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

NCT ID: NCT07213648

Last Updated: 2025-11-21

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-20

Study Completion Date

2026-09-30

Brief Summary

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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

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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

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Huntington Disease Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

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.

Group Type EXPERIMENTAL

MindTrails-Movement

Intervention Type BEHAVIORAL

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.

Group Type OTHER

Waitlist Control

Intervention Type OTHER

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

Intervention Type BEHAVIORAL

Waitlist Control

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

Intervention Type OTHER

Eligibility Criteria

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

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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Jessie Gibson, PhD, RN

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Univeristy of Virginia School of Nursing

Charlottesville, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jessie Gibson, PhD, RN

Role: CONTACT

434-924-0107

Facility Contacts

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Jessie Gibson, PhD, RN

Role: primary

434-924-0107

Other Identifiers

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K23NR020210

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HSR 220251

Identifier Type: -

Identifier Source: org_study_id

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