| CTRI Number |
CTRI/2019/05/018956 [Registered on: 06/05/2019] Trial Registered Prospectively |
| Last Modified On: |
10/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of psychoeducation along with treatment as usual in patients with late life depression. |
|
Scientific Title of Study
|
Effect of psychoeducation on short-term outcome in patients with late life depression: A Randomised Control Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ARCHANA SINGH |
| Designation |
PhD SCHOLAR |
| Affiliation |
KING GEORGES MEDICAL UNIVERSITY |
| Address |
RESEARCH ROOM, GROUND FLOOR, DEPARTMENT OF GERIATRIC MENTAL HEALTH KING GEORGES MEDICAL UNIVERSITY.
Lucknow
UTTAR PRADESH
226012
India |
| Phone |
9454953356 |
| Fax |
|
| Email |
archanajuhi92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ARCHANA SINGH |
| Designation |
PhD SCHOLAR |
| Affiliation |
KING GEORGES MEDICAL UNIVERSITY |
| Address |
RESEARCH ROOM, GROUND FLOOR, DEPARTMENT OF GERIATRIC MENTAL HEALTH KING GEORGES MEDICAL UNIVERSITY.
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9454953356 |
| Fax |
|
| Email |
archanajuhi92@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ARCHANA SINGH |
| Designation |
PhD SCHOLAR |
| Affiliation |
KING GEORGES MEDICAL UNIVERSITY |
| Address |
RESEARCH ROOM, GROUND FLOOR, DEPARTMENT OF GERIATRIC MENTAL HEALTH KING GEORGES MEDICAL UNIVERSITY.
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9454953356 |
| Fax |
|
| Email |
archanajuhi92@gmail.com |
|
|
Source of Monetary or Material Support
|
| Feroze Gandhi Institute of Engineering and Technology, Raebareli, Uttar Pradesh, India. |
|
|
Primary Sponsor
|
| Name |
KING GEORGES MEDICAL UNIVERSITY |
| Address |
LUCKNOW, UTTAR PRADESH, INDIA |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| KING GEORGES MEDICAL UNIVERSITY |
DEPARTMENT OF GERIATRIC MENTAL HEALTH KING GEORGES MEDICAL UNIVERSITY |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR SHRIKANT SRIVASTAVA |
KING GEROGES MEDICAL UNIVERSITY |
RESEARCH ROOM, GROUND FLOOR, DEPARTMENT OF GERIATRIC MENTAL HEALTH
Lucknow
UTTAR PRADESH |
9621373167
shrikantsrivastava@kgmcindia.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KING GEORGES MEDICAL UNIVERSITY INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F320||Major depressive disorder, singleepisode, mild, (2) ICD-10 Condition: F321||Major depressive disorder, singleepisode, moderate, (3) ICD-10 Condition: F322||Major depressive disorder, singleepisode, severe without psychotic features, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo or pseudo Psychoeducation |
Placebo or pseudo psyhoeduction will be given to the control group via video i.e. audio - visual aid at baseline and the duration for the same is 6 minutes 30 seconds to 7 minutes. |
| Intervention |
Psychoeducation |
Psychoeducation will be given to the case group via video i.e. audio - visual aid at baseline and the duration for the same is 6 minutes 30 seconds to 7 minutes. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1Patients aged 60 years and above
2Patients giving the informed consent
3Patients scoring 24 and above in the Hindi Mental Status Examination (HMSE)
4Patients with first episode of depression and no previously diagnosed psychiatric disorder
5Patients who have been clinically diagnosed with depression
6Patients’ diagnosis will be confirmed on Mini International Neuropsychiatric Interview 6.0 (MINI 6.0)
|
|
| ExclusionCriteria |
| Details |
1 Patients having any severe medical illness
2 Patients with hearing impairment or language problem or any other issue which is can be serious impediment to the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Psychoeducation will improve outcome in case group patients with late life depression. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Giving psychoeducation will lower down the scores of Hamilton Depression Rating Scale (HDRS) and Geriatric Depression Scale (GDS) in case group patients. |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="154"
Sample Size from India="154"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/05/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="1"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
One publication has been done in July 2020. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomised, parallel group, placebo controlled trial to see the effect of psychoeducation along with treatment as usual on short-term outcome in 154 patients with depression aged 60 years and above. It is a single centred study to be conducted in the Department of Geriatric Mental Health, King George’s Medical University, Lucknow, Uttar Pradesh, India. The intervention is that psychoeducation video will be shown to the case group and the control group will be shown placebo-psychoeducation video. The primary outcome is that psychoeducation will improve depression in the case group patients at 4 weeks. Since there will be improvement in depression, hence the scores of Hamilton Depression Rating Scale (HDRS) and Geriatric Depression Scale (GDS) will also lower down. |