Alzheimer DiseasePsychoCPNCT06755476
Psychological Counseling Program for Alzheimer's Patients' Caregivers
A study testing Psychological Counseling Program in people with Alzheimer Disease and Caregivers of Alzheimer's Disease or Memory Problem Patients, run by Aydan Akkurt Yalçıntürk.
Trial summary
Purpose: To investigate the effects of a psychological counseling program (PsychoCP) applied to caregivers of Alzheimer's patients on perceived stress, psychological well-being and care burden. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimer Disease, Caregivers of Alzheimer's Disease or Memory Problem Patients, Perceived Stress
- What is being tested?
- Psychological Counseling Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2025to 15 Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Providing informal care to an individual with mild or moderate Alzheimer's disease
- Being a primary caregiver
- Providing care to the patient for at least six months
- Providing care to the patient for at least six hours per day
- Being literate
- Being able to speak and understand Turkish
- Being 18 years of age or older
- Being willing and able to participate in the study
Who cannot join
- Not being able to understand questions and express ideas
- Having a psychiatric disorder
- Not receiving any therapy services during the study
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 Psychological Counseling Program (PsychoCP) for Alzheimer's Patients' Caregivers on Perceived Stress, Psychological Well-Being and Caregiver Burden
Purpose: To investigate the effects of a psychological counseling program (PsychoCP) applied to caregivers of Alzheimer's patients on perceived stress, psychological well-being and care burden.
Design: The study will be conducted in a pre-test post-test control group, randomized controlled experimental research design.
Read more
Method: The study is planned to be carried out in Bağcılar Municipality Vefahâne Life Center, Antalya Alzheimer Patients and Patient Relatives Meeting Center and Osmaniye Family and Social Policies Directorate. The sample of the study will consist of 80 caregivers. They will be assigned to intervention (n=40) and control groups (n=40) by randomization.
Hypotheses Hypothesis1: The perceived stress level of caregivers who received PsychoDP is lower than those who did not receive PsychoCP.
Hypothesis2: The psychological well-being levels of caregivers who received PsychoDP are higher than those who did not receive PsychoCP.
Hypothesis3: The care burden of caregivers who received PsychoDP is lower than those who did not receive PsychoCP.
- Conditions
- Alzheimer Disease, Caregivers of Alzheimer's Disease or Memory Problem Patients, Perceived Stress, Well-Being (Psychological Flourishing), Care Burden
- Being tested
- Psychological Counseling Program
- Medical subject headings
- Alzheimer Disease, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological Counseling ProgramOther
The Psychological Counseling Program consists of 8 sessions for caregivers of individuals diagnosed with Alzheimer's.
Aims of the sessions:
Session 1: Introduction, Collection of pretest data Session 2: It is aimed to inform Alzheimer's caregivers about the disease and its symptoms.
Session 3: It is aimed to strengthen caregivers' coping skills. Session 4: It is aimed to inform Alzheimer's patients about daily care practices.
Session 5: It is aimed to provide information to Alzheimer's caregivers about coping with stress.
Session 6: It is aimed to provide information about medical and financial support that individuals diagnosed with Alzheimer's and their relatives can receive in the region they live.
Session 7: It is aimed to conduct Q\&A sessions on the problems that caregivers bring.
Session 8: Collection of posttest data Sessions will be completed in 8 weeks, one day a week. Each session is planned to last approximately 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| PsychoCP | Experimental | Not described Receives: Other: Psychological Counseling Program |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Level
Perceived Stress Scale: It was developed to measure the stress level of specific situations in individuals' lives. This scale consists of 14 items and is evaluated by participants on a 5-point Likert-type scale ranging from "never (0)" to "very often (4)". The score range of the scale is 0-56. High scores obtained from the scale indicate that the individual's perceived stress level is high.
Measured: Two months
Psychological Well-being Level
Psychological Well-being Scale: It is a scale that evaluates the psychological well-being of an individual. The items of the scale are rated between 1 and 7 as strongly disagree (1) and strongly agree (7). The minimum score is 8 and the maximum score is 56. An increase in the score value indicates that the person has many psychological resources and strengths.
Measured: Two months
The Burden of Caregiving
Zarit Caregiver Burden Scale: The scale is used to measure the stress of caregivers. It contains 22 Likert-type statements. The statements range from zero to four as never (0), rarely (1), sometimes (2), quite often (3), almost always (4). A minimum of 0 and a maximum of 88 points can be obtained from the scale. As the score value increases, the stress experienced by the caregiver also increases.
