NCT07859865

Brief Summary

This study aims to investigate the feasibility and acceptability of a novel intervention, the CARE-MOVE program, which combines mindfulness-based dance/movement therapy (M-DMT), psychoeducation, and a support group for dementia care partners. The study also aims to provide proof of concept for the potential effects of the intervention on reducing stress, improving psychological well-being, and enhancing the caregiving relationship.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Apr 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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 Progress92%
Apr 2024Dec 2026

Study Start

First participant enrolled

April 30, 2024

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 6, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

October 8, 2026

Status Verified

October 1, 2026

Enrollment Period

2.6 years

First QC Date

September 30, 2026

Last Update Submit

October 5, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • Intervention Adherence

    Intervention adherence will be assessed as the percentage of enrolled participants who attend at least 8 of the 10 CARE-MOVE sessions. The prespecified feasibility benchmark is that more than 80% of participants will complete at least 8 sessions.

    Through completion of the 10-week intervention

  • Participant Retention

    Retention will be assessed as the percentage of enrolled participants who complete the 10-week CARE-MOVE intervention. Reasons for withdrawal or discontinuation will also be recorded. The prespecified benchmark is a dropout rate of 20% or less.

    Through completion of the 10-week intervention

  • Feasibility of Intervention Measure (FIM) Score

    Perceived intervention feasibility will be assessed using the 4-item Feasibility of Intervention Measure (FIM). Items are rated on a 5-point Likert scale from 1 (completely disagree) to 5 (completely agree), with higher scores indicating greater perceived feasibility. The protocol specifies a feasibility benchmark based on the summed FIM score.

    Post-intervention, approximately 10 weeks after baseline

  • Treatment Satisfaction

    Treatment satisfaction will be assessed using participant ratings of the intervention structure and content on a 5-point Likert scale ranging from 1 (not very satisfied) to 5 (very satisfied). Higher scores indicate greater satisfaction. The prespecified benchmark is a mean rating greater than 3.5.

    Post-intervention, approximately 10 weeks after baseline

Secondary Outcomes (7)

  • Perceived Stress

    Baseline, post-intervention at 10 weeks, and 3-month follow-up

  • Caregiver distress related to dementia-related behaviors

    Baseline, post-intervention at 10 weeks, and 3-month follow-up

  • Depressive symptoms

    Baseline, post-intervention at 10 weeks, and 3-month follow-up

  • Psychological well-being

    Baseline, post-intervention at 10 weeks, and 3-month follow-up

  • Caregiver-care recipient relationship quality

    Baseline, post-intervention at 10 weeks, and 3-month follow-up

  • +2 more secondary outcomes

Study Arms (1)

Mindfulness-based Dance/Movement Therapy

EXPERIMENTAL

Participants assigned to the CARE-MOVE arm will receive a 10-week online mindfulness-based dance/movement therapy program for dementia care partners. They will attend weekly 70-minute group sessions incorporating movement, mindfulness-based embodied practices, music, sensory exploration, creative self-expression, and peer support. Sessions are designed to support emotional awareness and regulation, empathy, nonverbal communication, adaptive coping, self-compassion, and the caregiving relationship.

Behavioral: Mindfulness-based Dance/Movement Therapy

Interventions

CARE-MOVE is a 10-week, synchronous online mindfulness-based dance/movement therapy intervention tailored for dementia care partners. Mindfulness principles are integrated into embodied and movement-based practices rather than taught as a separate comprehensive mindfulness curriculum. The intervention combines structured, self-directed, and interactive dance/movement, music, mindful meditation, sensory exploration, creative self-expression, and social support. The program progresses through five stages: emotional awareness and articulation, emotional expression and reciprocal attunement, empathy, affect modulation, and rhythmic synchrony.

Also known as: CARE-MOVE
Mindfulness-based Dance/Movement Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older
  • Informal care partner of a person living with dementia and has known the care recipient for at least 1 year
  • Care recipient has a diagnosis of Alzheimer's disease, frontotemporal dementia, vascular dementia, Lewy body disease, or mixed dementia
  • English speaking
  • Normal or corrected-to-normal visual acuity and normal color vision, based on self-report
  • Adequate hearing acuity, based on self-report
  • Able to use a tablet or computer, email, and complete online surveys independently or with readily available assistance
  • Has internet access with Wi-Fi at the location where CARE-MOVE sessions will be attended
  • Able to safely participate in a light- to moderate-intensity movement-based intervention
  • Willing to participate in the CARE-MOVE intervention

You may not qualify if:

  • Health condition that may contraindicate participation in light- to moderate-intensity movement, such as an unstable cardiac condition, previous myocardial infarction, angina, or chronic obstructive pulmonary disease, unless medical clearance is provided by a physician
  • Surgery within the previous 1 year
  • New pain medication or psychotropic medication, or a change in pain or psychotropic medication, within the previous 60 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Drexel University

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

  • Shim M, Gaydos M, Goldstein-Levitas N, Musalo N, Prakash N, Bradt J, Zhang F, Wenger S, Gonzalez A. Development and feasibility of a mindfulness-based dance/movement therapy intervention for chronic low back pain. Front Pain Res (Lausanne). 2024 Apr 10;5:1281085. doi: 10.3389/fpain.2024.1281085. eCollection 2024.

    PMID: 38689886BACKGROUND
  • Shim M, Kavanaugh M, Lacson C, Goldstein-Levitas N, Chang H, Zhang F, Palekar N, Gonzalez A, Fisher K. Connected through movement: a feasibility study of online mindfulness-based dance/movement therapy for older adults with age-related cognitive decline during COVID-19. Aging Ment Health. 2024 Dec;28(12):1676-1685. doi: 10.1080/13607863.2024.2364754. Epub 2024 Jun 23.

    PMID: 38910361BACKGROUND

Study Officials

  • Minjung Shim

    Drexel University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 30, 2026

First Posted

October 6, 2026

Study Start

April 30, 2024

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

October 8, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

Locations