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NCT Number: NCT04507633

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

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.

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Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yonghe Zhongxing Public Seniors Center

New Taipei City, 234, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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

Behavioral

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.

Primary outcomes

  1. cognitive functions

    Time frame: cognitive functions at baseline

    Short Portable Mental Status Questionnaire(SPMSQ)

  2. cognitive functions

    Time frame: cognitive functions after the completion of intervention

    Short Portable Mental Status Questionnaire(SPMSQ)

  3. cognitive functions

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

    Short Portable Mental Status Questionnaire(SPMSQ)

  4. depressive symptoms

    Time frame: depressive symptoms at baseline

    Cornell Scale for Depression in Dementia(CSDD)

  5. depressive symptoms

    Time frame: depressive symptoms after the completion of intervention

    Cornell Scale for Depression in Dementia(CSDD)

  6. depressive symptoms

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

    Cornell Scale for Depression in Dementia(CSDD)

  7. behavioral problems

    Time frame: behavioral problems at baseline

    Neuropsychiatric Inventory-Questionnaire(NPI-Q)

  8. behavioral problems

    Time frame: behavioral problems after the completion of intervention

    Neuropsychiatric Inventory-Questionnaire(NPI-Q)

  9. behavioral problems

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

    Neuropsychiatric Inventory-Questionnaire(NPI-Q)

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Registry information

Official study title

The Effect of ROMA Therapy on Improving Cognitive Functions, Depressive Symptoms and Behavioral Problems in the Population With Dementia

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 11, 2020
Registry last updated
Mar 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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