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CTRI Number  CTRI/2025/08/093844 [Registered on: 28/08/2025] Trial Registered Prospectively
Last Modified On: 28/08/2025
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 Impact of Dialectical Behavior Therapy on Motivation, Self-Efficacy, and Craving in Substance Abuse Patients at OOAT Clinics in Punjab 
Scientific Title of Study   A study to assess the effectiveness of Dialectical Behavior Therapy on treatment motivation, self efficacy and craving among substance abuse patients in the selected OOAT (Outpatient Opioid Assisted Treatment) clinics of Punjab. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ajay Kumar 
Designation  m.sc. nursing student 
Affiliation  CHITKARA UNIVERSITY 
Address  Chitkara University Chandigarh-Patiala National Highway (NH- 64 Village Jansla, Rajpura, Punjab 140401 India

Patiala
PUNJAB
140401
India 
Phone  8219981596  
Fax    
Email  ajay2401.don24@chitkara.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Kanu Mahajan 
Designation  assistant professor 
Affiliation  CHITKARA UNIVERSITY 
Address  Chitkara University Chandigarh-Patiala National Highway (NH- 64 Village Jansla, Rajpura, Punjab 140401 India

Patiala
PUNJAB
140401
India 
Phone  9464759592  
Fax    
Email  kanu.mahajan@chitkara.edu in  
 
Details of Contact Person
Public Query  
Name  Kanu Mahajan 
Designation  nursing assistant 
Affiliation  CHITKARA UNIVERSITY 
Address  Chitkara University Chandigarh-Patiala National Highway (NH- 64 Village Jansla, Rajpura, Punjab 140401 India

Patiala
PUNJAB
140401
India 
Phone  9464759592  
Fax    
Email  kanu.mahajan@chitkara.edu in  
 
Source of Monetary or Material Support  
self monetary 
 
Primary Sponsor  
Name  Ajay Kumar 
Address  ward number 5 ,village post office jhamber, tehsil and district una, pincode 174303 
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 
DrGaurav Kohli  community health center kalomajra and A P. Jain hospital rajpura  AP Jain Hospital, A P Jain Colony for Hospital Staff, Rajpura, Punjab 140401 GMF9+6X4, Kalo Majra, Jansla, Punjab 140601
Patiala
PUNJAB 		 9878521745

gauravkohli78@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL HUMAN ETHICAL COMMITTE CHITAKRA UNIVERSITY PUNJAB  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  substance abuse addiction 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dialectical Behavioral Therapy  The intervention involves a structured four-week Dialectical Behavior Therapy based skills training program for individuals with substance use disorders. The experimental group receives daily sessions focusing on mindfulness, distress tolerance, emotional regulation, and interpersonal effectiveness. Each session lasts around thirty to forty-five minutes and is conducted four to five days per week based on the weekly focus. In Week One, practices such as mindful breathing and body scan are introduced to build emotional awareness and manage cravings. Week Two emphasizes distress tolerance with techniques like radical acceptance, sensory soothing, and distraction strategies. Week Three develops emotional regulation using mindfulness meditation and grounding methods. Week Four enhances interpersonal effectiveness with structured communication techniques like DEAR MAN and FAST. Overall, each participant in the experimental group undergoes twenty structured sessions across the four-week period.  
Comparator Agent  no intervention provided  the control group does not receive any Dialectical Behavior Therapy intervention during the study. Outcomes including treatment motivation, self-efficacy, and craving levels will be assessed and compared between the two groups to evaluate the effectiveness of the intervention. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Male 
Details  1. Patients diagnosed with substance use disorder (opioid dependence) receiving treatment at selected OOAT clinics.

2. Patients aged between 18 and 50 years.

3. Patients who have been undergoing opioid-assisted treatment for at least one month.

4. Patients willing to participate in the study and provide informed consent.
5. Patients who can comprehend and communicate in Hindi, Punjabi, or English.

6.Patients who have not undergone Dialectical Behavior Therapy (DBT) .
 
 
ExclusionCriteria 
Details  1. Patients with severe psychiatric disorders (e.g., schizophrenia, bipolar disorder) that may interfere with therapy participation.
2. Patients with cognitive impairments or neurological disorders affecting comprehension.
3. Patients with co-existing severe medical conditions requiring intensive care.
4. Patients currently enrolled in other behavioral therapy programs.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Hypothesis 1 (H1): There will be significant difference between pre and post-test treatment motivation among substance abuse patients in experimental group.
Hypothesis 2 (H2): There will be significant difference between pre and post-test craving among substance abuse patients in experimental group.
Hypothesis 3 (H3): There will be significant difference between pre and post test self efficacy among substance abuse patients in experimental group.

 		 Week 1: Emotional Awareness & Mindfulness 30-45 mins daily (5 days a week)
Week 2: Distress Tolerance & Self-Soothing. 40-45mins daily (5 days a week)
Week 3: Emotional Regulation & Grounding. 20-30 mins daily (5 days a week)
Week 4: Interpersonal Effectiveness & Self-Respect. 20-30 mins daily (5 days a week) 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="144"
Sample Size from India="144" 
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)   20/10/2025 
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="0"
Months="0"
Days="30" 
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  

Dialectical Behavior Therapy (DBT) is an evidence-based psychotherapy that has been adapted to treat substance use disorders (SUDs), particularly in individuals with co-occurring borderline personality disorder (BPD). DBT combines cognitive-behavioral techniques with mindfulness practices to address emotional dysregulation and impulsivity, which are often underlying factors in addictive behaviors.

A structured four-week DBT intervention program for individuals with SUDs encompasses the following modules:

  1. Emotional Awareness & Mindfulness (Week 1)

1.      Mindful Breathing: Enhances present-moment awareness.

2.      Body Scan: Promotes connection between mind and body.

3.      Mindfulness of Craving: Develops non-judgmental observation of cravings.

4.      Informal Mindfulness: Integrates mindfulness into daily routines.

  1. Distress Tolerance & Self-Soothing (Week 2)

1.      Radical Acceptance: Encourages acceptance of situations beyond control.

2.      Self-Soothe with Senses: Utilizes sensory experiences for comfort.

3.      Distraction Techniques: Provides alternatives to focus away from distress.

    1. TIPP (Temperature, Intense Exercise, Paced Breathing, Progressive Muscle Relaxation): Offers immediate strategies to manage acute distress.
  1. Emotional Regulation & Grounding (Week 3)

1.      Mindfulness Meditation: Fosters emotional stability.

2.      Grounding Techniques: Anchors individuals to the present moment.

  1. Interpersonal Effectiveness (Week 4)

1.      DEAR MAN: Teaches assertive communication.

2.      FAST: Focuses on maintaining self-respect in interactions.

Implementing such a program can enhance treatment motivation, self-efficacy, and coping mechanisms, thereby supporting sustained recovery and improved psychological well-being. Integrating DBT into substance abuse treatment offers a promising pathway for individuals seeking to overcome addiction and achieve long-term sobriety.

 
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