Cognitive FlexibilityNCT07139197
The Effect of Cognitive Behavioral Therapy (CBT)-Based Psychoeducation on Cognitive Flexibility and Rumination in the Elderly
A study testing Cognitive Behavioral Approach-Based Psychoeducation Program in people with Cognitive Flexibility and Rumination, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cognitive Flexibility, Rumination, Elderly (People Aged 65 or More)
- What is being tested?
- Cognitive Behavioral Approach-Based Psychoeducation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 15 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kars Huzurevi Yaşlı Bakım ve Rehabilitasyon Merkezi / Kars Huzur Evi Elderly Care and Rehabilitation Center
Kars, Center, 36100
Leyla Altun, Research Assistant/PhD student, +90 545 650 57 82, leyla.altun.3695@gmail.com
Özlem ŞAHİN ALTUN, Assistant Professor, Ph.D., +90 530 289 52 92, ozlemsahinaltun@gmail.com
About this study
Official title: The Effect of a Cognitive Behavioral Approach-Based Psychoeducation Program on Cognitive Flexibility and Rumination in Elderly Individuals Living in Nursing Homes
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.
Read the detailed description
Aging causes neuroanatomical and physiological changes that affect cognitive processes such as memory, attention, and executive functions. Positive developments in healthcare worldwide, along with increasing socioeconomic levels and declining birth rates, have led to an increase in the elderly population. Our country, like many other countries around the world, is one of the rapidly aging countries. With the increase in the elderly population, the needs specific to the elderly are increasing, and it is inevitable to encounter a series of problems.
As age increases, the cognitive abilities of older adults decline. Research shows that working memory and long-term memory abilities decline, as do reasoning ability, processing speed, executive function, and attention control. As a result, individuals' quality of life, independence, and daily activities such as planning medication and grocery shopping may be negatively affected.
Cognitive flexibility plays a fundamental role in the ability to adapt to constantly changing environments and is associated with various goal-directed behaviors, including creativity, problem solving, multitasking, and decision making. Cognitive flexibility and the underlying processes (executive functions) have also been linked to self- and emotional regulation, as well as mental health outcomes. Cognitive flexibility refers to the ability to change one's cognitive organization, thinking, or attention in order to perceive, process, or respond to situations in different ways. The skills required for cognitive restructuring closely align with those related to cognitive flexibility. Cognitive flexibility encompasses the ability to generate diverse ideas, evaluate response alternatives, and modify behavior and cognition in response to changing environmental demands. These processes appear to be important for the successful implementation of cognitive restructuring, which requires the individual to identify negative automatic thoughts, generate evidence that contradicts these thoughts, and then produce a more adaptive or helpful way of interpreting the situation.
Rumination is associated with inflexible cognitive and emotional processes. Various characteristics of rumination-related thinking, including its negative value content, abstract level of interpretation, and passive approach to problem-solving, may also contribute to its maladaptive outcomes.
In order to successfully carry out daily activities, it is necessary to be able to flexibly switch from one behavior to another. This skill is referred to as cognitive flexibility. Individuals who ruminate experience cognitive rigidity by getting stuck on a certain thought and find it difficult to change the behaviors they focus on. At the same time, cognitive rigidity is also thought to be the underlying cause of repetitive thinking patterns in rumination. It is well known that mental rumination, a negative and evaluative mode of repetitive thinking, is the main psychological process that accelerates and sustains depressive mood. In this context, rumination may be a variable that predicts cognitive flexibility. In particular, perseverative thinking styles have been found to negatively affect the ability to learn cognitive restructuring. Further research is needed to clarify whether older adults with weak cognitive flexibility can develop their cognitive restructuring skills through repetition rather than treatment, or whether alternative skills should be considered.
To date, there has been little research examining whether declines in cognitive abilities have an impact on overall treatment outcomes or the acquisition of specific therapeutic skills. Given the aging of the world's population, it is important to focus more research on understanding the impact of age-related cognitive changes in older adults on the treatment of mental health problems. This study will focus on cognitive flexibility and rumination, which are processes responsible for producing changes in behavior and thought in dynamic contexts and are subject to fluctuations and rapid changes.
- Being tested
- Cognitive Behavioral Approach-Based Psychoeducation Program
- Keywords
- elderly, psychoeducation, cognitive flexibility, rumination, cognitive behavioral therapy
- Medical subject headings
- Rumination Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Approach-Based Psychoeducation ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 8 weeks
Secondary outcomes (1)
Standardized Mini Mental Test (SMMT)
A standardized version of the test was created, taking into account sociocultural differences in our country. This test consists of five subcategories-orientation, memory, attention and calculation, recall, and language-and 11 items. It is scored out of a total of 30 points, with each correct answer earning one point. The lowest possible score is 0, and the highest possible score is 30. A score between 0 and 12 indicates severe cognitive impairment, a score between 13 and 22 indicates moderate cognitive impairment, a score between 23 and 24 indicates early-stage cognitive impairment, and a score between 25 and 30 indicates no cognitive impairment.
Measured: 1 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion15 Sep 2025 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive FlexibilityStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe 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
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leyla ALTUN, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07139197
- Sponsor's protocol ID
- AU-SBF-LA-01
- Status last verified
- Aug 2025
- First submitted
- 17 Aug 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Cognitive Behavioral Approach-Based Psychoeducation Program on Cognitive Flexibility and Rumination in Elderly Individuals Living in Nursing Homes
- ClinicalTrials.gov ID
- NCT07139197
- Acronym / sponsor ID
- AU-SBF-LA-01
- Keywords
- elderly, psychoeducation, cognitive flexibility, rumination, cognitive behavioral therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 24 Aug 2025 (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.
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.
Detailed description
Aging causes neuroanatomical and physiological changes that affect cognitive processes such as memory, attention, and executive functions. Positive developments in healthcare worldwide, along with increasing socioeconomic levels and declining birth rates, have led to an increase in the elderly population. Our country, like many other countries around the world, is one of the rapidly aging countries. With the increase in the elderly population, the needs specific to the elderly are increasing, and it is inevitable to encounter a series of problems.
As age increases, the cognitive abilities of older adults decline. Research shows that working memory and long-term memory abilities decline, as do reasoning ability, processing speed, executive function, and attention control. As a result, individuals' quality of life, independence, and daily activities such as planning medication and grocery shopping may be negatively affected.
Cognitive flexibility plays a fundamental role in the ability to adapt to constantly changing environments and is associated with various goal-directed behaviors, including creativity, problem solving, multitasking, and decision making. Cognitive flexibility and the underlying processes (executive functions) have also been linked to self- and emotional regulation, as well as mental health outcomes. Cognitive flexibility refers to the ability to change one's cognitive organization, thinking, or attention in order to perceive, process, or respond to situations in different ways. The skills required for cognitive restructuring closely align with those related to cognitive flexibility. Cognitive flexibility encompasses the ability to generate diverse ideas, evaluate response alternatives, and modify behavior and cognition in response to changing environmental demands. These processes appear to be important for the successful implementation of cognitive restructuring, which requires the individual to identify negative automatic thoughts, generate evidence that contradicts these thoughts, and then produce a more adaptive or helpful way of interpreting the situation.
Rumination is associated with inflexible cognitive and emotional processes. Various characteristics of rumination-related thinking, including its negative value content, abstract level of interpretation, and passive approach to problem-solving, may also contribute to its maladaptive outcomes.
In order to successfully carry out daily activities, it is necessary to be able to flexibly switch from one behavior to another. This skill is referred to as cognitive flexibility. Individuals who ruminate experience cognitive rigidity by getting stuck on a certain thought and find it difficult to change the behaviors they focus on. At the same time, cognitive rigidity is also thought to be the underlying cause of repetitive thinking patterns in rumination. It is well known that mental rumination, a negative and evaluative mode of repetitive thinking, is the main psychological process that accelerates and sustains depressive mood. In this context, rumination may be a variable that predicts cognitive flexibility. In particular, perseverative thinking styles have been found to negatively affect the ability to learn cognitive restructuring. Further research is needed to clarify whether older adults with weak cognitive flexibility can develop their cognitive restructuring skills through repetition rather than treatment, or whether alternative skills should be considered.
To date, there has been little research examining whether declines in cognitive abilities have an impact on overall treatment outcomes or the acquisition of specific therapeutic skills. Given the aging of the world's population, it is important to focus more research on understanding the impact of age-related cognitive changes in older adults on the treatment of mental health problems. This study will focus on cognitive flexibility and rumination, which are processes responsible for producing changes in behavior and thought in dynamic contexts and are subject to fluctuations and rapid changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group: Cognitive Behavioral Therapy (CBT)-Based Psychoeducation Program | Experimental | Behavioral: Cognitive Behavioral Approach-Based Psychoeducation ProgramParticipants 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. |
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Cognitive Behavioral Approach-Based Psychoeducation ProgramIntervention 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. | Behavioural | Intervention Group: Cognitive Behavioral Therapy (CBT)-Based Psychoeducation Program |
Primary outcome
Cognitive Flexibility Inventory
Time frame: 8 weeks
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.
Self-Critical Rumination Scale
Time frame: 8 weeks
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.
1 secondary outcome
Standardized Mini Mental Test (SMMT)
Time frame: 1 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Approach-Based Psychoeducation Program in people with Cognitive Flexibility and Rumination, run by Ataturk 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 6 inclusion and 4 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: opening soon, as of the sponsor's last update on 4 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leyla ALTUN, Research Assistant/PhD student (+90 545 650 57 82, leyla.altun21@ogr.atauni.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Flexibility Inventory (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2025.