| CTRI Number |
CTRI/2024/10/074594 [Registered on: 01/10/2024] Trial Registered Prospectively |
| Last Modified On: |
02/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effective of Positive Psychotherapy in patients with moderate to severe depression who are not responding to Escitalopram |
|
Scientific Title of Study
|
Effectiveness of adjuvant Positive Psychotherapy on illness severity and wellbeing in Escitalopram non-responder patients with moderate to
severe Depression: A Randomized Control Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Michelle Melwyn Joel |
| Designation |
PhD Scholar |
| Affiliation |
AIIMS Bhopal |
| Address |
Department of Psychiatry, Academic block, AIIMS Bhopal, Saket Nagar, Bhopal
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9279006732 |
| Fax |
|
| Email |
michelle.phd2024@aiimsbhopal.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Abhijit R Rozatkar |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Bhopal |
| Address |
Room no. 3003, Department of Psychiatry, AIIMS Bhopal, Saket Nagar, Bhopal
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9279006732 |
| Fax |
|
| Email |
abhijit.psy@aiimsbhopal.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Michelle Melwyn Joel |
| Designation |
PhD Scholar |
| Affiliation |
AIIMS Bhopal |
| Address |
Department of Psychiatry, Academic Block, AIIMS Bhopal, Saket Nagar, Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9279006732 |
| Fax |
|
| Email |
michelle.phd2024@aiimsbhopal.edu.in |
|
|
Source of Monetary or Material Support
|
| AIIMS Bhopal, AIIMS Campus Rd, Saket Nagar, Habib Ganj, Bhopal, Madhya Pradesh 462026, India |
|
|
Primary Sponsor
|
| Name |
Michelle Melwyn Joel |
| Address |
Department of Psychiatry, Academic Block, AIIMS Bhopal,Habib Ganj, Bhopal, Madhya Pradesh 462026 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Michelle Melwyn Joel |
All India Institute of Medical Sciences Bhopal |
Room no.26, Psychiatry OPD, Ground Floor, Department of Psychiatry,All India Institute of Medical Sciences Bhopal,Saket Nagar, Bhopal
Bhopal
MADHYA PRADESH |
9279006732
Michelle.phd2024@aiimsbhopal.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee- Student Research (IHEC-SR) |
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 |
Positive Psychotherapy |
Intervention group will receive 10 sessions of positive psychotherapy along with Tablet Fluoxetine 20mg to 40mg once in a day. The intervention will be for a period of 2 months.
|
| Comparator Agent |
Tablet Fluoxetine along with psychoeducation and activity scheduling |
TAU group will get Tablet fluoxetine 20mg to 40mg once in a day for 2 months. This group will also be provided with 2 sessions of psychoeducation and activity scheduling. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Provision of signed and dated informed consent form
2. Clients diagnosed according to ICD-11 criteria for :
· 6A70.1 Single Episode Depressive Disorder, Moderate, without psychotic
symptoms
· 6A70.3 Single Episode Depressive Disorder, Severe, without psychotic
symptoms
· A71.1 Recurrent Depressive Disorder, Current Episode Moderate, without
psychotic symptoms
· 6A71.3 Recurrent Depressive Disorder, Current Episode Severe, without
psychotic symptoms
3. Age 18 to 50 years
4. Attend AIIMS Bhopal Psychiatry OPD
5. A score of 10 or above on the Patient Health Questionnaire 9 (PHQ-9)
6. Educated at least till 10th standard
7. Participants who are non responders of escitalopram |
|
| ExclusionCriteria |
| Details |
1.Women who are pregnant or are breastfeeding or lactating
2. Participants with a history of organicity, epilepsy, or other neurological deficits.
3. Participants with a history of intellectual disability, psychosis, including
schizophrenia spectrum disorders or bipolar disorder.
4. Participants planning to move out of the study area during the follow-up period.
5. Participants who do not speak either English or Hindi.
6. Participants who are undergoing psychotherapy for depression at the time of
recruitment.
7. Participants at imminent risk for suicide.
8. Participants who have documented non-response to fluoxetine in current or past
episodes |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Illness Severity of Depression using PHQ-9 score. A score less than 10 will show change in illness severity |
Baseline, 4 weeks, 10 weeks, 1 month post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Wellbeing using Mental Health Continuum score |
Baseline, 10 weeks |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
02/10/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Need for the study: Many studies have shown the
effectiveness of Positive Psychotherapy on depression.Positive
psychotherapy reduces depressive symptoms and improves wellbeing at a rate that
is comparable to or better than traditional psychotherapy. However, in India, studies using Positive
Psychotherapy/ Positive Psychology interventions is in its infancy and we could
not find any study been done on clinical population in the country. To the best of our knowledge we
could also not find literature on its effectiveness on first line treatment
non-responders specifically. Thus, the current study is to
examine the effectiveness of Positive Psychotherapy augmentation on
escitalopram treatment non responders of depression.
Statement of the problem: The present study aims to see
the effectiveness of adjuvant Positive Psychotherapy on the severity of
depression and psychological well-being in escitalopram non responders,
patients with moderate to severe depression. Hypotheses:
1. There
is no significant difference between intervention group and TAU in the
reduction of depressive symptoms among escitalopram non responders of moderate
to severe depression.
2. There
is no significant difference between intervention group and TAU in ameliorating
psychological wellbeing among escitalopram non responders of moderate to severe
depression
|