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Assessing the Feasibility and Impact of Physical Health Monitoring in Patients with First Episode Psychosis (AIIMS centre)

Assessing the Feasibility and Impact of Physical Health Monitoring in Patients with First Episode Psychosis (AIIMS centre)

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/08/035331
Enrollment
80
Registered
2021-08-02
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F23- Brief psychotic disorder Health Condition 2: F22- Delusional disorders Health Condition 3: F323- Major depressive disorder, singleepisode, severe with psychotic features Health Condition 4: F302- Manic episode, severe with psychotic symptoms Health Condition 5: F28- Other psychotic disorder not due to a substance or known physiological condition Health Condition 6: F25- Schizoaffective disorders Health Condition 7: F20- Schizophrenia Health Condition 8: F29- Unspecified

Interventions

Intervention1: Booklet-based intervention arm: Psychoeducation booklets and physical health monitoring used to provide psychosocial intervention for three months. Assessment will be done at baseline,

Sponsors

National Institute for Health Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria for Patient ï?· First presentation with psychotic symptoms at our centre ï?· Age 14-45 years ï?· No past history of psychosis ï?· Not received treatment >= 3 months ï?· Either sex ï?· Schizophrenia (F20), persistent delusional disorder (F22), acute and transient psychotic disorders (F 23), Schizo-affective disorder (F25), Other and Unspecified Psychosis (F28 & F29), Mania with psychotic symptoms (F30.2), Bipolar affective disorder, current episode manic with psychotic symptoms (F 31.2), Severe depressive episode with psychotic symptoms (F32.3) and Recurrent Depressive Disorder, current episode depression with psychotic symptoms (F 33.3) on ICD-10 (WHO 1993). Inclusion criteria for Caregiver A family member staying with patient and fulfilling any three of the following criteria (Maji et al, 2012): ï?· Parent or spouse ï?· Had most frequent contact with the patient ï?· Helped to support the patient financially ï?· Had most frequently been a participant in patientâ??s treatment ï?· To be contacted by treatment staff in case of an emergency

Exclusion criteria

Exclusion criteria: Exclusion criteria for Patient ï?· Presence of pervasive developmental disorder, specific learning disability and mental retardation (ascertained on history and clinical examination) ï?· Presence of organic brain damage, epilepsy (ascertained on history and clinical examination) ï?· Not willing or able to provide informed consent Exclusion criteria for Caregivers ï?· Not willing/or able to provide informed consent

Design outcomes

Primary

MeasureTime frame
SAPS,SANS, YMRS, MADRS,BPRS, GAF, SOFAS, EQ 5 D 5L, Assessment of Physical Health Checklist Weight, Height, BMI, Waist Circumference, Hip Circumference, Waistâ??to-Hip Ratio, Blood Pressure -Laboratory Investigations: ECG, haematology, liver function test, kidney function test, urine examination (for proteinuria and microalbuminuria), lipid profiling, fasting glucose and fasting insulin ( for Insulin Resistance ), HbA1C Timepoint: baseline, 1 month, 3 month

Secondary

MeasureTime frame
Food taking patterns Feasibility performaTimepoint: baseline, 1 month, 3 month

Countries

India

Contacts

Public ContactRakesh Kumar Chadda

AIIMS NEW DELHI

drrakeshchadda@gmail.com011-26593245

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026