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CTRI Number  CTRI/2024/09/073672 [Registered on: 09/09/2024] Trial Registered Prospectively
Last Modified On: 07/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Evaluating the effectiveness of Distress Tolerance techniques for OCD patients 
Scientific Title of Study   Efficacy of Distress Tolerance techniques of Dialectical Behavior Therapy in patients with Obsessive-Compulsive Disorder: A Randomised Control Trial study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mohit Kumar 
Designation  Ph.D. Research Scholar 
Affiliation  All India Institute of Medical Sciences 
Address  Room No. 3005, Department of Psychiatry, Third Floor, Academic Block, Hospital Building, All India Institute of Medical Sciences.

Bhopal
MADHYA PRADESH
462020
India 
Phone  09709040457  
Fax    
Email  mohit.cpsy@aiimsbhopal.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vijender Singh 
Designation  Professor of Psychiatry 
Affiliation  All India Institute of Medical Sciences 
Address  Room. No. H 3002, Department of Psychiatry, Third Floor, Academic Block, Hospital Building, All India Institute of Medical Sciences.

Bhopal
MADHYA PRADESH
462020
India 
Phone  9810930723  
Fax    
Email  vijender.psy@aiimsbhopal.edu.in  
 
Details of Contact Person
Public Query
 
Name  Mohit Kumar 
Designation  Ph.D. Research Scholar 
Affiliation  All India Institute of Medical Sciences 
Address  Room No. 3005, Department of Psychiatry, Third Floor, Academic Block, Hospital Building, All India Institute of Medical Sciences.

Bhopal
MADHYA PRADESH
462020
India 
Phone  9709040457  
Fax    
Email  mohit.cpsy@aiimsbhopal.edu.in  
 
Source of Monetary or Material Support  
Department of Psychiatry, All India Institute of Medical Sciences, Bhopal, M.P., India, Pincode: 462020 
 
Primary Sponsor  
Name  Mohit Kumar 
Address  Room no. 3005, Third Floor Academic Block, Department of Psychiatry, All India Institute of Medical Sciences, Bhopal, M. P. India, Pincode: 462020 
Type of Sponsor  Other [Self] 
 
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 Mohit Kumar  All India Institute of Medical Sciences, Bhopal  Room. No. 26, Psychiatry OPD, Department of Psychiatry, All India Institute of Medical Sciences, Bhopal, Madhya Pradesh
Bhopal
MADHYA PRADESH 
9709040457

mohit.cpsy@aiimsbhopal.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee-Student Research (IHEC-SR)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F422||Mixed obsessional thoughts and acts, (2) ICD-10 Condition: F429||Obsessive-compulsive disorder, unspecified, (3) ICD-10 Condition: F428||Other obsessive-compulsive disorder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Cognitve Behavior Therapy and Exposure Response Prevention   12 weeks consisting of 12 sessions where one sessions will be taken per week which lasted for approximately 45 minutes to 1 hour. 
Intervention  Distress Tolerance techniques of Dialectical Behavior Therapy  12 weeks consisting of 12 sessions where one sessions will be taken per week which lasted for approximately 45 minutes to 1 hour. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1.Patients diagnosed according to ICD-10 criteria (WHO, 1992) for:
I. Obsessive Compulsive Disorder, predominantly obsession (F 42.0)
II. Obsessive Compulsive Disorder, predominantly with compulsion (F42.1).
III. Obsessive Compulsive Disorder Mixed (F42.2).
2. Cases of OCD having more than 6 months of duration
3. As Severity of Y-BOCS Score of 16 and above
4. Age between 18 and 40 of any gender.
5. Ability to comprehend Hindi/English language
 
 
ExclusionCriteria 
Details  1. Patients with a history of organic illness, epilepsy or any other neurological deficits.
2. Patients with Intellectual Disability.
3. Patients with Psychotic illness.
4. Co-morbid diagnosis of severe depression.
5. Patients undergoing any psychological intervention for OCD in the last six months.
6. Patients with history of past psychiatric medication.
7. Patients with active self-harm or suicidal tendency
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
The primary outcome of this study is to assess the efficacy of the Distress Tolerance (DT) technique, a component of Dialectical Behavior Therapy (DBT), in reducing the severity of obsessive-compulsive symptoms in adult patients diagnosed with Obsessive-Compulsive Disorder (OCD). This will be measured using the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)  at baseline & 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcomes of this study include improving distress tolerance, reducing comorbid depressive symptoms, enhancing coping strategies, increasing acceptance of distressing emotions, & advancing mindfulness skills. These outcomes aim to provide a broader understanding of the benefits of the Distress Tolerance technique for patients with OCD  at baseline & 12 weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   18/09/2024 
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="2"
Months="0"
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  

In the current scenario, there is a trend towards a more integrative or multi-dimensional approach which takes a step forward from focusing only on pathology and illness to health, wellness and strengths of the individual as per the WHO‘s model so that personal growth can be achieved. Especially there is an increasing interest in third-wave psychotherapy which tends to reformulate and synthesize previous generations of behavioural and cognitive therapy and carries them forward into questions, issues, and domains previously addressed primarily by other traditions, in the hope of improving both understanding and outcomes. However, there is a scarcity of such published studies investigating the role of particular components of these interventions on various disorders. Further, DBT has been studied exclusively with persons with Borderline Personality Disorder and with successful trials in substance abuse, eating disorders and depression. Moreover, there is a dearth of studies on another group of disorders, especially in the anxiety spectrum. Though, the potential interaction of Distress tolerance and the development of obsessive compulsive symptoms have been investigated which implicated the need to reduce distress experienced in patients with Obsessive Compulsive Disorder bearing its effect on symptom reduction. Nevertheless, to the best of our knowledge, there is no such study that has tried to further explore this relationship using any psychological intervention. In India, research on Dialectical behaviour therapy or any of its techniques remains in its infancy with limited work looking into the mechanisms underlying the efficacy of this therapy. Thus, it was found important to investigate the impact of the Distress tolerance technique of Dialectical Behaviour Therapy (DBT) on these mechanisms in a clinical sample. Therefore, in the present study, an attempt will be made to examine the effects of Distress Tolerance Technique of Dialectical Behaviour Therapy on adult patients diagnosed with obsessive-compulsive disorder.

 
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