Modification of Threat Interpretation Bias to Reduce Anxiety in Neurodegenerative Movement Disorders (Aim 3)

University of Virginia

Status: Enrolling

Conditions: Parkinson Disease; Huntington Disease

Treatments: Other: Waitlist Control; Behavioral: MindTrails-Movement

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07213648

K23NR020210 (U.S. NIH Grant/Contract)

HSR 220251

Details and patient eligibility

About

The purpose of this study is to assess preliminary efficacy of a tailored cognitive bias modification for interpretation (CBM-I) app for reducing anxiety in Huntington's disease and Parkinson's disease.

Full description

The investigators will conduct a pilot randomized controlled trial of the MindTrails-Movement CBM-I app in patients with Huntington's disease and Parkinson's disease (N=136). Participants randomly assigned to the intervention group (N=68) will be asked to download the MindTrails-Movement mobile app and to complete daily CBM-I training sessions and nightly surveys, in addition to surveys at baseline and every 2 weeks for the duration of the 6-week intervention and at 4-week follow-up (week 10).

Participants assigned to the waitlist control group will download a control version of the app without CBM-I training sessions. They will be asked to complete surveys in the app at baseline and every 2 weeks for the duration of the 6-week intervention and at 4-week follow-up (week 10). After 10 weeks, they will be offered the opportunity to access the version of MindTrails-Movement with CBM-I training content.

Enrollment: 136 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of Huntington's disease or Parkinson's disease (genetic diagnosis of HD also acceptable)
• With anxiety symptoms (NeuroQoL Anxiety ≥12)

Exclusion criteria

• Cognitive decline precluding ability to consent or complete the intervention (MoCA 5 min/telephone ≤11)
• Unable to read and understand English
• Does not have regular access to an internet-connected device, capable of downloading and installing the mobile application (i.e., tablet or iPhone running iOS 10 or later or an Android phone running Android 5.0 or later)
• Not located in the USA
• <21 years old
• Active suicidality based on the answer "yes" to questions 4, 5, or 6b of the Columbia-Suicide Severity Rating Scale (Screen version)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 2 patient groups

MindTrails-Movement CBM-I Condition

Experimental group

Description:

The intervention group (N=68) will include participants with Huntington's disease (N=34) and Parkinson's disease (N=34). Participants will download the MindTrails-Movement app with active CBM-I training condition and will be prompted to complete brief, daily CBM-I training sessions for a period of 6 weeks. They will complete surveys assessing mood symptoms and interpretation bias at baseline, end of week 2, end of week 4, and end of week 6 (end of intervention), then again at the end of week 10.

Treatment:

Behavioral: MindTrails-Movement

Waitlist Control Condition

Other group

Description:

The waitlist control group (N=68) will include participants with Huntington's disease (N=34) and Parkinson's disease (N=34). Participants will be asked to download a control version of the app that includes access to a list of support resources but does not include daily CBM-I training content. They will complete surveys assessing mood symptoms and interpretation bias at baseline, end of week 2, end of week 4, and end of week 6, and end of week 10. Waitlist control participants will be offered the opportunity to complete the intervention version of the app after they complete their final study assessments.

Treatment:

Other: Waitlist Control