Modification of Threat Interpretation Bias to Reduce Anxiety in Neurodegenerative Movement Disorders (Aim 3)

Not Applicable

Not yet recruiting

• Conditions: Huntington Disease; Parkinson Disease

• Registration Number: NCT07213648
• Lead Sponsor: University of Virginia

Brief Summary

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.

Detailed Description

We 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).

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.

Study Timeline

• Status Verified: 2025-08
• Study Start: 2025-10-01
• Study First Submitted: 2025-10-02
• Study First Submitted QC: 2025-10-02
• Last Update Submitted: 2025-10-02
• Study First Posted: 2025-10-09
• Last Update Posted: 2025-10-09
• Primary Completion: 2026-08
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

• Clinical diagnosis of Huntington's disease or Parkinson's disease (genetic diagnosis of HD also acceptable)
• With anxiety symptoms (NeuroQoL Anxiety ≥12)

Exclusion Criteria

• Cognitive decline precluding ability to consent or complete the intervention (MoCA 5 min/telephone ≤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
• <21 years old

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
NeuroQoL-Anxiety short form	From baseline to end of week 6	Patient-reported anxiety symptoms will be measured using NeuroQoL-Anxiety short form (NeuroQoL-Anxiety) total raw scores

Secondary Outcome Measures

Name	Time	Method
Movement Disorders Interpretation Bias Scale (MDIB)	From baseline to end of week 6	Negative interpretation bias scores for internal and external factors will be calculated by averaging the likelihood ratings for negative explanations within each validated subscale
Parkinson Anxiety Scale	From baseline to end of week 6	The Parkinson Anxiety Scale (PAS) total score will be used as a secondary measure of patient-reported anxiety symptoms
Brief Body Sensations Interpretation Questionnaire	From baseline to end of week 6	Negative interpretation bias scores for internal and external factors will be calculated by averaging the likelihood ratings for negative explanations within each subscale

Trial Locations

Locations (1)

Univeristy of Virginia School of Nursing; 🇺🇸 Charlottesville, Virginia, United States