Investigation of the efficacy of Acceptance and Commitment Therapy (ACT) for the psychological treatment of patients with chronic kidney disease.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
104
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.
Fundación Renal Iñigo Alvarez de Toledo
Madrid, Spain
RECRUITINGChange 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 months
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 months
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 months
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 months
Change in coping skills assessed through coping strategies inventory -short form (CSI-SF)
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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 months
Change in mood assessed through Daylio App
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.
Time frame: Change from Baseline mood at 5 months