Health TrialsbyHealthPanel

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

ConditionsHuntington DiseaseParkinson Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorUniversity of Virginia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinical diagnosis of Huntington's disease or Parkinson's disease (genetic diagnosis of HD also acceptable)

With anxiety symptoms (NeuroQoL Anxiety ≥12)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • MindTrails-Movement

    Behavioral

    CBM-I training app with active CBM-I training condition

  • Waitlist Control

    Other intervention

    Version of MindTrails-Movement app including surveys and list of support resources but without active CBM-I training component

Treatment groups

136 Participants
are divided into 2 treatment groups
Group A: MindTrails-Movement CBM-I ConditionExperimental treatment 1 intervention
Group B: Waitlist Control ConditionOther 1 intervention

Trial outcomes

Primary outcomes

1

Quality of Life in Neurological Disorders (NeuroQoL) Anxiety short form

Patient-reported anxiety symptoms will be measured using the Quality of Life in Neurological Disorders Anxiety short form (NeuroQoL-Anxiety) total raw scores. This measure includes 8 items ranked 1-5, where the total score is the sum of item scores (range 8-40), and higher scores indicate worse anxiety symptoms.

Time frame
From baseline to end of week 6

Secondary outcomes

1

Movement Disorders Interpretation Bias Scale (MDIB)

Movement Disorders Interpretation Bias Scale (MDIB) is a measure of interpretation bias in people with movement disorders. Participants rate the likelihood (0-4) of three alternate explanations (two benign and one negative) for why an ambiguous event occurred. To obtain negative external and internal bias scores, the mean of 5 negative ratings for external threats (Items 3c, 5a, 7a, 10a, 11c) and the mean of 4 negative ratings for internal threats (Items 1b, 4c, 8b, 12b) will be computed, where higher scores (possible range: 0-4) reflect more severe negative interpretation biases.

Time frame
From baseline to end of week 6
2

Parkinson Anxiety Scale (PAS)

The Parkinson Anxiety Scale (PAS) total score will be used as a secondary measure of patient-reported anxiety symptoms. PAS includes 12 self-report items that make up three subscales (persistent and episodic anxiety and avoidant behavior). Items are ranked 0-4 with a maximum total score of 48, where higher scores indicate worse anxiety symptoms.

Time frame
From baseline to end of week 6
3

Brief Body Sensations Interpretation Questionnaire (BBSIQ)

Brief Body Sensations Interpretation Questionnaire (BBSIQ) is a general measure of interpretation bias. Participants rate the likelihood (0-4) of three alternate explanations (two benign and one negative) for why an ambiguous event occurred. To obtain negative external and internal bias scores, the mean of 7 negative ratings for external threats (Items 1c, 4c, 6a, 7b, 9b, 10b, 13c) and the mean of 7 negative ratings for internal threats (Items 2b, 3c, 5a, 8c, 11b, 12a, 14c) will be computed, where higher scores (possible range: 0-4) reflect more severe negative interpretation biases.

Time frame
From baseline to end of week 6

Other outcomes

1

Quality of Life in Neurological Disorders (NeuroQoL) Depression short form

Patient-reported depressive symptoms will be measured using the Quality of Life in Neurological Disorders Depression short form (NeuroQoL-Depression) total raw scores. This measure includes 8 items ranked 1-5, where the total score is the sum of item scores (range 8-40), and higher scores indicate worse depressive symptoms.

Time frame
From baseline to end of week 6

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Virginia

Lead sponsor

National Institute of Nursing Research (NINR)

Collaborator

Source ClinicalTrials.gov
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