Effects of an ACT-based Psychological Treatment in Patients With Chronic Kidney Disease

April 22, 2025 updated by: Universidad Europea de Madrid
Investigation of the efficacy of Acceptance and Commitment Therapy (ACT) for the psychological treatment of patients with chronic kidney disease.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

After being informed about the study, all patients giving written informed consent will be assessed to determine eligibility for study entry.

The clinical trial will include a control group (waiting list).

Patients who meet eligibility requirements will be assigned to control group or intervention group.

Psychological intervention will consist in an 8-session individual face-to-face delivered ACT-based treatment.

The participants will be assessed through self-report instruments before and after treatment and at 3 months follow-up.

Study Type

Interventional

Enrollment (Estimated)

104

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 Contact

Study Locations

  • Spain
      • Madrid, Spain, 28003
        • Recruiting
        • Fundación Renal Iñigo Alvarez de Toledo
        • Contact:

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:

  • Patients with chronic kidney disease on haemodialysis
  • Older than 18 years-old
  • At least 3 months on haemodialysis
  • HADS Global Scale Score ≥14

Exclusion Criteria:

  • Diagnosis of severe or chronic mental disorder, mental retardation and cognitive impairment, or disabling illness.
  • Antidepressant drugs consume
  • Insufficient understanding of Spanish.
  • Patients who are in the Advanced Chronic Kidney Disease Unit
  • Receiving other psychological treatment

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ACT group
8 individual weekly sessions which included ACT methods
Behavioral: ACT
Acceptance and Commitment Therapy methods were focused on promoting Values clarification, Acceptance, Cognitive defusion, Committed action and Flexible attention to the present moment, and included methods such as the Garden Metaphor, Funeral exercise or Mindfulness training.
No Intervention: Waiting list
Participants assigned to Waiting List arm waited for 5 months before receiving treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in emotional distress assessed through Hospital Anxiety and Depression Scale (HADS)
Time Frame: Change from Baseline Emotional Distress at 5 months
HADS assesses anxiety, depression and emotional distress. It is a 14-item four-point Likert-type scale. Scores range between 0 and 42. Higher the score in the overall score indicate higher levels of emotional distress and worse outcome.
Change from Baseline Emotional Distress at 5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in COOP/WONCA questionnaire
Time Frame: Change from Baseline health related Quality of Life at 5 months
COOP/WONCA assesses health related Quality of Life (HRQOL). It was selected the 7-item five-point Likert-type version of the scale. Scores range between 0 and 35. Higher scores indicate lower levels of HRQOL and worse outcome.
Change from Baseline health related Quality of Life at 5 months
Change in Acceptance and Action Questionnaire in the context of Haemodialysis (CAAH-II)
Time Frame: Change from Baseline psychological inflexibility at 5 months
Acceptance and Action Questionnaire' assesses psychological inflexibility. It is a 7-item, seven-point Likert-type scale. Scores range between 7 and 49. Higher scores indicate higher levels of psychological inflexibility and worse outcome.
Change from Baseline psychological inflexibility at 5 months
Change in Simplified Medication Adherence Questionnaire (SMAQ)
Time Frame: Change from Baseline Adherence at 5 months
SMAQ assesses adherence to medication. It is a 6-item questionnaire that evaluates different aspects of patient compliance with treatment: forgetfulness, routine, adverse effects, and omissions. A patient is classified as non-compliant if he/she responds to any of the questions with a non-adherence answer, and in terms of quantification, if the patient has lost more than two doses during the last week or has not taken medication during more than two complete days during the last three months.
Change from Baseline Adherence at 5 months
Change in coping skills assessed through coping strategies inventory -short form (CSI-SF)
Time Frame: Change from Baseline coping strategies at 5 months
CSI-SF is a 15-item, five-point Likert-type scale which includes four subscales: Problem Focused Engagement (PFE), Problem Focused Disengagement (PFD), Emotion Focused Engagement (EFE) and Emotion Focused Disengagement (EFD).
Change from Baseline coping strategies at 5 months
Change in mood assessed through Daylio App
Time Frame: Change from Baseline mood at 5 months
Daylio is a mobile app which allows daily assessing mood through emoticons which will be transformed into a five-point Likert-type scale. Scores range between 1 and 5. Higher scores indicate higher better mood and better outcome.
Change from Baseline mood at 5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Europea de Madrid

Collaborators

Fundación Renal Iñigo Alvarez De Toledo
Centro de Enseñanza Superior Cardenal Cisneros

Investigators

  • Principal Investigator: Francisco Montesinos, Ph.D., Universidad Europea de Madrid

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)

November 1, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

October 25, 2023

First Submitted That Met QC Criteria

October 25, 2023

First Posted (Actual)

October 31, 2023

Study Record Updates

Last Update Posted (Actual)

April 23, 2025

Last Update Submitted That Met QC Criteria

April 22, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC040-23_FJD-FRIAT

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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