Effects of an ACT-based Psychological Treatment in Patients With Chronic Kidney Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversidad Europea de Madrid
About this trial
Investigation of the efficacy of Acceptance and Commitment Therapy (ACT) for the psychological treatment of patients with chronic kidney disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with chronic kidney disease on haemodialysis
Older than 18 years-old
At least 3 months on haemodialysis
HADS Global Scale Score ≥14
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
ACT
BehavioralAcceptance 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.
Treatment groups
104 Participants
are divided into 2 treatment groupsGroup A: ACT groupExperimental treatment 1 intervention
Group B: Waiting listNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in emotional distress assessed through Hospital Anxiety and Depression Scale (HADS)
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.
Time frame
Change from Baseline Emotional Distress at 5 monthsSecondary outcomes
1
Change in Simplified Medication Adherence Questionnaire (SMAQ)
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.
Time frame
Change from Baseline Adherence at 5 months2
Change in COOP/WONCA questionnaire
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.
Time frame
Change from Baseline health related Quality of Life at 5 months3
Change in Acceptance and Action Questionnaire in the context of Haemodialysis (CAAH-II)
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.
Time frame
Change from Baseline psychological inflexibility at 5 months4
Change in coping skills assessed through coping strategies inventory -short form (CSI-SF)
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).
Time frame
Change from Baseline coping strategies at 5 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Universidad Europea de Madrid
Lead sponsor
Fundación Renal Iñigo Alvarez De Toledo
Collaborator
Centro de Enseñanza Superior Cardenal Cisneros
Collaborator
Source ClinicalTrials.gov