| CTRI Number |
CTRI/2021/08/035844 [Registered on: 23/08/2021] Trial Registered Prospectively |
| Last Modified On: |
10/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Music therapy] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of Music therapy for treating depression |
|
Scientific Title of Study
|
Effect of music therapy as add on treatment for patients with depression: analytical study with blinding of assessors |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Siddhant Mathur |
| Designation |
MD Psychiatry Resident |
| Affiliation |
MGM medical college and Hospital, Aurangabad |
| Address |
MGM medical college and Hospital, Aurangabad
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9568483045 |
| Fax |
|
| Email |
drsiddhantmathur@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manik Bhise |
| Designation |
Professor and Head of Department of psychiatry |
| Affiliation |
MGM medical college and Hospital, Aurangabad |
| Address |
MGM medical college and Hospital, Aurangabad
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
|
| Fax |
|
| Email |
dr.manik.bhise@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Siddhant Mathur |
| Designation |
MD Psychiatry Resident |
| Affiliation |
MGM medical college and Hospital, Aurangabad |
| Address |
MGM medical college and Hospital, Aurangabad
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9568483045 |
| Fax |
|
| Email |
drsiddhantmathur@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM medical college and hospital, Aurangabad |
|
|
Primary Sponsor
|
| Name |
MGM medical college and hospital |
| Address |
MGM medical college and hospital, N-6 Cidco, Aurangabad, Maharashtra |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Siddhant Mathur |
MGM medical college and Hospital |
Music room, Psychiatry ward, MGM medical college and hospital, N-6 Cidco
Aurangabad
MAHARASHTRA |
9568483045
drsiddhantmathur@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee For Research On Human Subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F332||Major depressive disorder, recurrent severe without psychotic features, (2) ICD-10 Condition: F331||Major depressive disorder, recurrent, moderate, (3) ICD-10 Condition: F321||Major depressive disorder, singleepisode, moderate, (4) ICD-10 Condition: F322||Major depressive disorder, singleepisode, severe without psychotic features, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Music Therapy |
Music therapy added to pharmacological therapy
7 sessions of Music therapy , each 1 hour duration at interval of 10 days (+-5 days). Of these 4 sessions will be individual and 3 will be group (2-6 subjects).
Every subject will be delivered the above intervention over a period of 2 and half months. |
| Comparator Agent |
Pharmacological therapy alone |
Only pharmacological, no add on music therapy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
• Patients attending OPD or IPD of psychiatry department.
• Patients of both sex in age group of 18 to 60 years
• Patients with diagnosis of moderate to severe unipolar depression (HAM-D Score >17)
• Recurrent depressive disorder with current episode of moderate to severe depression
|
|
| ExclusionCriteria |
| Details |
1 Patients suffering from depression with psychotic features.
2 Patients with sensory impairment like hearing
3 Patients with High suicide risk (C-SSRS- positive response in the suicidal thoughts section, item 4 or 5 in last 30 days or positive response in suicidal behavior section item 6 in last 90 days)
4 Patients requiring more than two antidepressants or adjuvant medications except benzodiazepines or melatonin for sleep
5 Patients requiring any additional treatment like ECTs or psychotherapy
6 Patients with any other co morbid psychiatric or medical illness
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of music therapy added to standard pharmacological care in comparison with standard pharmacological care alone, for the treatment of depression by comparing severity of depression using Hamilton rating scale for depression |
Baseline, post therapy or 2 and 1/2 months and 4 months follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the participants Quality of life using WHO-QOL BREF scale |
Baseline, post therapy or 2 and 1/2 months and 4 months follow up |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
23/08/2021 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Randomised trial, parallel groups, to assess the effect of music therapy as add on treatment with pharmacological care for treatment of patients with depression compared to pharmacological care alone using hamilton rating scale for depression and WHO QOL survey at baseline, post therapy and at 4 month follow up, 7 sessions of 1 hour each t 10+-5 days |