Back to resultsMeasurement and Modification of Threat Interpretation Bias in Neurodegenerative Movement Disorders (Aims 2 & 3)
Primary Purpose
Huntington Disease, Parkinson Disease
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MindTrails
Sponsored by
About this trial
This is an interventional treatment trial for Huntington Disease focused on measuring Anxiety, Interpretation bias, Cognitive bias modification
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of Huntington's disease or Parkinson's disease
- Age 21 or older
- Has anxiety symptoms (NeuroQoL Anxiety short form >12)
Exclusion Criteria:
- Unable to read and understand English
- Previously diagnosed with dementia
- Not located in the USA
Sites / Locations
- University of Virginia
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MindTrails pilot
Arm Description
This intervention involves completion of five, 20-minute MindTrails online training sessions over five weeks.
Outcomes
Primary Outcome Measures
Proportion of participants completing at least 50% of the MindTrails sessions
Proportion of participants completing at least 50% of the MindTrails sessions
Participant perceptions of perceived benefits and limitations of MindTrails
Semi-structured interviews
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05126862
Brief Title
Measurement and Modification of Threat Interpretation Bias in Neurodegenerative Movement Disorders (Aims 2 & 3)
Official Title
Measurement and Modification of Threat Interpretation Bias in Neurodegenerative Movement Disorders (Aims 2 & 3)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 10, 2021 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is conduct a pilot open trial of a web-based cognitive bias modification intervention to reduce anxiety symptoms in persons with Huntington's disease and persons with Parkinson's disease.
Detailed Description
After being informed about the study and giving informed consent, participants will enroll in a pilot open trial of MindTrails, a web-based cognitive bias modification intervention. Participants will complete five, 20-minute MindTrails training sessions over five weeks. Additionally, assessments of anxiety, interpretation bias, and other related outcomes will be completed at baseline, week 3, week 5, and 2 months following the last training session. Participants will each complete a semi-structured interview to provide qualitative feedback about their experiences with MindTrails and anxiety.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Huntington Disease, Parkinson Disease
Keywords
Anxiety, Interpretation bias, Cognitive bias modification
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Two single groups will be recruited: one including participants with Huntington's disease and the other including participants with Parkinson's disease.
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MindTrails pilot
Arm Type
Experimental
Arm Description
This intervention involves completion of five, 20-minute MindTrails online training sessions over five weeks.
Intervention Type
Behavioral
Intervention Name(s)
MindTrails
Intervention Description
MindTrails is a web-based cognitive bias modification intervention. Training sessions are designed to encourage cognitive flexibility through repeated practice assigning benign resolutions to ambiguous, anxiety-provoking situations.
Primary Outcome Measure Information:
Title
Proportion of participants completing at least 50% of the MindTrails sessions
Description
Proportion of participants completing at least 50% of the MindTrails sessions
Time Frame
Between baseline and week 5
Title
Participant perceptions of perceived benefits and limitations of MindTrails
Description
Semi-structured interviews
Time Frame
After completion of the intervention (week 5)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Huntington's disease or Parkinson's disease
Age 21 or older
Has anxiety symptoms (NeuroQoL Anxiety short form >12)
Exclusion Criteria:
Unable to read and understand English
Previously diagnosed with dementia
Not located in the USA
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessie S Gibson, PhD, RN
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Measurement and Modification of Threat Interpretation Bias in Neurodegenerative Movement Disorders (Aims 2 & 3)
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