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

The Effect of ROMA Therapy on Improving Cognitive Functions, Depressive Symptoms 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.

Study Overview

• Status: Completed
• Conditions: Dementia
• Intervention / Treatment: Behavioral: ROMA therapy(reminiacence therpy, orientation, music, and art)

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 63 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group; usual care
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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cognitive functions	Short Portable Mental Status Questionnaire(SPMSQ)	cognitive functions at baseline
cognitive functions	Short Portable Mental Status Questionnaire(SPMSQ)	cognitive functions after the completion of intervention
cognitive functions	Short Portable Mental Status Questionnaire(SPMSQ)	cognitive functions at 4 weeks after the completion of intervention
depressive symptoms	Cornell Scale for Depression in Dementia(CSDD)	depressive symptoms at baseline
depressive symptoms	Cornell Scale for Depression in Dementia(CSDD)	depressive symptoms after the completion of intervention
depressive symptoms	Cornell Scale for Depression in Dementia(CSDD)	depressive symptoms at 4 weeks after the completion of intervention
behavioral problems	Neuropsychiatric Inventory-Questionnaire(NPI-Q)	behavioral problems at baseline
behavioral problems	Neuropsychiatric Inventory-Questionnaire(NPI-Q)	behavioral problems after the completion of intervention
behavioral problems	Neuropsychiatric Inventory-Questionnaire(NPI-Q)	behavioral problems at 4 weeks after the completion of intervention

Collaborators and Investigators

• Sponsor: Taipei Medical University
• Investigators: Principal Investigator: Hui-Chuan Huang, PhD, School of Nursing, Taipei Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2020
• Primary Completion (Actual): July 30, 2021
• Study Completion (Actual): July 31, 2021

Study Registration Dates

• First Submitted: July 25, 2020
• First Submitted That Met QC Criteria: August 9, 2020
• First Posted (Actual): August 11, 2020

Study Record Updates

• Last Update Posted (Actual): March 21, 2022
• Last Update Submitted That Met QC Criteria: March 18, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Problem Behavior; Dementia
• Other Study ID Numbers: N202005108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No