NCT07139197

Brief Summary

This study aimed to investigate the effect of psychoeducation on rumination and cognitive flexibility in elderly individuals residing in nursing homes. Cognitive Behavioral Therapy (CBT)-based psychoeducation has recently been applied to multiple specific groups around the world and in our country. In general, executive functioning skills and, more specifically, cognitive flexibility appear to be important for the ability to use certain CBT techniques; however, considering that these skills naturally decline with age, further research is needed. It is anticipated that the results of this study will contribute to applications in the field of psychiatric nursing.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress87%
Sep 2025Jun 2026

First Submitted

Initial submission to the registry

August 17, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 24, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2026

Expected
Last Updated

September 4, 2025

Status Verified

August 1, 2025

Enrollment Period

14 days

First QC Date

August 17, 2025

Last Update Submit

August 27, 2025

Conditions

Keywords

elderlypsychoeducationcognitive flexibilityruminationcognitive behavioral therapy

Outcome Measures

Primary Outcomes (2)

  • Cognitive Flexibility Inventory

    The inventory was adapted into Turkish. The five-point Likert-type inventory consists of two subscales, "alternatives" and "control," and 20 items. The "alternatives" subscale consists of statements regarding the possibility of finding alternative solutions to difficult situations or alternative explanations for life circumstances and human behavior. The "control" subscale consists of statements about the controllability of difficult situations. The lowest possible score on the inventory is 20, and the highest possible score is 100. Items 2, 4, 7, 9, 11, and 17 of the scale are reverse-coded. High scores on the inventory indicate high cognitive flexibility. In the Turkish version of the inventory, the Cronbach's alfa coefficient (Cronbach's alpha) was calculated as .90 for the entire inventory, .90 for the alternatives subscale, and .84 for the control subscale.

    8 weeks

  • Self-Critical Rumination Scale

    The scale was adapted into Turkish. The scale is a unidimensional scale with a 4-point Likert scale (1 = Never, 2 = Somewhat, 3 = Mostly, 4 = Completely). The scale's fit indices were found to be chi-square/degrees of freedom (x²/df) = 3, Root Mean Square Error of Approximation (RMSEA) = .08, Tucker-Lewis Index (TLI) = .93, Comparative Fit Index (CFI) = .94, and Standardized Root Mean Square Residual (SRMR) = .04. In criterion-related validity, the correlation between the Ruminative Responses Scale short form (RRS) and the RRS was found to be r = .73, with the obsessive thinking subscale r = .73 and the deep thinking subscale r = .68. The internal consistency coefficient of the scale was Cronbach's alfa coefficient (Cronbach's alpha) = .89, and the test-retest reliability coefficient, measured five weeks apart, was .83.

    8 weeks

Secondary Outcomes (1)

  • Standardized Mini Mental Test (SMMT)

    1 weeks

Study Arms (2)

Intervention Group: Cognitive Behavioral Therapy (CBT)-Based Psychoeducation Program

EXPERIMENTAL

Participants in this group will receive a cognitive-behavioral psychoeducation program aimed at improving cognitive flexibility and reducing rumination. Pre-test assessments will be conducted before group allocation.

Behavioral: Cognitive Behavioral Approach-Based Psychoeducation Program

Control Group: Usual Care (Standard Nursing Home Care)

NO INTERVENTION

Participants in this group will not be subject to any intervention during the study period. Pre-test assessments will be conducted by an independent evaluator simultaneously with the intervention group. Upon completion of the study, control group participants will be offered the opportunity to participate in the psycho-education program if they wish.

Interventions

Intervention Group: Cognitive Behavioral Approach-Based Psychoeducation Program Participants will receive a cognitive-behavioral psychoeducation program designed to improve cognitive flexibility and reduce rumination. The sessions include structured activities, discussions, and exercises based on cognitive-behavioral principles. Pre-test assessments will be conducted before group allocation. Control Group: No intervention will be provided during the study period. Participants will complete pre-test assessments administered by an independent evaluator. After the study concludes, control group participants will be offered the opportunity to participate in the psychoeducation program if they wish.

Intervention Group: Cognitive Behavioral Therapy (CBT)-Based Psychoeducation Program

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Be 65 years of age or older,
  • Be willing to participate in the study,
  • Not have hearing or vision problems that would prevent understanding the training to be provided,
  • Have communication and comprehension skills,
  • Be literate,
  • Have a Standardized Mini Mental Test score between 25 and 30 points.

You may not qualify if:

  • Having any hearing or vision problems.
  • Having physical, neurological, or psychological health problems that could disrupt group harmony and integrity.
  • Having an illness or problem that could prevent them from responding to the measurement tools used in the study.
  • Having a Standardized Mini Mental Test score below 25.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kars Huzurevi Yaşlı Bakım ve Rehabilitasyon Merkezi / Kars Huzur Evi Elderly Care and Rehabilitation Center

Kars, Center, 36100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Rumination Syndrome

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesFeeding and Eating DisordersMental Disorders

Central Study Contacts

Leyla ALTUN, Research Assistant/PhD student

CONTACT

Özlem Şahin ALTUN, Associate Professor, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
During the pre-test phase, both the participants and the independent evaluators will be unaware of the group distribution. The allocation of group assignments will be determined subsequent to the completion of baseline assessments. Following randomisation, participants will be informed of the group distribution due to the nature of the psychoeducational intervention; however, the baseline assessment results will be conducted blindly.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study is planned to be conducted using a randomized controlled, pre-test-post-test, control group, and 1-month follow-up test experimental study design.To prevent contamination between groups, data collection for the intervention and control groups will be conducted at different times, except for the pre-test stage, which will be administered simultaneously by an independent assessor. The control group will not be subject to any intervention during the study period, but will be offered the psychoeducation programme after the study is completed if they wish.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

August 17, 2025

First Posted

August 24, 2025

Study Start

September 1, 2025

Primary Completion

September 15, 2025

Study Completion (Estimated)

June 15, 2026

Last Updated

September 4, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations