Kidney Failure, ChronicNCT06358534
The Effect of Acceptance and Commitment Therapy in Patients With Chronic Renal Failure
A study testing psychoeducation based on acceptance and commitment therapy in people with Kidney Failure, Chronic, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Chronic
- What is being tested?
- psychoeducation based on acceptance and commitment therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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
Who cannot join
- Receiving haemodialysis and peritoneal dialysis treatment,
- Pregnancy
- The presence of a psychiatric disorder requiring treatment,
- Individuals with transplantation and rejection transplantation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Recep Tayyip Erdoğan University Faculty of Health Sciences
Rize, Güneysu, 53100
About this study
Official title: 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.
Read the 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.
- Conditions
- Kidney Failure, Chronic
- Being tested
- psychoeducation based on acceptance and commitment therapy
- Keywords
- Kidney Failure, Chronic, Acceptance and Commitment Therapy, Psychiatric Nursing, psychological flexibility
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychoeducation based on acceptance and commitment therapyBehavioural
psychoeducation based on acceptance and commitment therapy prepared by the researchers was applied individually to the patients
| Study group | Role | What they receive |
|---|---|---|
| control groups | No intervention | No intervention was performed in chronic renal failure patients with eGFH values below 29 ml/dl/1.72m. |
| intervention groups | Experimental | 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 Receives: Behavioral: psychoeducation based on acceptance and commitment therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic Disease Adaptation Scale (CHAS):
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.
Measured: 8 weeks
Acceptance and Action Questionnaire-II Scale (AAQ-II)
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.
Measured: 8 weeks
Life Satisfaction Scale
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start1 Jun 2023
- Primary completion30 Nov 2023
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Failure, ChronicStudies 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
- Model description
- pretest-posttest, control and intervention groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kubra Berber, Recep Tayyip Erdogan University
- Investigators
- kübra berber, Principal investigator, Recep Tayyip Erdogan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06358534
- Sponsor's protocol ID
- RTEU-SBF-KB-01
- Status last verified
- Apr 2024
- First submitted
- 5 Apr 2024
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- 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 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acceptance and Commitment Therapy-based Psychoeducation Given to Chronic Renal Failure Patients on Illness Adaptation, Psychological Resilience and Life Satisfaction
- ClinicalTrials.gov ID
- NCT06358534
- Acronym / sponsor ID
- RTEU-SBF-KB-01
- Conditions
- Kidney Failure, Chronic
- Keywords
- Kidney Failure, Chronic, Acceptance and Commitment Therapy, Psychiatric Nursing, psychological flexibility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 10 Apr 2024 (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.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- pretest-posttest, control and intervention groups
| Arm | Type | Receives |
|---|---|---|
| control groups | No intervention | –No intervention was performed in chronic renal failure patients with eGFH values below 29 ml/dl/1.72m. |
| intervention groups | Experimental | Behavioral: psychoeducation based on acceptance and commitment therapyAn 8-session acceptance and commitment therapy-based psychoeducation was applied to chronic renal failure patients with eGFH values below 29 ml/dl/1.72m |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- Receiving haemodialysis and peritoneal dialysis treatment,
- Pregnancy
- The presence of a psychiatric disorder requiring treatment,
- Individuals with transplantation and rejection transplantation
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 |
|---|---|---|
| psychoeducation based on acceptance and commitment therapypsychoeducation based on acceptance and commitment therapy prepared by the researchers was applied individually to the patients | Behavioural | intervention groups |
Primary outcome
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- 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. This study is not recruiting at the moment.
kübra berber principal investigator
Recep Tayyip Erdogan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing psychoeducation based on acceptance and commitment therapy in people with Kidney Failure, Chronic, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).
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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic Disease Adaptation Scale (CHAS): (time frame: 8 weeks). 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 26 Apr 2024.