NCT05031559

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 29, 2021

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 2, 2021

Completed
Last Updated

September 2, 2021

Status Verified

August 1, 2021

Enrollment Period

6 days

First QC Date

August 23, 2021

Last Update Submit

August 26, 2021

Conditions

Keywords

Episodic future thinkingCompassionImpulsivitySelf-controlPandemicPublic Health

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Multiple times per day, for one week.

Secondary Outcomes (1)

  • Average number of resisted urges

    Multiple times per day, for one week.

Study Arms (3)

Episodic Future Thinking

EXPERIMENTAL
Behavioral: Episodic Future Thinking

Compassion

EXPERIMENTAL
Behavioral: Compassion Training

Control

SHAM COMPARATOR
Behavioral: Sham

Interventions

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.

Episodic Future Thinking

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.

Compassion
ShamBEHAVIORAL

Participants are invited to reflect on some COVID-19 related news, and reminded that their actions have bearing on the COVID-19 situation.

Control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Resides in the United Kingdom
  • Fluent in English
  • Must pass attention check in eligibility survey

You may not qualify if:

  • Less than 50% compliance with ecological momentary assessment surveys

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prolific online participant recruitment platform

Oxford, United Kingdom

Location

MeSH Terms

Conditions

Cooperative BehaviorSelf-ControlImpulsive Behavior

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants were not made aware whether they were in the control group or in one of the intervention groups.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 23, 2021

First Posted

September 2, 2021

Study Start

March 29, 2021

Primary Completion

April 4, 2021

Study Completion

April 4, 2021

Last Updated

September 2, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will share

Deidentified data are available on the Open Science Foundation (OSF) website.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
The data are permanently available.
More information

Locations