Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2026-05-03 @ 9:37 AM
Study NCT ID:
NCT02565056
Status:
COMPLETED
Last Update Posted:
2016-05-11
First Post:
2015-09-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility RCT of ACT Self-help for Depression in Haemodialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-10', 'studyFirstSubmitDate': '2015-09-23', 'studyFirstSubmitQcDate': '2015-09-30', 'lastUpdatePostDateStruct': {'date': '2016-05-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Patient Health Questionnaire (PHQ-9) at 2 and 4 months', 'timeFrame': 'Baseline; 2 months; 4 months', 'description': 'Validated self-report questionnaire assessing symptoms of depression'}], 'secondaryOutcomes': [{'measure': 'Change in EQ-5D-5L at 2 and 4 months', 'timeFrame': 'Baseline; 2 months; 4 months', 'description': 'Validated self-report questionnaire assessing health-related quality of life'}, {'measure': 'Change in Acceptance and Action Questionnaire - 2 (AAQ-2) at 2 and 4 months', 'timeFrame': 'Baseline; 2 months; 4 months', 'description': 'Validated self-report questionnaire assessing psychological flexibility'}, {'measure': 'Change in Valued Living Questionnaire (VLQ) at 2 and 4 months', 'timeFrame': 'Baseline; 2 months; 4 months', 'description': 'Validated self-report questionnaire assessing the extent to which individuals live consistently with their identified values'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acceptance and Commitment Therapy'], 'conditions': ['End-stage Renal Disease', 'Depression']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the feasibility of conducting a trial to evaluate a self-help treatment for depression in people with end-stage renal disease.', 'detailedDescription': "Chronic Kidney Disease (CKD) is a long-term condition in which the function of the kidneys - to filter out waste products from the blood - slowly declines. When renal function becomes sufficiently low it is described as End Stage Renal Disease (ESRD) and renal replacement therapy (RRT) is likely to be needed to prolong life. The most common type of RRT is haemodialysis, in which the patient's blood is filtered through a machine.\n\nIt is estimated that depression is experienced by 20-40% of people with ESRD. Depression not only affects the quality of life of individuals with ESRD but is also associated with higher rates of hospitalisation and poorer physical health outcomes.\n\nAcceptance and Commitment Therapy (ACT) has been found to be an effective treatment for depression and has been used successfully as a self-help treatment. However, no study has examined the effectiveness of an ACT self-help treatment for depression in ESRD. This study aims to assess the feasibility of conducting such a study and will look at suitability of recruitment, assessment methods and the acceptability of the self-help treatment, as well as helping to calculate the number of people needed for a definitive study.\n\nHaemodialysis patients receiving dialysis through an NHS renal service will be invited to participate. To participate they will be consenting, over 18 years of age and experiencing depressive symptoms at a clinical level. Those eligible will be randomly assigned into one of two conditionsÍž a control condition receiving treatment as usual (TAU), and an intervention condition receiving TAU alongside an ACT self-help manual with weekly telephone support. The manual will be completed over six weeks. Both groups will be asked to complete questionnaires prior to intervention and 2 and 4 months post-intervention. Participants from each condition will be asked to participate in interviews to explore their experiences of taking part."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* undergoing haemodialysis treatment at one of three identified units\n* receiving haemodialysis treatment for more than 6 months\n* moderate depression (as indicated by the PHQ-9)\n\nExclusion Criteria:\n\n* receiving concurrent psychological treatment\n* lacking mental capacity to consent due to cognitive impairment\n* inadequate reading ability (indicated by inability to complete PHQ-9 screening measure)\n* visual or hearing impairment that would prevent completion of the self-help book or engagement in telephone calls'}, 'identificationModule': {'nctId': 'NCT02565056', 'briefTitle': 'Feasibility RCT of ACT Self-help for Depression in Haemodialysis', 'organization': {'class': 'OTHER', 'fullName': 'University of Lincoln'}, 'officialTitle': 'Acceptance and Commitment Therapy Self-help Intervention for Depression in Haemodialysis Patients: A Feasibility Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '156756'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Self-help', 'description': 'Self-help book completed over 6 weeks with up to 30 minutes of telephone support per week.', 'interventionNames': ['Other: Self help book + telephone support']}, {'type': 'NO_INTERVENTION', 'label': 'Treatment as usual', 'description': 'Treatment as usual.'}], 'interventions': [{'name': 'Self help book + telephone support', 'type': 'OTHER', 'description': 'Self-help book based upon principles of Acceptance and Commitment Therapy', 'armGroupLabels': ['Self-help']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DE7 8LN', 'city': 'Ilkeston', 'state': 'Derbyshire', 'country': 'United Kingdom', 'facility': 'Shipley Dialysis Unit, Ilkeston Community Hospital', 'geoPoint': {'lat': 52.97055, 'lon': -1.30951}}, {'zip': 'NG17 4JL', 'city': 'Mansfield', 'state': 'Nottinghamshire', 'country': 'United Kingdom', 'facility': 'Mike Cassidy Dialysis Unit, Kings Mill Hospital', 'geoPoint': {'lat': 53.13333, 'lon': -1.2}}, {'zip': 'NG5 1PB', 'city': 'Nottingham', 'state': 'Nottinghamshire', 'country': 'United Kingdom', 'facility': 'Main Dialysis Unit & Centenary Dialysis Unit (same site), City Hospital', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'overallOfficials': [{'name': 'William Vogt, MSc, BSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Lincoln'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Lincoln', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nottingham University Hospitals NHS Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Trainee Clinical Psychologist', 'investigatorFullName': 'William Vogt', 'investigatorAffiliation': 'University of Lincoln'}}}}