| CTRI Number |
CTRI/2020/03/023693 [Registered on: 02/03/2020] Trial Registered Prospectively |
| Last Modified On: |
28/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Behavioral |
| Study Design |
Single Arm Study |
Public Title of Study
Modification(s)
|
Understanding utility of combining self-help and face-to-face brief therapy for managing depression |
|
Scientific Title of Study
|
Blended internet-based and face-to-face intervention for treatment of depression |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sindhuja Sudarshan |
| Designation |
PhD Research Scholar |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Clinical Psychology, 3rd Floor, Dr. M V Govindaswamy Building, National Institute of Mental Health and Neurosciences, Hosur Road, Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
9538003395 |
| Fax |
|
| Email |
sudarshan.sindhuja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seema Mehrotra |
| Designation |
Professor and Guide |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Clinical Psychology, 3rd Floor, Dr. M V Govindaswamy Building, National Institute of Mental Health and Neurosciences, Hosur Road, Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
08026995192 |
| Fax |
|
| Email |
drmehrotra_seema@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Sindhuja Sudarshan |
| Designation |
PhD Research Scholar |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Clinical Psychology, 3rd Floor, Dr. M V Govindaswamy Building, National Institute of Mental Health and Neurosciences,
Bangalore
KARNATAKA
560029
India |
| Phone |
9538003395 |
| Fax |
|
| Email |
sudarshan.sindhuja@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research, V Ramalingaswami Bhawan, PO Box 4911, Ansari Nagar, New Delhi 110029 |
| National Institute of Mental Health and Neurosciences, Hosur Road, Bangalore 560029 |
|
|
Primary Sponsor
|
| Name |
Sindhuja Sudarshan |
| Address |
Department of Clinical Psychology, 3rd Floor, Dr. M V Govindaswamy Building, National Institute of Mental Health and Neurosciences, Hosur Road, Bangalore 560029 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| National Institute of Mental Health and Neurosciences |
Hosur Road, Bangalore 560029 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sindhuja Sudarshan |
National Institute of Mental Health and Neurosciences |
Department of Clinical Psychology, 3rd Floor, Dr. MV Govindaswamy Building, Hosur Road, Bangalore 560029
Bangalore
KARNATAKA |
9538003395
sudarshan.sindhuja@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMHANS 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: F330||Major depressive disorder, recurrent, mild, (4) ICD-10 Condition: F331||Major depressive disorder, recurrent, moderate, (5) ICD-10 Condition: F341||Dysthymic disorder, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Blended intervention |
A combination of an internet-based self-help programme for depression along with face-to-face intervention for a duration of 6-8 weeks |
| Comparator Agent |
NIL |
NIL |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.A primary diagnosis of mild to moderate depression and/or dysthymia as per ICD-10 as determined through Mini International Neuropsychiatric Interview (MINI, Sheehan et al., 1998)
2.Score of 14 and above on Beck Depression Inventory(BDI II; Beck,Street & Brown; 1996)
3.Minimum education upto class X
4.Ability to read, write and comprehend English
5.Access to and comfort in using internet
6.Individuals in whom the anti-depressant dose has not been changed by over 25 percent over the past four weeks if on medication
|
|
| ExclusionCriteria |
| Details |
1.Diagnoses of Psychosis, Bipolar Affective Disorder, Severe Depression with/without psychotic symptoms, cluster B personality disorders, organic disorders
2.Individuals whose current problems predominantly indicate the need for current engagement in marital or family therapy as clinically adjudged
3.Current suicidality assessed as moderate or severe on MINI
4.Patients who are currently undergoing psychotherapy or who have undergone psychotherapy in the last 6 months in the form of more than 3 structured psychotherapy sessions.
|
|
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Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Severity of depressive symptoms,
Functioning |
Baseline, post assessment at 8 weeks, 3 month follow up |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Self-esteem |
Baseline, post assessment at 8 weeks, 3 month follow up |
| Psychological recovery |
Baseline, post assessment at 8 weeks, 3 month follow up |
|
Target Sample Size
Modification(s)
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/03/2020 |
| Date of Study Completion (India) |
05/10/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="4"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Sudarshan, S., Mehrotra, S. & Thirthalli, J. (2023). Integrating internet-based self-care program with face-to-face therapy for depression. Observations and emergent insights. Indian Journal of Psychological Medicine, 45 (4) 415-419. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The study aims to examine the feasibility, acceptability and effectiveness of a blended intervention which combines internet-based self-help with face-to-face sessions in the treatment of mild-to-moderate depression. A single group pre post follow up study design will be employed where participants will receive the blended intervention (n=60). The primary outcome measures will be severity of depression as assessed on Beck Depression Inventory (BDI) and functioning assessed on Work and Social Adjustment Scale (WSAS) at baseline, post assessment at 8 weeks and 3 month follow up. The secondary outcomes will be self-esteem and psychological recovery assessed at baseline, post assessment at 8 weeks and 3 month follow up. |