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start15 Feb 2025 (estimated)
- Primary completion15 Apr 2025 (estimated)
- Study completion15 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aydan Akkurt Yalçıntürk
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aydan Akkurt Yalçıntürk, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06755476
- Sponsor's protocol ID
- 20122024
- Acronym
- PsychoCP
- Status last verified
- Dec 2024
- First submitted
- 24 Dec 2024
- Last updated
- 1 Jan 2025
- Results posted
- No
- 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 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Psychological Counseling Program (PsychoCP) for Alzheimer's Patients' Caregivers on Perceived Stress, Psychological Well-Being and Caregiver Burden
- ClinicalTrials.gov ID
- NCT06755476
- Acronym / sponsor ID
- PsychoCP / 20122024
- Conditions
- Alzheimer Disease, Caregivers of Alzheimer's Disease or Memory Problem Patients, Perceived Stress, Well-Being (Psychological Flourishing), Care Burden
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Aydan Akkurt YalçıntürkUniversity, hospital or other
- Study start
- 15 Feb 2025 (estimated)
- Primary completion
- 15 Apr 2025 (estimated)
- Study completion
- 15 Aug 2025 (estimated)
- First posted
- 1 Jan 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.
Purpose: To investigate the effects of a psychological counseling program (PsychoCP) applied to caregivers of Alzheimer's patients on perceived stress, psychological well-being and care burden.
Design: The study will be conducted in a pre-test post-test control group, randomized controlled experimental research design.
Method: The study is planned to be carried out in Bağcılar Municipality Vefahâne Life Center, Antalya Alzheimer Patients and Patient Relatives Meeting Center and Osmaniye Family and Social Policies Directorate. The sample of the study will consist of 80 caregivers. They will be assigned to intervention (n=40) and control groups (n=40) by randomization.
Hypotheses Hypothesis1: The perceived stress level of caregivers who received PsychoDP is lower than those who did not receive PsychoCP.
Hypothesis2: The psychological well-being levels of caregivers who received PsychoDP are higher than those who did not receive PsychoCP.
Hypothesis3: The care burden of caregivers who received PsychoDP is lower than those who did not receive PsychoCP.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PsychoCP | Experimental | Other: Psychological Counseling Program |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Providing informal care to an individual with mild or moderate Alzheimer's disease
- Being a primary caregiver
- Providing care to the patient for at least six months
- Providing care to the patient for at least six hours per day
- Being literate
Key exclusion criteria (3 listed)
- Not being able to understand questions and express ideas
- Having a psychiatric disorder
- Not receiving any therapy services during the study
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 |
|---|---|---|
| Psychological Counseling ProgramThe Psychological Counseling Program consists of 8 sessions for caregivers of individuals diagnosed with Alzheimer's. Aims of the sessions: Session 1: Introduction, Collection of pretest data Session 2: It is aimed to inform Alzheimer's caregivers about the disease and its symptoms. Session 3: It is aimed to strengthen caregivers' coping skills. Session 4: It is aimed to inform Alzheimer's patients about daily care practices. Session 5: It is aimed to provide information to Alzheimer's caregivers about coping with stress. Session 6: It is aimed to provide information about medical and financial support that individuals diagnosed with Alzheimer's and their relatives can receive in the region they live. Session 7: It is aimed to conduct Q\&A sessions on the problems that caregivers bring. Session 8: Collection of posttest data Sessions will be completed in 8 weeks, one day a week. Each session is planned to last approximately 60 minutes. | Other | PsychoCP |
Primary outcome
Perceived Stress Level
Time frame: Two months
Perceived Stress Scale: It was developed to measure the stress level of specific situations in individuals' lives. This scale consists of 14 items and is evaluated by participants on a 5-point Likert-type scale ranging from "never (0)" to "very often (4)". The score range of the scale is 0-56. High scores obtained from the scale indicate that the individual's perceived stress level is high.
Psychological Well-being Level
Time frame: Two months
Psychological Well-being Scale: It is a scale that evaluates the psychological well-being of an individual. The items of the scale are rated between 1 and 7 as strongly disagree (1) and strongly agree (7). The minimum score is 8 and the maximum score is 56. An increase in the score value indicates that the person has many psychological resources and strengths.
The Burden of Caregiving
Time frame: Two months
Zarit Caregiver Burden Scale: The scale is used to measure the stress of caregivers. It contains 22 Likert-type statements. The statements range from zero to four as never (0), rarely (1), sometimes (2), quite often (3), almost always (4). A minimum of 0 and a maximum of 88 points can be obtained from the scale. As the score value increases, the stress experienced by the caregiver also increases.
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 1 Jan 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.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological Counseling Program in people with Alzheimer Disease and Caregivers of Alzheimer's Disease or Memory Problem Patients, run by Aydan Akkurt Yalçıntürk.
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 3 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 1 Jan 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 Aydan AKKURT YALÇINTÜRK (+905321392497, aydan.akkurtyalcinturk@uskudar.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress Level (time frame: Two months). The study lists 3 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 1 Jan 2025.