| CTRI Number |
CTRI/2024/08/071822 [Registered on: 02/08/2024] Trial Registered Prospectively |
| Last Modified On: |
02/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Managing Emotion Dysregulation among
Adolescents with Emotional Disorders |
|
Scientific Title of Study
|
Effectiveness of the Unified Therapy Approach for Managing Emotion Dysregulation among
Adolescents with Emotional Disorders |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harikrupa Sridhar |
| Designation |
PhD Clinical Psychology Student |
| Affiliation |
National Institute of Mental Health and Neurosciences, Bangalore |
| Address |
Department of Clinical Psychology, National Institute of Mental Health and Neurosciences, Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
08026995180 |
| Fax |
|
| Email |
harikrupacp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M. Thomas Kishore |
| Designation |
Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences, Bangalore |
| Address |
Department of Clinical Psychology, National Institute of Mental Health and Neurosciences, Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
08026995180 |
| Fax |
|
| Email |
thomas@nimhans.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Harikrupa Sridhar |
| Designation |
PhD Clinical Psychology Student |
| Affiliation |
National Institute of Mental Health and Neurosciences, Bangalore |
| Address |
Department of Clinical Psychology, National Institute of Mental Health and Neurosciences, Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
08026995180 |
| Fax |
|
| Email |
harikrupacp@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Mental Health and Neurosciences, Hosur Road, Hombegowda Nagar, Bangalore - 560029 |
| University Grants Commission, Bahadur Shah Zafar Marg, New Delhi 110002 |
|
|
Primary Sponsor
|
| Name |
University Grants Commission |
| Address |
UGC, Bahadur Shah Zafar Marg, New Delhi - 110002 |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Dr M Thomas Kishore |
National Institute of mental health and neurosciences Bangalore |
room 220 clinical psychology room CAP 200 department of child and adolescent psychiatry
Bangalore
KARNATAKA |
08026995574
harikrupacp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Behavioural Sciences Division), National Institute of Mental Health and Neurosciences, Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Unified Protocol for the Treatment of Emotional Disorders in Adolescence (Ehrenreich et al., 2009) |
Unified Protocol for the Treatment of Emotional Disorders in Adolescence (Ehrenreich et al., 2009) comprises of 8 therapy modules, aimed at providing transdiagnostic treatment of emotional disorders among adolescents aged between 12-17 years. The therapeutic intervention will span across 16 therapy sessions, where the modules will be addressed with the participants in a structured manner. They will also be provided with homework assignments between sessions. Assessments examining different outcome variables such as emotion Dysregulation, coping, cognitive and behavioural avoidance, psychological distress and over psychosocial wellbeing will be administered at regular intervals, and followed up 3 months post intervention. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
1. They are aged between 12 and 17 years.
2. They receive a principal diagnosis of generalized anxiety disorder, mild/moderate depressive episode, social anxiety disorder, separation anxiety disorder, adjustment disorder, somatic symptom disorder, eating disorder and dissociative disorder, as per the criteria stated in ICD 10, during routine psychiatric evaluation;
3. They have not received any form of structured psychotherapy beyond three sessions by a qualified professional, during the last 3 months. In addition, adolescents taking medication for mood or behavioral difficulties will be required to be on a stable dose of medication, as measured by one month of continuous medication treatment at the same dosage level (Ehrenreich et al., 2009).
4. They have been identified to have average intellectual functioning as per clinical impression in routine psychiatric evaluation
5. They can speak and read English, Tamil, Kannada or Hindi.
|
|
| ExclusionCriteria |
| Details |
1. They have a principal or comorbid diagnosis of bipolar disorder, psychotic disorder, severe depressive episode, substance related disorder, post-traumatic stress disorder, obsessive compulsive disorder, behavioral addiction, tics disorder or any form specific phobia.
2. They have attention deficit hyper-activity disorder, autism spectrum disorder
3. They have acute suicidal intent as identfied through routine psychiatric evaluation by the treating team.
4. They have emotional symptoms which are secondary to a medical condition.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Emotion Regulation skills
Severity of psychological distress
Coping skills |
at baseline, at 4 weeks, at 8 weeks, at 12 weeks, 16 weeks, follow up at 1 month post intervention and 3 months post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
psychological flexibility
cognitive avoidance
behavioural avoidance
psychosocial functioning |
at baseline at 8 weeks at 16 weeks follow up after 1 month follow up after 3 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
13/08/2024 |
| 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="4"
Months="0"
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
|
The study aims to test the effectiveness of the Unified Protocol for the Treatment of Emotional Disorders in Adolescence (UP-A) in reducing emotional dysregulation among adolescents in the Indian settings.
It involves the implementation of the ’Unified Protocol for emotional disorders’ among adolescents diagnosed with various forms of internalising disorders. In doing so, we are also looking at its effect on associated variables like emotion dysregulation, coping, information processing, and overall psychosocial functioning. The study has been approved by the Institute Ethics Review Board (May 2024).
The study will follow a single group pre-post experimental design. This study design follows a quasi-experimental method which will serve to examine the feasibility and acceptability of the UP-A treatment for adolescents with emotional dysregulation in Indian population. In the study, the outcome of interest will be measured at seven time points. These are prior to the intervention (baseline), 4th session/week, mid intervention (8th week/session), 12th session/week, post intervention (16th session) and follow ups at one month and three months after intervention is completed.
Adolescents between 12-17 years, diagnosed with emotional disorders (includes generalized anxiety disorder, mild/moderate depressive episode, social anxiety disorder, separation anxiety disorder, adjustment disorder, somatic symptom disorder, eating disorder and dissociative disorder) consulting in Child and Adolescent Psychiatry Unit. The adolescents with average intelligence, having no history of receiving structured psychotherapy in the past three months will be recruited for the study.
After obtaining informed consent and assent, the intervention will consist of administering baseline assessments and interviews with the participants. They will be administered the eight modules of the UP-A, which will span across 16- 21 sessions, conducted on a weekly basis. The sessions will be conducted face to face as well as through online medium depending upon the convenience of the participants. They will be administered assessments regularly to monitor their progress and will be followed up to three months post completion of the intervention. |