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

NCT06109493 | Recruiting

• 1 other identifier: EC040-23_FJD-FRIAT
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Kidney Diseases; Depression

Outcome Measures

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.

  Change from Baseline Emotional Distress at 5 months

Secondary Outcomes (5)

• Change in Simplified Medication Adherence Questionnaire (SMAQ)

  Change from Baseline Adherence at 5 months

• Change in COOP/WONCA questionnaire

  Change from Baseline health related Quality of Life at 5 months

• Change in Acceptance and Action Questionnaire in the context of Haemodialysis (CAAH-II)

  Change from Baseline psychological inflexibility at 5 months

• Change in coping skills assessed through coping strategies inventory -short form (CSI-SF)

  Change from Baseline coping strategies at 5 months

• Change in mood assessed through Daylio App

  Change from Baseline mood at 5 months

Study Arms (2)

ACT group

EXPERIMENTAL

8 individual weekly sessions which included ACT methods

Behavioral: ACT

Waiting list

NO INTERVENTION

Participants assigned to Waiting List arm waited for 5 months before receiving treatment

Interventions

ACT BEHAVIORAL

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.

ACT group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with chronic kidney disease on haemodialysis
• Older than 18 years-old
• At least 3 months on haemodialysis
• HADS Global Scale Score ≥14

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Fundación Renal Iñigo Alvarez de Toledo

Madrid, 28003, Spain

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Depression

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Francisco Montesinos, Ph.D.

  Universidad Europea de Madrid

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francisco Montesinos, Ph.D.

CONTACT

+34647413773; francisco.montesinos@universidadeuropea.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants did not know that two different treatments were delivered.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization assigned participants to 2 arms: * ACT group * Waiting list

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: October 31, 2023
• Study Start: November 1, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 23, 2025

Record last verified: 2025-02

Locations

ES (1)