Clinical trial NCT04507633: ROMA (Reminiscence, Reality Orientation, Music and Art ) Therapy, Cognition, Depression and Behavioral Problems in the Population With Dementia
Official title: The Effect of ROMA Therapy on Improving Cognitive Functions, Depressive Symptoms and Behavioral Problems in the Population With Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2020-08-11
Enrollment: 45
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: cognitive functions
timeFrame: cognitive functions at baseline
measure: cognitive functions
timeFrame: cognitive functions after the completion of intervention
measure: cognitive functions
timeFrame: cognitive functions at 4 weeks after the completion of intervention
measure: depressive symptoms
timeFrame: depressive symptoms at baseline
measure: depressive symptoms
timeFrame: depressive symptoms after the completion of intervention
measure: depressive symptoms
timeFrame: depressive symptoms at 4 weeks after the completion of intervention
measure: behavioral problems
timeFrame: behavioral problems at baseline
measure: behavioral problems
timeFrame: behavioral problems after the completion of intervention
measure: behavioral problems
timeFrame: behavioral problems at 4 weeks after the completion of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Yonghe Zhongxing Public Seniors Center
Study officials:
affiliation: School of Nursing, Taipei Medical University
name: Hui-Chuan Huang, PhD
role: PRINCIPAL_INVESTIGATOR
References: