Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-25 @ 4:36 AM
NCT ID:
NCT04007718
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:
NCT04007718
Study Brief:
Protocol Section:
NCT04007718