Changing threat interpretation to reduce anxiety in Parkinson's and Huntington's disease
Modification of Threat Interpretation Bias to Reduce Anxiety in Neurodegenerative Movement Disorders (Aim 3)
This project tests a tailored mobile app that trains people with Parkinson's or Huntington's disease to shift threat-related thinking and reduce anxiety.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 136 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | University of Virginia Academic / other |
| Locations | 1 site (Charlottesville, Virginia) |
| Trial ID | NCT07213648 on ClinicalTrials.gov |
What this trial studies
This is a pilot randomized controlled trial enrolling 136 participants with Parkinson's disease or Huntington's disease and measurable anxiety symptoms. Half of participants will use the MindTrails-Movement app with daily cognitive bias modification for interpretation (CBM-I) training and nightly surveys for six weeks, while the waitlist control group uses a version of the app without CBM-I and completes the same surveys. Outcomes are collected at baseline, every two weeks during the 6-week intervention, and at a 4-week follow-up (week 10). The trial excludes people with cognitive impairment that prevents consent or use of the app, active suicidality, non-English speakers, those without an internet-connected device, and people living outside the USA.
Who should consider this trial
Good fit: Ideal candidates are adults in the USA with Parkinson's disease or Huntington's disease who have measurable anxiety symptoms, can consent, and can use a smartphone or tablet.
Not a fit: Patients with significant cognitive impairment, active suicidality, no regular internet-connected device, non-English speakers, or who live outside the USA are unlikely to benefit from or be eligible for this intervention.
Why it matters
Potential benefit: If successful, this could provide a low-cost, home-delivered way to reduce anxiety symptoms for people with Parkinson's and Huntington's disease.
How similar studies have performed: CBM-I approaches have produced modest anxiety reduction in general and some clinical populations, but mobile, tailored CBM-I for Parkinson's and Huntington's disease is relatively novel and not yet validated in larger trials.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Charlottesville, Virginia
- Univeristy of Virginia School of Nursing — Charlottesville, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Jessie Gibson, PhD, RN
- Email: MindTrailsMovement@uvahealth.org
- Phone: 434-924-0107
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.