Dementia CaregiverCARE-MOVENCT07859865
Mindfulness-based Movement Therapy for Persons With Dementia and Family Caregivers
A study testing Mindfulness-based Dance/Movement Therapy in people with Dementia Caregiver, run by Drexel University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia Caregiver
- What is being tested?
- Mindfulness-based Dance/Movement Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2024to 31 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Specific Aim 1: To examine the feasibility and acceptability of the online CARE-MOVE program for dementia care partners.
The feasibility and acceptability of a 10-week online CARE-MOVE program will be evaluated among dementia care partners (n = 36). The program integrates M-DMT, psychoeducation, and support group components. Feasibility and acceptability outcomes will include enrollment, retention, protocol adherence, program satisfaction, perceptions of program components, barriers to engagement, and adverse events. Findings will be used to refine and optimize the intervention protocol for future efficacy testing in a larger randomized controlled trial.
Specific Aim 2: To establish proof of concept for the CARE-MOVE intervention in reducing stress, improving psychological well-being, and enhancing the caregiving relationship among dementia care partners.
Preliminary intervention effects will be examined with respect to stress, psychological well-being, caregiving burden, and the caregiving relationship. This exploratory evaluation is intended to generate initial evidence regarding the potential benefits of CARE-MOVE and to inform the design of future efficacy studies.
The study hypotheses are that participation in CARE-MOVE will be associated with (a) decreased stress, (b) improved psychological well-being, and (c) enhanced caregiving relationships among dementia care partners.
Specific Aim 3: To characterize how dementia reshapes embodied communication and connection within the caregiving relationship.
Changes in embodied and nonverbal relational processes, including touch, proximity, movement coordination, and co-regulation, will be examined across the caregiving trajectory. Care partners' experiences of these changes will also be explored, including how shifts in embodied communication and connection relate to ambiguous loss, identity change, and grief. Findings will identify intervention-relevant targets and inform refinement of the existing CARE-MOVE program.
- Conditions
- Dementia Caregiver
- Being tested
- Mindfulness-based Dance/Movement Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based Dance/Movement TherapyBehavioural
Also called CARE-MOVE
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mindfulness-based Dance/Movement Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Post-intervention, approximately 10 weeks after baseline
Secondary outcomes (7)
Perceived Stress
Perceived stress will be assessed using the 10-item Perceived Stress Scale (PSS-10), which assesses the extent to which participants perceive their lives as unpredictable, uncontrollable, and overwhelming. Items are rated on a 5-point frequency scale; higher scores indicate greater perceived stress.
Measured: Baseline, post-intervention at 10 weeks, and 3-month follow-up
Caregiver distress related to dementia-related behaviors
Caregiver distress associated with dementia-related behaviors will be assessed using the Revised Memory and Behavior Problems Checklist. The Reaction component assesses how much each reported behavior bothers or upsets the caregiver, with higher scores indicating greater caregiver distress.
Measured: Baseline, post-intervention at 10 weeks, and 3-month follow-up
Depressive symptoms
Depressive symptoms will be assessed using the 20-item CES-D. Items are rated from 0 to 3 based on symptom frequency during the past week. Total scores range from 0 to 60, with higher scores indicating greater depressive symptoms.
Measured: Baseline, post-intervention at 10 weeks, and 3-month follow-up
Psychological well-being
Psychological well-being will be assessed using the 5-item WHO-5 Well-Being Index. Items assess positive mood, vitality, and general interest. Higher scores indicate greater psychological well-being.
Measured: Baseline, post-intervention at 10 weeks, and 3-month follow-up
Caregiver-care recipient relationship quality
Relationship quality will be assessed using the 14-item Quality of Carer-Patient Relationship measure, which evaluates aspects of the current caregiver-care recipient relationship such as closeness, similarity of views, and getting along. Items are rated on a five-point scale and summed to produce a total score ranging from 14 to 70. Higher scores indicate better relationship quality and therefore a better outcome.
Measured: Baseline, post-intervention at 10 weeks, and 3-month follow-up
Interpersonal mindfulness
Interpersonal mindfulness will be assessed using the 19-item Interpersonal Mindfulness Questionnaire. The measure assesses detachment from the mind, body-anchored presence, attention to and awareness of another person, and mindful responding. Items are rated from 1 (not at all) to 5 (very much), with higher scores indicating greater interpersonal mindfulness.
Measured: Baseline, post-intervention at 10 weeks, and 3-month follow-up
Sleep disturbance
Sleep disturbance will be assessed using the 4-item PROMIS Sleep Disturbance 4a measure, which assesses perceived sleep quality, depth, and restoration. Items have five response options. Higher scores indicate greater sleep disturbance
Measured: Baseline, post-intervention at 10 weeks, and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start30 Apr 2024
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dementia CaregiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Minjung Shim, PhD, Drexel University
- Investigators
- Minjung Shim, Principal investigator, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07859865
- Sponsor's protocol ID
- 2306009949
- Acronym
- CARE-MOVE
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38689886Shim 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.
PubMed 38910361