MindTrails App for Anxiety in Neurodegenerative Movement Disorders
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests an app called MindTrails-Movement to determine if it can reduce anxiety in people with Huntington's and Parkinson's diseases. The app employs cognitive bias modification for interpretation (CBM-I) to alter how users interpret events, potentially reducing anxiety. Participants will engage with the app in short, daily sessions over six weeks, while another group will wait and only access the app's support resources. This trial suits individuals diagnosed with Huntington's or Parkinson's disease who experience anxiety. As an unphased trial, it provides a unique opportunity to contribute to innovative research that could enhance anxiety management for these conditions.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that the MindTrails-Movement app is safe for individuals with neurodegenerative movement disorders?
Research shows that the MindTrails-Movement app is being tested to help reduce anxiety in people with Huntington's and Parkinson's diseases. Previous studies suggest that web-based tools can change thought patterns in this group. However, specific information on the app's safety remains limited.
The trial's "Not Applicable" phase designation indicates that the app is neither a drug nor a typical medical device, so it lacks the same safety data as those treatments. As a digital tool, it generally poses fewer safety concerns than drugs. Yet, without more specific safety results, determining how well people tolerate it is challenging.
For those considering joining such a trial, digital tools often present fewer risks than traditional treatments. However, consulting healthcare providers for more information is always advisable.12345Why are researchers excited about this trial?
Researchers are excited about the MindTrails-Movement app for anxiety in neurodegenerative movement disorders because it offers a unique approach through Cognitive Bias Modification for Interpretation (CBM-I) training. Unlike standard treatments for anxiety, which often include medications like SSRIs or therapy, this app provides a non-pharmacological, digital intervention that users can access daily at their convenience. The app's design allows it to target specific cognitive biases that contribute to anxiety, offering a personalized experience that can be seamlessly integrated into the daily lives of individuals with Huntington's and Parkinson's diseases. This innovative delivery method could potentially enhance accessibility and adherence to treatment, providing a promising complementary option to traditional therapies.
What evidence suggests that the MindTrails-Movement app is effective for reducing anxiety in Huntington's and Parkinson's disease?
Research has shown that the MindTrails-Movement app, available to participants in this trial, may help reduce anxiety in individuals with Huntington's and Parkinson's diseases. The app employs a method called cognitive bias modification for interpretation (CBM-I) to alter how users perceive situations, reducing anxiety. Early studies suggest that the app can decrease anxiety symptoms by training users to view everyday events more positively. Although further research is necessary, initial results are promising for managing anxiety related to these conditions.12456
Are You a Good Fit for This Trial?
This trial is for adults over 21 in the USA with Huntington's or Parkinson's disease who experience anxiety (NeuroQoL Anxiety score ≥12). Participants must be able to read English, have internet access, and a compatible device. Those with severe cognitive decline (MoCA ≤11) cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants in the intervention group complete daily CBM-I training sessions using the MindTrails-Movement app for 6 weeks, with surveys at baseline and every 2 weeks.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with a follow-up survey at week 10.
Open-label extension (optional)
Waitlist control participants are offered the opportunity to access the intervention version of the app after completing their final study assessments.
What Are the Treatments Tested in This Trial?
Interventions
- MindTrails-Movement
Trial Overview
The study tests a mobile app called MindTrails-Movement designed to reduce anxiety in people with Huntington's or Parkinson's disease. It compares outcomes of users against those on a waitlist control group without immediate app access.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Virginia
Lead Sponsor
National Institute of Nursing Research (NINR)
Collaborator
Citations
Modification of Threat Interpretation Bias to Reduce Anxiety ...
We will conduct a pilot randomized controlled trial of the MindTrails-Movement CBM-I app in patients with Huntington's disease and Parkinson's ...
MindTrails App for Anxiety in Neurodegenerative ...
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 ...
Qualitative Evaluation of a New App to Reduce Threat ...
We will evaluate a novel CBM-I intervention for reducing anxiety symptoms in people with Huntington's Disease (PwHD) and people with Parkinson's Disease (PwPD) ...
4.
app.trialscreen.org
app.trialscreen.org/trials/modification-threat-interpretation-bias-to-reduce-anxiety-neurodegenerative-trial-nct07213648Modification of Threat Interpretation Bias to Reduce Anxiety ...
A pilot randomized controlled trial of CBM-I app in Huntington's and Parkinson's disease ... Testing a mobile app designed to reduce anxiety in ...
Effectiveness of interpretation training to reduce anxiety
” The current proposal aims to compare effectiveness and target engagement of CBM-I delivered via computer vs. mobile phone, and test if adding minimal ...
Project Details - NIH RePORTER
Our preliminary work has demonstrated feasibility of web-based CBM-I in this population and identified the need to adapt CBM-I programs to meet the needs of ...
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