NCT02957773

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
299

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 8, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 23, 2018

Status Verified

September 1, 2016

Enrollment Period

10 months

First QC Date

September 28, 2016

Last Update Submit

March 21, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • WHOQOL-BREF

    The brief version of the World Health Organization Quality of Life (WHOQOL-BREF) (The WHO Group, 1998) was developed to assess the quality of life. It contains a total of 26 questions. All items are rated on a five-point Likert scale using response categories such as 1 represents very poor, and 5 represents very well with the statement. The instrument consists of four domains: psychological health, physiological health, social relationships, and environmental health. The test - re-test reliability for WHOQOL-BREF lies within 0.81 to 0.90.

    Change from Baseline to 8 weeks, 3 and 6 months

Secondary Outcomes (5)

  • SWLS

    Change from Baseline to 8 weeks, 3 and 6 months

  • The Indo BDI-II

    Change from Baseline to 8 weeks, 3 and 6 months

  • GDS-15

    Change from Baseline to 8 weeks, 3 and 6 months

  • MMSE

    Change from Baseline to 8 weeks, 3 and 6 months

  • SF-36

    Change from Baseline to 8 weeks, 3 and 6 months

Study Arms (4)

Qigong and art activities

EXPERIMENTAL

An integrated group of Qigong and art activities for 90 minutes.

Behavioral: Qigong and art activities

Art activities

EXPERIMENTAL

Art activities and daily activities group for 90 minutes.

Behavioral: Art activities

Qigong

EXPERIMENTAL

A Qigong and daily activities group for 90 minutes

Behavioral: Qigong

Daily activities

OTHER

A daily activities group for 90-minutes.

Behavioral: Daily activities

Interventions

Participants join a 90-minute session of integrated Qigong and art activity consisting of 30 minutes Qigong followed by 60 minutes art activity.

Qigong and art activities
Art activitiesBEHAVIORAL

Participants join a 90-minute session that consists of 60-minute art activities followed by 30 minutes daily activities.

Art activities
QigongBEHAVIORAL

Participants join a 90-minute session that consists of 30-minutes Qigong exercise followed by 60 minutes daily activities (watching television, reading or sitting together).

Qigong

Participants do their daily activities routine for 90-minutes, such as watching television, reading and sitting together or participants can do free individual activities on their own.

Daily activities

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Panti wredha

Jakarta, Indonesia

Location

Related Publications (26)

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    PMID: 6399758BACKGROUND
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    PMID: 1202204BACKGROUND
  • Hays RD, Sherbourne CD, Mazel RM. The RAND 36-Item Health Survey 1.0. Health Econ. 1993 Oct;2(3):217-27. doi: 10.1002/hec.4730020305.

    PMID: 8275167BACKGROUND
  • Thyme, K. E., Sundin, E. C., Stahlberg, G., Lindstrom, B., Eklof, H., & Wiberg, B. (2007). The outcome of short-term psychodynamic art therapy compared to short-term psychodynamic verbal therapy for depressed women. Psychoanalytic Psychotherapy, 21, 250-264.

    BACKGROUND
  • Wang F, Man JK, Lee EK, Wu T, Benson H, Fricchione GL, Wang W, Yeung A. The effects of qigong on anxiety, depression, and psychological well-being: a systematic review and meta-analysis. Evid Based Complement Alternat Med. 2013;2013:152738. doi: 10.1155/2013/152738. Epub 2013 Jan 14.

    PMID: 23401706BACKGROUND
  • Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychol Med. 1998 May;28(3):551-8. doi: 10.1017/s0033291798006667.

    PMID: 9626712BACKGROUND
  • Ginting, H., Näring, G., van der Veld, W.M., Srisayekti, W., & Becker, E. S. (2013). Validating the Beck Depression Inventory-II in Indonesia's general population and coronary heart disease patients. International Journal of Clinical and Health Psychology, 13, 235-242. DOI: 10.1016/S1697-2600(13)70028-0.

    BACKGROUND
  • Sheikh, J.I., & Yesavage, J.A. (1986). Geriatric Depression Scale (GDS) recent evidence and development of a shorter version. In: Brink TL, editor. Clinical Gerontology : A Guide to Assessment and Intervention. New York: The Haworth Press, pp. 165-173.

    BACKGROUND
  • Ali, U. & Hasan, S. (2010). The effectiveness of relaxation therapy in the reduction of anxiety related symptoms (a case study). International Journal of Psychological Studies, 2, 2; 202-208. www.ccsenet.org/ijps

    BACKGROUND
  • Blomdahl, Gunnarsson, Guregård, S., & Björklund, A. (2013). A realist review of art therapy for clients with depression. The Arts in Psychotherapy, 40, 322- 330. DOI:10.1016/j.aip.2013.05.009

    BACKGROUND
  • Cloosterman, N.H.M., Laan, A. J., & Alphen, B.P.J.V. (2013). Characteristics of psychotherapeutic integration for depression in older adults: A delphi study. Clinical Gerontologist, 36:5, 395-410. DOI: 10.1080/07317115.2013.816815.

