A Research Study to Evaluate the Benefits of a Self-management Booklet to Promote Wellbeing During the COVID-19 Pandemic

NCT04408157 | Completed

• 1 other identifier: v1.1 06.05.2020
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 1

Brief Summary

Background The immediate psychological impact of COVID-19 is already emerging. The investigators are interested in the benefits of a self-management booklet focused on the current circumstances in response to the COVID-19 pandemic on people's physical and mental wellbeing. Who can participate? The investigators are looking for participants aged 18 and over who live in the UK and can read and write in English, without any current serious mental health problems (e.g. bipolar disorder, PTSD, active thoughts of self-harm, or severe anxiety/depression), and who feel that their physical and/or mental wellbeing have been affected since the COVID-19 pandemic. What does the study involve? Eligible participants will complete questionnaires at baseline following which they will be randomly allocated to either receive the self-management booklet right away (via email) or after 4 months (waiting-list, in the meantime participants will be provided a link to educational materials). Participants will not be able to choose whether they will receive the self-management booklet right away or be in the waiting-list as a computer system (Qualtrics randomiser) will allocate them to one of the two groups at random. Participants in both conditions will be asked to complete online questionnaires at multiple time points, 2-months and 4-months after allocation. Participants in the waiting-list condition will also be asked to complete the same set of questionnaires at 6- and 8-months after allocation to assess how beneficial they found the self-management booklet. Participants will also be invited to take part in an audio-recorded interview after T2 to tell us more about how they found the self-management booklet or the educational materials. The investigators will select 30 participants (15 from each condition) for the interview out of those who opt-in to capture a wide range of experiences and backgrounds. What are the possible benefits and risks of participating? Risks to participants are small. Participants may find reflecting on the impact of COVID-19 on their lives distressing. However, these effects are anticipated to be short lived, as participants will learn psychological techniques during the intervention that can help them manage better in the current circumstances and improve their wellbeing. Where is the study run from? The lead site is King's College London. The study is run online via Qualtrics. When is the study starting and how long is it expected to run for? May 2020 to May 2021 Who is the main contact? Dr Federica Picariello federica.picariello@kcl.ac.uk

Conditions

COVID

Keywords

wellbeing; covid19

Outcome Measures

Primary Outcomes (1)

• Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS): Tennant et al., 2007

  validated self-report measure; scores range from 14 to 70 and higher scores indicate greater positive mental wellbeing.

  2 months post-randomisation

Secondary Outcomes (23)

• Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS): Tennant et al., 2007

  4 months post-randomisation

• Self-rated health status: Bombak, 2013

  2 months post-randomisation

• Self-rated health status: Bombak, 2013

  4 months post-randomisation

• Brief Resilience Scale (BRS): Smith et al., 2008

  2 months post-randomisation

• Brief Resilience Scale (BRS): Smith et al., 2008

  4 months post-randomisation

Other Outcomes (13)

• COVID-related behaviours

  Baseline (before randomisation), 2 and 4 months post-randomisation both arms, and 6 and 8 months post-randomisation control arm only.

• Change from baseline to follow-up on the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS): Tennant et al., 2007

  4 months post-randomisbaseline (before randomisation), 2 and 4 months post-randomisation both arms, and 6 and 8 months post-randomisation control arm only (non-randomised comparison of change)

• Change from baseline to follow-up on the Self-rated health status: Bombak, 2013

  4 months post-randomisbaseline (before randomisation), 2 and 4 months post-randomisation both arms, and 6 and 8 months post-randomisation control arm only (non-randomised comparison of change)

Study Arms (2)

Self-management booklet

EXPERIMENTAL

Self-management booklet: developed drawing on existing evidence and work conducted by researchers at the Health Psychology section at KCL, tailored to the current circumstances in response to the COVID-19 pandemic.

Behavioral: Self-management booklet (SWitCh: Stay well during COVID-19)

Education only (waiting-list)

NO INTERVENTION

Participants allocated to the waiting-list control arm will receive a link via email to educational materials related to COVID produced by King's College London for an online event and will be provided with the self-management booklet after completing the T2 assessment and qualitative interview. The topics covered in the online event are the same as the ones included in the self-management booklet, without structured guidance and behaviour change techniques to facilitate behaviour change.

Interventions

Self-management booklet (SWitCh: Stay well during COVID-19) BEHAVIORAL

The purpose of this booklet is to support adjustment to the current circumstances of the COVID-19 pandemic and facilitate the development and maintenance of healthy behaviours at home. The booklet covers a range of topics, including understanding bodily sensations and symptoms of COVID-19, managing the uncertainty surrounding COVID-19, physical activity, sedentary behaviour, sleep, social support and isolation, nutrition and alcohol consumption, sex and intimate relationships, and coping with children at home. The booklet will provide structured guidance on the various topics through the use of effective behaviour change techniques, in particular self-monitoring, goal setting, and problem solving and signposting to additional helpful resources, such as drinking or nutrition tracking apps.

Self-management booklet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 and over who live in the UK and can read and write in English, without any current serious mental health problems (e.g. bipolar disorder, PTSD, active thoughts of self-harm, or severe anxiety/depression) and who feel that their physical and/or mental wellbeing have been affected since the COVID-19 pandemic.

You may not qualify if:

• Any current serious mental health problems (e.g. bipolar disorder, PTSD, active thoughts of self-harm, or severe anxiety/depression) or who feel that their physical and/or mental wellbeing have not been affected by COVID-19

Sponsors & Collaborators

• King's College London: lead

Study Sites (1)

Online recruitment through Qualtrics

London, United Kingdom

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Federica Picariello, PhD

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinding not possible as passive control arm and using self-report outcomes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-arm parallel randomised-controlled trial with nested qualitative study

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: May 29, 2020
• Study Start: May 20, 2020
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: October 13, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)