Learning Effective New Strategies for Worry in Parkinson's Disease (LENS-PD)

Learning Effective New Strategies - Parkinson's Disease

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 Overview

• Status: Unknown
• Conditions: Parkinson Disease; Anxiety
• Intervention / Treatment: Behavioral: Interpretation bias training

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE5 8AF
    • Recruiting
    • King's College London
    • Contact: Lonneke A van Tuijl, PhD; Phone Number: +31 503616655; Email: Lonneke.van_tuijl@kcl.ac.uk
    • Contact: Hannah C Krzyzanowski, MSc; Phone Number: +44 207848 5025; Email: hannah.c.krzyzanowski@kcl.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control	Behavioral: Interpretation bias training; Active: 50% positive endings to scenarios, 50% generation of positive endings to ambiguous scenarios Control: 100% ambiguous endings to scenarios with no instructions to imagine positive endings
Experimental: Active	Behavioral: Interpretation bias training; Active: 50% positive endings to scenarios, 50% generation of positive endings to ambiguous scenarios Control: 100% ambiguous endings to scenarios with no instructions to imagine positive endings

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability; rating of online training	Whether participants accept the online nature of the training (extent of positive feedback compared to negative feedback)	At approximately 4 weeks (during the feasibility interview)
Acceptability; lack of face-to-face contact	Whether participants accept the lack of face-to-face contact	At approximately 4 weeks (during the feasibility interview)
Acceptability; number of assignments	Whether participants accept the number of assignments	At approximately 4 weeks (during the feasibility interview)
Acceptability; duration of assignments	Whether participants accept the duration of assignments	At approximately 4 weeks (during the feasibility interview)
Acceptability; reminders	Whether participants accept the text messages/e-mail/phone call reminders	At approximately 4 weeks (during the feasibility interview)
Acceptability; randomisation	Proportion of eligible participants who agree to being randomised to those who do not agree	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.
Training feasibility; rate of recruitment	The feasibility of the training based on the rate of recruitment	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)
Training feasibility; retention rates	The feasibility of the training based on the retention rates during the training	Duration of study (approximately 5 months)
Training feasibility; study adherence	The feasibility of the training based on the adherence to the study (number of assignments completed)	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.
Training feasibility; retention at one-month follow-up	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)	Duration of study (approximately 5 months)
Training feasibility; retention at three-month follow-up	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)	Duration of study (approximately 5 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease in worry (estimation of effect size); post-training	The extent that worry has changed from before to after training in the active condition compared to the control condition based on the Penn State Worry Questionnaire (scores can range from 16 to 80; higher scores indicate more worry)	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	The extent that worry has changed from before training to the one month follow-up in the active compared to the control condition, as mediated by post-training worry scores, based on the Penn State Worry Questionnaire (scores can range from 16 to 80; higher scores indicate more worry)	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	The extent that worry has changed from before training to three months after training in the active condition compared to the control condition, as mediated by post-training worry scores, based on the Penn State Worry Questionnaire (scores can range from 16 to 80; higher scores indicate more worry)	Baseline worry scores will be compared to worry scores at the three-months follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in interpretation bias (scrambled sentences task)	Whether scores on the scrambled sentences task have changed specifically in the training condition. The scrambled sentences tasks involves unscrambling 20 sentences to form either position or negative solutions and is calculated by the proportion of negative solutions to positive solution (i.e., higher scores = more negative interpretation bias).	Comparing baseline scores to post-training (assessment 2; completed approximately 3 weeks later) scores
Improvement in interpretation bias (recognition test)	Whether scores on the recognition test have changed specifically in the training condition. The recognition test involves reading ten (ambiguous) scenarios and subsequently rating 4 sentences per scenario on how similar in meaning the (positive and negative) sentences are to the original scenario. Scores are based on how highly negative sentences are scored compared to positive sentences (i.e., higher scores = more negative interpretation bias).	Comparing baseline scores to post-training (assessment 2; completed approximately 3 weeks later) scores

Collaborators and Investigators

• Sponsor: King's College London

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2019
• Primary Completion (Anticipated): March 31, 2020
• Study Completion (Anticipated): March 31, 2020

Study Registration Dates

• First Submitted: June 24, 2019
• First Submitted That Met QC Criteria: July 2, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): October 31, 2019
• Last Update Submitted That Met QC Criteria: October 30, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: HR-18/19-8816

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Given the small sample size and specific characteristics of the sample - there is increased likeliness of identifying someone who took part. Other researchers can request data - this will be reviewed by the team per request to ensure there is no possibility to identify any individuals.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No