Alzheimer Disease, Posttraumatic GrowthNCT06976294
The Effects of Cognitive Behavioral Approach-Based Psychoeducation on Caregivers of Alzheimer's Patients
A study testing Cognitive Behavioral Approach-Based Psychoeducation in people with Alzheimer Disease, Posttraumatic Growth, run by Pamukkale University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Alzheimer Disease, Posttraumatic Growth
- What is being tested?
- Cognitive Behavioral Approach-Based Psychoeducation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2025to 31 Dec 2025
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Primary caregivers who have participated in any psychoeducation group
- Caregivers who have been diagnosed with any mental health disorder
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Alzheimer Disease, Posttraumatic Growth
- Being tested
- Cognitive Behavioral Approach-Based Psychoeducation
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Approach-Based PsychoeducationOther
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
| Study group | Role | What they receive |
|---|---|---|
| Primary Caregivers of Individuals Diagnosed with Alzheimer's (Experimental group) | Experimental | Not described Receives: Other: Cognitive Behavioral Approach-Based Psychoeducation |
| Primary Caregivers of Individuals Diagnosed with Alzheimer's (Control group) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Socio-Demographic Characteristics Form
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.
Measured: two weeks
Secondary outcomes (5)
Post-Traumatic Growth Inventory
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
Measured: two weeks
Psychological Resilience Scale for Adults
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.
Measured: two weeks
Event-Related Rumination Inventory
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.
Measured: two weeks
Beck Depression Inventory
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.
Measured: two weeks
Beck Anxiety Inventory
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.
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start15 Sep 2025 (estimated)
- Primary completion20 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer Disease, Posttraumatic GrowthStudies of the same condition, open and under way.
- More trials run by Pamukkale 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Sevda Bozkurt, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976294
- Sponsor's protocol ID
- PAU-SBF-PSB-01
- Status last verified
- May 2025
- First submitted
- 9 May 2025
- Last updated
- 16 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06976294
- Acronym / sponsor ID
- PAU-SBF-PSB-01
- Conditions
- Alzheimer Disease, Posttraumatic Growth
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 20 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 May 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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Caregivers of Individuals Diagnosed with Alzheimer's (Experimental group) | Experimental | Other: Cognitive Behavioral Approach-Based Psychoeducation |
| Primary Caregivers of Individuals Diagnosed with Alzheimer's (Control group) | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- Primary caregivers who have participated in any psychoeducation group
- Caregivers who have been diagnosed with any mental health disorder
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 PsychoeducationThe '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 | Other | Primary Caregivers of Individuals Diagnosed with Alzheimer's (Experimental group) |
Primary outcome
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.
5 secondary outcomes
Post-Traumatic Growth Inventory
Time frame: two weeks
Psychological Resilience Scale for Adults
Time frame: two weeks
Event-Related Rumination Inventory
Time frame: two weeks
Beck Depression Inventory
Time frame: two weeks
Beck Anxiety Inventory
Time frame: two 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 16 May 2025.
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.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Approach-Based Psychoeducation in people with Alzheimer Disease, Posttraumatic Growth, run by Pamukkale University.
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 8 inclusion and 2 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 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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 PINAR SEVDA BOZKURT (05397071799, pinargul1694@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Socio-Demographic Characteristics Form (time frame: two weeks). 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 16 May 2025.