| 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
|
|
|
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
|
|
|
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
|
|
|
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. |