NCT04007718: LENS-PD

Learning Effective New Strategies for Worry in Parkinson's Disease

Status unknown NA Last updated 31 October 2019

What this trial tests

NA trial testing Interpretation bias training in Parkinson Disease in 60 participants. Status unknown.

Timeline

15 July 2019

Primary endpoint
31 March 2020

31 March 2020

Quick facts

Lead sponsor	King's College London
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	other
Enrollment	60
Start date	15 July 2019
Primary completion	31 March 2020
Estimated completion	31 March 2020
Sites	1 location across United Kingdom

Drugs / interventions tested

• Interpretation bias training

Conditions studied

• Parkinson Disease — all drugs for Parkinson Disease →
• Anxiety — all drugs for Anxiety →

Sponsor

King's College London

Who can join

18 and older, any sex, with Parkinson Disease or Anxiety. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The neuropsychiatry of Parkinson's disease: advances and challenges.
   Weintraub D, Aarsland D, Chaudhuri KR, Dobkin RD, et al · · 2022 · cited 288× · PMID 34942142 · DOI 10.1016/s1474-4422(21)00330-6