NCT05377814

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
6,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 17, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

May 30, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

May 26, 2022

Status Verified

May 1, 2022

Enrollment Period

7 months

First QC Date

May 11, 2022

Last Update Submit

May 19, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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?"

    6 months

Secondary Outcomes (1)

  • Capability, opportunity and motivation (based on Capability, Opportunity, Motivation-Behaviour model)

    6 months

Study Arms (2)

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.

Behavioral: Volitional help sheet

Interventions

Participants are asked to choose from a list of strategies for increasing physical activity

Intervention (volitional help sheet)

Eligibility Criteria

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

You may qualify if:

  • Aged 18 and over Good verbal and written understanding of English

You may not qualify if:

  • Aged under 18 years of age Poor verbal and written understanding of English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Manchester

Manchester, M13 9PL, United Kingdom

Location

Related Publications (6)

  • 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.

    PMID: 33731056BACKGROUND
  • Conroy 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.

    PMID: 35014578BACKGROUND
  • Gollwitzer, P. M. (1993). Goal achievement: The role of intentions. European review of social psychology, 4(1), 141-185.

    BACKGROUND
  • 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.

    PMID: 27054302BACKGROUND
  • Keyworth 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.

    PMID: 32314500BACKGROUND
  • Armitage 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.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in Psychology

Study Record Dates

First Submitted

May 11, 2022

First Posted

May 17, 2022

Study Start

May 30, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

May 26, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations