Clinical trial NCT02957773: Integration of Social Art Activities and Qigong for Older People in Nursing Home in Indonesia
Official title: Integration of Social Art Activities and Qigong Exercises to Increase the Well-Being of Older People in Nursing Homes in Indonesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Well-being
Depressive Symptoms
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Universitas Tarumanagara
First posted: 2016-11-08
Enrollment: 299
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This project will be a randomised controlled trial to investigate the effectiveness of an integrated programme by using social art activity (SA) and exercise, for instance, Qigong (QG, a traditional Chinese exercise) as a therapeutic medium.

This integrated programme aims to increase the well-being and reduce the depressive symptoms that are frequently ascertained in older people who live in nursing homes. The combination of SA and QG might be more beneficial to older people than either individual activity on its own, given that they are addressing different areas of functioning. The art activity focuses on self-expression in non-verbal activity using fine motor movement, whereas physical exercise like Qigong focuses on awareness of breathing and a calm state of mind. This is to help the older person achieve mental and physical relaxation by using gross motor movement. When the interventions are combined by utilising Qigong ahead of the art activities (thus, including both fine and gross motor movements) older people will reach a state of mental and physical relaxation, and moreover, will be able to express their feelings more simply in the social art activities.

Detailed description: Depression is one of the most common mental disorders with regards to older people. It is a serious disease affecting an individual's entire life-situation, which can lead to suffering and a reduced level of activity in everyday life. Depression inhibits thinking capacity in self-expression and reduces the ability to communicate. Furthermore, older people with depression often use a considerable amount of energy attempting to avoid distressing emotions and negative thinking, which is one of the principal symptoms of depression.

Research findings describing the use of relaxation or meditation to prepare clients prior to the art activities are effective treatment methods in the reduction of depression and anxiety. However, adding Qigong as an initial therapy prior to the art activities enhances the effectiveness of art therapy. When older people achieve deep states of mental and physical relaxation, they will be able to activate their thinking capacity regarding self-expression by means of the use of art media. Thus, their negative feelings will be directed toward art activities, which in turn will reduce the depressive feelings.

This study is conducted as a randomised controlled trial with four groups. The four groups will be (1) Qigong exercise and art activity group as an integrated intervention (2) An art activity group; (3) A Qigong group; and (4) no intervention/daily activities. The investigators begins by allocating participants at random to one of the intervention groups. The process of randomising the participants will be collected by sealed-envelopes used in the selection process. The participants will assemble in one room and each participant will receive a sealed-envelope, which contains a card labelled with information regarding the intervention that will follow. The information will comprise the number of sessions, time period and checklist column that must be marked by the participants, in order to indicate that they are willing to follow the intervention. Once the participants know the intervention group that they are assigned to, the investigators will conduct an initial interview to obtain demographic information and to acquire data about the reason they decided to live in a nursing home. Finally, informed consent will be obtained from the participants during the initial interview. The intervention will be conducted in 8 weeks and consists of 16 sessions that will be given twice a week; each session will be last for 90 minutes.

Furthermore, the investigators will evaluate participants who meet the criteria before the intervention. The measurement of the inclusion and exclusion criteria will be assessed by using MMSE and the MINI Neuropsychiatric Interview. Social demographic characteristics are included to collect data about age, sex and ethnicity, education, marital status (married or never married), family group, perceived economic status (upper, middle or lower), financial resources, medical history, lifestyle/exercise habits and information relating to admission to the nursing home. The MMSE is a brief indicator of cognitive ability of the elderly, and the MINI will be used as a screening tool to measure severe psychiatric disorders. The measurements will be given before and after the intervention using WHOQOL-BREF; SWLS, BDI-II and GDS 15-item, MMSE and SF-36.

The intervention process of the social art activities will be provided and participants will use art materials, for instance, drawing paper, pencils and coloured pencils, magazine, objects, glue, scissors/box cutters, collage and additional material. The materials are selected based on the consideration that they are not too messy or too complicated to work with. The Qigong consists of nine simple and slow movements that are suitable for older people. The integrated intervention will be presented in one session; hence, Qigong will be provided as the initial therapeutic activity preceding the art activities. The healing mechanisms to depressed older people using the art activities and Qigong can be obtained during the "therapeutic process", which consists of sensory stimulation, self-exploration, self-expression, communication, understanding and explanation, symbolic thinking and creativity.

During the intervention, participants will be observed based on the observation form, to know if there is any improvement in social interaction, communication and involvement in the activities, in addition to their expression and impression during the activities. A follow-up measurement will take place 3 and 6 months after the intervention, including a follow-up interview to obtain descriptive data concerning the older person's well-being, following participation in the intervention.

The control condition consists of groups of older people engaged in regular, daily activities, for instance, watching television or just sitting and reading. The participants do activities on a regular basis in nursing homes and they are not receiving any therapeutic interventions, as above. Therefore, the investigators may consider these groups as the no-treatment groups. In addition, the participants will be assembled in one room for approximately 90 minutes and they could choose to participate in daily activities in the groups.

Eligibility criteria: Inclusion Criteria:

* Aged 50 years or older
* Deemed to be cognitively capable of participating in an in-depth interview
* Admitted to the nursing home at least 3 months ago
* Healthy physical condition (able to walk and to do daily activity without assistance)
* Consent to randomization and follow-up.

Exclusion Criteria:

* Severe cognitive impairment or dementia based on MMSE
* Blind and have severe hearing or speech impairment that might interfere with participation in the interview
* Psychotic disorders based on MINI Neuropsychiatric Interview (Sheehan et al., 1998)
* Severe physical disorder
* Severe communication problem
* Alcohol/drug misuse.

Primary outcomes:
measure: WHOQOL-BREF
timeFrame: Change from Baseline to 8 weeks, 3 and 6 months
Secondary outcomes:
measure: SWLS
timeFrame: Change from Baseline to 8 weeks, 3 and 6 months
measure: The Indo BDI-II
timeFrame: Change from Baseline to 8 weeks, 3 and 6 months
measure: GDS-15
timeFrame: Change from Baseline to 8 weeks, 3 and 6 months
measure: MMSE
timeFrame: Change from Baseline to 8 weeks, 3 and 6 months
measure: SF-36
timeFrame: Change from Baseline to 8 weeks, 3 and 6 months
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Panti wredha
Study officials:
affiliation: Behavioural Science Institute, Radboud University, The Netherlands; and Tarumanagara University, Jakarta, Indonesia
name: Roswiyani Roswiyani, M.Psi
role: PRINCIPAL_INVESTIGATOR
affiliation: Behavioural Science Institute, Radboud University, The Netherlands, and Pro Persona Mental Health Care, Depression Expertise Centre, Nijmegen, the Netherlands
name: Jan Spijker, Prof. dr.
role: STUDY_DIRECTOR
affiliation: Behavioural Science Institute, Radboud University, The Netherlands
name: Cilia Witteman, Prof. dr.
role: STUDY_DIRECTOR
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