The Effect of Occupational Therapy on Anxiety, Depression, and Psychological Well-Being Symptoms in the ElderlyNCT05576558
The Effect of Occupational Therapy on Anxiety, Depression, and Psychological Well-Being Symptoms in the Elderly: A Single-Blind Randomized-Controlled Study
An observational study of The Effect of Occupational Therapy on Anxiety, Depression, and Psychological Well-Being Symptoms in the Elderly, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
Trial summary
Participants were assigned to intervention and control groups according to the randomization list previously prepared by the researchers. All participants were first informed about the study and their informed consent was obtained. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- The Effect of Occupational Therapy on Anxiety, Depression, and Psychological Well-Being Symptoms in the Elderly
- How many people
- 3 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 19 Sep 2022
- How long will I take part?
- 7 Weeks
- Phase
- Observational
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study was carried out between April and August 2022 with the elderly living in a private elderly care center in Istanbul/Turkey. The elderly, who agreed to participate in the study, were aged 60 and over, were cooperative, had no communication problems, and did not receive any training, course, or practice on coping with anxiety, tension, and stress were included in the sample.
Who may be able to join
- The elderly, who agreed to participate in the study,
- were aged 60 and over, were cooperative,
- had no communication problems,
- and did not receive any training, course, or practice on coping with anxiety, tension, and stress were included in the sample.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Participants were assigned to intervention and control groups according to the randomization list previously prepared by the researchers. All participants were first informed about the study and their informed consent was obtained. Participant Information Form, Geriatric Anxiety Scale, Psychological Well-Being Scale, and Geriatric Depression Scale were filled out by all participants.
The elderly in the intervention group were divided into 5 groups of 10 and a time was determined for the session in cooperation with the participants in each subgroup. A 60-minute therapy session was administered by the occupational expert. The applications were carried out in a total of 7 sessions as a daily session. The control group was not subjected to any application. Geriatric Anxiety Scale, Psychological Well-Being Scale, and Geriatric Depression Scale were refilled for the second time in all elderly on the 7th day after the application.
Read the detailed description
Participants were assigned to intervention and control groups according to the randomization list previously prepared by the researchers. All participants were first informed about the study and their informed consent was obtained. Participant Information Form, Geriatric Anxiety Scale, Psychological Well-Being Scale, and Geriatric Depression Scale were filled out by all participants.
The elderly in the intervention group were divided into 5 groups of 10 and a time was determined for the session in cooperation with the participants in each subgroup. A 60-minute therapy session was administered by the occupational expert. The applications were carried out in a total of 7 sessions as a daily session. The control group was not subjected to any application. Geriatric Anxiety Scale, Psychological Well-Being Scale, and Geriatric Depression Scale were refilled for the second time in all elderly on the 7th day after the application.
- Medical subject headings
- Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Information Form
It was created in line with the literature. It is a form containing sociodemographic data such as age, gender, educational status, etc.
Measured: From April to August 2022
Geriatric Anxiety Scale:
It is a measurement tool that consists of 28 items and provides self-anxiety reporting of the elderly. The scale was developed by Pachana et al. (Pachana et al., 2007), and adapted to the Turkish language by Karahan et al. (Karahan et al., 2018). Participants were asked to indicate how often they experienced each symptom during the week including today. The response format uses a 4-point Likert scale ranging from 0 (never) to 3 (always), with higher scores indicating higher levels of anxiety. The scale covers three different subscales common among older adults. These are somatic (physical) subscale, 1, 6, 7, 15, 19, 20, 21 (7 items), cognitive symptoms 2, 3, 10, 14, 16, 17, 22, 23 (8 items), and mood subscale, 4, 5, 8, 9, 11, 12, 13, 18 (8 items). The GAS total score is based on the first 23 items. Since items 24-28 are used by clinicians to determine the area of anxiety, they are not used in total scoring.
