- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05031559
Episodic Future Thinking and Compassion
August 26, 2021 updated by: Antonio Verdejo-García, Monash University
Episodic Future Thinking and Compassion Reduce Public Health Guideline Noncompliance Urges: A Randomised Controlled Trial
During the COVID-19 (Coronavirus Disease 2019) pandemic, public health departments have issued guidelines to limit viral transmission.
In this environment, people will feel urges to engage in activities that violate these guidelines, but research on guideline adherence has been reliant on surveys asking people to self-report their typical behaviour, which may fail to capture these urges as they unfold.
Guideline adherence could be improved through behaviour change interventions, but considering the wide range of behaviours that COVID-19 guidelines prescribe, there are few methods that allow observing changes of aggregate guideline adherence in the 'wild'.
In order to administer interventions and to obtain contemporaneous data on a wide range of behaviours, the researchers use ecological momentary assessment.
In this preregistered parallel randomised trial, 95 participants aged 18-65 from the United Kingdom were assigned to three conditions using blinded block randomisation, and engage in episodic future thinking (n = 33), compassion exercises (n = 31), or a sham procedure (n = 31) and report regularly on the intensity of their occurrent urges (min. 1, max.
10) and their ability to control them.
The researchers investigate whether state impulsivity and vaccine attitudes predict guideline adherence, while assessing through which mechanism these predictors affect behaviour.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
95
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Oxford, United Kingdom
- Prolific online participant recruitment platform
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Resides in the United Kingdom
- Fluent in English
- Must pass attention check in eligibility survey
Exclusion Criteria:
- Less than 50% compliance with ecological momentary assessment surveys
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Episodic Future Thinking
|
Participants are invited to imagine themselves in a positive situation after COVID-19 public health restrictions and guidelines are lifted.
They are then reminded that their actions are able to change how soon this future can be achieved.
|
EXPERIMENTAL: Compassion
|
Participants are invited to imagine themselves in someone else's situation, who is in a bad situation due to COVID-19 (e.g., ER nurse, family of someone in ICU).
They are then reminded that their decisions have an impact on the occurrence of these situations.
|
SHAM_COMPARATOR: Control
|
Participants are invited to reflect on some COVID-19 related news, and reminded that their actions have bearing on the COVID-19 situation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average strength of urges in ecological momentary assessment surveys
Time Frame: Multiple times per day, for one week.
|
Throughout each day, participants would receive 5 ecological momentary assessment surveys that were available for 1 hour.
In randomised order, they were asked whether since the last survey they had felt an urge to not wash their hands, not cover their mouths when coughing or sneezing, not socially distance (e.g. to hug, shake hands), not leave details for contact tracing, or whether they had felt an urge to leave their house, touch their face, or avoid getting tested when it would have been better to do the opposite - from a COVID-19 standpoint.
Participants responded using a slider [0,10], where 0 indicated no urge, 1 indicated a very weak urge, and 10 indicated a very strong urge.
|
Multiple times per day, for one week.
|
Average probability of controlling urges in ecological momentary assessment surveys
Time Frame: Multiple times per day, for one week.
|
Throughout each day, participants would receive 5 ecological momentary assessment surveys that were available for 1 hour.
In randomised order, they were asked whether since the last survey they had felt an urge to not wash their hands, not cover their mouths when coughing or sneezing, not socially distance (e.g. to hug, shake hands), not leave details for contact tracing, or whether they had felt an urge to leave their house, touch their face, or avoid getting tested when it would have been better to do the opposite - from a COVID-19 standpoint.
Participants responded using a slider [0,10], where 0 indicated no urge, 1 indicated a very weak urge, and 10 indicated a very strong urge.
Following that urge, participants are asked whether they gave in to that urge.
|
Multiple times per day, for one week.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average number of resisted urges
Time Frame: Multiple times per day, for one week.
|
Throughout each day, participants would receive 5 ecological momentary assessment surveys that were available for 1 hour.
In randomised order, they were asked whether since the last survey they had felt an urge to not wash their hands, not cover their mouths when coughing or sneezing, not socially distance (e.g. to hug, shake hands), not leave details for contact tracing, or whether they had felt an urge to leave their house, touch their face, or avoid getting tested when it would have been better to do the opposite - from a COVID-19 standpoint.
Participants responded using a slider [0,10], where 0 indicated no urge, 1 indicated a very weak urge, and 10 indicated a very strong urge.
Following that urge, participants are asked whether they tried to resist that urge.
|
Multiple times per day, for one week.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 29, 2021
Primary Completion (ACTUAL)
April 4, 2021
Study Completion (ACTUAL)
April 4, 2021
Study Registration Dates
First Submitted
August 23, 2021
First Submitted That Met QC Criteria
August 26, 2021
First Posted (ACTUAL)
September 2, 2021
Study Record Updates
Last Update Posted (ACTUAL)
September 2, 2021
Last Update Submitted That Met QC Criteria
August 26, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 26253
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Deidentified data are available on the Open Science Foundation (OSF) website.
IPD Sharing Time Frame
The data are permanently available.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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