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

Phase 3

• Registration Number: CTRI/2021/08/035331
• Lead Sponsor: ational Institute for Health Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SAPS,SANS, YMRS, MADRS,BPRS, GAF, SOFAS, EQ 5 D 5L, Assessment of Physical Health Checklist <br/ ><br> <br/ ><br>Weight, Height, BMI, Waist Circumference, Hip Circumference, Waistâ??to-Hip Ratio, Blood Pressure <br/ ><br> <br/ ><br>-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 <br/ ><br> <br/ ><br>Timepoint: baseline, 1 month, 3 month

Secondary Outcome Measures

Name	Time	Method
Food taking patterns <br/ ><br>Feasibility performaTimepoint: baseline, 1 month, 3 month