Nctid:
NCT06231238
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000094024", "term"=>"Post-Acute COVID-19 Syndrome"}], "ancestors"=>[{"id"=>"D000086382", "term"=>"COVID-19"}, {"id"=>"D011024", "term"=>"Pneumonia, Viral"}, {"id"=>"D011014", "term"=>"Pneumonia"}, {"id"=>"D012141", "term"=>"Respiratory Tract Infections"}, {"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D014777", "term"=>"Virus Diseases"}, {"id"=>"D018352", "term"=>"Coronavirus Infections"}, {"id"=>"D003333", "term"=>"Coronaviridae Infections"}, {"id"=>"D030341", "term"=>"Nidovirales Infections"}, {"id"=>"D012327", "term"=>"RNA Virus Infections"}, {"id"=>"D008171", "term"=>"Lung Diseases"}, {"id"=>"D012140", "term"=>"Respiratory Tract Diseases"}, {"id"=>"D000094025", "term"=>"Post-Infectious Disorders"}, {"id"=>"D002908", "term"=>"Chronic Disease"}, {"id"=>"D020969", "term"=>"Disease Attributes"}, {"id"=>"D010335", "term"=>"Pathologic Processes"}], "browseLeaves"=>[{"id"=>"M2561", "name"=>"COVID-19", "relevance"=>"LOW"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M3013", "name"=>"Post-Acute COVID-19 Syndrome", "asFound"=>"Long COVID", "relevance"=>"HIGH"}, {"id"=>"M13904", "name"=>"Pneumonia", "relevance"=>"LOW"}, {"id"=>"M13914", "name"=>"Pneumonia, Viral", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M14978", "name"=>"Respiratory Tract Infections", "relevance"=>"LOW"}, {"id"=>"M17522", "name"=>"Virus Diseases", "relevance"=>"LOW"}, {"id"=>"M20490", "name"=>"Coronavirus Infections", "relevance"=>"LOW"}, {"id"=>"M6555", "name"=>"Coronaviridae Infections", "relevance"=>"LOW"}, {"id"=>"M23685", "name"=>"Nidovirales Infections", "relevance"=>"LOW"}, {"id"=>"M15149", "name"=>"RNA Virus Infections", "relevance"=>"LOW"}, {"id"=>"M11168", "name"=>"Lung Diseases", "relevance"=>"LOW"}, {"id"=>"M14977", "name"=>"Respiratory Tract Diseases", "relevance"=>"LOW"}, {"id"=>"M3014", "name"=>"Post-Infectious Disorders", "relevance"=>"LOW"}, {"id"=>"M6147", "name"=>"Chronic Disease", "relevance"=>"LOW"}, {"id"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}, {"id"=>"T170", "name"=>"Acute Graft Versus Host Disease", "relevance"=>"LOW"}, {"id"=>"T1303", "name"=>"Chronic Graft Versus Host Disease", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE", "whoMasked"=>["INVESTIGATOR", "OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>196}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-03", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2025-09", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-29", "studyFirstSubmitDate"=>"2024-01-29", "studyFirstSubmitQcDate"=>"2024-01-29", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-02", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"36-item Short Form Health Survey (SF-36)", "timeFrame"=>"Week 0, 14 and 20"}], "secondaryOutcomes"=>[{"measure"=>"EuroQol 5 Dimension - 5 Levels (EQ-5D-5L)", "timeFrame"=>"Week 0, 14 and 20"}, {"measure"=>"Service use", "timeFrame"=>"Week 0 and 20"}, {"measure"=>"Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)", "timeFrame"=>"Week 0, 7, 14 and 20"}, {"measure"=>"Modified Clinical Global Impressions Scale- Improvement (CGI-I)", "timeFrame"=>"Week 0, 14 and 20"}, {"measure"=>"Pittsburgh Sleep Quality Index (PSQI)", "timeFrame"=>"Week 0, 7, 14 and 20"}, {"measure"=>"Modified Patient Health Questionnaire-15 (PHQ-15)", "timeFrame"=>"Week 0, 7, 14 and 20"}, {"measure"=>"Montreal cognitive assessment (MoCA)", "timeFrame"=>"Week 0, 14 and 20"}, {"measure"=>"Perceived Deficits Questionnaire (PDQ)", "timeFrame"=>"Week 0, 7, 14 and 20"}, {"measure"=>"Patient Health Questionnaire-8 (PHQ-8)", "timeFrame"=>"Week 0, 7, 14 and 20"}, {"measure"=>"Generalised Anxiety Disorder-7 (GAD-7)", "timeFrame"=>"Week 0, 7, 14 and 20"}, {"measure"=>"Work and social adjustment scale (WSAS)", "timeFrame"=>"Week 0, 14 and 20"}, {"measure"=>"Modified DePaul Post exertional malaise questionnaire", "timeFrame"=>"Week 0, 7, 14 and 20"}, {"measure"=>"Post Traumatic Stress Disorder Checklist (PCL-5)", "timeFrame"=>"Week 0, 14 and 20"}, {"measure"=>"Nijmegen Questionnaire (NQ)", "timeFrame"=>"Week 0, 14 and 20"}, {"measure"=>"Dyspnoea-12", "timeFrame"=>"Week 0, 14 and 20"}, {"measure"=>"Modified Medical Research Council Dyspnea Scale (mMRC)", "timeFrame"=>"Week 0, 14 and 20"}, {"measure"=>"Lung function (spirometry, Resting pulse oximetry; SpO2)", "timeFrame"=>"Week 0, 14 and 20"}, {"measure"=>"Muscle strength", "timeFrame"=>"Week 0, 14 and 20"}, {"measure"=>"Muscle fatigue", "timeFrame"=>"Week 0, 14 and 20", "description"=>"Handgrip volitional