NCT07262177

Brief Summary

This 12-week study protocol outlines a randomized controlled trial designed to evaluate the effectiveness of a Dance-Mindfulness intervention integrating Modern Theatre Dance with mindfulness-based embodied practices to enhance psychological wellbeing, nervous system regulation, and embodied awareness in adults. The intervention combines: (1) polyvagal-informed breath-movement synchronization (nasal breathing, grounding); (2) ISTD (Imperial Society of Teachers of Dancing) Modern Theatre Dance technique progression and dance movements (Grades 2-4); (3) nervous system regulation through somatic practices; and (4) phenomenological reflection via weekly journaling and post-session integration. Study Design: Parallel-assignment randomized controlled trial (approx. N=320; n=160 intervention, n=160 waitlist control). Randomization uses computer-generated block randomization (block sizes 4-6). Outcomes: Perceived stress, mindfulness psychological wellbeing (happiness, life satisfaction), emotional regulation, social connection, movement confidence. Qualitative Component: Phenomenological interviews and weekly reflective journals from subsample (approx. n=20) analyzed via Interpretative Phenomenological Analysis and Reflexive Thematic Analysis. Intervention Delivery: 90-100 minute weekly sessions delivered over 12 weeks by qualified facilitator(s) trained in Modern Theatre Dance, mindfulness (≥3 years personal practice, MBSR, yoga or equivalent), trauma-informed care, and group facilitation. Sessions include 8 structured components: breath-grounding (9-10 min), technical dance work (14-15 min), conditioning (9-10 min), break-settling (4-5 min), rhythm improvisation (8-9 min), choreographed sequences (15-17 min), cool-down-integration (8-9 min), and phenomenological journaling (10-20 min). Safety \& Fidelity: Structured facilitator guidelines, session checklists, weekly supervision, adverse event protocols, and external fidelity monitoring ensure protocol integrity. Classroom size: 15-18 participants per session. Data Collection: Baseline (Week 0), mid-intervention (Week 6 only for qualitative), post-intervention (Week 12), and optional 1-3 month follow-up. Intent to treat analysis and mixed-effects modeling for between-group comparisons. Population: Adults (age 18+) seeking wellbeing enhancement through recreation or stress reduction. Eligible participants without acute mental health crisis. Primary Purpose: Health promotion and mental health improvement through nervous system regulation, embodied awareness, and psychosocial wellbeing enhancement.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable healthy-volunteers

Timeline
1mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress91%
Sep 2025May 2026

Study Start

First participant enrolled

September 2, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 3, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Expected
Last Updated

January 6, 2026

Status Verified

January 1, 2026

Enrollment Period

7 months

First QC Date

November 20, 2025

Last Update Submit

January 1, 2026

Conditions

Keywords

somatic educationembodied phenomenologycommunity-based dance educationdance movement therapypsychological wellbeingmindfulnesscreative movementinteroceptionautonomic regulationembodied awarenessemotional regulationvagal regulationstress reductionmotor learning

Outcome Measures

Primary Outcomes (5)

  • Life Satisfaction (Satisfaction With Life Scale - SWLS)

    The Satisfaction With Life Scale (SWLS) is a 5-item self-report measure assessing global life satisfaction. Items are rated on a 7-point Likert scale (1 = Strongly Disagree, 7 = Strongly Agree). Total score ranges 5-35, with higher scores indicating greater life satisfaction. Scoring: 31-35 = High satisfaction, 26-30 = Moderate satisfaction, 21-25 = Low satisfaction, 15-20 = Dissatisfied, 5-14 = Highly dissatisfied. The scale has demonstrated reliability (α = .79) and validity across diverse populations. Administration time: 2-3 minutes.

    Baseline (Week 0) and Post-intervention (Week 12)

  • Psychological Distress (DASS-21: Depression, Anxiety, Stress Scale)

    The DASS-21 is a 21-item self-report scale measuring depression, anxiety, and stress across three 7-item subscales. Items are rated 0-3 (0 = Never, 3 = Almost Always). Subscale scores range 0-21 each, with higher scores indicating greater symptom severity. Interpretation per subscale: 0-7 = Normal/Minimal, 8-9 = Mild, 10-14 = Moderate, 15-19 = Severe, 20-21 = Extremely Severe. The scale demonstrates good internal consistency (α = .81-.87 across subscales) and has been validated in Greek populations. Subscales measure: Depression (emotional dysphoria, hopelessness), Anxiety (autonomic arousal, fear, worry), and Stress (tension, irritability, difficulty relaxing). Administration time: 5-7 minutes.

    Baseline (Week 0) and Post-intervention (Week 12)

  • Mindfulness (Mindful Attention Awareness Scale - MAAS)

    The Mindful Attention Awareness Scale (MAAS) is a 15-item unidimensional measure of trait mindfulness, assessing the ability to maintain present-moment attention and awareness. Items are rated on a 6-point Likert scale (1 = Almost Always, 6 = Almost Never). Total scores range 15-90, with higher scores indicating greater mindfulness capacity and present-moment awareness. Interpretation: 15-40 = Low mindfulness, 41-65 = Moderate mindfulness, 66-90 = High mindfulness. The scale demonstrates good internal consistency (α = .82) and has been validated cross-culturally. MAAS captures the core mechanism of mindfulness-based interventions attentional awareness in daily life. Administration time: 4-5 minutes.

