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CTRI Number  CTRI/2025/08/093078 [Registered on: 14/08/2025] Trial Registered Prospectively
Last Modified On: 13/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   This study will see if 8 weeks of mindfulness or dance/movement therapy can help young adults with difficult childhood experiences who struggle to manage emotions. Participants will be assigned to one therapy, with progress checked before starting therapy, after therapy ends, and two months later. 
Scientific Title of Study   Efficacy of Mindfulness-Based Intervention and Dance Movement Therapy for Emotion Regulation among Young Adults with Adverse Childhood Experiences: A Non-Inferiority Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shreya Pooja Deuri 
Designation  PhD Scholar 
Affiliation  Lokopriya Gopinath Bordoloi Regional Institute of Mental Health 
Address  Department of Clinical Psychology, Lokopriya Gopinath Bordoloi Regional Institute of Mental Health, Tezpur, Assam.

Sonitpur
ASSAM
784001
India 
Phone  8011531407  
Fax    
Email  spdeuri22@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vikas 
Designation  Assistant Professor 
Affiliation  Lokopriya Gopinath Bordoloi Regional Institute of Mental Health 
Address  Department of Clinical Psychology, Lokopriya Gopinath Bordoloi Regional Institute of Mental Health, Tezpur, Assam.

Sonitpur
ASSAM
784001
India 
Phone  9992144462  
Fax    
Email  vikas85punia@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Priyadarshee Abhishek 
Designation  Assistant Professor 
Affiliation  Lokopriya Gopinath Bordoloi Regional Institute of Mental Health 
Address  Department of Clinical Psychology, Lokopriya Gopinath Bordoloi Regional Institute of Mental Health, Tezpur, Assam.

Sonitpur
ASSAM
784001
India 
Phone  7664924224  
Fax    
Email  psy.pabhishek@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Shreya Pooja Deuri 
Address  Department of Clinical Psychology, Lokopriya Gopinath Bordoloi Regional Institute of Mental Health, Tezpur, Assam 784001. 
Type of Sponsor  Other [Self-sponsored] 
 
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 Vikas  Lokopriya Gopinath Bordoloi Regional Institute of Mental Health  Department of Clinical Psychology, 5th Floor, Academic Block.
Sonitpur
ASSAM 
9992144462

vikas85punia@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, LGBRIMH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy young adults with no current psychiatric diagnosis, who have experienced Adverse Childhood Experiences (ACEs) and self-reported difficulties in emotion regulation. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dance Movement Therapy  Group-based, manualised program adapted for young adults with emotion regulation difficulties, consisting of 8 weekly sessions of 60–90 minutes each. Sessions will be facilitated by the principal investigator. The intervention incorporates elements such as structured warm-up, body awareness activities, emotional expression and regulation through movement, and group reflection. The manual content has been reviewed and validated by qualified professionals with expertise in dance movement therapy. 
Comparator Agent  Mindfulness-Based Intervention  Group-based, manualised program adapted for young adults with emotion regulation difficulties, consisting of 8 weekly sessions of 60–90 minutes each. Sessions will be facilitated by the principal investigator. The intervention incorporates elements such as guided breath awareness, body scan, mindful meditation, and group discussion, adapted from established Mindfulness-Based Therapy protocols. The manual content has been reviewed and validated by qualified professionals with expertise in mindfulness-based approaches. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  1. Aged between 18 to 25 years and currently enrolled in a college or university
2. Score in the moderate to severe range on at least one subscale of the Childhood Trauma Questionnaire – Short Form, based on the following cutoff scores: emotional abuse greater than or equal to 13, physical abuse greater than or equal to 10, sexual abuse greater than or equal to 8, emotional neglect greater than or equal to 15, and physical neglect greater than or equal to 10 (Bernstein & Fink, 1998)
3. Score between 39 to 54 on the Difficulties in Emotion Regulation Scale 16, indicating mild to moderate difficulty in Emotion Regulation (Burton et al., 2022)
4. Provide informed consent and express willingness to participate in either DMT or MBI intervention arm.
5. Physically able to participate in group-based movement or mindfulness sessions. 
 
ExclusionCriteria 
Details  1. Have a clinical psychiatric diagnosis or substance use disorder, as indicated by self-report or medical records.
2. Are currently receiving psychotropic medication or engaged in ongoing psychotherapy.
3. Have medical contraindications for movement, including diagnosed movement disorders, recent surgical procedures, or any condition that significantly restricts safe physical activity.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Emotion Regulation  T1 — Pre-intervention assessment (baseline)
T2 — Post-intervention assessment (immediately after 8-week intervention)
T3 — Two-month follow-up assessment 
 
Secondary Outcome  
Outcome  TimePoints 
Emotional Distress, Mindfulness and Body Connection  T1 — Pre-intervention assessment (baseline)
T2 — Post-intervention assessment (immediately after 8-week intervention)
T3 — Two-month follow-up assessment 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   01/10/2025 
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="2"
Months="2"
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  

Background: 

Adverse Childhood Experiences (ACEs) are known to disrupt emotional development, often resulting in persistent emotional dysregulation (ED), a transdiagnostic construct implicated across a wide range of psychiatric conditions. Emotional dysregulation has been identified as a key mediator linking ACEs to long-term mental health difficulties. Since emotion regulation skills can be cultivated through targeted interventions, they represent a promising avenue for mitigating the psychological impact of early adversity. Emotion regulation involves both top-down processes (thinking and self-control led by the brain’s prefrontal cortex) and bottom-up processes (automatic emotional reactions driven by deeper brain regions like the amygdala). ACEs can disturb this balance, making emotional reactions stronger and harder to manage, while weakening the brain’s ability to regulate them. While prominent psychotherapeutic approaches to managing emotional dysregulation largely focus on enhancing top-down control mechanisms, Dance Movement Therapy (DMT) offers a prominently bottom-up, body-based alternative. However, evidence comparing its efficacy to more established approaches like Mindfulness-Based Interventions (MBIs) remains limited. 

Aim: 

To study the efficacy of dance movement therapy (DMT) in comparison with mindfulness-based intervention (MBI) for emotion regulation among young adults with adverse childhood experiences. 

Objectives:

 To study the efficacy of mindfulness-based intervention for emotion regulation among young adults with adverse childhood experiences.

 To study the efficacy of dance movement therapy for emotion regulation among young adults with adverse childhood experiences.

 To examine if dance movement therapy will be non-inferior to mindfulness- based interventions. 

 To study and compare emotional distress, mindfulness and body connection before, after and at follow-up of mindfulness-based intervention and dance movement therapy among young adults with adverse childhood experiences. 

Methodology: 

The proposed study will employ a quantitative research approach using a non-inferiority randomized controlled trial design to compare the efficacy of Mindfulness-Based Interventions (MBIs) and Dance Movement Therapy (DMT) in enhancing emotion regulation among college-going young adults (aged 18–25 years). Participants will be recruited through purposive sampling and initially screened using the Childhood Trauma Questionnaire – Short Form (CTQ-SF). Those scoring above the established cut-off will be assessed using the Difficulties in Emotion Regulation Scale – 16 item version (DERS-16). Individuals identified as having mild to moderate difficulties in emotion regulation will be recruited for interventions. Eligible participants will then be randomly assigned to either an 8-session DMT program or an 8-session MBI program. Standardized assessments including the DERS-16, Scale of Body Connection (SBC), Five Facet Mindfulness Questionnaire (FFMQ), and Depression, Anxiety, and Stress Scales (DASS-21), will be administered at baseline, post-intervention, and at an 8-week follow-up.

Data Analysis: 

Data will be analysed using the intention-to-treat principle with repeated measures ANOVA to examine intervention effects.  

Clinical Implication: 

This study aims to inform evidence-based interventions by integrating cognitive and embodied approaches to trauma, enhancing emotion regulation in subclinical populations and mitigating the risk of progression to clinical disorders.

 
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