| CTRI Number |
CTRI/2025/11/096962 [Registered on: 06/11/2025] Trial Registered Prospectively |
| Last Modified On: |
04/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing Two Therapies (CBT and EMDR) for People with Social Anxiety Disorder. |
|
Scientific Title of Study
|
A Comparative Evaluation of Cognitive Behavioral Therapy and Eye Movement Desensitization and Reprocessing for Social Anxiety Disorder: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NA |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
S Ajeetha |
| Designation |
PhD Scholar |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University) |
| Address |
Outpatient consultation room 2nd floor G block Department of Psychiatry Sri Ramachandra Institute of Higher Education and Research Porur Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
7010319658 |
| Fax |
|
| Email |
u022401099@sriramachandra.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sabari Sridhar OT |
| Designation |
Professor and Head of Department |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University) |
| Address |
Room no 11 A1 first floor Medical Centre Department of Psychiatry Sri Ramachandra Institute of Higher Education and Research (Deemed to be University) Porur Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9443557921 |
| Fax |
|
| Email |
hod.psychiatry@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sabari Sridhar OT |
| Designation |
Professor and Head of Department |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University) |
| Address |
Room no 11 A1 first floor Medical Centre Department of Psychiatry Sri Ramachandra Institute of Higher Education and Research (Deemed to be University) Porur Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9443557921 |
| Fax |
|
| Email |
hod.psychiatry@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ajeetha S |
| Address |
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University) Faculty of Behavioral and Social Sciences Porur Chennai 600116 Tamil Nadu India. |
| 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 Sabari |
Sri Ramachandra Hospital ( G-Block) |
Department of Psychiatry OutPatient room Porur Chennai
TAMIL NADU
Chennai
TAMIL NADU |
7825871984
hod.psychiatry@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F401||Social phobias, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cognitive Behavioral Therapy |
Participants assigned to the CBT group will be given their routine medical treatment and with that will first undergo a baseline assessment using the Liebowitz Social Anxiety Scale (LSAS) and the Brief Fear of Negative Evaluation Scale (FNE-B) to measure the initial severity of their social anxiety symptoms. They will then participate in eight weekly CBT sessions focused on cognitive restructuring, social skills training, and gradual exposure to feared social situations. During the sessions, they will learn to identify and challenge negative thought patterns, develop more balanced thinking, and build confidence through structured behavioral exercises. After completing the intervention, participants will again be assessed using the same tools to evaluate changes in symptom severity and cognitive patterns relative to their baseline scores. |
| Intervention |
Eye Movement Desensitization and Reprocessing |
Participants assigned to the EMDR group will be given their routine medical treatment and with that will first undergo a baseline assessment using the Liebowitz Social Anxiety Scale (LSAS) and the Brief Fear of Negative Evaluation Scale (FNE-B) to evaluate the severity of their social anxiety symptoms. They will then receive eight weekly EMDR therapy sessions focused on targeting distressing social memories and maladaptive beliefs associated with social anxiety. Using bilateral stimulation techniques (such as guided eye movements), the therapy will aim to desensitize emotional triggers and facilitate adaptive reprocessing of past social experiences. After the completion of the sessions, participants will be reassessed using the same tools to measure any changes in symptom severity and cognitive distress compared to their baseline levels. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
People diagnosed with Social Anxiety Disorder based on DSM-5 and ICD-10 criteria. |
|
| ExclusionCriteria |
| Details |
Severe comorbid psychiatric disorders (e.g., psychosis, substance use disorders).
Neurological disorders that may preclude participation.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcomes of this study are the changes in social anxiety symptom severity and fear of negative evaluation from baseline to post-intervention. These outcomes will be assessed using the Liebowitz Social Anxiety Scale (LSAS) and the Brief Fear of Negative Evaluation Scale (BFNE-B) |
Assessments will be conducted at two time points: a baseline assessment before the first therapy session and a post-treatment assessment after the completion of the therapy. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
01/12/2025 |
| 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="1"
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
|
Title
A Comparative Study on the Effectiveness of Cognitive Behavioral Therapy (CBT) and Eye Movement Desensitization and Reprocessing (EMDR) in Reducing Symptoms of Social Anxiety Disorder (SAD)
Background & Objective
Cognitive Behavioral Therapy (CBT) is the gold-standard treatment for Social Anxiety Disorder (SAD), but not all individuals fully benefit due to its cognitive demands. Emerging evidence suggests that EMDR, commonly used for PTSD, may also reduce social anxiety symptoms. However, direct comparisons between CBT and EMDR for SAD are limited. This study aims to evaluate and compare the effectiveness of CBT and EMDR in reducing symptoms of SAD to inform more personalized treatment approaches.
Methodology
A randomized controlled trial (RCT) will be conducted with 42 participants (aged 18–50), diagnosed with SAD per DSM-5 and ICD-10. Participants will be randomly assigned to one of two groups: CBT or EMDR. Pre- and post-intervention assessments will be conducted using the Liebowitz Social Anxiety Scale (LSAS) and Brief Fear of Negative Evaluation Scale (FNE-B). The CBT group will undergo 8 weekly sessions focused on cognitive restructuring and social skills training, while the EMDR group will receive 8 sessions targeting distressing social memories using bilateral stimulation. Data will be analyzed using paired and independent t-tests with effect sizes, using SPSS and R. |