Well-beingNCT02957773
Integration of Social Art Activities and Qigong for Older People in Nursing Home in Indonesia
A study testing Qigong and art activities, Art activities and Qigong in people with Well-being and Depressive Symptoms, run by Radboud University Medical Center at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Well-being, Depressive Symptoms
- What is being tested?
- Qigong and art activities, Art activities and Qigong
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 299 participants
- Where
- 1 siteIndonesia
- Study dates
- Jan 2017to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integration of Social Art Activities and Qigong Exercises to Increase the Well-Being of Older People in Nursing Homes in Indonesia
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.
Read the 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.
- Conditions
- Well-being, Depressive Symptoms
- Being tested
- Qigong and art activities, Art activities, Qigong, Daily activities
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qigong and art activitiesBehavioural
Participants join a 90-minute session of integrated Qigong and art activity consisting of 30 minutes Qigong followed by 60 minutes art activity.
Art activitiesBehavioural
Participants join a 90-minute session that consists of 60-minute art activities followed by 30 minutes daily activities.
QigongBehavioural
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).
Daily activitiesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Qigong and art activities | Experimental | An integrated group of Qigong and art activities for 90 minutes. Receives: Behavioral: Qigong and art activities |
| Art activities | Experimental | Art activities and daily activities group for 90 minutes. Receives: Behavioral: Art activities |
| Qigong | Experimental | A Qigong and daily activities group for 90 minutes Receives: Behavioral: Qigong |
| Daily activities | Other | A daily activities group for 90-minutes. Receives: Behavioral: Daily activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline to 8 weeks, 3 and 6 months
Secondary outcomes (5)
SWLS
The satisfaction with life scale (SWLS) (Diener, 1984) was developed to assess satisfaction with the respondent's life as a whole. It consists of five statements that the client could either agree or disagree with on a scale of 1 - 7, where 1 represents strongly disagree, and 7 represents strongly agree with the statement. Diener (1985) reported a Cronbach's alpha of 0.87 for the scale and a test - retest stability coefficient of 0.82.
Measured: Change from Baseline to 8 weeks, 3 and 6 months
The Indo BDI-II
Beck Depression Inventory-II for Indonesian general population (Beck, Steer, \& Brown, 1996; Ginting, Näring, van der Veld, Srisayekti \& Becker, 2013), contains 21-item self-report inventory measuring the severity of depression in adolescents and adults. All items are rated on a 4-point Likert-type scale ranging from 0 to 3, based on the severity of each item. Cronbach's alpha of the Indo BDI-II per group was .90 for healthy participants, and .91 for depressed patients. The test-retest correlation of the Indo BDI-II was significant (r = .55, p < .01).
Measured: Change from Baseline to 8 weeks, 3 and 6 months
GDS-15
Geriatric Depression Scale 15-item (GDS 15-item) adapted from the Sheikh and Yesavage (1986). The GDS was designed as a screening tool for depression in elderly populations. It consists of 15 questions with YES or NO answer; where YES was treated as 0 and NO-treated as 1. A score > 5 point is suggestive of depression. The Cronbach's α coefficient was 0,71.
Measured: Change from Baseline to 8 weeks, 3 and 6 months
MMSE
Mini-Mental State Exam (MMSE; Folstein, Folstein, \& McHugh, 1975) used as a brief indicator of cognitive status. It is an 11-question measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. The maximum score is 30. A score of 23 or lower is indicative of cognitive impairment.
Measured: Change from Baseline to 8 weeks, 3 and 6 months
SF-36
A 36-item short-form (SF-36; Ware Jr, 1993; Perwitasari, 2012) is a widely used questionnaire for measuring self-reported physical and mental health status. It is a short-form health survey with only 36 questions. Estimates of reliability in the physical and mental sections are typically above 0.90.
