Parkinson DiseaseLENS-PDNCT04007718
Learning Effective New Strategies for Worry in Parkinson's Disease
A study testing Interpretation bias training in people with Parkinson Disease and Anxiety, run by King's College London at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Anxiety
- What is being tested?
- Interpretation bias training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jul 2019to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
King's College London
London, SE5 8AF
Lonneke A van Tuijl, PhD, +31 503616655, Lonneke.van_tuijl@kcl.ac.uk
Hannah C Krzyzanowski, MSc, +44 207848 5025, hannah.c.krzyzanowski@kcl.ac.uk
About this study
Official title: 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.
Read more
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.
- Conditions
- Parkinson Disease, Anxiety
- Being tested
- Interpretation bias training
- Medical subject headings
- Parkinson Disease, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpretation bias trainingBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Not described Receives: Behavioral: Interpretation bias training |
| Control | Sham comparator | Not described Receives: Behavioral: Interpretation bias training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability; rating of online training
Whether participants accept the online nature of the training (extent of positive feedback compared to negative feedback)
Measured: 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
Measured: At approximately 4 weeks (during the feasibility interview)
Acceptability; number of assignments
Whether participants accept the number of assignments
Measured: At approximately 4 weeks (during the feasibility interview)
Acceptability; duration of assignments
Whether participants accept the duration of assignments
Measured: At approximately 4 weeks (during the feasibility interview)
Acceptability; reminders
Whether participants accept the text messages/e-mail/phone call reminders
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Duration of study (approximately 5 months)
Secondary outcomes (3)
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)
Measured: 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)
Measured: 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)
Measured: Baseline worry scores will be compared to worry scores at the three-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start15 Jul 2019
- Primary completion31 Mar 2020 (estimated)
- Study completion31 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Lonneke van_Tuijl, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04007718
- Sponsor's protocol ID
- HR-18/19-8816
- Acronym
- LENS-PD
- Status last verified
- Oct 2019
- First submitted
- 24 Jun 2019
- Last updated
- 31 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning Effective New Strategies - Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04007718
- Acronym / sponsor ID
- LENS-PD / HR-18/19-8816
- Conditions
- Parkinson Disease, Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 31 Mar 2020 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Behavioral: Interpretation bias training |
| Control | Sham comparator | Behavioral: Interpretation bias training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interpretation bias trainingActive: 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 | Behavioural | Active, Control |
Primary outcome
Acceptability; rating of online training
Time frame: At approximately 4 weeks (during the feasibility interview)
Whether participants accept the online nature of the training (extent of positive feedback compared to negative feedback)
Acceptability; lack of face-to-face contact
Time frame: At approximately 4 weeks (during the feasibility interview)
Whether participants accept the lack of face-to-face contact
Acceptability; number of assignments
Time frame: At approximately 4 weeks (during the feasibility interview)
Whether participants accept the number of assignments
Acceptability; duration of assignments
Time frame: At approximately 4 weeks (during the feasibility interview)
Whether participants accept the duration of assignments
Acceptability; reminders
Time frame: At approximately 4 weeks (during the feasibility interview)
Whether participants accept the text messages/e-mail/phone call reminders
Acceptability; randomisation
Time frame: 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.
Proportion of eligible participants who agree to being randomised to those who do not agree
Training feasibility; rate of recruitment
Time frame: 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)
The feasibility of the training based on the rate of recruitment
Training feasibility; retention rates
Time frame: Duration of study (approximately 5 months)
The feasibility of the training based on the retention rates during the training
Training feasibility; study adherence
Time frame: 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.
The feasibility of the training based on the adherence to the study (number of assignments completed)
Training feasibility; retention at one-month follow-up
Time frame: Duration of study (approximately 5 months)
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)
Training feasibility; retention at three-month follow-up
Time frame: Duration of study (approximately 5 months)
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)
3 secondary outcomes
Decrease in worry (estimation of effect size); post-training
Time frame: 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
Time frame: 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
Time frame: Baseline worry scores will be compared to worry scores at the three-months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2019.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interpretation bias training in people with Parkinson Disease and Anxiety, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability; rating of online training (time frame: At approximately 4 weeks (during the feasibility interview)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2019.