Learning Effective New Strategies for Worry in Parkinson's Disease
NCT ID: NCT04007718
Last Updated: 2019-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2019-07-15
2020-03-31
Brief Summary
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In the current study, the aim is to test the acceptability and feasibility of an online training program that aims to encourage more positive interpretation bias in high worrying PwP. Participants complete an online baseline assessment, and are then invited to complete ten training sessions over a period of three weeks followed by another assessment and follow-up assessments (at 1 month \& 3 months). Participants are randomized into either the active condition or control condition. Across both conditions, participants will listen to short, everyday scenarios which are ambiguous (could end positively or negatively). In the active condition, a positive ending is given in half of the scenarios. In the other half, participants are instructed to imagine positive endings to ambiguous scenarios. In the control condition, all scenarios end ambiguously and no instructions are given about imagining positive endings.
The primary aim of the study is to test the acceptability and feasibility of the online training platform. Participants will complete a feasibility interview after completing the training. Specifically, the acceptability of the following will be tested: i) the online nature of the training (and lack of face-to-face contact); ii) being randomised into one of the two conditions; iii) the number and duration of the assignments; and iv) the text messages/e-mail/phone call reminders to complete the assignments. The feasibility of the online training platform will be judged on the i) rate of recruitment; ii) retention rates during the training; iii) adherence to the study (i.e., number of assignments completed); iv) retention rates at follow-up. The secondary aim is to estimate the effect size of the active condition (vs. control; on worry scores post-training, and at follow-ups) to inform power analyses for a future randomised control trial.
It is hypothesised that the training will be acceptable and feasible in a high worrying PwP sample. It is also hypothesised that the training will be effective in reducing worry and improving interpretation bias.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Active
Interpretation bias training
Active: 50% positive endings to scenarios, 50% generation of positive endings to ambiguous scenarios Control: 100% ambiguous endings to scenarios with no instructions to imagine positive endings
Control
Interpretation bias training
Active: 50% positive endings to scenarios, 50% generation of positive endings to ambiguous scenarios Control: 100% ambiguous endings to scenarios with no instructions to imagine positive endings
Interventions
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Interpretation bias training
Active: 50% positive endings to scenarios, 50% generation of positive endings to ambiguous scenarios Control: 100% ambiguous endings to scenarios with no instructions to imagine positive endings
Eligibility Criteria
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Inclusion Criteria
* can use a computer independently
* have (correct to) normal hearing
* scores above 62 on the Penn State Worry Questionnaire
Exclusion Criteria
* Currently or have recently (past six months) received psychological treatment.
* If participants are currently taking anti-depressants or anti-anxiety medication, they need to have been stable on the same dose for at least six weeks.
* Participants who score 2 or higher on the ninth item of the Patient Health Questionnaire-- (measuring suicidal ideation) at screening will be excluded.
* If individuals do not have regular access to a computer and/or the internet, they will be excluded.
* Those who can not concentrated on the questions asked during the Modified Telephone Interview for Cognitive Status, or are confused by the questions asked.
18 Years
ALL
No
Sponsors
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King's College London
OTHER
Responsible Party
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Dr Lonneke van_Tuijl
Research associate
Locations
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King's College London
London, , United Kingdom
Countries
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Facility Contacts
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Lonneke A van Tuijl, PhD
Role: primary
Hannah C Krzyzanowski, MSc
Role: backup
Other Identifiers
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HR-18/19-8816
Identifier Type: -
Identifier Source: org_study_id