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Psychosocial intervention for sub-clinical Common Psychological Problems-a a multi-centric study from Central India

Randomized Controlled Trial to Assess the Feasibility of Delivering Psycho-Social Interventions and Effectiveness in Improving the Common Psychological Problems of the Non-Clinical Population: a multi-centric and multi-setting study from central India - nil

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/065769
Enrollment
170
Registered
2024-04-16
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

None listed

Interventions

Intervention1: comprehensive wellness intervention package (comprehensive wellness program for mental health-COMeWELL with PRiMEHElp ?): Intervention arm (to be delivered over 3wks): Wellness program

Sponsors

Indian Council of Medical Research (ICMR)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: I. Age: above 18years. II. Resides in the catchment area of the Primary Health Centre OR able to follow-up in the hospital regularly III. Individuals visiting: the Primary Health Centre OR screening out-screening out-patient dept (of its equivalent) in the tertiary care hospital OR family members (up to three-degree relatives)/acquaintances of the

Exclusion criteria

Exclusion criteria: I. Suffering from a severe medical illness (uncontrolled Diabetes, hypertension, COPD/asthma, etc.) Sub-syndromic psychotic or manic symptoms, or other severe mental illnesses. II. Diagnosed to be a case of mental disorder (as assessed on structured instruments (Structured Clinical Interview for DSM-5 Disorders, Clinical Trials Version (SCID-CT). III. Already receiving any kind of treatment (pharmacological or non-pharmacological) from the mental health professionals for their sub-syndromic mental health problems.

Design outcomes

Primary

MeasureTime frame
Change in the scores on the DASS-21 (anxiety, depression, and stress), SSS-8 (somatic symptoms), and WHO-QoL-BREF (total as well as domain-specific) from baseline to end-of-session, 1months, and 3months post-intervention.Timepoint: at baseline (0 month), to end-of-session (3wks+/-1wk), 1months (1month 3wks+/-1wk), and 3months (3 months 3wks+/-1wk) post-intervention.

Secondary

MeasureTime frame
feasibility (acceptibility, reproducibility, demand, limited efficacy testing)Timepoint: 0, 1, 3months

Countries

India

Contacts

Public ContactDr Ashish Pakhre

All India Institute of Medical Sciences, Bhopal

Sjmc.Ashish@gmail.com9871891011

Outcome results

None listed

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