- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06358534
The Effect of Acceptance and Commitment Therapy in Patients With Chronic Renal Failure
April 25, 2024 updated by: Kubra Berber, Recep Tayyip Erdogan University
The Effect of Acceptance and Commitment Therapy-based Psychoeducation Given to Chronic Renal Failure Patients on Illness Adaptation, Psychological Resilience and Life Satisfaction
Psychological flexibility, life satisfaction and adaptation to the disease of individuals with chronic kidney disease were increased with psychoeducation based on acceptance and commitment therapy to be given to individuals with chronic kidney disease.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Chronic renal failure is a condition that affects the kidneys and has long-term consequences for physical, psychological, and social well-being.
It reduces quality of life, productivity, and independence, leading to increased costs and the need for care.
In order to ensure treatment compliance and maintain living standards, it is important to enhance individuals' readiness for treatment.
While there are psychological intervention studies during the treatment process, there are few studies that focus on psychological readiness before dialysis.
This study highlights acceptance and determination-based approaches to help individuals become aware of their feelings and thoughts and accept them, minimizing resistance to treatment and improving treatment compliance.
By managing negative emotions and thoughts towards the treatment, this study aims to increase disease compliance, provide psychological support during pre-dialysis trainings, diversify the use of acceptance and commitment therapy-based approaches, and promote psychosocial support in chronic diseases in psychiatric nursing practices.
Study Type
Interventional
Enrollment (Actual)
32
Phase
- 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 Locations
-
-
Güneysu
-
Rize, Güneysu, Turkey, 53100
- Recep Tayyip Erdoğan University Faculty of Health Sciences
-
-
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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Acceptance to participate in the research
- Diagnosis of CKD Stage 4-5
- GFR below 29ml/min/1.72m2
- 18 years of age and over
- Being literate
- No barriers to verbal communication
- No psychiatric treatment
Exclusion Criteria:
- Receiving haemodialysis and peritoneal dialysis treatment,
- Pregnancy
- The presence of a psychiatric disorder requiring treatment,
- Individuals with transplantation and rejection transplantation
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: control groups
No intervention was performed in chronic renal failure patients with eGFH values below 29 ml/dl/1.72m.
|
|
|
Experimental: intervention groups
An 8-session acceptance and commitment therapy-based psychoeducation was applied to chronic renal failure patients with eGFH values below 29 ml/dl/1.72m
|
psychoeducation based on acceptance and commitment therapy prepared by the researchers was applied individually to the patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Chronic Disease Adaptation Scale (CHAS):
Time Frame: 8 weeks
|
The scale, which consists of three sub-dimensions (physical adaptation, social adaptation, psychological adaptation) and 25 items, is a 5-point Likert scale (1: Strongly Disagree, 2: Disagree, 3: Undecided, 4: Agree, 5: Strongly Agree).The total score obtained from the scale is 125.
The increase in the scores obtained from the sub-dimensions and/or the whole scale means that the patients' level of adaptation to the disease increases.
|
8 weeks
|
|
Acceptance and Action Questionnaire-II Scale (AAQ-II)
Time Frame: 8 weeks
|
The KEF-II is a 7-point Likert-type self-report scale consisting of a total of 7 items.
Scale items are graded from 1 ("Never true") to 7 ("Always true").
The lowest score that can be obtained from the scale is 7 and the highest score is 49.
Higher total scores indicate an increase in the level of psychological rigidity, while lower scores indicate an increase in the level of psychological flexibility.
|
8 weeks
|
|
Life Satisfaction Scale
Time Frame: 8 weeks
|
The scale consisting of five questions is in the form of a five-point Likert scale ranging from '1=not at all appropriate' to '5=very appropriate'.
The lowest score that can be obtained from the scale, which has no sub-dimensions, is 5 and the highest score is 25.
The high score obtained from the scale indicates a high degree of satisfaction.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: kübra berber, Recep Tayyip Erdogan 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 (Actual)
June 1, 2023
Primary Completion (Actual)
November 30, 2023
Study Completion (Estimated)
July 30, 2024
Study Registration Dates
First Submitted
April 5, 2024
First Submitted That Met QC Criteria
April 5, 2024
First Posted (Actual)
April 10, 2024
Study Record Updates
Last Update Posted (Actual)
April 26, 2024
Last Update Submitted That Met QC Criteria
April 25, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RTEU-SBF-KB-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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