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

NCT07213648 | Recruiting DMC

• 2 other identifiers: HSR 220251K23NR020210
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Huntington Disease; Parkinson Disease

Keywords

CBM-I; cognitive bias modification; interpretation bias; anxiety; mobile app; Huntington; Parkinson

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Movement Disorders Interpretation Bias Scale (MDIB)

  From baseline to end of week 6

• Parkinson Anxiety Scale (PAS)

  From baseline to end of week 6

• Brief Body Sensations Interpretation Questionnaire (BBSIQ)

  From baseline to end of week 6

Other Outcomes (1)

• Quality of Life in Neurological Disorders (NeuroQoL) Depression short form

  From baseline to end of week 6

Study Arms (2)

MindTrails-Movement CBM-I Condition

EXPERIMENTAL

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.

Behavioral: MindTrails-Movement

Waitlist Control Condition

OTHER

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.

Other: Waitlist Control

Interventions

MindTrails-Movement BEHAVIORAL

CBM-I training app with active CBM-I training condition

MindTrails-Movement CBM-I Condition

Waitlist Control OTHER

Version of MindTrails-Movement app including surveys and list of support resources but without active CBM-I training component

Waitlist Control Condition

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• Active suicidality based on the answer "yes" to questions 4, 5, or 6b of the Columbia-Suicide Severity Rating Scale (Screen version)

Sponsors & Collaborators

• University of Virginia: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Univeristy of Virginia School of Nursing

Charlottesville, Virginia, 22903, United States

RECRUITING

MeSH Terms

Conditions

Huntington Disease; Parkinson Disease; Anxiety Disorders

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Chorea; Dyskinesias; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Parkinsonian Disorders; Synucleinopathies

Central Study Contacts

Jessie Gibson, PhD, RN

CONTACT

434-924-0107; MindTrailsMovement@uvahealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: October 9, 2025
• Study Start: November 20, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

US (1)