Increased Adherence to Wearing Face CoveringsNCT05377814
Using Implementation Intentions Plans to Support Public Use of Face Coverings
A study testing Volitional help sheet in people with Increased Adherence to Wearing Face Coverings, run by University of Manchester at 1 site in United Kingdom.
Trial summary
The aim of the present research is to test the effectiveness of an implementation intention-based intervention for promoting the wearing of face coverings in three key settings, namely: transport, workplaces and leisure activities. Each participant will be randomly allocated to one of two conditions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Increased Adherence to Wearing Face Coverings
- What is being tested?
- Volitional help sheet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 May 2022to 31 Dec 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 and over Good verbal and written understanding of English
Who cannot join
- Aged under 18 years of age Poor verbal and written understanding of English
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The University of Manchester
Manchester, M13 9PL
Chris Keyworth, PhD, 0161 275 2589, c.keyworth@leeds.ac.uk
Chris Armitage, PhD, 01613066000, chris.armitage@manchester.ac.uk
About this study
The aim of the present research is to test the effectiveness of an implementation intention-based intervention for promoting the wearing of face coverings in three key settings, namely: transport, workplaces and leisure activities.
Each participant will be randomly allocated to one of two conditions. The two conditions are: (1) a control condition, and (2) intervention (form multiple implementation intentions from a drop-down menu). The main outcome measure will be use of face coverings.
Read the detailed description
Background and study aims
The investigators' previous research showed high levels of adherence to government instructions among a representative sample of the UK adult population during the COVID-19 pandemic (April 2020). The investigators were also able to provide concrete recommendations for interventions to support people's capabilities, opportunities and motivations in order to sustain behaviour change in the long term. One key recommendation was that interventions designed to bolster people's "automatic motivation" (i.e., habits, emotions) would likely lead to the largest improvements in adherence.
However, the research is limited by not looking separately at face coverings, which were not recommended at the time (April 2020), but were made mandatory in certain settings by July 2020. Since July 2020 Government guidance on whether or not people should wear face coverings to protect themselves and others in various settings has fluctuated and is currently (Feb 10 2022) 'recommended'. Vacillations in government advice may undermine future attempts to reinstate mandatory wearing of face coverings, when the need arises.
The investigators' more recent work on the wearing of face coverings specifically, carried out with opportunistic samples of 297 participants from two UK Universities, showed high levels of adherence to face coverings and similarly found that interventions designed to target automatic motivation would similarly have the largest benefits for increasing adherence.
The question then arises as to how one changes automatic motivation at scale in a public health setting. There is a long track record of research showing that implementation intentions are an effective means of changing behaviour, and that such changes in behaviour can be sustained over years. Implementation intentions help people overcome automatic motivation by making the critical situations that may elicit unwanted habits more salient, and ensuring that alternative strategies are deployed. They are best thought of as "if-then" plans: specifying an "if" ensures that triggers to unwanted habits receive greater attention and linking "ifs" with "thens" (e.g., seeking help from someone) ensures that the appropriate responses are automatized and replace the unwanted habit. Forming "if-then" plans thus overcome habits.
Aims
To test the effectiveness of an implementation intention-based intervention for promoting the wearing of face coverings in three key settings, namely: transport, workplaces and leisure activities.
Who can participate?
Adults aged over 18 years of age and have good verbal and written understanding of English
What does the study involve?
Participants complete a series of questionnaires about their wearing of face coverings and are then randomly allocated to one of the two groups. In the intervention group (volitional help sheet), participants will be presented with the stem "If I am tempted not to wear a face covering consistently…" and given 10 options with which to complete as many "if-then" plans as they like. These ten options have been taken from the literature and have been shown to be effective with respect to changing numerous behaviours, including self-harm, smoking, alcohol consumption and physical activity. Participants are asked to make a link (using drop-down menus as part of the online questionnaire) from the situation to their chosen solutions. They can create as many situation and solution pairs as they want. The (passive) control condition includes the same questionnaire as the experimental group (participants are not presented with the intervention). After 6 months participants are asked the same face covering questions to see if the intervention has increased adherence to wearing face coverings.
What are the possible benefits and risks of participating?
By taking part, participants will be helping to understand more about brief interventions to support increased adherence to wearing face coverings. By constructing their own "IF-THEN" plans participants are encouraged to construct their own action plans to deal with potential situations where face coverings would be beneficial.
Below are the main ethical issues and how they will be addressed:
Before giving consent (which will be online, as this is an online-based questionnaire), all project participants will be informed that YouGov will ensure that all data collected is stored confidentially in accordance with their privacy policy.
Participants are still free to withdraw themselves/their data until the data is anonymised (one week after the follow-up questionnaire). There will be no personally identifiable data in the research publication or in the SPSS file that YouGov send to the research team.
Data will not be shared with any researcher or organisation other than in ways detailed on the PIS. Data (which will be anonymised with no identifiable personal information) may be used for secondary analysis within the research team only.
Where is the study run from?
The University of Manchester (UK)
When is the study starting and how long is it expected to run for?
May 2022 to January 2023
Who is funding the study?
This work was supported by funding from the PROTECT COVID-19 National Core Study on transmission and environment, managed by the Health and Safety Executive on behalf of HM Government
Who is the main contact?
- Prof Christopher J. Armitage Chris.armitage@manchester.ac.uk
- Dr Chris Keyworth c.keyworth@leeds.ac.uk
Scientific title
Using IF-THEN plans to support public use of face coverings
Study hypothesis
Current study hypothesis as of 14/04/2022:
The condition that completes a volitional help sheet will report higher adherence to wearing of face coverings at follow-up than the control condition
Study design
Two-arm randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Increased adherence to wearing face coverings
Intervention
Participants complete a series of questionnaires about their current use of face coverings and are then randomly assigned to one of the two conditions:
- Participants in the intervention group will additionally be asked to form implementation intentions with respect to wearing face coverings. Participants will be presented with the stem "If I am tempted not to wear a face covering consistently…" and given 10 options with which to complete as many "if-then" plans as they like. These ten options have been taken from the literature and have been shown to be effective with respect to changing numerous behaviours, including self-harm, smoking, alcohol consumption and physical activity.
- The (passive) control condition includes the same questionnaire as the experimental group (participants are not presented with the intervention).
After 6 months participants are asked to report how often they have worn face coverings to see if the intervention has increased adherence to wearing face coverings.
Intervention type
Behavioural
- Being tested
- Volitional help sheet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volitional help sheetBehavioural
Participants are asked to choose from a list of strategies for increasing physical activity
| Study group | Role | What they receive |
|---|---|---|
| Passive control | No intervention | The (passive) control condition includes the same questionnaire as the experimental group, however participants are not presented with the intervention. |
| Intervention (volitional help sheet) | Experimental | Participants in the intervention group will be asked to form implementation intentions with respect to wearing face coverings. Participants will be presented with the stem "If I am tempted not to wear a face covering consistently…" and given 10 options with which to complete as many "if-then" plans as they like. These ten options have been taken from the literature and have been shown to be effective with respect to changing numerous behaviours, including self-harm, smoking, alcohol consumption and physical activity. Receives: Behavioral: Volitional help sheet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of face coverings
Participants will be asked to rate the extent to which they wear face coverings on 0-100% scales using the items, "Of the time you spent at work / on public transport / doing leisure activities that brought you into contact with other people in indoor spaces (e.g., cinemas, theatres, live music, nightclubs) in the last 7 days, roughly what percentage of it did you spend wearing a face covering?"
Measured: 6 months
Secondary outcomes (1)
Capability, opportunity and motivation (based on Capability, Opportunity, Motivation-Behaviour model)
Measured using the Capability, Opportunity, Motivation questionnaire. Each of the items (0-10 scale) will be analysed separately as these each measure a separate construct. Higher scores indicate higher agreement with statements.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start30 May 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Increased Adherence to Wearing Face CoveringsStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leeds
- Responsible party
- Principal investigator, Dr Chris Keyworth, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05377814
- Sponsor's protocol ID
- 2021-13300-21577
- Status last verified
- May 2022
- First submitted
- 11 May 2022
- Last updated
- 26 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Armitage CJ, Keyworth C, Leather JZ, Byrne-Davis L, Epton T. Identifying targets for interventions to support public adherence to government instructions to reduce transmission of SARS-CoV-2. BMC Public Health. 2021 Mar 17;21(1):522. doi: 10.1186/s12889-021-10574-6.
PubMed 33731056Conroy D, Smith DM, Armitage CJ. Very small effects of an imagery-based randomised trial to promote adherence to wearing face coverings during the COVID-19 pandemic and identification of future intervention targets. Psychol Health. 2023 Sep-Oct;38(10):1288-1308. doi: 10.1080/08870446.2021.2012574. Epub 2022 Jan 11.
PubMed 35014578Gollwitzer, P. M. (1993). Goal achievement: The role of intentions. European review of social psychology, 4(1), 141-185.
Armitage CJ. Evidence that implementation intentions can overcome the effects of smoking habits. Health Psychol. 2016 Sep;35(9):935-43. doi: 10.1037/hea0000344. Epub 2016 Apr 7.
PubMed 27054302Keyworth C, Epton T, Goldthorpe J, Calam R, Armitage CJ. Acceptability, reliability, and validity of a brief measure of capabilities, opportunities, and motivations ("COM-B"). Br J Health Psychol. 2020 Sep;25(3):474-501. doi: 10.1111/bjhp.12417. Epub 2020 Apr 20.
