Modification of Threat Interpretation Bias to Reduce Anxiety in Neurodegenerative Movement Disorders (Aim 3)
NCT ID: NCT07213648
Last Updated: 2025-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
136 participants
INTERVENTIONAL
2025-11-20
2026-09-30
Brief Summary
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Detailed Description
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Participants 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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MindTrails-Movement CBM-I Condition
The intervention group (N=68) will include participants with Huntington's disease (N=34) and Parkinson's disease (N=34). Participants will download the MindTrails-Movement app with active CBM-I training condition and will be prompted to complete brief, daily CBM-I training sessions for a period of 6 weeks. They will complete surveys assessing mood symptoms and interpretation bias at baseline, end of week 2, end of week 4, and end of week 6 (end of intervention), then again at the end of week 10.
MindTrails-Movement
CBM-I training app with active CBM-I training condition
Waitlist Control Condition
The waitlist control group (N=68) will include participants with Huntington's disease (N=34) and Parkinson's disease (N=34). Participants will be asked to download a control version of the app that includes access to a list of support resources but does not include daily CBM-I training content. They will complete surveys assessing mood symptoms and interpretation bias at baseline, end of week 2, end of week 4, and end of week 6, and end of week 10. Waitlist control participants will be offered the opportunity to complete the intervention version of the app after they complete their final study assessments.
Waitlist Control
Version of MindTrails-Movement app including surveys and list of support resources but without active CBM-I training component
Interventions
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MindTrails-Movement
CBM-I training app with active CBM-I training condition
Waitlist Control
Version of MindTrails-Movement app including surveys and list of support resources but without active CBM-I training component
Eligibility Criteria
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Inclusion Criteria
* With anxiety symptoms (NeuroQoL Anxiety ≥12)
Exclusion Criteria
* 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
* \<21 years old
* Active suicidality based on the answer "yes" to questions 4, 5, or 6b of the Columbia-Suicide Severity Rating Scale (Screen version)
21 Years
ALL
No
Sponsors
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National Institute of Nursing Research (NINR)
NIH
University of Virginia
OTHER
Responsible Party
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Jessie Gibson, PhD, RN
Assistant Professor
Locations
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Univeristy of Virginia School of Nursing
Charlottesville, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HSR 220251
Identifier Type: -
Identifier Source: org_study_id
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