NCT06197230

Brief Summary

The study will consist of two stages. The first stage of the study expects to find associations within dependent variables: depression level, resourcefulness, spiritual resourcefulness, and spiritual health in older adults. The second stage estimated that art drawing interventions will be effective for improving depression levels, resourcefulness, spiritual resourcefulness, and spiritual health.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 23, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 26, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 9, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

January 9, 2024

Status Verified

December 1, 2023

Enrollment Period

7 months

First QC Date

December 26, 2023

Last Update Submit

December 26, 2023

Conditions

Keywords

Drawing InterventionsDepressionResourcefulnessSpiritual HealthOlder Adults

Outcome Measures

Primary Outcomes (3)

  • Geriatry Depression Scale (GDS)

    Geriatric Depression Scale is one of depression scales known globally. The Geriatric Depression Scale (GDS), developed by Yesavage et al. in 1983, is a self-report instrument consisting of 30 items.

    14 weeks

  • Resourcefulness Scale

    The Resourcefulness Scale developed by Zauszniewski et al. (2006) will be used to test the degree of resourcefulness in older adults. The scale consists of 28-items on a 6-point Likert-type scale

    14 weeks

  • Spiritual Health/Spiritual Self-assessment index for older adult

    consists of 20 items, five measuring each of the constructs: (1) meaning and purpose, (2) hope and coping, (3) transcendence in relationships with God and others, and (4) religious practices. This tool offers options to the participants with a degree of agreement for each item using a five-point Likert scale. A numerical value will be assigned to each category: strongly disagree = 1, disagree = 2, uncertain = 3, agree = 4, and strongly agree = 5. Item responses total score that could range from 20 to 100. Higher scores indicated a greater degree of spiritual wellness. Each of the four subscales consisted of five items, permitting a scoring range from 5 to 25. Items one through five, representing measuring hope and coping; six through ten will measure transcendence; eleven through fifteen for meaning and purpose; and sixteen through twenty focused on religious practices.

    14 weeks

Study Arms (2)

Intervention group ; Drawing Intervention

EXPERIMENTAL

The intervention will be applied every week for 6 weeks. The level of depression, resourcefulness, spiritual resourcefulness, and spiritual health will be tested at the first week before the intervention (T0), the 3rd week (T1), the 6th week right after the interventions (T2), 1 month follow-up after the interventions (T3), and 2 months post-intervention.

Other: Drawing Intervention

Control

OTHER

The control group will receive standard care in nursing home

Other: Drawing Intervention

Interventions

The primary sections of Drawing Intervention will be the "art-making" and "art-sharing" sections. During the art-making segment, the group leader will guide the participants through a paper-warming exercise before assigning them a specific subject to draw freely for 20-30 minutes. The leader will then ask participants to talk about the meaning of their artwork, encouraging them to explore their emotions regarding the theme and their drawing. This procedure will be implemented in each segment of the intervention (6 sessions).

ControlIntervention group ; Drawing Intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Currently live in nursing home
  • Have no physical impairment.
  • Have been staying in nursing home for at least 6 months.
  • Speak Bahasa Indonesia

You may not qualify if:

  • Have been diagnosed with psychiatric illness.
  • Have been diagnosed with severe physical disorders such as advanced cancer or motor impairments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

BPSTW Budi Luhur

Bantul, D.I Yogyakarta, 55184, Indonesia

RECRUITING

Balai Pelayanan Sosial Tresna Wreda Unit Abiyoso

Yogyakarta, D.I Yogyakarta, 55582, Indonesia

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Irna Kartina

    National Taipei University of Nursing and Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Irna Kartina, Master

CONTACT

Chien Yu Lai, AssProf

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
This intervention study is designed as single-blind; all the participants will be blinded to the allocation. To prevent participants from developing expectations regarding the intervention, they will be blinded to their group assignment.The investigator will not tell which is intervention and control group member
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized control trial with longitudinal design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ms

Study Record Dates

First Submitted

December 26, 2023

First Posted

January 9, 2024

Study Start

November 23, 2023

Primary Completion

June 30, 2024

Study Completion

November 30, 2024

Last Updated

January 9, 2024

Record last verified: 2023-12

Locations