Learning Effective New Strategies - Parkinson's Disease
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- King's College London
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Acceptability; rating of online training
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Active
Intervention: Interpretation bias training (Behavioral)
Control
Intervention: Interpretation bias training (Behavioral)
Outcomes
Primary Outcomes
Acceptability; rating of online training
Time Frame: At approximately 4 weeks (during the feasibility interview)
Whether participants accept the online nature of the training (extent of positive feedback compared to negative feedback)
Training feasibility; rate of recruitment
Time Frame: 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)
The feasibility of the training based on the rate of recruitment
Training feasibility; study adherence
Time Frame: 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.
The feasibility of the training based on the adherence to the study (number of assignments completed)
Acceptability; duration of assignments
Time Frame: At approximately 4 weeks (during the feasibility interview)
Whether participants accept the duration of assignments
Acceptability; number of assignments
Time Frame: At approximately 4 weeks (during the feasibility interview)
Whether participants accept the number of assignments
Acceptability; reminders
Time Frame: At approximately 4 weeks (during the feasibility interview)
Whether participants accept the text messages/e-mail/phone call reminders
Acceptability; randomisation
Time Frame: 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.
Proportion of eligible participants who agree to being randomised to those who do not agree
Training feasibility; retention at one-month follow-up
Time Frame: Duration of study (approximately 5 months)
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)
Training feasibility; retention at three-month follow-up
Time Frame: Duration of study (approximately 5 months)
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)
Acceptability; lack of face-to-face contact
Time Frame: At approximately 4 weeks (during the feasibility interview)
Whether participants accept the lack of face-to-face contact
Training feasibility; retention rates
Time Frame: Duration of study (approximately 5 months)
The feasibility of the training based on the retention rates during the training
Secondary Outcomes
- Decrease in worry (estimation of effect size); post-training(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(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(Baseline worry scores will be compared to worry scores at the three-months follow-up)
Investigators
Dr Lonneke van_Tuijl
Research associate
King's College London