Measurement and Modification of Threat Interpretation Bias in Neurodegenerative Movement Disorders (Aims 2 & 3)

Not Applicable

Completed

• Conditions: Huntington Disease; Parkinson Disease

• Registration Number: NCT05126862
• Lead Sponsor: University of Virginia

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.

Study Timeline

• Study First Submitted: 2021-11-09
• Study First Submitted QC: 2021-11-09
• Study First Posted: 2021-11-19
• Study Start: 2021-12-10
• Primary Completion: 2023-07-09
• Study Completion: 2023-07-09
• Results First Submitted: 2024-07-01
• Status Verified: 2024-12
• Results First Submitted QC: 2024-12-16
• Last Update Submitted: 2024-12-16
• Results First Posted: 2025-03-25
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Proportion of Participants Completing at Least 50% of the MindTrails Sessions	Between baseline and week 5	Proportion of participants completing at least 50% of the MindTrails sessions (defined as proportion of participants who completed outcome assessments for at least 2 of the 3 timepoints measured during the intervention: baseline, week 3, and week 5)
Participant Perceptions of Perceived Benefits and Limitations of MindTrails	After completion of the intervention (week 5)	All participants in each arm were invited to complete a semi-structured interview to assess their experience with the intervention or barriers to beginning or completing the intervention. Interviews were transcribed, and separate codebooks were developed for PD and HD transcripts. Each transcript was coded by 2 coders, and any disagreements were resolved by a third coder. Frequency of overlapping codes under the "Experiences completing MindTrails" theme for each group (PD and HD) are reported here.

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States