Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 11:32 PM
Study NCT ID:
NCT06109493
Status:
RECRUITING
Last Update Posted:
2025-04-23
First Post:
2023-10-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of an ACT-based Psychological Treatment in Patients With Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-07-08', 'size': 141875, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-10-13T08:09', 'hasProtocol': True}, {'date': '2023-07-08', 'size': 173930, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-10-13T08:08', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants did not know that two different treatments were delivered.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomization assigned participants to 2 arms:\n\n* ACT group\n* Waiting list'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 104}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-22', 'studyFirstSubmitDate': '2023-10-25', 'studyFirstSubmitQcDate': '2023-10-25', 'lastUpdatePostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in emotional distress assessed through Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': 'Change from Baseline Emotional Distress at 5 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Change in Simplified Medication Adherence Questionnaire (SMAQ)', 'timeFrame': 'Change from Baseline Adherence at 5 months', 'description': '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.'}, {'measure': 'Change in COOP/WONCA questionnaire', 'timeFrame': 'Change from Baseline health related Quality of Life at 5 months', 'description': '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.'}, {'measure': 'Change in Acceptance and Action Questionnaire in the context of Haemodialysis (CAAH-II)', 'timeFrame': 'Change from Baseline psychological inflexibility at 5 months', 'description': "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."}, {'measure': 'Change in coping skills assessed through coping strategies inventory -short form (CSI-SF)', 'timeFrame': 'Change from Baseline coping strategies at 5 months', 'description': '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).'}, {'measure': 'Change in mood assessed through Daylio App', 'timeFrame': 'Change from Baseline mood at 5 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Kidney Diseases', 'Depression']}, 'descriptionModule': {'briefSummary': 'Investigation of the efficacy of Acceptance and Commitment Therapy (ACT) for the psychological treatment of patients with chronic kidney disease.', 'detailedDescription': 'After being informed about the study, all patients giving written informed consent will be assessed to determine eligibility for study entry.\n\nThe clinical trial will include a control group (waiting list).\n\nPatients who meet eligibility requirements will be assigned to control group or intervention group.\n\nPsychological intervention will consist in an 8-session individual face-to-face delivered ACT-based treatment.\n\nThe participants will be assessed through self-report instruments before and after treatment and at 3 months follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with chronic kidney disease on haemodialysis\n* Older than 18 years-old\n* At least 3 months on haemodialysis\n* HADS Global Scale Score ≥14\n\nExclusion Criteria:\n\n* Diagnosis of severe or chronic mental disorder, mental retardation and cognitive impairment, or disabling illness.\n* Antidepressant drugs consume\n* Insufficient understanding of Spanish.\n* Patients who are in the Advanced Chronic Kidney Disease Unit\n* Receiving other psychological treatment'}, 'identificationModule': {'nctId': 'NCT06109493', 'briefTitle': 'Effects of an ACT-based Psychological Treatment in Patients With Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Europea de Madrid'}, 'officialTitle': 'Effects of an ACT-based Psychological Treatment in Patients With Chronic Kidney Disease', 'orgStudyIdInfo': {'id': 'EC040-23_FJD-FRIAT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ACT group', 'description': '8 individual weekly sessions which included ACT methods', 'interventionNames': ['Behavioral: ACT']}, {'type': 'NO_INTERVENTION', 'label': 'Waiting list', 'description': 'Participants assigned to Waiting List arm waited for 5 months before receiving treatment'}], 'interventions': [{'name': 'ACT', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['ACT group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28003', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Lola Arenas', 'role': 'CONTACT', 'email': 'mdarenas@friat.es', 'phone': '+34673429833'}], 'facility': 'Fundación Renal Iñigo Alvarez de Toledo', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'Francisco Montesinos, Ph.D.', 'role': 'CONTACT', 'email': 'francisco.montesinos@universidadeuropea.es', 'phone': '+34647413773'}], 'overallOfficials': [{'name': 'Francisco Montesinos, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Europea de Madrid'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Europea de Madrid', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundación Renal Iñigo Alvarez De Toledo', 'class': 'OTHER'}, {'name': 'Centro de Enseñanza Superior Cardenal Cisneros', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}