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NCT Number: NCT06109493

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fundación Renal Iñigo Alvarez de Toledo

Madrid, 28003, Spain

Location status: Recruiting

Location contact

Lola Arenas

CONTACT

[email protected]

+34673429833

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in emotional distress assessed through Hospital Anxiety and Depression Scale (HADS)

    Time frame: 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 outcomes

  1. Change in Simplified Medication Adherence Questionnaire (SMAQ)

    Time frame: 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.

  2. Change in COOP/WONCA questionnaire

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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).

  5. Change in mood assessed through Daylio App

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Francisco Montesinos, Ph.D.

CONTACT

[email protected]

+34647413773

Sponsors and collaborators

Lead sponsor

Universidad Europea de Madrid

Other

Collaborators

  • Centro de Enseñanza Superior Cardenal Cisneros
  • Fundación Renal Iñigo Alvarez De Toledo

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Oct 31, 2023
Registry last updated
Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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