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

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04507633
• Other study ID #: N202005108
• Status: Completed
• Phase: N/A
• Start date: August 25, 2020
• Est. completion date: July 31, 2021

Study information

• Verified date: March 2022
• Source: Taipei Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 31, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia
• Problem Behavior

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.

Locations

Country	Name	City	State
Taiwan	Yonghe Zhongxing Public Seniors Center	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

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