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CompletedNCT04507633Updated Mar 21, 2022

ROMA (Reminiscence, Reality Orientation, Music and Art ) Therapy, Cognition, Depression and Behavioral Problems in the Population With Dementia

An interventional study of ROMA therapy(reminiacence therpy, orientation, music, and art) in Dementia, sponsored by Taipei Medical University. Completed at 1 site in Taiwan. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2022-03-21.

Sponsored by Taipei Medical University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study summary

This study aimed to conduct a randomized controlled trial to examine the effectiveness of ROMA therapy( Reminiscence, Reality Orientation, Music, and Art) on improving cognitive function, behavioral and psychological symptoms in population with dementia. The hypotheis of this study is that these patients with dementia receiving ROMA therapy featuring reminiscence, reality orientation, music, and art would improve their cognition, depressive symptoms, and behavioral symptoms.

Read the detailed description

This study aimed to conduct a randomized controlled trial to examine the effectiveness of ROMA therapy( Reminiscence, Reality Orientation, Music, and Art) on improving cognitive function, behavioral and psychological symptoms in demented population. A total of 60 patients with mild to moderate dementia will be recruited and randomly assigned to two groups: experimental group and control group. The experimental group will undergo ROMA therapy with a 60 minute per week for eight weeks. The control group will receive three times ROMA therapy after completing outcome measurements. Two groups will receive questionnaire interview at pre-test, post-test, and at 4 weeks after intervention. The measurements comprises: Short Portable Mental Status Questionnaire(SPMSQ), Cornell Scale for Depression in Dementia(CSDD),and Neuropsychiatric Inventory-Questionnaire(NPI-Q). By identifying the effectiveness of ROMA therapy, suitable intervention can be suggested for those demented population to improve cognitive function, behavioral and psychological symptoms.

02

Conditions studied

  • Dementia

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03

In context

Dementia

2,230 studies on the registry are indexed under Dementia; 549 are open to participants now.

This study's enrollment of 45 is below the median of 83 across 1,669 interventional studies indexed under Dementia.

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Lead sponsor

Taipei Medical University is the lead sponsor of 256 studies on the registry; 59 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Been diagnosed as mild to moderate dementia and CDR score between 0.5\~2
  2. can communicate in Chinese or Taiwanese
  3. without visual or auditory impairment after equipping assist devices

Exclusion criteria

Exclusion Criteria:

  1. severe dementia and Clinical Dementia Rating (CDR) score more than 2 points
  2. functional dependence
  3. incapable of expressing their feelings
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    ROMA therapy

    ROMA therapy combines four elements including reminiscence, reality orientation, music, and art in the intervention.

    Behavioral: ROMA therapy(reminiacence therpy, orientation, music, and art)

  • No intervention
    control group

    usual care

Interventions

  • BehavioralROMA therapy(reminiacence therpy, orientation, music, and art)

    An intervention comprising reminiscence of annual festivals, orientation, and familiar music listening and singing, and animation interaction to improve cognitive functions, depressive symptoms and behaviors problems.

06

What researchers measure

Primary outcomes

  1. cognitive functions

    Short Portable Mental Status Questionnaire(SPMSQ)

    Time frame: cognitive functions at baseline

  2. cognitive functions

    Short Portable Mental Status Questionnaire(SPMSQ)

    Time frame: cognitive functions after the completion of intervention

  3. cognitive functions

    Short Portable Mental Status Questionnaire(SPMSQ)

    Time frame: cognitive functions at 4 weeks after the completion of intervention

  4. depressive symptoms

    Cornell Scale for Depression in Dementia(CSDD)

    Time frame: depressive symptoms at baseline

  5. depressive symptoms

    Cornell Scale for Depression in Dementia(CSDD)

    Time frame: depressive symptoms after the completion of intervention

  6. depressive symptoms

    Cornell Scale for Depression in Dementia(CSDD)

    Time frame: depressive symptoms at 4 weeks after the completion of intervention

  7. behavioral problems

    Neuropsychiatric Inventory-Questionnaire(NPI-Q)

    Time frame: behavioral problems at baseline

  8. behavioral problems

    Neuropsychiatric Inventory-Questionnaire(NPI-Q)

    Time frame: behavioral problems after the completion of intervention

  9. behavioral problems

    Neuropsychiatric Inventory-Questionnaire(NPI-Q)

    Time frame: behavioral problems at 4 weeks after the completion of intervention

07

Study locations

1 site
  • Yonghe Zhongxing Public Seniors Center
    New Taipei City, 234, Taiwan
08

References and documents

Publications

  • Tz-Han L, Wan-Ru W, I-Hui C, Hui-Chuan H. Reminiscence music intervention on cognitive, depressive, and behavioral symptoms in older adults with dementia. Geriatr Nurs. 2023 Jan-Feb;49:127-132. doi: 10.1016/j.gerinurse.2022.11.014. Epub 2022 Dec 8. PubMed 36495795 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2020 to primary completion in Jul 2021, 11 months.

Of 835 non-industry interventional studies with no phase under Dementia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's 11 months is below that.

Counting every sponsor, half of 875 studies reached it within 24 months; a quarter within 11 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 25, 2020
First posted
Aug 11, 2020
StartActual
Aug 25, 2020
Primary completionActual
Jul 30, 2021
CompletionActual
Jul 31, 2021
Last update
Mar 21, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04507633
Lead sponsor
Taipei Medical University
Responsible party
Huang, Hui-Chuan (Associate Professor, Taipei Medical University) — Principal investigator
First posted
Aug 11, 2020
Start date
Aug 25, 2020
Primary completion
Jul 30, 2021
Completion
Jul 31, 2021
Last update
Mar 21, 2022

Study contacts

Hui-Chuan Huang, PhD
principal investigator · School of Nursing, Taipei Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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