| CTRI Number |
CTRI/2015/01/005394 [Registered on: 13/01/2015] Trial Registered Retrospectively |
| Last Modified On: |
14/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Metacognitive (awareness about thinking or thoughts) therapy for persons with social anxiety |
|
Scientific Title of Study
|
Efficacy of meta cognitive therapy for Social Anxiety Disorder |
| Trial Acronym |
MCT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Paulomi M Sudhir |
| Designation |
Additional Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Clinical Psychology, NIMHANS, Hosur Road, Bangalore
Department of Clinical Psychology, NIMHANS, Hosur Road, Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
919886176879 |
| Fax |
08026564830 |
| Email |
paulomi.sudhir@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Paulomi M Sudhir |
| Designation |
Additional Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Clinical Psychology, NIMHANS, Hosur Road, Bangalore
Department of Clinical Psychology, NIMHANS, Hosur Road, Bangalore
KARNATAKA
560029
India |
| Phone |
919886176879 |
| Fax |
08026564830 |
| Email |
paulomi.sudhir@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Paulomi M Sudhir |
| Designation |
Additional Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Clinical Psychology, NIMHANS, Hosur Road, Bangalore
Department of Clinical Psychology, NIMHANS, Hosur Road, Bangalore
KARNATAKA
560029
India |
| Phone |
919886176879 |
| Fax |
08026564830 |
| Email |
paulomi.sudhir@gmail.com |
|
|
Source of Monetary or Material Support
|
| PhD Fellow- ship, NIMHANS |
|
|
Primary Sponsor
|
| Name |
NIMHANS |
| Address |
Hosur Road, NIMHANS, Bangalore 560029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Ms Lakshmi J |
Behavioural Medicine Unit |
Hosur Road, NIMHANS
Bangalore
KARNATAKA |
08026995177
08026564830
lakshminair999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMHANSInstitute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G||Mental Health, Social Anxiety disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Applied Relaxation |
Training in deep muscle relaxation.
It involves 10-12 individually conducted sessions or training in relaxation and application to anxiety provoking cues. Sessions are conducted weekly or biweekly for a duration of 2 1/2- 3 months |
| Intervention |
Metacognitive Therapy |
Psychological therapy aimed at modifying metacognitions such as thinking about anxious thoughts, excessive monitoring of anxiety, avoidance. Therapy involves 10-12 sessions conducted individually. Sessions are conducted weekly or biweekly for a duration of 2 1/2- 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Primary Diagnosis of Social Anxiety Disorder, with or without anxious avoidant personality disorder |
|
| ExclusionCriteria |
| Details |
Psychotic Symptoms, severe depression with psychotic symptoms, current psychoactive substance dependence, Previous psychological therapy in the last 1 year, head injury or other neurological disorder |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical Global improvement, severity of social anxiety, post event processing |
baseline, post intervention and follow-up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Depression, quality of life, self consciouness |
Baseline post treatment and 3 month follow up |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="3" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Lakshmi J, Sudhir PM, Sharma MP, Bada Math S. Effectiveness of metacognitive therapy in patients with social anxiety disorder: a preliminary investigation. Indian Psy Med 2016; 38; 466-71. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The trial includes two arms, both of which include psychological interventions, Metaccognitive Therapy and Applied Relaxation with exposure respectively. A total of 50 patients with a primary diagnosis of Social Anxiety disorder are being recruited and randomly allocated to either of the two groups. Therapy will comprise of 10-12 individual sessions, with baseline, post and follow up assessments. The trial is open to recruitment. |