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NCT Number: NCT06755476

Psychological Counseling Program for Alzheimer's Patients' Caregivers

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.

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Key information

Conditions

Alzheimer Disease Behavior Behavioral Symptoms Brain Diseases Care Burden Caregiver Burden Caregivers of Alzheimer's Disease or Memory Problem Patients Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Perceived Stress Stress, Psychological Tauopathies Well-Being (Psychological Flourishing)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Not being able to understand questions and express ideas
Having a psychiatric disorder
Not receiving any therapy services during the study

Treatment and study plan

Psychological Counseling Program

Other

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.

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Aydan AKKURT YALÇINTÜRK

CONTACT

[email protected]

+905321392497

Sponsors and collaborators

Lead sponsor

Aydan Akkurt Yalçıntürk

Other

Registry information

Official study title

The Effect of Psychological Counseling Program (PsychoCP) for Alzheimer's Patients' Caregivers on Perceived Stress, Psychological Well-Being and Caregiver Burden

Acronym: PsychoCP

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Jan 1, 2025
Registry last updated: Jan 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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