Measured: Change from Baseline to 8 weeks, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startJan 2017
- Primary completionNov 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Well-beingStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Universitas Tarumanagara
- Responsible party
- Sponsor
- Investigators
- Roswiyani Roswiyani, M.Psi, Principal investigator, Behavioural Science Institute, Radboud University, The Netherlands; and Tarumanagara University, Jakarta, IndonesiaJan Spijker, Prof. dr., Study director, Behavioural Science Institute, Radboud University, The Netherlands, and Pro Persona Mental Health Care, Depression Expertise Centre, Nijmegen, the NetherlandsCilia Witteman, Prof. dr., Study director, Behavioural Science Institute, Radboud University, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02957773
- Sponsor's protocol ID
- SAAQE-R053
- Status last verified
- Sep 2016
- First submitted
- 28 Sep 2016
- Last updated
- 23 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Diener E. Subjective well-being. Psychol Bull. 1984 May;95(3):542-75. No abstract available.
PubMed 6399758Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
PubMed 1202204Hays 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.
PubMed 8275167Thyme, 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.
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.
PubMed 23401706Development 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.
PubMed 9626712Ginting, 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.
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.
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
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
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.
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.
PubMed 16603029Etemadi, 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
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.
PubMed 20854510Gunnarsson 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.
PubMed 17203673
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of Social Art Activities and Qigong Exercises to Increase the Well-Being of Older People in Nursing Homes in Indonesia
- ClinicalTrials.gov ID
- NCT02957773
- Acronym / sponsor ID
- SAAQE-R053
- Conditions
- Well-being, Depressive Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Universitas Tarumanagara
- Study start
- Jan 2017
- Primary completion
- Nov 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 8 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Qigong and art activities | Experimental | Behavioral: Qigong and art activitiesAn integrated group of Qigong and art activities for 90 minutes. |
| Art activities | Experimental | Behavioral: Art activitiesArt activities and daily activities group for 90 minutes. |
| Qigong | Experimental | Behavioral: QigongA Qigong and daily activities group for 90 minutes |
| Daily activities | Other | Behavioral: Daily activitiesA daily activities group for 90-minutes. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qigong and art activitiesParticipants join a 90-minute session of integrated Qigong and art activity consisting of 30 minutes Qigong followed by 60 minutes art activity. | Behavioural | Qigong and art activities |
| Art activitiesParticipants join a 90-minute session that consists of 60-minute art activities followed by 30 minutes daily activities. | Behavioural | Art activities |
| QigongParticipants join a 90-minute session that consists of 30-minutes Qigong exercise followed by 60 minutes daily activities (watching television, reading or sitting together). | Behavioural | Qigong |
| Daily activitiesParticipants 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. | Behavioural | Daily activities |
Primary outcome
WHOQOL-BREF
Time frame: Change from Baseline to 8 weeks, 3 and 6 months
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.
5 secondary outcomes
SWLS
Time frame: Change from Baseline to 8 weeks, 3 and 6 months
The Indo BDI-II
Time frame: Change from Baseline to 8 weeks, 3 and 6 months
GDS-15
Time frame: Change from Baseline to 8 weeks, 3 and 6 months
MMSE
Time frame: Change from Baseline to 8 weeks, 3 and 6 months
SF-36
Time frame: Change from Baseline to 8 weeks, 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2018.
- Background: PubMed 6399758Diener E. Subjective well-being. Psychol Bull. 1984 May;95(3):542-75. No abstract available.
- Background: PubMed 1202204Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
- Background: PubMed 8275167Hays 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.
- BackgroundThyme, 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: PubMed 23401706Wang 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.
- Background: PubMed 9626712Development 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.
- BackgroundGinting, 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.
- BackgroundSheikh, 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.
- BackgroundAli, 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
- BackgroundBlomdahl, 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
- BackgroundCloosterman, 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: PubMed 16603029Djernes 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roswiyani Roswiyani, M.Psi principal investigator
Behavioural Science Institute, Radboud University, The Netherlands; and Tarumanagara University, Jakarta, Indonesia
Jan Spijker, Prof. dr. study director
Behavioural Science Institute, Radboud University, The Netherlands, and Pro Persona Mental Health Care, Depression Expertise Centre, Nijmegen, the Netherlands
Cilia Witteman, Prof. dr. study director
Behavioural Science Institute, Radboud University, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qigong and art activities, Art activities and Qigong in people with Well-being and Depressive Symptoms, run by Radboud University Medical Center at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WHOQOL-BREF (time frame: Change from Baseline to 8 weeks, 3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02957773, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2018.