    BACKGROUND
  • Djernes JK. Prevalence and predictors of depression in populations of elderly: a review. Acta Psychiatr Scand. 2006 May;113(5):372-87. doi: 10.1111/j.1600-0447.2006.00770.x.

    PMID: 16603029BACKGROUND
  • Etemadi, A., & Ahmadi, K. (2009). Psychological disorders of elderly home residents. Journal of Applied Sciences, 9:3, 549-554. DOI: 10.3923/jas.2009.549.554

    BACKGROUND
  • Gunnarsson AB, Eklund M. The Tree Theme Method as an intervention in psychosocial occupational therapy: client acceptability and outcomes. Aust Occup Ther J. 2009 Jun;56(3):167-76. doi: 10.1111/j.1440-1630.2008.00738.x.

    PMID: 20854510BACKGROUND
  • Gunnarsson AB, Jansson JA, Eklund M. The Tree Theme Method in psychosocial occupational therapy: a case study. Scand J Occup Ther. 2006 Dec;13(4):229-40. doi: 10.1080/11038120600772908.

    PMID: 17203673BACKGROUND
  • Hass-Cohen, N.,&Carr, R. (Eds.). (2008). Art therapy and clinical neuroscience. London, England: Jessica Kingsley.

    BACKGROUND
  • Isaksson, C., Norlén, A.-K., Englund, B., & Lindqvist, R. (2009). Changes in self-imagesas seen in tree paintings. The Arts in Psychotherapy, 36, 304-312. Doi:10.1016/j.aip.2009.07.004.

    BACKGROUND
  • Jongenelis K, Pot AM, Eisses AM, Beekman AT, Kluiter H, Ribbe MW. Prevalence and risk indicators of depression in elderly nursing home patients: the AGED study. J Affect Disord. 2004 Dec;83(2-3):135-42. doi: 10.1016/j.jad.2004.06.001.

    PMID: 15555706BACKGROUND
  • Monti DA, Peterson C, Kunkel EJ, Hauck WW, Pequignot E, Rhodes L, Brainard GC. A randomized, controlled trial of mindfulness-based art therapy (MBAT) for women with cancer. Psychooncology. 2006 May;15(5):363-73. doi: 10.1002/pon.988.

    PMID: 16288447BACKGROUND
  • Neufeld, E., Freeman, S., Joling, K., & Hirdes, J.P. (2014) "When the golden years are blue": Changes in depressive symptoms over time among older adults newly admitted to long-term care facilities. Clinical Gerontologist, 37:3, 298-315. DOI:10.1080/07317115.2014.885919.

    BACKGROUND
  • Segal, Z.V.,Williams,J.M.G.,&Teasdale,J.D.(2002). Mindfulness-based cognitive therapy for depression. New York: The Guilford Press.

    BACKGROUND
  • Vinson, L.D., MA , Crowther, M.R., Austin, A.D., & Guin, S.M. (2014). African Americans, mental health, and aging. Clinical Gerontologist, 37:1, 4-17. DOI: 10.1080/07317115.2013.847515.

    BACKGROUND
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    BACKGROUND
  • Perwitasari, D. A. (2012). Development the validation of indonesian version of sf-36 questionnaire in cancer disease. Indonesian Journal of Pharmacy, 248-253.

    BACKGROUND
  • Ware, J. E. (1993). Sf-36 health survey: Manual and interpretation guide. Boston, MA: Nimrod Press.

    BACKGROUND
  • Roswiyani R, Hiew CH, Witteman CLM, Satiadarma MP, Spijker J. Art activities and qigong exercise for the well-being of older adults in nursing homes in Indonesia: a randomized controlled trial. Aging Ment Health. 2020 Oct;24(10):1569-1578. doi: 10.1080/13607863.2019.1617239. Epub 2019 May 30.

MeSH Terms

Conditions

Depression

Interventions

QigongActivities of Daily Living

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Breathing ExercisesMind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy ModalitiesRehabilitationAftercareContinuity of Patient CarePatient CareHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Roswiyani Roswiyani, M.Psi

    Behavioural Science Institute, Radboud University, The Netherlands; and Tarumanagara University, Jakarta, Indonesia

    PRINCIPAL INVESTIGATOR
  • Jan Spijker, Prof. dr.

    Behavioural Science Institute, Radboud University, The Netherlands, and Pro Persona Mental Health Care, Depression Expertise Centre, Nijmegen, the Netherlands

    STUDY DIRECTOR
  • Cilia Witteman, Prof. dr.

    Behavioural Science Institute, Radboud University, The Netherlands

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2016

First Posted

November 8, 2016

Study Start

January 1, 2017

Primary Completion

November 1, 2017

Study Completion

December 1, 2017

Last Updated

March 23, 2018

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations