Clinical trial NCT04007718: Learning Effective New Strategies for Worry in Parkinson's Disease
Official title: Learning Effective New Strategies - Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Anxiety
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Acceptability; rating of online training
timeFrame: At approximately 4 weeks (during the feasibility interview)
measure: Acceptability; lack of face-to-face contact
timeFrame: At approximately 4 weeks (during the feasibility interview)
measure: Acceptability; number of assignments
timeFrame: At approximately 4 weeks (during the feasibility interview)
measure: Acceptability; duration of assignments
timeFrame: At approximately 4 weeks (during the feasibility interview)
measure: Acceptability; reminders
timeFrame: At approximately 4 weeks (during the feasibility interview)
measure: Acceptability; randomisation
timeFrame: 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.
measure: Training feasibility; rate of recruitment
timeFrame: 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)
measure: Training feasibility; retention rates
timeFrame: Duration of study (approximately 5 months)
measure: Training feasibility; study adherence
timeFrame: 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.
measure: Training feasibility; retention at one-month follow-up
timeFrame: Duration of study (approximately 5 months)
measure: Training feasibility; retention at three-month follow-up
timeFrame: Duration of study (approximately 5 months)
Secondary outcomes:
measure: Decrease in worry (estimation of effect size); post-training
timeFrame: Baseline worry scores will be compared to worry scores after the training (assessment 2; completed approximately 3 weeks later)
measure: Decrease in worry (estimation of effect size); at one-month follow-up
timeFrame: Baseline worry scores will be compared to worry scores at the one-month follow-up
measure: Decrease in worry (estimation of effect size); at three-months follow-up
timeFrame: Baseline worry scores will be compared to worry scores at the three-months follow-up
Other outcomes:
measure: Improvement in interpretation bias (scrambled sentences task)
timeFrame: Comparing baseline scores to post-training (assessment 2; completed approximately 3 weeks later) scores
measure: Improvement in interpretation bias (recognition test)
timeFrame: Comparing baseline scores to post-training (assessment 2; completed approximately 3 weeks later) scores
Locations:
city: London
country: United Kingdom
facility: King's College London
Study officials:
References: