[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07213648":3,"trial-entities:NCT07213648":95,"trial-summary:NCT07213648":99},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":47,"secondary_outcomes":52,"sex":62,"minimum_age":63,"maximum_age":64,"healthy_volunteers":65,"eligibility_criteria":66,"std_ages":78,"locations":81,"central_contacts":91,"overall_officials":92,"references":93,"see_also_links":94},"NCT07213648","HSR 220251","Modification of Threat Interpretation Bias to Reduce Anxiety in Neurodegenerative Movement Disorders (Aim 3)","ACTIVE_NOT_RECRUITING","2026-09","2026-07","2026-07-20","2025-11-20","University of Virginia","OTHER",true,"The purpose of this study is to assess preliminary efficacy of a tailored cognitive bias modification for interpretation (CBM-I) app for reducing anxiety in Huntington's disease and Parkinson's disease.","The investigators will conduct a pilot randomized controlled trial of the MindTrails-Movement CBM-I app in patients with Huntington's disease and Parkinson's disease (N=136). Participants randomly assigned to the intervention group (N=68) will be asked to download the MindTrails-Movement mobile app and to complete daily CBM-I training sessions and nightly surveys, in addition to surveys at baseline and every 2 weeks for the duration of the 6-week intervention and at 4-week follow-up (week 10).\n\nParticipants assigned to the waitlist control group will download a control version of the app without CBM-I training sessions. They will be asked to complete surveys in the app at baseline and every 2 weeks for the duration of the 6-week intervention and at 4-week follow-up (week 10). After 10 weeks, they will be offered the opportunity to access the version of MindTrails-Movement with CBM-I training content.",[18,19],"Huntington Disease","Parkinson Disease",[21,22,23,24,25,26,27],"CBM-I","cognitive bias modification","interpretation bias","anxiety","mobile app","Huntington","Parkinson","INTERVENTIONAL","SUPPORTIVE_CARE",[31],"NA",{"count":33,"type":34},136,"ESTIMATED",[36,42],{"type":37,"name":38,"description":39,"armGroupLabels":40},"BEHAVIORAL","MindTrails-Movement","CBM-I training app with active CBM-I training condition",[41],"MindTrails-Movement CBM-I Condition",{"type":13,"name":43,"description":44,"armGroupLabels":45},"Waitlist Control","Version of MindTrails-Movement app including surveys and list of support resources but without active CBM-I training component",[46],"Waitlist Control Condition",[48],{"measure":49,"description":50,"timeFrame":51},"Quality of Life in Neurological Disorders (NeuroQoL) Anxiety short form","Patient-reported anxiety symptoms will be measured using the Quality of Life in Neurological Disorders Anxiety short form (NeuroQoL-Anxiety) total raw scores. This measure includes 8 items ranked 1-5, where the total score is the sum of item scores (range 8-40), and higher scores indicate worse anxiety symptoms.","From baseline to end of week 6",[53,56,59],{"measure":54,"description":55,"timeFrame":51},"Movement Disorders Interpretation Bias Scale (MDIB)","Movement Disorders Interpretation Bias Scale (MDIB) is a measure of interpretation bias in people with movement disorders. Participants rate the likelihood (0-4) of three alternate explanations (two benign and one negative) for why an ambiguous event occurred. To obtain negative external and internal bias scores, the mean of 5 negative ratings for external threats (Items 3c, 5a, 7a, 10a, 11c) and the mean of 4 negative ratings for internal threats (Items 1b, 4c, 8b, 12b) will be computed, where higher scores (possible range: 0-4) reflect more severe negative interpretation biases.",{"measure":57,"description":58,"timeFrame":51},"Parkinson Anxiety Scale (PAS)","The Parkinson Anxiety Scale (PAS) total score will be used as a secondary measure of patient-reported anxiety symptoms. PAS includes 12 self-report items that make up three subscales (persistent and episodic anxiety and avoidant behavior). Items are ranked 0-4 with a maximum total score of 48, where higher scores indicate worse anxiety symptoms.",{"measure":60,"description":61,"timeFrame":51},"Brief Body Sensations Interpretation Questionnaire (BBSIQ)","Brief Body Sensations Interpretation Questionnaire (BBSIQ) is a general measure of interpretation bias. Participants rate the likelihood (0-4) of three alternate explanations (two benign and one negative) for why an ambiguous event occurred. To obtain negative external and internal bias scores, the mean of 7 negative ratings for external threats (Items 1c, 4c, 6a, 7b, 9b, 10b, 13c) and the mean of 7 negative ratings for internal threats (Items 2b, 3c, 5a, 8c, 11b, 12a, 14c) will be computed, where higher scores (possible range: 0-4) reflect more severe negative interpretation biases.","ALL","21 Years",null,false,{"inclusion":67,"exclusion":70,"raw_text":77},[68,69],"Clinical diagnosis of Huntington's disease or Parkinson's disease (genetic diagnosis of HD also acceptable)","With anxiety symptoms (NeuroQoL Anxiety ≥12)",[71,72,73,74,75,76],"Cognitive decline precluding ability to consent or complete the intervention (MoCA 5 min\u002Ftelephone ≤11)","Unable to read and understand English","Does not have regular access to an internet-connected device, capable of downloading and installing the mobile application (i.e., tablet or iPhone running iOS 10 or later or an Android phone running Android 5.0 or later)","Not located in the USA","\\\u003C21 years old","Active suicidality based on the answer \"yes\" to questions 4, 5, or 6b of the Columbia-Suicide Severity Rating Scale (Screen version)","Inclusion Criteria:\n\n* Clinical diagnosis of Huntington's disease or Parkinson's disease (genetic diagnosis of HD also acceptable)\n* With anxiety symptoms (NeuroQoL Anxiety ≥12)\n\nExclusion Criteria:\n\n* Cognitive decline precluding ability to consent or complete the intervention (MoCA 5 min\u002Ftelephone ≤11)\n* Unable to read and understand English\n* Does not have regular access to an internet-connected device, capable of downloading and installing the mobile application (i.e., tablet or iPhone running iOS 10 or later or an Android phone running Android 5.0 or later)\n* Not located in the USA\n* \\\u003C21 years old\n* Active suicidality based on the answer \"yes\" to questions 4, 5, or 6b of the Columbia-Suicide Severity Rating Scale (Screen version)",[79,80],"ADULT","OLDER_ADULT",[82],{"facility":83,"city":84,"state":85,"zip":86,"country":87,"geoPoint":88},"Univeristy of Virginia School of Nursing","Charlottesville","Virginia","22903","United States",{"lat":89,"lon":90},38.02931,-78.47668,[],[],[],[],{"nct_id":4,"conditions":96,"biomarkers":98},[97,19],"Huntington's Disease",[],{"nct_id":4,"found":65,"summary":64,"prompt_version":64}]