    Baseline (Week 0) and Post-intervention (Week 12)

  • Subjective Happiness (Subjective Happiness Scale - SHS)

    The Subjective Happiness Scale (SHS) is a brief 4-item self-report measure of overall happiness and positive affect. Items use varied response formats with 7-point scales. Total scores range 4-28, with higher scores reflecting greater happiness. Interpretation: 4-10 = Unhappy, 11-18 = Moderately happy, 19-28 = Very happy. The scale has demonstrated good reliability (α = .86) and validity as a global well-being indicator. Direction: Higher scores on this measure are desirable and indicate better psychological well-being. Administration time: 2-3 minutes.

    Baseline (Week 0) and Post-intervention (Week 12)

  • Leisure Involvement (Leisure Involvement Scale)

    The Leisure Involvement Scale is a 13-item self-report measure assessing the depth of psychological engagement, personal meaning, and commitment to recreational activities. Items examine dimensions including: activity attractiveness/interest, centrality to life, and personal identity/self-identification through the activity. Participants rate each item on a 7-point Likert scale (1 = Strongly Disagree, 7 = Strongly Agree). Total scores range 13-91, with higher scores indicating greater psychological involvement, personal meaning-making, and identification with recreational dance participation. Direction: Higher scores are desirable and reflect greater embodied engagement, movement identity development, and psychological investment in leisure. The scale has demonstrated reliability and validity for assessing leisure involvement in Greek populations (Theodorakis, Panopoulou, \& Vlachopoulos, 2007). Administration time: 5-7 minutes.

    Baseline (Week 0) and Post-intervention (Week 12)

Secondary Outcomes (1)

  • Movement Identity and Personal Meaning-Making (Qualitative Narrative Analysis)

    Weekly journals (Weeks 1-12); Post-intervention interviews (Week 12)

Study Arms (2)

Dance-Mindfulness Intervention

EXPERIMENTAL

Participants assigned to the Dance-Mindfulness intervention arm receive 12 weekly sessions (90-100 minutes each) over 12 weeks. Each session integrates: (1) polyvagal-informed breath-movement synchronization, (2) ISTD Modern Theatre Dance technique and dance movements (Grades 2-4), (3) nervous system regulation through somatic practices, and (4) phenomenological reflection via weekly journaling. Sessions follow a standardized 8-component structure with 15-18 participants per session delivered by trained facilitators. Classroom-based, in-person delivery at participating dance schools.

Behavioral: Dance-Mindfulness Intervention

Control

NO INTERVENTION

Participants assigned to the waitlist control arm continue their usual dance activities for 12 weeks, excluding mind-body practices (Pilates, yoga, tai-chi etc). After the 12-week assessment period, all control participants are offered access to the Dance-Mindfulness intervention.

Interventions

A 12-week integrated dance-mindfulness program combining ISTD Modern Theatre Dance technique with polyvagal-informed breathing, somatic practices, and phenomenological reflection. Sessions are 90-100 minutes weekly, delivered in groups of 15-18 participants by trained facilitator(s). The intervention integrates breath-movement synchronization (9-10 min), technical dance work (14-15 min), conditioning (9-10 min), rhythm \& improvisation (8-9 min), choreographed sequences (15-17 min), cool-down integration (8-9 min), and phenomenological journaling (10-20 min). Three-phase progression: Phase 1 (Weeks 1-4) establishes safety and foundational skills; Phase 2 (Weeks 5-8) expands embodied exploration; Phase 3 (Weeks 9-12) focuses on expressive integration and self-regulation consolidation.

Also known as: Mindful Embodied Movement, Modern Dance-Mindfulness Program, ISTD Dance-Mindfulness Integration
Dance-Mindfulness Intervention

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adults aged 18 years and older
  • Enrolled in dance classes (preferring modern/contemporary) at participating schools for at least 6 months prior to study enrollment
  • Able and willing to attend weekly sessions for 12 consecutive weeks (minimum 70% attendance required)
  • Able to understand and complete study questionnaires in Greek language
  • Able to engage in moderate-intensity movement and dance activities without acute medical contraindications
  • Written informed consent provided
  • Willing to be randomly assigned to intervention or waitlist control group

You may not qualify if:

  • Musculoskeletal or neurological conditions limiting safe participation in moderate-intensity movement (e.g., acute injury, severe arthritis, neurological disease affecting coordination/balance)
  • Current severe psychological distress or mental health crisis requiring immediate clinical intervention (screened via DASS-21; cutoff: Severe or Extremely Severe on any subscale)
  • Pregnancy or planning pregnancy during the 12-week study period
  • Current concurrent participation in other psychological interventions, therapy, or mind-body programs (Pilates, yoga, tai-chi, other mindfulness-based interventions)
  • Unable to attend ≥70% of weekly sessions due to scheduling constraints or anticipated absences
  • Inability to provide informed consent or complete questionnaires in Greek
  • Acute medical illness or hospitalization within 2 weeks of study start
  • History of substance abuse disorder currently active or untreated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of PE and Sport Science (DPESS), University of Thessaly

Trikala, Thessaly, 42100, Greece

RECRUITING

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehavior

Study Officials

  • Aglaia Zafeiroudi, SES

    University of Thessaly

    STUDY CHAIR
  • Charilaos Kouthouris

    University of Thessaly

    STUDY DIRECTOR
  • Aglaia Zafeiroudi, SES

    University of Thessaly

    PRINCIPAL INVESTIGATOR

Central Study Contacts

AGLAIA ZAFEIROUDI, Special Educational Staff

CONTACT

CHARILAOS KOUTHOURIS, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Academic Staff, Department of Physical Education and Sport Science

Study Record Dates

First Submitted

November 20, 2025

First Posted

December 3, 2025

Study Start

September 2, 2025

Primary Completion

April 10, 2026

Study Completion (Estimated)

May 31, 2026

Last Updated

January 6, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations