EmotionMiMNCT02219620
Examining the Effects of (MiM) Treatment on Emotional and Cognitive Functioning of Residents in Long-term Care
A study testing Music, Imagery, Movement in people with Emotion and Impaired Cognition, run by George Mason University at 1 site in United States.
Trial summary
To examine the effects of a music, imagery, and movement (MiM) intervention on emotional and cognitive functioning in residents living in a community-based adult long-term care facility. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Emotion, Impaired Cognition
- What is being tested?
- Music, Imagery, Movement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Resident in assisted living at long-term care facility with MMSE score above 20
Who cannot join
- co-morbid psychiatric diagnosis and/or staff clinical evaluation that determines inappropriateness for study inclusion
Trial locations and contacts
1 site in 1 country.
United States1 site
Assisted Living at Birmingham Green
Manassas, Virginia, 20110
About this study
To examine the effects of a music, imagery, and movement (MiM) intervention on emotional and cognitive functioning in residents living in a community-based adult long-term care facility.
Hypothesis 1: Residents who participate in the MiM group will improve in emotional functioning, as compared to residents in the control group.
Hypothesis 2: Residents who participate in the MiM group will improve in cognitive functioning, as compared to residents in the control group.
Read the detailed description
To implement a community-based integrated music, art and imagery, and movement intervention to improve mood and promote cognitive functioning in older adult residents living in a long-term care facility.
- Conditions
- Emotion, Impaired Cognition
- Being tested
- Music, Imagery, Movement, Social Control
- Keywords
- creative arts, older adults, intervention study
- Medical subject headings
- Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music, Imagery, MovementBehavioural
Implementation of music, art and imagery activation, and movement in group modality
Social ControlBehavioural
social conversational group facilitated by care counselor
| Study group | Role | What they receive |
|---|---|---|
| Music, Imagery, Movement intervention | Experimental | Music, Imagery, Movement intervention: psychosocial intervention incorporating Music, Imagery and Movement Receives: Behavioral: Music, Imagery, Movement |
| Social Control | Active comparator | social control/interaction group Receives: Behavioral: Social Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
emotional functioning
Measured: pre-post 10 week treatment and 6 week FU
Secondary outcomes (1)
cognitive functioning
Measured: pre-post 10 week intervention and 6 week FU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmotionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Mason University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Holly Matto, George Mason University
- Investigators
- Holly Matto, Ph.D., Principal investigator, George Mason UniversityCathy Tompkins, Ph.D., Principal investigator, George Mason UniversityEmily Ihara, Ph.D., Principal investigator, George Mason University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02219620
- Sponsor's protocol ID
- 14-953118
- Acronym
- MiM
- Status last verified
- Jun 2016
- First submitted
- 28 Jul 2014
- Last updated
- 21 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effects of (MiM) Treatment on Emotional and Cognitive Functioning of Residents in Long-term Care
- ClinicalTrials.gov ID
- NCT02219620
- Acronym / sponsor ID
- MiM / 14-953118
- Conditions
- Emotion, Impaired Cognition
- Keywords
- creative arts, older adults, intervention study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- George Mason UniversityUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 19 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To examine the effects of a music, imagery, and movement (MiM) intervention on emotional and cognitive functioning in residents living in a community-based adult long-term care facility.
Hypothesis 1: Residents who participate in the MiM group will improve in emotional functioning, as compared to residents in the control group.
Hypothesis 2: Residents who participate in the MiM group will improve in cognitive functioning, as compared to residents in the control group.
Detailed description
To implement a community-based integrated music, art and imagery, and movement intervention to improve mood and promote cognitive functioning in older adult residents living in a long-term care facility.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music, Imagery, Movement intervention | Experimental | Behavioral: Music, Imagery, MovementMusic, Imagery, Movement intervention: psychosocial intervention incorporating Music, Imagery and Movement |
| Social Control | Active comparator | Behavioral: Social Controlsocial control/interaction group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Resident in assisted living at long-term care facility with MMSE score above 20
Key exclusion criteria (1 listed)
- co-morbid psychiatric diagnosis and/or staff clinical evaluation that determines inappropriateness for study inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music, Imagery, MovementImplementation of music, art and imagery activation, and movement in group modality | Behavioural | Music, Imagery, Movement intervention |
| Social Controlsocial conversational group facilitated by care counselor | Behavioural | Social Control |
Primary outcome
emotional functioning
Time frame: pre-post 10 week treatment and 6 week FU
1 secondary outcome
cognitive functioning
Time frame: pre-post 10 week intervention and 6 week FU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2016.
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Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Holly Matto, Ph.D. principal investigator
George Mason University
Cathy Tompkins, Ph.D. principal investigator
George Mason University
Emily Ihara, Ph.D. principal investigator
George Mason University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music, Imagery, Movement in people with Emotion and Impaired Cognition, run by George Mason University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
emotional functioning (time frame: pre-post 10 week treatment and 6 week FU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2016.