PubMed 32314500Armitage CJ, Keyworth C, Gartland N, Coleman A, Fishwick D, Johnson S, van Tongeren M. Theory-based Trial to Promote Uptake and Sustained Use of Face Coverings During the COVID-19 Pandemic. Ann Behav Med. 2023 Oct 16;57(11):921-928. doi: 10.1093/abm/kaad039.
PubMed 37656890
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Implementation Intentions Plans to Support Public Use of Face Coverings
- ClinicalTrials.gov ID
- NCT05377814
- Acronym / sponsor ID
- 2021-13300-21577
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- University of Leeds
- Study start
- 30 May 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 17 May 2022 (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.
The aim of the present research is to test the effectiveness of an implementation intention-based intervention for promoting the wearing of face coverings in three key settings, namely: transport, workplaces and leisure activities.
Each participant will be randomly allocated to one of two conditions. The two conditions are: (1) a control condition, and (2) intervention (form multiple implementation intentions from a drop-down menu). The main outcome measure will be use of face coverings.
Detailed description
Background and study aims
The investigators' previous research showed high levels of adherence to government instructions among a representative sample of the UK adult population during the COVID-19 pandemic (April 2020). The investigators were also able to provide concrete recommendations for interventions to support people's capabilities, opportunities and motivations in order to sustain behaviour change in the long term. One key recommendation was that interventions designed to bolster people's "automatic motivation" (i.e., habits, emotions) would likely lead to the largest improvements in adherence.
However, the research is limited by not looking separately at face coverings, which were not recommended at the time (April 2020), but were made mandatory in certain settings by July 2020. Since July 2020 Government guidance on whether or not people should wear face coverings to protect themselves and others in various settings has fluctuated and is currently (Feb 10 2022) 'recommended'. Vacillations in government advice may undermine future attempts to reinstate mandatory wearing of face coverings, when the need arises.
The investigators' more recent work on the wearing of face coverings specifically, carried out with opportunistic samples of 297 participants from two UK Universities, showed high levels of adherence to face coverings and similarly found that interventions designed to target automatic motivation would similarly have the largest benefits for increasing adherence.
The question then arises as to how one changes automatic motivation at scale in a public health setting. There is a long track record of research showing that implementation intentions are an effective means of changing behaviour, and that such changes in behaviour can be sustained over years. Implementation intentions help people overcome automatic motivation by making the critical situations that may elicit unwanted habits more salient, and ensuring that alternative strategies are deployed. They are best thought of as "if-then" plans: specifying an "if" ensures that triggers to unwanted habits receive greater attention and linking "ifs" with "thens" (e.g., seeking help from someone) ensures that the appropriate responses are automatized and replace the unwanted habit. Forming "if-then" plans thus overcome habits.
Aims
To test the effectiveness of an implementation intention-based intervention for promoting the wearing of face coverings in three key settings, namely: transport, workplaces and leisure activities.
Who can participate?
Adults aged over 18 years of age and have good verbal and written understanding of English
What does the study involve?
Participants complete a series of questionnaires about their wearing of face coverings and are then randomly allocated to one of the two groups. In the intervention group (volitional help sheet), participants will be presented with the stem "If I am tempted not to wear a face covering consistently…" and given 10 options with which to complete as many "if-then" plans as they like. These ten options have been taken from the literature and have been shown to be effective with respect to changing numerous behaviours, including self-harm, smoking, alcohol consumption and physical activity. Participants are asked to make a link (using drop-down menus as part of the online questionnaire) from the situation to their chosen solutions. They can create as many situation and solution pairs as they want. The (passive) control condition includes the same questionnaire as the experimental group (participants are not presented with the intervention). After 6 months participants are asked the same face covering questions to see if the intervention has increased adherence to wearing face coverings.
What are the possible benefits and risks of participating?
By taking part, participants will be helping to understand more about brief interventions to support increased adherence to wearing face coverings. By constructing their own "IF-THEN" plans participants are encouraged to construct their own action plans to deal with potential situations where face coverings would be beneficial.
Below are the main ethical issues and how they will be addressed:
Before giving consent (which will be online, as this is an online-based questionnaire), all project participants will be informed that YouGov will ensure that all data collected is stored confidentially in accordance with their privacy policy.
Participants are still free to withdraw themselves/their data until the data is anonymised (one week after the follow-up questionnaire). There will be no personally identifiable data in the research publication or in the SPSS file that YouGov send to the research team.
Data will not be shared with any researcher or organisation other than in ways detailed on the PIS. Data (which will be anonymised with no identifiable personal information) may be used for secondary analysis within the research team only.
Where is the study run from?
The University of Manchester (UK)
When is the study starting and how long is it expected to run for?
May 2022 to January 2023
Who is funding the study?
This work was supported by funding from the PROTECT COVID-19 National Core Study on transmission and environment, managed by the Health and Safety Executive on behalf of HM Government
Who is the main contact?