fatigue, Quadriceps non-volitional fatigue"}, {"measure"=>"1 minute sit-to-stand test", "timeFrame"=>"Week 0, 14 and 20"}, {"measure"=>"4 metre gait speed", "timeFrame"=>"Week 0, 14 and 20"}, {"measure"=>"Short Physical Performance Battery (SPPB)", "timeFrame"=>"Week 0, 14 and 20"}, {"measure"=>"International Physical Activity Questionnaire - Short Form (IPAQ-SF)", "timeFrame"=>"Week 0, 7, 14 and 20"}, {"measure"=>"Heartrate variability", "timeFrame"=>"Week 0, 7 and 14"}, {"measure"=>"Cognitive and Behavioural Responses Questionnaire (CBRQ)", "timeFrame"=>"Week 0, 7, 14 and 20"}, {"measure"=>"Comprehensive assessment of Acceptance and Commitment Therapy processes", "timeFrame"=>"Week 0, 7, 14 and 20"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Post-COVID-19 Syndrome", "Long COVID"]}, "descriptionModule"=>{"briefSummary"=>"This randomised controlled trial aims to investigate the efficacy of a psychological intervention for long COVID (LC) / post-COVID-19 syndrome (PCS) called Balance Acceptance and Commitment Therapy (Balance ACT).\n\nThe primary objective of this trial is to investigate whether Balance-ACT improves quality of life over treatment as usual (i.e., self-help leaflet) in people with PCS/LC."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Age 18 or older\n2. LC/PCS diagnosis as defined by National Health Service (NHS) / National Institute for Health and Care Excellence (NICE) (i.e., symptoms that develop during or after an infection consistent with COVID-19, continue for more than 12 weeks and are not explained by an alternative diagnosis). A checklist will be used to ensure participants fulfil the diagnostic criteria as per the NICE guidelines\n3. Ability to travel to the research site for the study assessments\n4. Consent to wear a smartwatch throughout the study\n5. Having registered with a General Practitioner (GP) in the United Kingdom (UK) and consent to provide their details for the study team to contact\n6. Ability to provide informed consent\n7. Ability to read and write English\n\nExclusion Criteria:\n\n1. Current diagnosis of an active major mental health disorder likely to interfere with participation\n2. Unstable alcohol / drug dependency\n3. Unstable complications associated with LC/PCS\n4. Past hospitalisation for COVID-19\n5. Current or recent participation in other treatment intervention studies (\\<4 weeks after completion)\n6. Currently receiving psychological support or psychotherapy\n7. Implanted medical devices (ie., Pacemaker/defibrillator or implanted neurostimulator/infusion device; implanted metal objects; artificial hip/knee replacement, spinal surgery; cardiac surgery requiring the placement of metal clips, valves or wires)\n8. Pregnancy"}, "identificationModule"=>{"nctId"=>"NCT06231238", "acronym"=>"BalanceACT", "briefTitle"=>"Balance Acceptance and Commitment Therapy for Long COVID", "organization"=>{"class"=>"OTHER", "fullName"=>"King's College London"}, "officialTitle"=>"A Randomised Controlled Trial Assessing the Efficacy of Balance Acceptance and Commitment Therapy (ACT) for Long COVID.", "orgStudyIdInfo"=>{"id"=>"326529"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Balance ACT", "description"=>"Participants randomised to Balance ACT will receive 10 therapy sessions with a therapist.", "interventionNames"=>["Behavioral: Balance Acceptance and Commitment Therapy"]}, {"type"=>"NO_INTERVENTION", "label"=>"Treatment as usual", "description"=>"Information leaflet about PCS/LC."}], "interventions"=>[{"name"=>"Balance Acceptance and Commitment Therapy", "type"=>"BEHAVIORAL", "description"=>"Balance-ACT is an ACT-based psychological intervention specifically designed for people with PCS/LC. Balance-ACT will use ACT techniques and mindfulness and will focus on establishing a balance psychologically and physiologically and regulating homeostasis. More specifically, Balance ACT will aim to regulate behaviours such as sleep, stress and activity, which can subsequently have an impact on homeostasis and physiology. Balance-ACT will also encourage people to live a values-based life and set goals according to their values.", "armGroupLabels"=>["Balance ACT"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Trudie Chalder, PhD", "role"=>"CONTACT", "email"=>"trudie.chalder@kcl.ac.uk", "phone"=>"+44 (0)20 7848 0406"}, {"name"=>"Caroline Jolley, PhD", "role"=>"CONTACT", "email"=>"caroline.jolley@kcl.ac.uk"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"King's College London", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
