SchizophreniaNCT06043778
Digital Implementation Support to Achieve Uptake and Integration of Task-Shared Care for Schizophrenia in Primary Care in India
A study testing Community care for People with Schizophrenia in India (COPSI) and mindLAMP Mobile Application in people with Schizophrenia and Schizophrenia and Related Disorders, run by Harvard Medical School (HMS and HSDM).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Schizophrenia and Related Disorders, Psychosocial Functioning
- What is being tested?
- Community care for People with Schizophrenia in India (COPSI) and mindLAMP Mobile Application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 31 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Being tested
- Community care for People with Schizophrenia in India (COPSI), mindLAMP Mobile Application
- Keywords
- schizophrenia, psychosocial intervention, digital technology, task sharing, implementation, smartphone app
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community care for People with Schizophrenia in India (COPSI)Behavioural
Also called Psychosocial rehabilitation intervention
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 ApplicationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Community care for People with Schizophrenia in India (COPSI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 6 months, and 12 months
Secondary outcomes (5)
Positive and Negative Syndrome Scale (PANSS)
30-item self-report measure of positive and negative symptoms and general psychopathology
Measured: Baseline, 6 months, and 12 months
Generalized Anxiety Disorder Assessment-7 (GAD-7)
7-item self-report measure of anxiety symptom severity based on DSM-5 criteria
Measured: Baseline, 6 months, and 12 months
Patient Health Questionnaire-9 (PHQ-9)
9-item self-report measure of depression severity based on DSM-5 criteria
Measured: Baseline, 6 months, and 12 months
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
Measured: Baseline, 6 months, and 12 months
Brief Assessment of Cognition in Schizophrenia (BACS)
Newly developed instrument to assess aspects of cognition in patients with schizophrenia
Measured: Baseline, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Oct 2026 (estimated)
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harvard Medical School (HMS and HSDM)
- Sponsor type
- University, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Sangath, National Institute of Mental Health and Neuro Sciences, India, All India Institute of Medical Sciences, Bhopal
- Responsible party
- Principal investigator, John A. Naslund, Harvard Medical School (HMS and HSDM)
- Investigators
- John A Naslund, PhD, Principal investigator, Harvard Medical School (HMS and HSDM)John Torous, MD, Principal investigator, Beth Israel Deaconess Medical CenterNarayana Manjunatha, MD, MBBS, Principal investigator, National Institute of Mental Health and Neuro Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06043778
- Sponsor's protocol ID
- R01MH133230
- Status last verified
- Jul 2026
- First submitted
- 12 Sep 2023
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 36988785Bondre 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.
PubMed 36688236Naslund 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.
PubMed 36429654Lakhtakia 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.
PubMed 36386246Rodriguez-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.
PubMed 34512999Rodriguez-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.
PubMed 33541463Cohen 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.
PubMed 36707524
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Implementation Support to Achieve Uptake and Integration of Task-Shared Care for Schizophrenia in Primary Care in India
- ClinicalTrials.gov ID
- NCT06043778
- Acronym / sponsor ID
- R01MH133230
- Keywords
- schizophrenia, psychosocial intervention, digital technology, task sharing, implementation, smartphone app
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Harvard Medical School (HMS and HSDM)University, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Sangath, National Institute of Mental Health and Neuro Sciences, India, All India Institute of Medical Sciences, Bhopal
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPSI plus mindLAMP | Experimental | Behavioral: Community care for People with Schizophrenia in India (COPSI), Behavioral: mindLAMP Mobile ApplicationParticipants 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. |
| COPSI | Active comparator | Behavioral: Community care for People with Schizophrenia in India (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community care for People with Schizophrenia in India (COPSI)Also: Psychosocial rehabilitation interventionThis 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). | Behavioural | COPSI, COPSI plus mindLAMP |
| mindLAMP Mobile ApplicationParticipants 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. | Behavioural | COPSI plus mindLAMP |
Primary outcome
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
5 secondary outcomes
Positive and Negative Syndrome Scale (PANSS)
Time frame: Baseline, 6 months, and 12 months
Generalized Anxiety Disorder Assessment-7 (GAD-7)
Time frame: Baseline, 6 months, and 12 months
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline, 6 months, and 12 months
Clinical Global Impression-Schizophrenia (CGI-SCH) Scale
Time frame: Baseline, 6 months, and 12 months
Brief Assessment of Cognition in Schizophrenia (BACS)
Time frame: Baseline, 6 months, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Background: PubMed 36988785Tyagi 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.
- Background: PubMed 36688236Bondre 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.
- Background: PubMed 36429654Naslund 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.
- Background: PubMed 36386246Lakhtakia 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.
- Background: PubMed 34512999Rodriguez-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.
- Background: PubMed 33541463Rodriguez-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.
- Background: PubMed 36707524Cohen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John A Naslund, PhD principal investigator
Harvard Medical School (HMS and HSDM)
John Torous, MD principal investigator
Beth Israel Deaconess Medical Center
Narayana Manjunatha, MD, MBBS principal investigator
National Institute of Mental Health and Neuro Sciences, India
Questions about this trial
What is this clinical trial studying?
A study testing Community care for People with Schizophrenia in India (COPSI) and mindLAMP Mobile Application in people with Schizophrenia and Schizophrenia and Related Disorders, run by Harvard Medical School (HMS and HSDM).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John A Naslund, PhD (617-432-3712, john_naslund@hms.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Indian Disability Evaluation and Assessment Scale (IDEAS) (time frame: Baseline, 6 months, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06043778, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.