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Community based Depression Intervention Programme (ComDIP) for women

Development of a Comprehensive Intervention Programme for Management of Depression at the level of a Primary Health Centre - ComDIP Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2011/08/001978
Enrollment
162
Registered
2011-08-30
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

Health Condition 1: null- Depression

Interventions

Intervention1: Community based Depression Intervention Programme (ComDIP): 1.Sertraline 50mg once daily as night dose prescribed by the Medical Officer of the Primary Health Centre 2.Home based Psycho

Sponsors

Dr InduPS
Lead Sponsor
Dr Ramdas Pisharody
Collaborator
DrKAKumar
Collaborator
DrKVijayakumar
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age group 18-60 years 2. Permanent residents living in the area of MCH unit Pangappara for at least past 6 months 3. Diagnosis of moderate to severe depression 4. Informed consent to participate in the trial , to record examination findings and use the data in research and future publication 5. Literacy to read and write in Malayalam 6. Have an active phone number

Exclusion criteria

Exclusion criteria: Past or current diagnosis or history of treatment for bipolar disorder, dementia, psychosis 2. Currently being managed by a psychiatrist or psychologist 3. Taking any psychotropic drug 4. High risk of suicidality as measured by a suicidality score above 17 5. Pregnant, breastfeeding or planning to become pregnant in next 6 months 6. Seriously ill or bedridden patient 7. A woman who is not able to communicate with the health worker

Design outcomes

Primary

MeasureTime frame
Remission of depression at 12 weeks as measured by 50% reduction in score from baseline in Hamilton Rating Scale for Depression ( HAM-D) or Montgomery Asberg Depression Rating Scale ( MADRS) or remission as per Mini Neuropsychiatric Interview (MINI) for DepressionTimepoint: 2 weeks, 4weeks, 8 weeks, 12 weeks Interim analysis will be done at 8 weeks

Secondary

MeasureTime frame
acceptabilityTimepoint: 2,6,8,12 weeks;Clinical Global Impression for Change or Improvement ( CGI-C / CGI-I)Timepoint: 2,6,8,12 weeks;Clinical Global Impression for Severity (CGI-S) scoreTimepoint: 2, 6, 8 and 12 weeks Interim analysis will be done at 8 weeks;Improvement in suicidality scoreTimepoint: 2 weeks, 6 weeks, 8 weeks, 12weeks;modified Global Assessment of Functioning (mGAF) scoreTimepoint: 2,6,8,12 weeks;treatment adherenceTimepoint: 2,6,8,12 weeks

Countries

India

Contacts

Public ContactDr Indu P S

Govt Medical College, Trivandrum

indupsanil@hotmail.com09495980886

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 7, 2026