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

Not Applicable

Recruiting

• Conditions: Depression; Chronic Kidney Diseases
• Interventions: Behavioral: ACT

• Registration Number: NCT06109493
• Lead Sponsor: Universidad Europea de Madrid

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-10-25
• Study First Submitted QC: 2023-10-25
• Study First Posted: 2023-10-31
• Study Start: 2023-11-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-23
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 104

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACT group	ACT	8 individual weekly sessions which included ACT methods

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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.
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.
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).

Trial Locations

Locations (1)

Fundación Renal Iñigo Alvarez de Toledo; 🇪🇸 Madrid, Spain