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

• ClinicalTrials.gov Identifier: NCT06043778
• Recruitment Status: Not yet recruiting
• First Posted: September 21, 2023
• Last Update Posted: September 21, 2023
• Sponsor: Harvard Medical School (HMS and HSDM)
• Collaborators: Beth Israel Deaconess Medical Center; Sangath; National Institute of Mental Health and Neuro Sciences, India; All India Institute of Medical Sciences, Bhopal
• Information provided by (Responsible Party): John A. Naslund, Harvard Medical School (HMS and HSDM)

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Schizophrenia; Schizophrenia and Related Disorders; Psychosocial Functioning	Behavioral: Community care for People with Schizophrenia in India (COPSI); Behavioral: mindLAMP Mobile Application	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 240 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Masking Description: In this trial, the Outcome Assessors administering study assessments at baseline, midpoints and the endpoint will be masked to the intervention arm that participants are allocated to receive. The Study Investigators will also be masked to the intervention arm that participants are allocated to receive. Masking Outcome Assessors and Study Investigators will minimize potential bias due to knowledge of which arm the participant is allocated to, and can ensure unbiased ascertainment of study outcomes is possible. For allocation concealment, the intervention allocation for each participant will not be revealed to the participant until they have been enrolled into the trial, to avoid selection bias.
• Primary Purpose: Treatment
• Official Title: Digital Implementation Support to Achieve Uptake and Integration of Task-Shared Care for Schizophrenia in Primary Care in India
• Estimated Study Start Date: January 2025
• Estimated Primary Completion Date: July 2028
• Estimated Study Completion Date: December 2028

Arms and Interventions

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 Name: 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 Name: Psychosocial rehabilitation intervention

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 Outcome Measures:

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Contacts

Contact: John A Naslund, PhD; 617-432-3712; john_naslund@hms.harvard.edu

Sponsors and Collaborators

Harvard Medical School (HMS and HSDM)

Beth Israel Deaconess Medical Center

Sangath

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

More Information

Publications:

Tyagi V, Khan A, Siddiqui S, Kakra Abhilashi M, Dhurve P, Tugnawat D, Bhan A, Naslund JA. Development of a Digital Program for Training Community Health Workers in the Detection and Referral of Schizophrenia in Rural India. Psychiatr Q. 2023 Jun;94(2):141-163. doi: 10.1007/s11126-023-10019-w. Epub 2023 Mar 29.

Bondre AP, Shrivastava R, Raghuram H, Tugnawat D, Khan A, Gupta S, Kumar M, Mehta UM, Keshavan M, Lakhtakia T, Chand PK, Thirthalli J, Patel V, Torous J, Rozatkar AR, Naslund JA, Bhan A. A qualitative exploration of perceived needs and barriers of individuals with schizophrenia, caregivers and clinicians in using mental health applications in Madhya Pradesh, India. SSM Ment Health. 2022 Dec;2:100063. doi: 10.1016/j.ssmmh.2022.100063.

Naslund JA, Tyagi V, Khan A, Siddiqui S, Kakra Abhilashi M, Dhurve P, Mehta UM, Rozatkar A, Bhatia U, Vartak A, Torous J, Tugnawat D, Bhan A. Schizophrenia Assessment, Referral and Awareness Training for Health Auxiliaries (SARATHA): Protocol for a Mixed-Methods Pilot Study in Rural India. Int J Environ Res Public Health. 2022 Nov 13;19(22):14936. doi: 10.3390/ijerph192214936.

Lakhtakia T, Bondre A, Chand PK, Chaturvedi N, Choudhary S, Currey D, Dutt S, Khan A, Kumar M, Gupta S, Nagendra S, Reddy PV, Rozatkar A, Scheuer L, Sen Y, Shrivastava R, Singh R, Thirthalli J, Tugnawat DK, Bhan A, Naslund JA, Patel V, Keshavan M, Mehta UM, Torous J. Smartphone digital phenotyping, surveys, and cognitive assessments for global mental health: Initial data and clinical correlations from an international first episode psychosis study. Digit Health. 2022 Nov 8;8:20552076221133758. doi: 10.1177/20552076221133758. eCollection 2022 Jan-Dec.

Rodriguez-Villa E, Rozatkar AR, Kumar M, Patel V, Bondre A, Naik SS, Dutt S, Mehta UM, Nagendra S, Tugnawat D, Shrivastava R, Raghuram H, Khan A, Naslund JA, Gupta S, Bhan A, Thirthall J, Chand PK, Lakhtakia T, Keshavan M, Torous J. Cross cultural and global uses of a digital mental health app: results of focus groups with clinicians, patients and family members in India and the United States. Glob Ment Health (Camb). 2021 Aug 24;8:e30. doi: 10.1017/gmh.2021.28. eCollection 2021.

Rodriguez-Villa E, Mehta UM, Naslund J, Tugnawat D, Gupta S, Thirthalli J, Bhan A, Patel V, Chand PK, Rozatkar A, Keshavan M, Torous J. Smartphone Health Assessment for Relapse Prevention (SHARP): a digital solution toward global mental health - CORRIGENDUM. BJPsych Open. 2021 Feb 5;7(2):e48. doi: 10.1192/bjo.2021.6. No abstract available.

Cohen A, Naslund JA, Chang S, Nagendra S, Bhan A, Rozatkar A, Thirthalli J, Bondre A, Tugnawat D, Reddy PV, Dutt S, Choudhary S, Chand PK, Patel V, Keshavan M, Joshi D, Mehta UM, Torous J. Relapse prediction in schizophrenia with smartphone digital phenotyping during COVID-19: a prospective, three-site, two-country, longitudinal study. Schizophrenia (Heidelb). 2023 Jan 27;9(1):6. doi: 10.1038/s41537-023-00332-5.

• Responsible Party: John A. Naslund, Instructor of Global Health and Social Medicine, Harvard Medical School (HMS and HSDM)
• ClinicalTrials.gov Identifier: NCT06043778
• Other Study ID Numbers: R01MH133230 ( U.S. NIH Grant/Contract )
• First Posted: September 21, 2023
• Last Update Posted: September 21, 2023
• Last Verified: September 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by John A. Naslund, Harvard Medical School (HMS and HSDM):

schizophrenia; psychosocial intervention; digital technology; task sharing; implementation; smartphone app

Additional relevant MeSH terms:

Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders