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

Universidad Europea de Madrid (Other)
Overall Status
Not yet recruiting
CT.gov ID
Fundación Renal Iñigo Alvarez De Toledo (Other), Centro de Enseñanza Superior Cardenal Cisneros (Other)

Study Details

Study Description

Brief Summary

Investigation of the efficacy of Acceptance and Commitment Therapy (ACT) for the psychological treatment of patients with chronic kidney disease.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: ACT

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 Design

Study Type:
Anticipated Enrollment :
104 participants
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomization assigned participants to 2 arms: ACT group Waiting listRandomization assigned participants to 2 arms:ACT group Waiting list
Single (Participant)
Masking Description:
Participants did not know that two different treatments were delivered.
Primary Purpose:
Official Title:
Effects of an ACT-based Psychological Treatment in Patients With Chronic Kidney Disease
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Oct 31, 2024
Anticipated Study Completion Date :
Jul 31, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in emotional distress assessed through Hospital Anxiety and Depression Scale (HADS) [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.

Secondary Outcome Measures

  1. Change in Simplified Medication Adherence Questionnaire (SMAQ) [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.

  2. Change in COOP/WONCA questionnaire [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.

  3. Change in Acceptance and Action Questionnaire in the context of Haemodialysis (CAAH-II) [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.

  4. Change in coping skills assessed through coping strategies inventory -short form (CSI-SF) [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).

  5. Change in mood assessed through Daylio App [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.

Eligibility Criteria


Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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

Contacts and Locations


Site City State Country Postal Code
1 Fundación Renal Iñigo Alvarez de Toledo Madrid Spain 28003

Sponsors and Collaborators

  • Universidad Europea de Madrid
  • Fundación Renal Iñigo Alvarez De Toledo
  • Centro de Enseñanza Superior Cardenal Cisneros


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

Study Documents (Full-Text)

More Information


None provided.
Responsible Party:
Universidad Europea de Madrid
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • EC040-23_FJD-FRIAT
First Posted:
Oct 31, 2023
Last Update Posted:
Nov 7, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 7, 2023