Home » Trials » SLCTR/2024/007
Effectiveness of Internet-based emotional healing with an expressive arts therapy program on burden, depression, and self-esteem among family caregivers of older adults with dementia: A randomized control trial
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SLCTR Registration Number
SLCTR/2024/007
Date of Registration
The date of last modification
Mar 15, 2024
Scientific Title of Trial
Effectiveness of Internet-based emotional healing with an expressive arts therapy program on burden, depression, and self-esteem among family caregivers of older adults with dementia: A randomized control trial
Public Title of Trial
Effectiveness of Internet-based emotional healing with an expressive arts therapy program on burden, depression, and self-esteem among family caregivers of older adults with dementia compered to usual care: A randomized control trial.
Disease or Health Condition(s) Studied
Mental Health of carers in dementia
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1304-2886
Any other number(s) assigned to the trial and issuing authority
COA No.118/2566 (ERC Faculty of Nursing, Thammasat University, Thailand)
What is the research question being addressed?
What is the effectiveness of internet-based emotional healing with an expressive arts therapy program on the burden, depression, and self-esteem among family caregivers of older adults with dementia compared to usual care?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Single
Purpose
Supportive care
Study Phase
Not Applicable
Intervention(s) planned
Setting: The Alzheimer’s Disease and Related Disorders Association of Thailand (ADRA) (Alzheimer Thailand, 2023).
Randomization: The experimental and control groups will be randomly assigned following stratified block randomization.
Intervention: The Internet-based emotional healing with expressive arts therapy program is an Internet-based intervention that supports family caregivers of older adults with dementia. It is delivered in groups, and focuses on emotional healing. The program includes expressive arts therapy, defined as visual arts, music, and storytelling. The program emphasizes the following themes: fostering social support, creative expression, personal growth, a positive attitude, and making meaning. The researcher will give the participants the necessary tools and materials and then encourage them to continue with their groups (3–12 people per group). The researcher will give assignments and materials for the participants to do art activities at home with one assignment/2 weeks. The completed program is eight weeks and consists of 6 sessions. The researcher meets with the group in weeks 1, 2, 4, 6, and 8 via LINE, Facebook, Google Meet, or Zoom application. The researcher will give the participants the tools and materials they need and encourage them to continue in groups (3–12 people per group) online and do an activity for 6 sessions (45–60 min./session). Session1: Introduction by visual art, and storytelling (Week 1) Session2: art activities by music, Body movement, writing and storytelling (Week 2) Session3: art activities by visual art, writing (Week 3) Session4: art activities by music, visual art, writing and storytelling (Week 4) Session 5: Art activities by visual art, music, Body movement, writing and storytelling (Weeks 5, 6). Session 6: Art activities by visual art, music, Body movement, writing and storytelling (Weeks 7- 8).
Standard therapy: Support members through community awareness, consulting, and counseling regarding Alzheimer's disease and related dementias.
Inclusion criteria
(1) A family caregiver, male and female aged 20–59 years, unpaid and living as a family member with an older adult diagnosed with moderate to severe dementia. (2) Able to read, speak, and write in Thai. (3) Able to use Internet-based communication; the family caregivers of older adults with mid-term/severe dementia will use video calls via the LINE application, Facebook, Google Meet, or Zoom application. (4) Provision of care for at least 3 months and performing caregiving tasks for at least 4 hours daily. (5) Mild to moderate level perception of depression. (***9Q =7-18 score) **Patient Health Questionnaire for Screening Major Depression (9Q), Thai Version.
Exclusion criteria
(1) Caregivers with health problems such as congestive heart failure, cancer, asthma, neurological disease who cannot participate in the activities. (2) Psychiatric disorders such as severe schizophrenia or severe depression.
Primary outcome(s)
1.
The burden of caregiving as assessed by the Burden of Caregiving Scale; the Zarit Burden Interview, translated into Thai. The Zarit Burden Interview for dementia caregivers contains 22 questions with scoring for each question divided into a 5-point rating scale. |
[ Week 0 (baseline), After week 4, Week 8. ] |
2.
Depression of caregivers as assessed by a Depression Scale; The Center for Epidemiological Studies-Depression (CES-D) Thai version. This consists of a 20-item measure that asks caregivers to rate the frequency with which they experienced depressive symptoms such as restless sleep, poor appetite, and feelings of isolation during the past week. |
[ Week 0 (baseline), After week 4, Week 8. ] |
3.
Self-esteem of carers as assessed by a Self-esteem Scale; the Rosenberg’s Self-esteem scale, Thai version (RSES-TR-10). The scale was created to measure feelings of self-acceptance and self-esteem. The ten questions consist of five positive questions, five negative questions, and an inverse rating on 5-point scales. |
[ Week 0 (baseline), After week 4, Week 8. ] |
Secondary outcome(s)
Target number/sample size
90 participants (45 in each arm)
Countries of recruitment
Thailand
Anticipated start date
2024-02-27
Anticipated end date
2024-05-30
Date of first enrollment
2024-02-28
Date of study completion
Recruitment status
Recruiting
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2023-12-12
Approval number
COA No.118/2566 Project No. 66NU131
Details of Ethics Review Committee
Name: | The Human Research Ethics Committee of Thammasat University |
Institutional Address: | Thammasat University Rangsit Campus, Prathumthani 12121 Thailand |
Telephone: | 0-2564-4440 ext.7358 |
Email: | ecsctu3@tu.ac.th |
Contact person for Scientific Queries/Principal Investigator
Yadarat Baljay
Advanced Practice Nurse (Gerontological Nursing) and Ph.D. Candidate
Faculty of Nursing
Thammasat University Rangsit Campus, Prathumthani 12121 Thailand
025644440
0924915624
None
yadarat059@nurse.tu.ac.th
https://nurse.tu.ac.th
Contact Person for Public Queries
Associate Prof. Dr. Rangsiman Soonthornchaiya
Associate Professor
Faculty of Nursing
Thammasat University Rangsit Campus, Prathumthani 12121 Thailand
+66 29869213 (Ext. 7342)
None
rangsiman@nurse.tu.ac.th
https://nurse.tu.ac.th
Primary study sponsor/organization
Faculty of Nursing, Thammasat University
Thammasat University Rangsit Campus, Prathumthani 12121 Thailand
025644440
None
phd_program@nurse.tu.ac.th
https://nurse.tu.ac.th
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results