Chronic Kidney DiseasesNCT06109493
Effects of an ACT-based Psychological Treatment in Patients With Chronic Kidney Disease
A study testing ACT in people with Chronic Kidney Diseases and Depression, run by Universidad Europea de Madrid at 1 site in Spain.
Trial summary
Investigation of the efficacy of Acceptance and Commitment Therapy (ACT) for the psychological treatment of patients with chronic kidney disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Depression
- What is being tested?
- ACT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2023to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic kidney disease on haemodialysis
- Older than 18 years-old
- At least 3 months on haemodialysis
- HADS Global Scale Score ≥14
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Fundación Renal Iñigo Alvarez de Toledo
Madrid, 28003
Lola Arenas, +34673429833, mdarenas@friat.es
About this study
Investigation of the efficacy of Acceptance and Commitment Therapy (ACT) for the psychological treatment of patients with chronic kidney disease.
Read the 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.
- Conditions
- Chronic Kidney Diseases, Depression
- Being tested
- ACT
- Medical subject headings
- Renal Insufficiency, Chronic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ACT group | Experimental | 8 individual weekly sessions which included ACT methods Receives: Behavioral: ACT |
| Waiting list | No intervention | Participants assigned to Waiting List arm waited for 5 months before receiving treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline Emotional Distress at 5 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: Change from Baseline psychological inflexibility at 5 months
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).
Measured: 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.
Measured: Change from Baseline mood at 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start1 Nov 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization assigned participants to 2 arms: * ACT group * Waiting list
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Renal Iñigo Alvarez De Toledo, Centro de Enseñanza Superior Cardenal Cisneros
- Responsible party
- Sponsor
- Investigators
- Francisco Montesinos, Ph.D., Principal investigator, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06109493
- Sponsor's protocol ID
- EC040-23_FJD-FRIAT
- Status last verified
- Feb 2025
- First submitted
- 25 Oct 2023
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an ACT-based Psychological Treatment in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06109493
- Acronym / sponsor ID
- EC040-23_FJD-FRIAT
- Conditions
- Chronic Kidney Diseases, Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Collaborators
- Fundación Renal Iñigo Alvarez De Toledo, Centro de Enseñanza Superior Cardenal Cisneros
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomization assigned participants to 2 arms: * ACT group * Waiting list
| Arm | Type | Receives |
|---|---|---|
| ACT group | Experimental | Behavioral: ACT8 individual weekly sessions which included ACT methods |
| Waiting list | No intervention | –Participants assigned to Waiting List arm waited for 5 months before receiving treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with chronic kidney disease on haemodialysis
- Older than 18 years-old
- At least 3 months on haemodialysis
- HADS Global Scale Score ≥14
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACTAcceptance 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. | Behavioural | ACT group |
Primary outcome
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.
5 secondary outcomes
Change in Simplified Medication Adherence Questionnaire (SMAQ)
Time frame: Change from Baseline Adherence at 5 months
Change in COOP/WONCA questionnaire
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)
Time frame: Change from Baseline psychological inflexibility at 5 months
Change in coping skills assessed through coping strategies inventory -short form (CSI-SF)
Time frame: Change from Baseline coping strategies at 5 months
Change in mood assessed through Daylio App
Time frame: Change from Baseline mood at 5 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francisco Montesinos, Ph.D. principal investigator
Universidad Europea de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT in people with Chronic Kidney Diseases and Depression, run by Universidad Europea de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francisco Montesinos, Ph.D. (+34647413773, francisco.montesinos@universidadeuropea.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in emotional distress assessed through Hospital Anxiety and Depression Scale (HADS) (time frame: Change from Baseline Emotional Distress at 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.