Compliant BehaviorNCT05031559
Episodic Future Thinking and Compassion
A study testing Episodic Future Thinking and Compassion Training in people with Compliant Behavior and Self-Control, run by Monash University at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Compliant Behavior, Self-Control, Impulsive Behavior
- What is being tested?
- Episodic Future Thinking and Compassion Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Mar 2021to 4 Apr 2021
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Resides in the United Kingdom
- Fluent in English
- Must pass attention check in eligibility survey
Who cannot join
- Less than 50% compliance with ecological momentary assessment surveys
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Prolific online participant recruitment platform
Oxford
About this study
Official title: 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.
- Conditions
- Compliant Behavior, Self-Control, Impulsive Behavior
- Being tested
- Episodic Future Thinking, Compassion Training, Sham
- Keywords
- Episodic future thinking, Compassion, Impulsivity, Self-control, Pandemic, Public Health
- Medical subject headings
- Cooperative Behavior, Self-Control, Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Episodic Future ThinkingBehavioural
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.
Compassion TrainingBehavioural
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.
ShamBehavioural
Participants are invited to reflect on some COVID-19 related news, and reminded that their actions have bearing on the COVID-19 situation.
| Study group | Role | What they receive |
|---|---|---|
| Episodic Future Thinking | Experimental | Not described Receives: Behavioral: Episodic Future Thinking |
| Compassion | Experimental | Not described Receives: Behavioral: Compassion Training |
| Control | Sham comparator | Not described Receives: Behavioral: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average strength of urges in ecological momentary assessment surveys
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.
Measured: Multiple times per day, for one week.
Average probability of controlling urges in ecological momentary assessment surveys
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.
Measured: Multiple times per day, for one week.
Secondary outcomes (1)
Average number of resisted urges
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.
Measured: Multiple times per day, for one week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start29 Mar 2021
- Primary completion4 Apr 2021
- Study completion4 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compliant BehaviorStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monash University
- Sponsor type
- University, hospital or other
- Collaborators
- Martin & Loreto Hosking's Three Springs Foundation, Australian Research Council
- Responsible party
- Principal investigator, Antonio Verdejo-García, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031559
- Sponsor's protocol ID
- 26253
- Status last verified
- Aug 2021
- First submitted
- 23 Aug 2021
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data are available on the Open Science Foundation (OSF) website.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Episodic Future Thinking and Compassion Reduce Public Health Guideline Noncompliance Urges: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05031559
- Acronym / sponsor ID
- 26253
- Conditions
- Compliant Behavior, Self-Control, Impulsive Behavior
- Keywords
- Episodic future thinking, Compassion, Impulsivity, Self-control, Pandemic, Public Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Monash UniversityUniversity, hospital or other
- Collaborators
- Martin & Loreto Hosking's Three Springs Foundation, Australian Research Council
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 4 Apr 2021 (actual)
- Study completion
- 4 Apr 2021 (actual)
- First posted
- 2 Sep 2021 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Episodic Future Thinking | Experimental | Behavioral: Episodic Future Thinking |
| Compassion | Experimental | Behavioral: Compassion Training |
| Control | Sham comparator | Behavioral: Sham |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Resides in the United Kingdom
- Fluent in English
- Must pass attention check in eligibility survey
Key exclusion criteria (1 listed)
- Less than 50% compliance with ecological momentary assessment surveys
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 |
|---|---|---|
| Episodic Future ThinkingParticipants 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. | Behavioural | Episodic Future Thinking |
| Compassion TrainingParticipants 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. | Behavioural | Compassion |
| ShamParticipants are invited to reflect on some COVID-19 related news, and reminded that their actions have bearing on the COVID-19 situation. | Behavioural | Control |
Primary outcome
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.
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.
1 secondary outcome
Average number of resisted urges
Time frame: Multiple times per day, for one week.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
- Individual participant dataSharing planned: Yes. Deidentified data are available on the Open Science Foundation (OSF) website.
Related trials for Compliant Behavior
Not yet recruiting
A Hybrid Effectiveness-Implementation and Cost-Utility Evaluation of a Support Programme for Informal Carers of People With Dementia in Primary Care (EsCuidar2)
Quality of Life
Active, not recruitingPhase 3
Outcomes of the PLHIV With Suboptimal Viral Suppression to Injectable Long-acting Antiretrovirals
HIV-1-infection, Non-Adherence, Medication
Active, not recruiting
A Multilevel Intervention to Improve Adherence to Childhood Cancer Survivorship
Childhood Cancer, Survivorship
Recruiting
Resistance vs Aerobic Prehabilitation Before Colorectal Cancer Surgery
Colorectal Cancer, Colorectal Neoplasms
Enrolling by invitation
Investigation of a Patient Support Intervention for Statin Medication Adherence
Medication Adherence
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Episodic Future Thinking and Compassion Training in people with Compliant Behavior and Self-Control, run by Monash University 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 2 Sep 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average strength of urges in ecological momentary assessment surveys (time frame: Multiple times per day, for one week.). The study lists 2 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 2 Sep 2021.