| 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
|
|
|
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
|
|
|
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
|
|
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Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
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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. |