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

NCT05126862 | Completed Results

• 2 other identifiers: HSR 210113KL2TR003016
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Huntington Disease; Parkinson Disease

Keywords

Anxiety; Interpretation bias; Cognitive bias modification

Outcome Measures

Primary Outcomes (2)

• Proportion of Participants Completing at Least 50% of the MindTrails Sessions

  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)

  Between baseline and week 5

• Participant Perceptions of Perceived Benefits and Limitations of MindTrails

  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.

  After completion of the intervention (week 5)

Study Arms (1)

MindTrails pilot

EXPERIMENTAL

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

Behavioral: MindTrails

Interventions

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.

MindTrails pilot

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Huntington's disease or Parkinson's disease
• Age 21 or older
• Has anxiety symptoms (NeuroQoL Anxiety short form \>12)

You may not qualify if:

• Unable to read and understand English
• Previously diagnosed with dementia
• Not located in the USA

Sponsors & Collaborators

• University of Virginia: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Huntington Disease; Parkinson Disease; Anxiety Disorders

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Chorea; Dyskinesias; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Parkinsonian Disorders; Synucleinopathies

Results Point of Contact

• Title: Jessie Gibson, PhD, RN
• Organization: University of Virginia School of Nursing

js6zn@virginia.edu

434-924-0107

Study Officials

• Jessie S Gibson, PhD, RN

  University of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Two single groups will be recruited: one including participants with Huntington's disease and the other including participants with Parkinson's disease.

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: November 19, 2021
• Study Start: December 10, 2021
• Primary Completion: July 9, 2023
• Study Completion: July 9, 2023
• Last Updated: December 20, 2024
• Results First Posted: December 20, 2024

Record last verified: 2024-12

Locations

US (1)