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NCT Number: NCT07213648

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Univeristy of Virginia School of Nursing

Charlottesville, Virginia, 22903, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

MindTrails-Movement

Behavioral

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

Waitlist Control

Other

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

Primary outcomes

  1. Quality of Life in Neurological Disorders (NeuroQoL) Anxiety short form

    Time frame: From baseline to end of week 6

    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.

Secondary outcomes

  1. Movement Disorders Interpretation Bias Scale (MDIB)

    Time frame: From baseline to end of week 6

    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.

  2. Parkinson Anxiety Scale (PAS)

    Time frame: 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. 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.

  3. Brief Body Sensations Interpretation Questionnaire (BBSIQ)

    Time frame: From baseline to end of week 6

    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.

Other outcomes

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

    Time frame: From baseline to end of week 6

    Patient-reported depressive symptoms will be measured using the Quality of Life in Neurological Disorders Depression short form (NeuroQoL-Depression) 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 depressive symptoms.

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 9, 2025
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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