- Prof Christopher J. Armitage Chris.armitage@manchester.ac.uk
- Dr Chris Keyworth c.keyworth@leeds.ac.uk
Scientific title
Using IF-THEN plans to support public use of face coverings
Study hypothesis
Current study hypothesis as of 14/04/2022:
The condition that completes a volitional help sheet will report higher adherence to wearing of face coverings at follow-up than the control condition
Study design
Two-arm randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Increased adherence to wearing face coverings
Intervention
Participants complete a series of questionnaires about their current use of face coverings and are then randomly assigned to one of the two conditions:
- Participants in the intervention group will additionally be asked to form implementation intentions with respect to wearing face coverings. Participants will be presented with the stem "If I am tempted not to wear a face covering consistently…" and given 10 options with which to complete as many "if-then" plans as they like. These ten options have been taken from the literature and have been shown to be effective with respect to changing numerous behaviours, including self-harm, smoking, alcohol consumption and physical activity.
- The (passive) control condition includes the same questionnaire as the experimental group (participants are not presented with the intervention).
After 6 months participants are asked to report how often they have worn face coverings to see if the intervention has increased adherence to wearing face coverings.
Intervention type
Behavioural
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Passive control | No intervention | –The (passive) control condition includes the same questionnaire as the experimental group, however participants are not presented with the intervention. |
| Intervention (volitional help sheet) | Experimental | Behavioral: Volitional help sheetParticipants in the intervention group will be asked to form implementation intentions with respect to wearing face coverings. Participants will be presented with the stem "If I am tempted not to wear a face covering consistently…" and given 10 options with which to complete as many "if-then" plans as they like. These ten options have been taken from the literature and have been shown to be effective with respect to changing numerous behaviours, including self-harm, smoking, alcohol consumption and physical activity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Aged 18 and over Good verbal and written understanding of English
Key exclusion criteria (1 listed)
- Aged under 18 years of age Poor verbal and written understanding of English
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 |
|---|---|---|
| Volitional help sheetParticipants are asked to choose from a list of strategies for increasing physical activity | Behavioural | Intervention (volitional help sheet) |
Primary outcome
Use of face coverings
Time frame: 6 months
Participants will be asked to rate the extent to which they wear face coverings on 0-100% scales using the items, "Of the time you spent at work / on public transport / doing leisure activities that brought you into contact with other people in indoor spaces (e.g., cinemas, theatres, live music, nightclubs) in the last 7 days, roughly what percentage of it did you spend wearing a face covering?"
1 secondary outcome
Capability, opportunity and motivation (based on Capability, Opportunity, Motivation-Behaviour model)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Background: PubMed 33731056Armitage CJ, Keyworth C, Leather JZ, Byrne-Davis L, Epton T. Identifying targets for interventions to support public adherence to government instructions to reduce transmission of SARS-CoV-2. BMC Public Health. 2021 Mar 17;21(1):522. doi: 10.1186/s12889-021-10574-6.
- Background: PubMed 35014578Conroy D, Smith DM, Armitage CJ. Very small effects of an imagery-based randomised trial to promote adherence to wearing face coverings during the COVID-19 pandemic and identification of future intervention targets. Psychol Health. 2023 Sep-Oct;38(10):1288-1308. doi: 10.1080/08870446.2021.2012574. Epub 2022 Jan 11.
- BackgroundGollwitzer, P. M. (1993). Goal achievement: The role of intentions. European review of social psychology, 4(1), 141-185.
- Background: PubMed 27054302Armitage CJ. Evidence that implementation intentions can overcome the effects of smoking habits. Health Psychol. 2016 Sep;35(9):935-43. doi: 10.1037/hea0000344. Epub 2016 Apr 7.
- Background: PubMed 32314500Keyworth C, Epton T, Goldthorpe J, Calam R, Armitage CJ. Acceptability, reliability, and validity of a brief measure of capabilities, opportunities, and motivations ("COM-B"). Br J Health Psychol. 2020 Sep;25(3):474-501. doi: 10.1111/bjhp.12417. Epub 2020 Apr 20.
- Derived from this study: PubMed 37656890Armitage CJ, Keyworth C, Gartland N, Coleman A, Fishwick D, Johnson S, van Tongeren M. Theory-based Trial to Promote Uptake and Sustained Use of Face Coverings During the COVID-19 Pandemic. Ann Behav Med. 2023 Oct 16;57(11):921-928. doi: 10.1093/abm/kaad039.
- Individual participant dataSharing planned: No
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 Volitional help sheet in people with Increased Adherence to Wearing Face Coverings, run by University of Manchester 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 1 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: status not confirmed, as of the sponsor's last update on 26 May 2022. 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. 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?
Use of face coverings (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05377814, which also lists 6 linked publications.
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 26 May 2022.