- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07274592
The Effect of Psychoeducation Program Applied to Older Adults Based on Psychosocial Development Theory on Self-critical Rumination, Self-esteem and Psychological Well-being
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This research is designed as a randomized controlled trial. The reporting of the research will be structured according to the CONSORT checklist. The Psychoeducational Program, grounded in Erikson's Psychosocial Theory, is designed to help older adults cope with self-critical ruminative thoughts and improve their psychological well-being and self-esteem. Based on Erikson's eight stages of development, this program aims to help older individuals review their life journeys and understand how they experienced crises at each stage. Throughout the program, participants are encouraged to reframe their past experiences in a positive way, increase their current well-being, and strengthen their self-esteem. Older adults may face more of their past experiences and uncertainties about the future in the later stages of their lives. During this process, repetitive thoughts, i.e., negative or worrisome thoughts that constantly occupy the mind, can negatively affect individuals' mental health. Psychoeducation programs are an important tool for developing coping skills for such thoughts and improving individuals' quality of life.
The research is planned to be conducted at Dr. İsmail Işık Retirement and Rehabilitation Center in Konya province. The sample size calculation for the study was carried out using the G*Power 3.1.9.7 program. It was calculated that a total of 48 adults, would be sufficient, with an effect size of 0.96, 95% test power, and a margin of error of 0.05. Considering the possibility of data loss in the study, the sample size was increased by 10% to include 52 older adults. The Standardized Mini Mental Test will be administered to the elderly to determine the inclusion criteria. Individuals over the age of 65, who are literate, have a Standardized Mini Mental Test score of 25 or higher, have no cognitive or perceptual problems, and volunteer to participate in the study will be included. This study also planned to use the Sociodemographic Information Form, the Self-Critical Rumination Scale, the Psychological Well-Being Scale for the Elderly, and the Rosenberg Self-Esteem Scale. The psychoeducation program consists of eight sessions. Each session will be held face-to-face once a week for the intervention group. The sessions will be conducted by a researcher (graduate student) once a week (on a day deemed appropriate and recommended by the nursing home) in three groups. Eight 45-minute sessions are planned. During their graduate studies, the researcher has acquired theoretical knowledge about psychoeducation as well as practical knowledge about its application based on the literature.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Konya, Turkey (Türkiye)
- Dr. İsmail Işık Retirement and Rehabilitation Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being 65 years of age or older,
- Being literate,
- Scoring 25 or above on the Standardized Mini Mental Test,
- Having no hearing or vision problems,
- Volunteering to participate in the study
Exclusion Criteria:
- Not attending more than two psychoeducation sessions,
- Not wishing to continue the study,
- Being unable to attend due to any physical or mental health condition.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
A standardized mini mental test will be administered at the beginning of the study to determine the inclusion criteria.
Sociodemographic Information Form, Self-Critical Rumination Scale, Psychological Well-Being Scale for Older Adults, and Rosenberg Self-Esteem Scale will be applied to the control group.
No intervention will be made.
Measurement tools will be applied for the posttest.
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|
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Experimental: Psychoeducation Program
A standardized mini mental test will be administered at the beginning of the study to determine the inclusion criteria.
Sociodemographic Information Form, Self-Critical Rumination Scale, Psychological Well-Being Scale for Older Adults, and Rosenberg Self-Esteem Scale will be applied to pretest.
The psychoeducation will be conducted once a week (on a day deemed appropriate and recommended by the nursing home) by a researcher (graduate student) with three groups.
Eight sessions, each lasting 45 minutes, are planned.
At the end of the sessions, post-tests of the measurement tools will be performed.
|
The Psychoeducation Program, grounded in Erikson's Psychosocial Theory, is designed to help older adults cope with self-critical ruminative thoughts and improve their psychological well-being and self-esteem.
Based on Erikson's eight stages of development, this program aims to help older individuals review their life journeys and understand how they experienced crises at each stage.
Throughout the program, participants are encouraged to reframe their past experiences in a positive way, increase their current well-being, and strengthen their self-esteem.
Older adults may face more challenges with past experiences and uncertainties about the future as they progress through life.
During this process, repetitive thoughts, i.e., negative or worrisome thoughts that constantly occupy the mind, can negatively affect individuals' mental health.
Psychoeducation programs are an important tool for developing coping skills for such thoughts and improving individuals' quality of life.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The effect of the psychoeducation program on self-critical rumination, psychological well-being, and self-esteem
Time Frame: At the beginning of the study and at the end of the 8th week
|
Self-Critical Rumination Scale: The Self-Critical Rumination Scale was created to determine individuals' self-critical rumination. Developed by Smart et al. (2016), the scale was adapted to Turkish by Kocalar (2019). It is a four-point Likert-type measurement tool. The scale has a 10-item, single-factor structure. There is no reverse scoring for the scale items. (Kocalar, 2019). Psychological Well-Being Scale in the Elderly: Developed by Gümüş Demir (2023) to measure the levels of psychological well-being in elderly individuals, the scale consists of 15 items. It is a five-point Likert-type scale. Questions 8 and 13 are reverse-coded, and the minimum score is 15 and the maximum score is 75. As the psychological well-being score increases, so does the level of well-being. Rosenberg Self-Esteem Scale: The scale, developed by Rosenberg (1963), was adapted into Turkish by Çuhadaroğlu (1986). The 10-item scale is rated as "very true," "true," "false," and "very false." |
At the beginning of the study and at the end of the 8th week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Effect of Psychoeducation Program Applied to Older Adults Based on Psychosocial Development Theory on Self-critical Rumination, Self-esteem and Psychological Well-being
Time Frame: At the beginning of the study
|
Sociodemographic Information Form: This form was created by the researcher by reviewing the literature (Akgöz, 2024; Önder, 2021).
There are a total of 9 questions, including age, gender, marital status, number of children, educational status, how long the patient has been staying in a nursing home, how many rooms the patient has stayed in, the reason for staying in the nursing home (own request or family request), etc.
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At the beginning of the study
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Adeviye AYDIN, Necmettin Erbakan University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 26003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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