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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06109493
• Other study ID #: EC040-23_FJD-FRIAT
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: July 31, 2025

Study information

• Verified date: October 2023
• Source: Universidad Europea de Madrid
• Contact: Francisco Montesinos, Ph.D.
• Phone: +34647413773
• Email: francisco.montesinos[@]universidadeuropea.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: July 31, 2025
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Depression
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
Spain	Fundación Renal Iñigo Alvarez de Toledo	Madrid

Sponsors (3)

Lead Sponsor	Collaborator
Universidad Europea de Madrid	Centro de Enseñanza Superior Cardenal Cisneros, Fundación Renal Iñigo Alvarez De Toledo

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from Baseline Emotional Distress at 5 months
Secondary	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.	Change from Baseline Adherence at 5 months
Secondary	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.	Change from Baseline health related Quality of Life at 5 months
Secondary	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.	Change from Baseline psychological inflexibility at 5 months
Secondary	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).	Change from Baseline coping strategies at 5 months
Secondary	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.	Change from Baseline mood at 5 months