-item self-report measure of sleep quality for patients with psychiatric disorders

Time frame
Baseline, 6 months, and 12 months
2

EuroQol-5D (EQ5D)

25-item self-report standardized measure of health status and quality of life to provide a generic measure of health for clinical appraisal

Time frame
Baseline, 6 months, and 12 months
3

Social Functioning Scale (SFS)

A measure with 7 subscales used to assess functioning in patients with psychosis

Time frame
Baseline, 6 months, and 12 months
4

Framingham Risk Score

A measure used to assess cardiovascular risk using quantitative information to aid in targeting lower risk factors

Time frame
Baseline, 6 months, and 12 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Harvard Medical School (HMS and HSDM)

Lead sponsor

Beth Israel Deaconess Medical Center

Collaborator

Sangath

Collaborator

National Institute of Mental Health and Neuro Sciences, India

Collaborator

All India Institute of Medical Sciences, Bhopal

Collaborator

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