COPSI-Plus
- Conditions
- Health Condition 1: F20- Schizophrenia
- Registration Number
- CTRI/2023/09/057223
- Lead Sponsor
- ational Institute of Mental Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Illness duration of =12 months and an overall moderate severity of the illness based on the Clinical Global Impression- Schizophrenia (CGI-SCH) scale. Eligible patients must also have at least one risk factor for early mortality which commonly occurs among individuals with schizophrenia such as hypertension, diabetes, dyslipidemia, current tobacco use, and/or overweight or obesity.
Participants who are planning to move out of the study catchment areas in the next 12 months, and those who do not speak either of the primary local languages, Hindi in Madhya Pradesh or Kannada in Karnataka, individuals with a diagnosis of dementia, or evidence of significant cognitive impairment, individuals who have major visual impairment or who cannot operate a smartphone will be excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patient-Level Outcome Measures: <br/ ><br>1. Disability <br/ ><br>Implementation-Level Outcome Measures: <br/ ><br>1. Patient engagement in COPSITimepoint: Baseline, 6 and 12 months
- Secondary Outcome Measures
Name Time Method Implementation-Level Outcome Measures: <br/ ><br>1. Fidelity of COPSI delivery <br/ ><br>2. Costs of COPSI and mindLAMP vs. COPSI <br/ ><br>Timepoint: Baseline, 6 and 12 months;Patient-Level Outcome Measures: <br/ ><br>1. Mental health: Symptoms, cognition. <br/ ><br>2. Physical health and functional: sleep, QoL, social functioning, cardiovascular risk, health metrics. <br/ ><br>3. Digital dataTimepoint: Baseline, 6 and 12 months