NCT06755476

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable alzheimer-disease

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable alzheimer-disease

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 24, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 1, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

February 15, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
Last Updated

January 1, 2025

Status Verified

December 1, 2024

Enrollment Period

2 months

First QC Date

December 24, 2024

Last Update Submit

December 24, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Two months

Study Arms (2)

PsychoCP

EXPERIMENTAL
Other: Psychological Counseling Program

Control

NO INTERVENTION

Interventions

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.

PsychoCP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alzheimer DiseaseCaregiver Burden

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersStress, PsychologicalBehavioral SymptomsBehavior

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

December 24, 2024

First Posted

January 1, 2025

Study Start

February 15, 2025

Primary Completion

April 15, 2025

Study Completion

August 15, 2025

Last Updated

January 1, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share