Measured: From April to August 2022
Psychological Well-Being Scale
The scale developed by Diener, Scollon, \& Lucas, (2009) to measure the level of psychological well-being has eight items. It identifies important elements of human function, including positive relationships, feeling of efficacy, and having a meaningful and purposeful life. The Turkish validity and reliability of the scale were made by Telef in 2013. Scale items are scored between 1 (strongly disagree) and 7 (strongly agree). All items are structured positively. Scores range from 8 (strongly disagree with all items) to 56 (strongly agree with all items). A high score on the scale indicates a high psychological strength of the individual.
Measured: From April to August 2022
Geriatric Depression Scale
It was developed by Yesavage to evaluate the depressive symptoms of elderly individuals and consists of a total of 15 questions (Yesavage \& Sheikh, 1986). It is designed in such a way that the elderly can mark it easily and can be answered as "yes" or "no". Items 1, 5, 7, 11, and 13 in the scale are structured positively, while other items are structured negatively. In the scoring of the scale, 1 point is given for each response in favor of depression and 0 points for other responses. A score of "5 and above" on the scale is considered a significant finding for the diagnosis of depression (Akturk, Sahin, Dagdeviren \& Ozer, 2002).
Measured: From April to August 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start1 Apr 2022
- Primary completion26 Aug 2022
- Study completion19 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for The Effect of Occupational Therapy on Anxiety, Depression, and Psychological Well-Being Symptoms in the ElderlyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
- Target duration
- 7 Weeks
Sponsor and investigators
- Lead sponsor
- Istanbul Aydın University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SEDA DEĞİRMENCİ ÖZ, Istanbul Aydın University
- Investigators
- SEDA DEĞİRMENCİ ÖZ, Dr., Study chair, Istanbul Aydın University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05576558
- Sponsor's protocol ID
- Istanbul AU
- Status last verified
- Oct 2022
- First submitted
- 29 Sep 2022
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Degirmenci Oz S, Sezer E, Yildirim D. The effect of occupational therapy on anxiety, depression, and psychological well-being in older adults: a single-blind randomized-controlled study. Eur Geriatr Med. 2024 Feb;15(1):217-223. doi: 10.1007/s41999-023-00900-z. Epub 2023 Dec 16.
PubMed 38103144
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Occupational Therapy on Anxiety, Depression, and Psychological Well-Being Symptoms in the Elderly: A Single-Blind Randomized-Controlled Study
- ClinicalTrials.gov ID
- NCT05576558
- Acronym / sponsor ID
- Istanbul AU
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Istanbul Aydın UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 26 Aug 2022 (actual)
- Study completion
- 19 Sep 2022 (actual)
- First posted
- 12 Oct 2022 (actual)
- 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.
Participants were assigned to intervention and control groups according to the randomization list previously prepared by the researchers. All participants were first informed about the study and their informed consent was obtained. Participant Information Form, Geriatric Anxiety Scale, Psychological Well-Being Scale, and Geriatric Depression Scale were filled out by all participants.
The elderly in the intervention group were divided into 5 groups of 10 and a time was determined for the session in cooperation with the participants in each subgroup. A 60-minute therapy session was administered by the occupational expert. The applications were carried out in a total of 7 sessions as a daily session. The control group was not subjected to any application. Geriatric Anxiety Scale, Psychological Well-Being Scale, and Geriatric Depression Scale were refilled for the second time in all elderly on the 7th day after the application.
Detailed description
Participants were assigned to intervention and control groups according to the randomization list previously prepared by the researchers. All participants were first informed about the study and their informed consent was obtained. Participant Information Form, Geriatric Anxiety Scale, Psychological Well-Being Scale, and Geriatric Depression Scale were filled out by all participants.
