Huntington DiseaseNCT07213648

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

A study testing MindTrails-Movement in people with Huntington Disease and Parkinson Disease, run by University of Virginia at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Huntington Disease, Parkinson Disease
What is being tested?: MindTrails-Movement
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 136 participants
Where: 1 siteUnited States
Study dates: 20 Nov 2025to Sep 2026
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

Univeristy of Virginia School of Nursing
Charlottesville, Virginia, 22903

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About this study

Read the detailed description

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).

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: Huntington Disease, Parkinson Disease
Being tested: MindTrails-Movement, Waitlist Control
Keywords: CBM-I, cognitive bias modification, interpretation bias, anxiety, mobile app, Huntington, Parkinson
Medical subject headings: Huntington Disease, Parkinson Disease, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MindTrails-MovementBehavioural
CBM-I training app with active CBM-I training condition
Waitlist ControlOther
Version of MindTrails-Movement app including surveys and list of support resources but without active CBM-I training component

Study groups in NCT07213648
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Waitlist Control

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: From baseline to end of week 6

Secondary outcomes (3)

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.
Measured: From baseline to end of week 6
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.
Measured: From baseline to end of week 6
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.
Measured: From baseline to end of week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Nov 2025Sep 2026

First posted9 Oct 2025
Study start20 Nov 2025
Primary completionAug 2026 (estimated)
Study completionSep 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Huntington DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 136 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07213648
Sponsor's protocol ID: HSR 220251
Other IDs: K23NR020210
Status last verified: Jul 2026
First submitted: 2 Oct 2025
Last updated: 20 Jul 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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