Digital Implementation Support to Achieve Uptake and Integration of Task-Shared Care for Schizophrenia in Primary Care in India
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ClinicalTrials.gov Identifier: NCT06043778 |
Recruitment Status :
Not yet recruiting
First Posted : September 21, 2023
Last Update Posted : September 21, 2023
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Condition or disease | Intervention/treatment | Phase |
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Schizophrenia Schizophrenia and Related Disorders Psychosocial Functioning | Behavioral: Community care for People with Schizophrenia in India (COPSI) Behavioral: mindLAMP Mobile Application | Not Applicable |
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 |
Arm | Intervention/treatment |
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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.
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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.
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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 |
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06043778
Contact: John A Naslund, PhD | 617-432-3712 | john_naslund@hms.harvard.edu |
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 |
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 Key Record Dates |
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 |
schizophrenia psychosocial intervention digital technology |
task sharing implementation smartphone app |
Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders |