The Effects of Cognitive Behavioral Approach-Based Psychoeducation on Caregivers of Alzheimer's Patients

May 15, 2025 updated by: Pınar Sevda Bozkurt, Pamukkale University

The Effect of Cognitive Behavioral Approach-Based Psychoeducation on Post-Traumatic Growth, Psychological Resilience, and Ruminative Thoughts in Primary Caregivers of Individuals Diagnosed With Alzheimer's Disease

Alzheimer's disease is a progressive and chronic neurocognitive disorder. Individuals who assume the role of primary caregivers and are responsible for meeting the care needs of the patient often develop serious health problems over time. It is particularly important to assess the psychological resilience of those who struggle to manage the caregiving process, to identify ruminative thoughts developed in response to negative experiences, and ultimately to determine the presence of post-traumatic growth. Cognitive Behavioral Therapy (CBT)-based psychoeducational interventions are highly effective in the holistic assessment and support of primary caregivers.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Alzheimer's disease is a progressive and chronic neurocognitive disorder characterized by the deterioration of higher-level cortical functions, leading to cognitive decline, neuropsychiatric behavioral changes, and a reduced ability to perform daily activities. As the disease progresses, patients gradually lose functional abilities, resulting in an increased demand for care. Primary caregivers, who are directly responsible for meeting these care needs, often face significant emotional, physical, social, and financial burdens. Providing long-term care to elderly individuals is a major source of chronic stress and can exceed caregivers' coping capacities. In this context, psychological resilience serves as a critical protective factor. Interventions that enhance the resilience of caregivers supporting individuals with chronic mental illness are essential for caregiver empowerment. Caregivers with low resilience are more prone to maladaptive coping mechanisms, such as ruminative thinking. Rumination can intensify psychological distress when negative thoughts interact with depressive mood states during the processing of traumatic experiences. However, not all traumatic experiences lead to negative outcomes; in some cases, individuals may grow stronger and experience positive psychological changes, known as post-traumatic growth (PTG). PTG refers to the positive transformation that can emerge from the struggle with highly challenging life circumstances. The psychological toll of caregiving highlights the importance of supportive psychological interventions. Psychoeducational programs based on Cognitive Behavioral Therapy (CBT) offer a comprehensive approach by addressing the needs of caregivers while also considering both the patients and the broader family systems. This study aims to examine the effects of CBT-based psychoeducation on post-traumatic growth, psychological resilience, and ruminative thinking among primary caregivers of individuals diagnosed with Alzheimer's disease.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: GÜLAY TAŞDEMİR, Associate Professor Doctor
  • Phone Number: 05386418674
  • Email: gyigitoglu@pau.edu.tr

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged 18 years or older
  • Willing to participate in the study
  • A member of the Denizli Alzheimer Association
  • At least a primary school graduate
  • Able to communicate effectively
  • Providing primary care to an individual diagnosed with Alzheimer's for at least one year
  • Providing primary care to a patient diagnosed with moderate to advanced stage Alzheimer's
  • Serving as a primary caregiver for at least six months

Exclusion Criteria:

  • Primary caregivers who have participated in any psychoeducation group
  • Caregivers who have been diagnosed with any mental health disorder

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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Primary Caregivers of Individuals Diagnosed with Alzheimer's (Experimental group)
Other: Cognitive Behavioral Approach-Based Psychoeducation
The 'Socio-Demographic Characteristics Form', the 'Post-Traumatic Growth Inventory', the 'Psychological Resilience Scale for Adults', and the 'Event-Related Rumination Inventory' will be administered to individuals in both the intervention and control groups. No intervention will be applied to the control group. For the intervention group, psychoeducation groups based on the cognitive behavioral approach will be formed for the primary caregivers. Eight face-to-face sessions, each lasting 60 to 90 minutes, will be conducted
No Intervention: Primary Caregivers of Individuals Diagnosed with Alzheimer's (Control group)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Socio-Demographic Characteristics Form
Time Frame: two weeks
It consists of questions covering descriptive characteristics of the primary caregivers of Alzheimer's patients, such as age, gender, education level, degree of relationship with the patient, and the duration of caregiving.
two weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Post-Traumatic Growth Inventory
Time Frame: two weeks
The inventory consists of 21 items and five factors. It is a self-report scale in a five-point Likert format, scored between '0 (I did not experience this change)' and '5 (I experienced this change to a very great degree)'. The total score that can be obtained from the inventory ranges from 0 to 105. Higher scores indicate greater post-traumatic growth
two weeks
Psychological Resilience Scale for Adults
Time Frame: two weeks
The scale consists of a total of 33 items. Each item presents two opposing statements regarding a specific situation, and respondents are asked to mark the option that best reflects their level of agreement or appropriateness.
two weeks
Event-Related Rumination Inventory
Time Frame: two weeks
The inventory consists of 20 items and is divided into two sections of 10 items each, assessing two types of rumination: 'intrusive' and 'deliberate'. It is structured as a 4-point Likert scale, where a score of 0 indicates 'never' and a score of 3 indicates 'often.
two weeks
Beck Depression Inventory
Time Frame: two weeks
It is a 21-item assessment scale that measures depressive symptoms and characteristic attitudes. It uses a 4-point Likert-type format, with each item scored between 0 and 3. The total score ranges from 0 to 63.
two weeks
Beck Anxiety Inventory
Time Frame: two weeks
It is a 21-item assessment scale. Each item includes four options scored from 0 to 3. The total score from the 21 items ranges from 0 to 63, with higher scores indicating increased anxiety symptoms.
two weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pamukkale 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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 9, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 16, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PAU-SBF-PSB-01

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.

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