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OpenTrials
Completed

NCT Number: NCT05126862

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MindTrails

Behavioral

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 outcomes

  1. Proportion of Participants Completing at Least 50% of the MindTrails Sessions

    Time frame: 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)

  2. Participant Perceptions of Perceived Benefits and Limitations of MindTrails

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 19, 2021
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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