The elderly in the intervention group were divided into 5 groups of 10 and a time was determined for the session in cooperation with the participants in each subgroup. A 60-minute therapy session was administered by the occupational expert. The applications were carried out in a total of 7 sessions as a daily session. The control group was not subjected to any application. Geriatric Anxiety Scale, Psychological Well-Being Scale, and Geriatric Depression Scale were refilled for the second time in all elderly on the 7th day after the application.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 7 Weeks
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study was carried out between April and August 2022 with the elderly living in a private elderly care center in Istanbul/Turkey. The elderly, who agreed to participate in the study, were aged 60 and over, were cooperative, had no communication problems, and did not receive any training, course, or practice on coping with anxiety, tension, and stress were included in the sample.
Key inclusion criteria (4 listed)
- The elderly, who agreed to participate in the study,
- were aged 60 and over, were cooperative,
- had no communication problems,
- and did not receive any training, course, or practice on coping with anxiety, tension, and stress were included in the sample.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Participant Information Form
Time frame: From April to August 2022
It was created in line with the literature. It is a form containing sociodemographic data such as age, gender, educational status, etc.
Geriatric Anxiety Scale:
Time frame: From April to August 2022
It is a measurement tool that consists of 28 items and provides self-anxiety reporting of the elderly. The scale was developed by Pachana et al. (Pachana et al., 2007), and adapted to the Turkish language by Karahan et al. (Karahan et al., 2018). Participants were asked to indicate how often they experienced each symptom during the week including today. The response format uses a 4-point Likert scale ranging from 0 (never) to 3 (always), with higher scores indicating higher levels of anxiety. The scale covers three different subscales common among older adults. These are somatic (physical) subscale, 1, 6, 7, 15, 19, 20, 21 (7 items), cognitive symptoms 2, 3, 10, 14, 16, 17, 22, 23 (8 items), and mood subscale, 4, 5, 8, 9, 11, 12, 13, 18 (8 items). The GAS total score is based on the first 23 items. Since items 24-28 are used by clinicians to determine the area of anxiety, they are not used in total scoring.
Psychological Well-Being Scale
Time frame: From April to August 2022
The scale developed by Diener, Scollon, \& Lucas, (2009) to measure the level of psychological well-being has eight items. It identifies important elements of human function, including positive relationships, feeling of efficacy, and having a meaningful and purposeful life. The Turkish validity and reliability of the scale were made by Telef in 2013. Scale items are scored between 1 (strongly disagree) and 7 (strongly agree). All items are structured positively. Scores range from 8 (strongly disagree with all items) to 56 (strongly agree with all items). A high score on the scale indicates a high psychological strength of the individual.
Geriatric Depression Scale
Time frame: From April to August 2022
It was developed by Yesavage to evaluate the depressive symptoms of elderly individuals and consists of a total of 15 questions (Yesavage \& Sheikh, 1986). It is designed in such a way that the elderly can mark it easily and can be answered as "yes" or "no". Items 1, 5, 7, 11, and 13 in the scale are structured positively, while other items are structured negatively. In the scoring of the scale, 1 point is given for each response in favor of depression and 0 points for other responses. A score of "5 and above" on the scale is considered a significant finding for the diagnosis of depression (Akturk, Sahin, Dagdeviren \& Ozer, 2002).
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 12 Oct 2022.
- Derived from this study: PubMed 38103144Degirmenci Oz S, Sezer E, Yildirim D. The effect of occupational therapy on anxiety, depression, and psychological well-being in older adults: a single-blind randomized-controlled study. Eur Geriatr Med. 2024 Feb;15(1):217-223. doi: 10.1007/s41999-023-00900-z. Epub 2023 Dec 16.
- Individual participant dataSharing planned: No
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.
SEDA DEĞİRMENCİ ÖZ, Dr. study chair
Istanbul Aydın University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of The Effect of Occupational Therapy on Anxiety, Depression, and Psychological Well-Being Symptoms in the Elderly, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
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 4 inclusion and 0 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 12 Oct 2022. 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 Turkey (Türkiye). 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?
Participant Information Form (time frame: From April to August 2022). The study lists 4 primary outcomes in all. 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 NCT05576558, which also lists 1 linked publication.
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 12 Oct 2022.