Learning Effective New Strategies for Worry in Parkinson's Disease

Study Overview
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Brief Summary
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High rates of anxiety and worry has been observed in people with Parkinson's (PwP). Previous research outside of PwP has shown that individuals with anxiety have a habit of interpreting ambiguous information in a negative manner (i.e., interpretation bias), and that it is possible to encourage a more positive interpretation bias through an online training. 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.

Official Title
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Learning Effective New Strategies - Parkinson's Disease

Conditions
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Parkinson Disease, Anxiety

Intervention / Treatment
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* Behavioral: Interpretation bias training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with idiopathic Parkinson's Disease can use a computer independently have (correct to) normal hearing scores above 62 on the Penn State Worry Questionnaire Exclusion Criteria: Those who have previously taken part in lab-based studies at King's College London where measures of interpretation bias were included. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br> | Behavioral: Interpretation bias training<br>* 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<br>|
| Sham Comparator: Control<br> | Behavioral: Interpretation bias training<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability; rating of online training | Whether participants accept the online nature of the training (extent of positive feedback compared to negative feedback) | At approximately 4 weeks (during the feasibility interview) | 
| Acceptability; lack of face-to-face contact | Whether participants accept the lack of face-to-face contact | At approximately 4 weeks (during the feasibility interview) | 
| Acceptability; number of assignments | Whether participants accept the number of assignments | At approximately 4 weeks (during the feasibility interview) | 
| Acceptability; duration of assignments | Whether participants accept the duration of assignments | At approximately 4 weeks (during the feasibility interview) | 
| Acceptability; reminders | Whether participants accept the text messages/e-mail/phone call reminders | At approximately 4 weeks (during the feasibility interview) | 
| Acceptability; randomisation | Proportion of eligible participants who agree to being randomised to those who do not agree | Participants are asked during the eligibility call prior to starting the training if they are happy to be randomised. As such, acceptability to be randomised is at baseline. | 
| Training feasibility; rate of recruitment | The feasibility of the training based on the rate of recruitment | From recruitment start (moment when Parkinson's UK [United Kingdom] advertise the study) till study close (either end of November, 2019, or when the recruitment target is met; approximately 5 months) | 
| Training feasibility; retention rates | The feasibility of the training based on the retention rates during the training | Duration of study (approximately 5 months) | 
| Training feasibility; study adherence | The feasibility of the training based on the adherence to the study (number of assignments completed) | Assignments are completed over three weeks, with a possibility of a one week extension for those who have not completed at least 8 in the three weeks. | 
| Training feasibility; retention at one-month follow-up | The feasibility of the training based on the retention rates at follow-up (i.e., number of missing cases or drop outs at the one month follow-up) | Duration of study (approximately 5 months) | 
| Training feasibility; retention at three-month follow-up | The feasibility of the training based on the retention rates at follow-up (i.e., number of missing cases or drop outs at the three month follow-up) | Duration of study (approximately 5 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in worry (estimation of effect size); post-training | The extent that worry has changed from before to after training in the active condition compared to the control condition based on the Penn State Worry Questionnaire (scores can range from 16 to 80; higher scores indicate more worry) | Baseline worry scores will be compared to worry scores after the training (assessment 2; completed approximately 3 weeks later) | 
| Decrease in worry (estimation of effect size); at one-month follow-up | The extent that worry has changed from before training to the one month follow-up in the active compared to the control condition, as mediated by post-training worry scores, based on the Penn State Worry Questionnaire (scores can range from 16 to 80; higher scores indicate more worry) | Baseline worry scores will be compared to worry scores at the one-month follow-up | 
| Decrease in worry (estimation of effect size); at three-months follow-up | The extent that worry has changed from before training to three months after training in the active condition compared to the control condition, as mediated by post-training worry scores, based on the Penn State Worry Questionnaire (scores can range from 16 to 80; higher scores indicate more worry) | Baseline worry scores will be compared to worry scores at the three-months follow-up |