NCT06358534

Brief 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.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
active not 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

Study Start

First participant enrolled

June 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 10, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

April 26, 2024

Status Verified

April 1, 2024

Enrollment Period

6 months

First QC Date

April 5, 2024

Last Update Submit

April 25, 2024

Conditions

Keywords

Kidney Failure, ChronicAcceptance and Commitment TherapyPsychiatric Nursingpsychological flexibility

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    8 weeks

Study Arms (2)

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

Behavioral: psychoeducation based on acceptance and commitment therapy

Interventions

psychoeducation based on acceptance and commitment therapy prepared by the researchers was applied individually to the patients

intervention groups

Eligibility Criteria

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

You may qualify if:

  • Acceptance to participate in the research
  • Diagnosis of CKD Stage 4-5
  • GFR below 29ml/min/1.72m2
  • years of age and over
  • Being literate
  • No barriers to verbal communication
  • No psychiatric treatment

You may not qualify if:

  • Receiving haemodialysis and peritoneal dialysis treatment,
  • Pregnancy
  • The presence of a psychiatric disorder requiring treatment,
  • Individuals with transplantation and rejection transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Recep Tayyip Erdoğan University Faculty of Health Sciences

Rize, Güneysu, 53100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • kübra berber

    Recep Tayyip Erdogan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: pretest-posttest, control and intervention groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
LECTURER

Study Record Dates

First Submitted

April 5, 2024

First Posted

April 10, 2024

Study Start

June 1, 2023

Primary Completion

November 30, 2023

Study Completion

July 30, 2024

Last Updated

April 26, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations