Clincosm LogoSign in Get a demo

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

Sponsor
University of Virginia (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05126862
Collaborator
(none)
40
Enrollment
1
Location
1
Arm
11.7
Anticipated Duration (Months)
3.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: MindTrails
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Two single groups will be recruited: one including participants with Huntington's disease and the other including participants with Parkinson's disease.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)
Primary Purpose:
Treatment
Official Title:
Measurement and Modification of Threat Interpretation Bias in Neurodegenerative Movement Disorders (Aims 2 & 3)
Actual Study Start Date :
Dec 10, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: MindTrails pilot

This intervention involves completion of five, 20-minute MindTrails online training sessions over five weeks.

Behavioral: MindTrails
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.

Outcome Measures

Primary Outcome Measures

  1. 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

  2. Participant perceptions of perceived benefits and limitations of MindTrails [After completion of the intervention (week 5)]

    Semi-structured interviews

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Virginia Charlottesville Virginia United States 22903

Sponsors and Collaborators

  • University of Virginia

Investigators

  • Principal Investigator: Jessie S Gibson, PhD, RN, University of Virginia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jessie Gibson, PhD, RN, Assistant Professor, University of Virginia
ClinicalTrials.gov Identifier:
NCT05126862
Other Study ID Numbers:
  • HSR 210113
First Posted:
Nov 19, 2021
Last Update Posted:
May 25, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jessie Gibson, PhD, RN, Assistant Professor, University of Virginia
Anxiety
Interpretation bias
Cognitive bias modification
Additional relevant MeSH terms:
Parkinson Disease
Huntington Disease
Movement Disorders

Study Results

No Results Posted as of May 25, 2022