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.
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
- Are there results?
- Not yet: the study is under way
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
About this study
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 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 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.
- 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.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- 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)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Jessie Gibson, PhD, RN, University of Virginia
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modification of Threat Interpretation Bias to Reduce Anxiety in Neurodegenerative Movement Disorders (Aim 3)
- ClinicalTrials.gov ID
- NCT07213648
- Acronym / sponsor ID
- HSR 220251
- Conditions
- Huntington Disease, Parkinson Disease
- Keywords
- CBM-I, cognitive bias modification, interpretation bias, anxiety, mobile app, Huntington, Parkinson
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 9 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MindTrails-Movement CBM-I Condition | Experimental | Behavioral: MindTrails-MovementThe 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. |
| Waitlist Control Condition | Other | Other: Waitlist ControlThe 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of Huntington's disease or Parkinson's disease (genetic diagnosis of HD also acceptable)
- With anxiety symptoms (NeuroQoL Anxiety ≥12)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MindTrails-MovementCBM-I training app with active CBM-I training condition | Behavioural | MindTrails-Movement CBM-I Condition |
| Waitlist ControlVersion of MindTrails-Movement app including surveys and list of support resources but without active CBM-I training component | Other | Waitlist Control Condition |
Primary outcome
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.
3 secondary outcomes
Movement Disorders Interpretation Bias Scale (MDIB)
Time frame: From baseline to end of week 6
Parkinson Anxiety Scale (PAS)
Time frame: From baseline to end of week 6
Brief Body Sensations Interpretation Questionnaire (BBSIQ)
Time frame: From baseline to end of week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MindTrails-Movement in people with Huntington Disease and Parkinson Disease, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life in Neurological Disorders (NeuroQoL) Anxiety short form (time frame: From baseline to end of week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.