Community based Depression Intervention Programme (ComDIP) for women

Completed

Conditions: Depression

Registration Number: CTRI/2011/08/001978

Lead Sponsor: Dr InduPS

Brief Summary: This was a randomised control trial conducted in the primary care setting to evaluate the effectiveness of Community based Depression Intervention Programme (ComDIP)( developed by the investigators) , compared to Treatment as Usual (TAU) in reducing the severity of depression in women with moderate to severe depression. ComDIP had two components. One administered by the Medical Officer, which included Sertraline also, and the other implemented by the Junior Public Nurse, which was a psycho-social intervention. The primary outcome was reduction in severity of depression measured by the Hamilton Depression (HAM-D) Rating Scale. The mean scores of HAM-D were significantly lower in the ComDIP arm, compared to the TAU arm . Research papers from this study are being published

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 162

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Improvement in suicidality score	2 weeks, 6 weeks, 8 weeks, 12weeks
Clinical Global Impression for Severity (CGI-S) score	2, 6, 8 and 12 weeks
Clinical Global Impression for Change or Improvement ( CGI-C / CGI-I)	2,6,8,12 weeks
modified Global Assessment of Functioning (mGAF) score	2,6,8,12 weeks
treatment adherence	2,6,8,12 weeks
acceptability	2,6,8,12 weeks

Trial Locations

Locations (1): Medical College Health Unit, Pangappara, Trivandrum
🇮🇳
Thiruvananthapuram, KERALA, India
Medical College Health Unit, Pangappara, Trivandrum
🇮🇳Thiruvananthapuram, KERALA, India
DrInduPS
Principal investigator
09495980886
indupsanil@hotmail.com