| CTRI Number |
CTRI/2025/02/080655 [Registered on: 17/02/2025] Trial Registered Prospectively |
| Last Modified On: |
06/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the efficacy of EMDR and CBT among Young Adults |
|
Scientific Title of Study
|
A Randomized Controlled Trial Comparing the efficacy of Eye Movement Desensitization and Reprocessing (EMDR) and Cognitive Behavioral Therapy (CBT) among Young Adults with Psychological Distress and Adverse Childhood Experiences |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kailash Sureshkumar |
| Designation |
Professor |
| Affiliation |
Chettinad Hospital and Research Institute |
| Address |
Chettinad Hospital and Research Institute, Chettinad Academy of Research and Education, Department of Psychiatry, Chettinad Health City, Rajiv Gandhi Salai, Kelambakkam
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
|
| Fax |
|
| Email |
kaidoc02@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nellore Pratika Reddy |
| Designation |
Research Scholar |
| Affiliation |
Chettinad Academy of Research and Education |
| Address |
Chettinad Academy of Research and Education, Faculty of Allied Health Sciences, Chettinad Health City, Rajiv Gandhi Salai, Kelambakkam
Chennai
TAMIL NADU
603103
India |
| Phone |
9790985794 |
| Fax |
|
| Email |
pratikanellore@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nellore Pratika Reddy |
| Designation |
Research Scholar |
| Affiliation |
Chettinad Academy of Research and Education |
| Address |
Chettinad Academy of Research and Education, Faculty of Allied Health Sciences, Chettinad Health City, Rajiv Gandhi Salai, Kelambakkam
Chennai
TAMIL NADU
603103
India |
| Phone |
9790985794 |
| Fax |
|
| Email |
pratikanellore@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chettinad Academy of Research and Education, Chettinad Health City, SH 49A, Kelambakkam, Tamil Nadu, India - 603103 |
|
|
Primary Sponsor
|
| Name |
Dr Kailash Sureshkumar |
| Address |
Chettinad Hospital and Research Institute, Chettinad Academy of Research and Education, Department of Psychiatry, Chettinad Health City, Rajiv Gandhi Salai, Kelambakkam |
| 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 |
| Dr Kailash Sureshkumar |
Chettinad Hospital and Research Institute |
Department of Psychiatry, Chettinad Health City, SH 49A, Dist, Kelambakkam, Tamil Nadu 603103
Kancheepuram
TAMIL NADU |
9841227487
kaidoc02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Human Ethics Committee for Student Research (CARE IHEC-I) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Young Adults with Adverse Childhood Experiences and Psychological Distress |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cognitive Behavioral Therapy |
Cognitive Behavioral Therapy intervention protocol developed by Dr. Aaron T. Beck will be used to identify and challenge negative thought patterns that contribute to emotional distress and maladaptive behaviors among the participants. A total of 12 sessions will be conducted for a duration of 1 hour for each session. |
| Intervention |
Eye Movement Desensitization and Reprocessing |
Eye Movement Desensitization and Reprocessing (EMDR) protocol developed by Dr.Francine Shapiro will be used to help the participants process traumatic memories and reduce the emotional distress associated with them using bilateral stimulation. A total of 12 sessions will be conducted for a duration of 1 hour for each session. |
| Comparator Agent |
waitlist control group |
The participants in the waitlist control group do not receive any intervention but are put on a waiting list to receive the intervention after the active treatment group does. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Young adults in the age group of 18-25.
Young adults of any gender
Young Adults with a minimum of 3 Adverse Childhood Experiences
Young Adults with at least moderate psychological distress
Young adults who possessed the ability to read and write in English.
|
|
| ExclusionCriteria |
| Details |
Young adults diagnosed with any major medical condition.
Those who do not fall in the age category of 18-25
Those who do not consent to participate in the intervention |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of psychological distress and interpersonal cognitive distortions. |
The level of psychological distress and interpersonal cognitive distortions will be assessed during
pre-test, post-test and follow-up phase
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Increase in quality of life and Resilience |
The level of quality of life and Resilience will be assessed during pre-test, post-test and follow-up phase
|
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
17/02/2025 |
| 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="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
|
Adverse childhood experiences (ACEs) have been
linked to poor behavioural and health outcomes. ACEs include child abuse
and neglect and growing up in dysfunctional households characterized by
domestic violence, mental illness and incarceration of a household member,
parental divorce or separation, and household drug or alcohol abuse. The
current study investigates and compares the effects of Eye Movement
Desensitization and Reprocessing (EMDR) and Cognitive Behavioral Therapy
(CBT) interventions on interpersonal cognitive distortions, quality of life, and resilience among young adults with adverse
childhood experiences (ACEs) and psychological distress. The study involves two phases: 1) a
survey phase to assess baseline levels of the
key variables and their relationships, and 2) a randomized controlled
trial phase.
Standardized measures will be used to evaluate interpersonal cognitive
distortions, psychological distress, quality of life, resilience, and ACEs.
Statistical analyses will examine relationships between demographic factors
and the key variables, as well as differences between the intervention
groups. The findings may inform more holistic and effective interventions for
addressing the long-term impacts of ACEs on mental health and well-being in
young Indian adults.
|
|