| CTRI Number |
CTRI/2011/08/001978 [Registered on: 30/08/2011] Trial Registered Prospectively |
| Last Modified On: |
07/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Community based Depression Intervention Programme (ComDIP) for women |
|
Scientific Title of Study
|
Development of a Comprehensive Intervention Programme for Management of Depression at the level of a Primary Health Centre |
| Trial Acronym |
ComDIP Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1123-8959 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Indu P S |
| Designation |
Associate Professor |
| Affiliation |
Govt Medical College, Trivandrum |
| Address |
Anandam, PKRA- A-43
NAVAMI GARDENS
Sreekaryam.P.O
Trivandrum-695017
Kerala
Dept of Community Medicine
Govt Medical College
Trivandrum-695011
Kerala
Thiruvananthapuram
KERALA
695017
India |
| Phone |
09495980886 |
| Fax |
04712448825 |
| Email |
indupsanil@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Indu P S |
| Designation |
Associate Professor |
| Affiliation |
Govt Medical College, Trivandrum |
| Address |
Anandam, PKRA- A-43
NAVAMI GARDENS
Sreekaryam.P.O
Trivandrum-695017
Kerala
Dept of Community Medicine
Govt Medical College
Trivandrum-695011
Kerala
Thiruvananthapuram
KERALA
695017
India |
| Phone |
09495980886 |
| Fax |
04712448825 |
| Email |
indupsanil@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Indu P S |
| Designation |
Associate Professor |
| Affiliation |
Govt Medical College, Trivandrum |
| Address |
Anandam, PKRA- A-43
NAVAMI GARDENS
Sreekaryam.P.O
Trivandrum-695017
Kerala
Dept of Community Medicine
Govt Medical College
Trivandrum-695011
Kerala
Thiruvananthapuram
KERALA
695017
India |
| Phone |
09495980886 |
| Fax |
04712448825 |
| Email |
indupsanil@hotmail.com |
|
|
Source of Monetary or Material Support
|
| No funding source. Investigator herself spends |
|
|
Primary Sponsor
|
| Name |
Dr InduPS |
| Address |
Associate Professor in Community Medicine, Govt Medical College, Trivandrum |
| Type of Sponsor |
Other [Investigator spends. No external funding] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Ramdas Pisharody |
Principal, Govt Medical College, Trivandrum |
| DrKAKumar |
Former Professor& Head, Dept of Psychiatry,Govt Medical College, Trivandrum & Former Director of Medical Education, Kerala |
| DrKVijayakumar |
Professor and Head
Dept of Community Medicine
Govt Medical College, Trivandrum |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrInduPS |
Medical College Health Unit, Pangappara, Trivandrum |
Medical College Health Unit, Pangappara, Trivandrum
Thiruvananthapuram
KERALA |
09495980886
04172448825
indupsanil@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Ethics Commitee, Govt Medical College, Trivandrum |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Depression , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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 Psychosocial intervention is provided by the female health worker,based on a module. This has been developed by the investigator based on analyais of qualitative research and by adopting NICE and WHO guidelines. This will be implemented by the health workers in 6 sessions spread over 8 weeks. Each session will last for 30 minutes and will be delivered during house visit of he health worker
3.Weekly telephonic reinforcement lasting for 5-10minutes done by the health worker . |
| Comparator Agent |
Treatment as Usual (TAU) |
This is the standard practice.Pateint will be referred to a psychiatrist either in Medical College hospital, mental health centre or general hospital or private sector |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
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 Depression |
2 weeks, 4weeks, 8 weeks, 12 weeks
Interim analysis will be done at 8 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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
Interim analysis will be done at 8 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 |
|
|
Target Sample Size
|
Total Sample Size="162"
Sample Size from India="162"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Published Effectiveness of community-based depression intervention programme (ComDIP) to manage women with depression in primary care- randomised control trial in Asian Journal of Psychiatry in
April 2018. More papers being published
DOI: 10.1016/j.ajp.2018.04.022 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
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 |