The Effect of Occupational Therapy on Anxiety, Depression, and Psychological Well-Being Symptoms in the Elderly: A Single-Blind Randomized-Controlled Study

October 11, 2022 updated by: SEDA DEĞİRMENCİ ÖZ, Istanbul Aydın University

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 Overview

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 Type

Observational

Enrollment (Actual)

3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Istanbul, Turkey
        • Seda Değirmenci Öz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From April to August 2022
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.
From April to August 2022
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.
From April to August 2022
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).
From April to August 2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: SEDA DEĞİRMENCİ ÖZ, Dr., İstanbul Aydın University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Actual)

August 26, 2022

Study Completion (Actual)

September 19, 2022

Study Registration Dates

First Submitted

September 29, 2022

First Submitted That Met QC Criteria

October 11, 2022

First Posted (Actual)

October 12, 2022

Study Record Updates

Last Update Posted (Actual)

October 12, 2022

Last Update Submitted That Met QC Criteria

October 11, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • Istanbul AU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on The Effect of Occupational Therapy on Anxiety, Depression, and Psychological Well-Being Symptoms in the Elderly

3
Subscribe