Ignite Creation Date:
2024-05-06 @ 1:21 PM
Last Modification Date:
2024-10-26 @ 1:13 PM
Study NCT ID:
NCT04007718
Status:
UNKNOWN
Last Update Posted:
2019-10-31
First Post:
2019-06-24
Brief Title:
Learning Effective New Strategies for Worry in Parkinsons Disease
Sponsor:
Kings College London
Organization:
Kings College London
Study Overview
Official Title:
Learning Effective New Strategies - Parkinsons Disease
Status:
UNKNOWN
Status Verified Date:
2019-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LENS-PD
Brief Summary:
High rates of anxiety and worry has been observed in people with Parkinsons PwP Previous research outside of PwP has shown that individuals with anxiety have a habit of interpreting ambiguous information in a negative manner ie 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 messagese-mailphone 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 ie 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
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 messagese-mailphone 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 ie 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None