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

NCT06043778 | Not Yet Recruiting DMC

• 1 other identifier: R01MH133230
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Schizophrenia; Schizophrenia and Related Disorders; Psychosocial Functioning

Keywords

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

Outcome Measures

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

  Baseline, 6 months, and 12 months

Secondary Outcomes (5)

• Positive and Negative Syndrome Scale (PANSS)

  Baseline, 6 months, and 12 months

• Generalized Anxiety Disorder Assessment-7 (GAD-7)

  Baseline, 6 months, and 12 months

• Patient Health Questionnaire-9 (PHQ-9)

  Baseline, 6 months, and 12 months

• Clinical Global Impression-Schizophrenia (CGI-SCH) Scale

  Baseline, 6 months, and 12 months

• Brief Assessment of Cognition in Schizophrenia (BACS)

  Baseline, 6 months, and 12 months

Other Outcomes (4)

• Pittsburgh Sleep Questionnaire Index (PSQI)

  Baseline, 6 months, and 12 months

• EuroQol-5D (EQ5D)

  Baseline, 6 months, and 12 months

• Social Functioning Scale (SFS)

  Baseline, 6 months, and 12 months

Study Arms (2)

COPSI plus mindLAMP

EXPERIMENTAL

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); Behavioral: mindLAMP Mobile Application

COPSI

ACTIVE COMPARATOR

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)

Interventions

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).

Also known as: Psychosocial rehabilitation intervention

COPSI; COPSI plus mindLAMP

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.

COPSI plus mindLAMP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Harvard Medical School (HMS and HSDM): lead
• 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

Related Publications (7)

• 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.

  PMID: 36988785 BACKGROUND

• 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.

  PMID: 36688236 BACKGROUND

• 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.

  PMID: 36429654 BACKGROUND

• 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.

  PMID: 36386246 BACKGROUND

• 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.

  PMID: 34512999 BACKGROUND

• 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.

  PMID: 33541463 BACKGROUND

• 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.

  PMID: 36707524 BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John A Naslund, PhD

CONTACT

617-432-3712; john_naslund@hms.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of Global Health and Social Medicine

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 21, 2023
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): March 31, 2029
• Last Updated: February 12, 2026

Record last verified: 2026-02