FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2016/01/006479 [Registered on: 04/01/2016] Trial Registered Retrospectively
Last Modified On: 14/02/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Behavioral 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   CBT for Obsessive compulsive disorder 
Scientific Title of Study   Cognitive behaviour therapy for partial responders with OCD: A randomized controlled trial 
Trial Acronym  CBT 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Paulomi Sudhir 
Designation  Additional Professor 
Affiliation  NIMHANS 
Address  Hosur Road Department of Clinical Psychology, NIMHANS
Hosur Road Department of Clinical Psychology, NIMHANS
Bangalore
KARNATAKA
560029
India 
Phone  918026995184  
Fax  918026564830  
Email  paulomi.sudhir@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Paulomi Sudhir 
Designation  Additional Professor 
Affiliation  NIMHANS 
Address  Hosur Road Department of Clinical Psychology, NIMHANS
Hosur Road Department of Clinical Psychology, NIMHANS
Bangalore
KARNATAKA
560029
India 
Phone  918026995184  
Fax  918026564830  
Email  paulomi.sudhir@gmail.com  
 
Details of Contact Person
Public Query  
Name  Paulomi Sudhir 
Designation  Additional Professor 
Affiliation  NIMHANS 
Address  Hosur Road Department of Clinical Psychology, NIMHANS
Hosur Road Department of Clinical Psychology, NIMHANS
Bangalore
KARNATAKA
560029
India 
Phone  918026995184  
Fax  918026564830  
Email  paulomi.sudhir@gmail.com  
 
Source of Monetary or Material Support  
Indian Council for Medical Resaerch (ICMR), V Ramalingaswami Bhawan, Ansari Nagar, New Delhi-110029 
 
Primary Sponsor  
Name  Indian Council for Medical Research ICMR New Delhi 
Address  Indian Council for Medical Research(ICMR) Ramalingaswami Building Ansari Nagar, PO Box 4900, New Delhi 29 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Paulomi M Sudhir  National Institute of Mental Health and Neurosciences  Room No.4, Speciality Clinic, Outpatient Block, OCD Clinic, NationalInstitute of Mental Health and Neurosciences, Bengaluru
Bangalore
KARNATAKA 		 918026995184
918026564830
paulomi.sudhir@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NIMHANS IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F422||Mixed obsessional thoughts and acts, Obsessive Compulsive Disorder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Antipsychotic augmentation (risperidone)  patients receiving risperidone will be given instructions in stress management strategies (including Psycho education about OCD, Problem solving skills, Relaxation strategies; 
Intervention  Cognitive Behaviour therapy and Risperidone (antipsychotic augmentation)  Eligible participants fulfilling the criteria for at least partial response to SRIs will be randomized to one of the two study groups CBT (SRI+CBT+risperidone pill placebo), risperidone (SRI+Risperidone+Stress management training) augmentation group. Randomization will be carried out using a computer-generated list. The CBT group will also receive risperidone pill placebo and the risperidone group, the stress management training. In order to control for effects of attention or additional time spent by the researcher in the CBT group patients receiving risperidone will be given instructions in stress management strategies (including Psycho education about OCD, Problem solving skills, Relaxation strategies; Simpson et al., 2008). Those in the CBT group will receive risperidone pill placebo to mask the effect of risperidone.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Patients fulfilling the criteria for primary diagnosis of Obsessive Compulsive Disorder according to DSM-IV. (300.3).
2. Age-18 –50 years.
3.Patient with both obsessions and compulsions (Mixed subtype of OCD).
Partial treatment response to adequate trial with at least one of the SRIs.
Y – BOCS Symptom severity score of 16 and above.
4. Symptom duration of at least 1 year.
5. Stabilized on medications for at least 4 weeks prior to recruitment.
 
 
ExclusionCriteria 
Details  1. A primary diagnosis of schizophrenia, bipolar affective disorder, severe depression, mental retardation, epilepsy, head injury or other neurological disorders.
2. Substance use, dependence, excepting Nicotine dependence in the past 6 months prior to recruitment.
3. Previous exposure to structured cognitive behaviour therapy for obsessive-compulsive disorder (15 sessions or more of CBT comprising of exposure and response prevention) in the last 6 months.
4. Symptom duration greater than 15 years.
5. Pregnancy, nursing or any other unstable medical condition
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Symptom severity on Yale Brown obsessive compulsive scale YBOCS- at baseline mid and post therapy
CGI-Scale (improvement) at post therapy
at post therapy 		 Yale Brown obsessive compulsive scale YBOCS- at baseline- mid therapy
CGI-Scale (improvement)
at mid and post therapy 
 
Secondary Outcome  
Outcome  TimePoints 
HAMD (depression)HARS, (anxiety), functioning, Quality of life  Baseline, post and follow-up 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "43"
Final Enrollment numbers achieved (India)="43" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   02/06/2015 
Date of Study Completion (India) 15/12/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="6" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  
To examine the relative efficacy of CBT and antipsychotic augmentation (risperidone) in reducing Obsessive Compulsive Symptoms and improving overall functioning and quality of life in partial responders with OCD.

 

Primary outcome measure is the response to treatment post-therapy. Secondary outcome measures include remission, quality of life, global functioning and improvement in measure of depression and anxiety

            Patients will be recruited from the OCD clinic as well as in patient and out patient services of the National Institute of Mental Health and Neurosciences (NIMHANS), Bangalore. Eligible participants fulfilling the criteria for at least partial response to SRIs will be randomized to one of the two study groups CBT (SRI+CBT+risperidone pill placebo), risperidone (SRI+Risperidone+Stress management training) augmentation group. Randomization will be carried out using a computer-generated list. The CBT group will also receive risperidone pill placebo and the risperidone group, the stress management training. In order to control for effects of attention or additional time spent by the researcher in the CBT group patients receiving risperidone will be given instructions in stress management strategies (including Psycho education about OCD, Problem solving skills, Relaxation strategies; Simpson et al., 2008). Those in the CBT group will receive risperidone pill placebo to mask the effect of risperidone.  Participants will continue to receive the SRI medication in both groups, but no changes will be made to SRI medication unless patient develops intolerable side effects or any serious adverse events. Participants will be assessed at baseline, mid-therapy (10 sessions), Post treatment (after about 20 sessions), 3 and 6 months, using the CGI-I, YBOCS, Hamilton Anxiety Rating scale and Hamilton Depression Rating Scale, GAF and the Quality of life and Enjoyment Scale by an independent blinded rater.

   The sample size will comprise of 50 patients in each of the two groups, based on selection criteria. The sample size has been calculated using the power analysis. Forty-one subjects will be required in each arm to attain a two-tailed significance of .05 and 80% power with an expected difference in the response rate of about 25% between the groups. A final sample size of 50 in each group will be aimed at taking into consideration drop outs both groups.

            There will no additional medications until the completion of study period. Only anticholinergic medications and short acting benzodiazepines/zolpidem may be added for the extrapyramidal symptoms and insomnia respectively. Patients who require major changes in medication during the course of the study will be considered a drop-out.

 
Close