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

27 Feb 2024

The date of last modification

Mar 15, 2024



Application Summary


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)


Trial Details


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



State of Ethics Review Approval


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 & Sponsor Information


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

Secondary study sponsor (If any)







Trial Completion details


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