Clinical trial NCT04408157: A Research Study to Evaluate the Benefits of a Self-management Booklet to Promote Wellbeing During the COVID-19 Pandemic
Official title: A Research Study to Evaluate the Efficacy of a Self-management Booklet (Stay Well During COVID-19; SWitCh) to Promote Wellbeing During the COVID-19 Pandemic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID
Keywords: wellbeing; covid19
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm parallel randomised-controlled trial with nested qualitative study
Primary purpose: TREATMENT

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

Detailed description: In the UK, over 4 in 5 Britons are worried about the effect COVID-19 is having on their life, with over half reporting that their wellbeing has been affected. Providing support for individuals to build optimal structures to maintain their physical and mental wellbeing is key to mitigate the consequences of the pandemic on day-to-day life and in the longer term. The investigators would like to conduct a randomised-controlled trial to test the efficacy of a theory-based self-management booklet to improve physical and mental wellbeing versus education alone. The trial will include a nested qualitative study to explore in a subgroup of participants their experiences of the self-management booklet or education alone. The primary objective is to examine the efficacy of the self-management booklet at improving wellbeing as compared to the waiting-list control arm 2-months post-randomisation. The investigators also want to explore the treatment effects of the self-management booklet on secondary outcomes (health status, day-to-day activities, resilience, intolerance of uncertainty, loneliness, social support, sleep quality, napping, sedentary behaviour, physical activity, and COVID-19-related behaviours, symptom complaints). Tertiary objectives include exploring changes in self-reported primary and secondary outcomes over time in a non-randomised analysis combining data from both arms and qualitatively exploring participants' perceptions of the acceptability and usefulness of the self-management booklet. These objectives will be addressed by a two-armed parallel randomised controlled trial (RCT) with a nested qualitative study. The study will be conducted through Qualitrics (including recruitment, randomisation, and data collection). Participants in both arms will be followed-up at 2 and 4 months post-randomisation. Additionally, participants in the control arm will receive the self-management booklet after the 4-months follow-up assessment and will be followed-up at 6 and 8 months post-randomisation.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS): Tennant et al., 2007
timeFrame: 2 months post-randomisation
Secondary outcomes:
measure: Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS): Tennant et al., 2007
timeFrame: 4 months post-randomisation
measure: Self-rated health status: Bombak, 2013
timeFrame: 2 months post-randomisation
measure: Self-rated health status: Bombak, 2013
timeFrame: 4 months post-randomisation
measure: Brief Resilience Scale (BRS): Smith et al., 2008
timeFrame: 2 months post-randomisation
measure: Brief Resilience Scale (BRS): Smith et al., 2008
timeFrame: 4 months post-randomisation
measure: Intolerance of Uncertainty Scale (IUS-12): Carleton et al., 2007
timeFrame: 2 months post-randomisation
measure: Intolerance of Uncertainty Scale (IUS-12): Carleton et al., 2007
timeFrame: 4 months post-randomisation
measure: Positive Affect subscale of the Positive and Negative Affect Scale-X (PANAS-X): Watson & Clark, 1999
timeFrame: 2 months post-randomisation
measure: Positive Affect subscale of the Positive and Negative Affect Scale-X (PANAS-X): Watson & Clark, 1999
timeFrame: 4 months post-randomisation
measure: UCLA 3 item loneliness scale: Russell, 1996
timeFrame: 2 months post-randomisation
measure: UCLA 3 item loneliness scale: Russell, 1996
timeFrame: 4 months post-randomisation
measure: Multidimensional Scale of Perceived Social Support (MSPSS): Zimet et al., 1988
timeFrame: 2 months post-randomisation
measure: Multidimensional Scale of Perceived Social Support (MSPSS): Zimet et al., 1988
timeFrame: 4 months post-randomisation
measure: Subjective Health Complaint Scale (SHC): Eriksen, Ihlebæk, & Ursin, 1999
timeFrame: 2 months post-randomisation
measure: Subjective Health Complaint Scale (SHC): Eriksen, Ihlebæk, & Ursin, 1999
timeFrame: 4 months post-randomisation
measure: Leeds Sleep Evaluation Questionnaire (LSEQ): Parrott & Hindmarch, 1980
timeFrame: 2 months post-randomisation
measure: Leeds Sleep Evaluation Questionnaire (LSEQ): Parrott & Hindmarch, 1980
timeFrame: 4 months post-randomisation
measure: Self-reported napping: Stone et al., 2018
timeFrame: 2 months post-randomisation
measure: Self-reported napping: Stone et al., 2018
timeFrame: 4 months post-randomisation
measure: Work and Social Adjustment Scale (WSAS): Mundt et al., 2002
timeFrame: 2 months post-randomisation
measure: Work and Social Adjustment Scale (WSAS): Mundt et al., 2002
timeFrame: 4 months post-randomisation
measure: International Physical Activity Questionnaire -short form (IPAQ-SF): Craig et al., 2003
timeFrame: 2 months post-randomisation
measure: International Physical Activity Questionnaire -short form (IPAQ-SF): Craig et al., 2003
timeFrame: 4 months post-randomisation
Other outcomes:
measure: COVID-related behaviours
timeFrame: Baseline (before randomisation), 2 and 4 months post-randomisation both arms, and 6 and 8 months post-randomisation control arm only.
measure: Change from baseline to follow-up on the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS): Tennant et al., 2007
timeFrame: 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)
measure: Change from baseline to follow-up on the Self-rated health status: Bombak, 2013
timeFrame: 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)
measure: Change from baseline to follow-up on the Brief Resilience Scale (BRS): Smith et al., 2008
timeFrame: 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)
measure: Change from baseline to follow-up on the Intolerance of Uncertainty Scale (IUS-12): Carleton et al., 2007
timeFrame: 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)
measure: Change from baseline to follow-up on the UCLA 3 item loneliness scale: Russell, 1996
timeFrame: 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)
measure: Change from baseline to follow-up on the Multidimensional Scale of Perceived Social Support (MSPSS): Zimet et al., 1988
timeFrame: 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)
measure: Change from baseline to follow-up on the Leeds Sleep Evaluation Questionnaire (LSEQ): Parrott & Hindmarch, 1980
timeFrame: 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)
measure: Change from baseline to follow-up on the Work and Social Adjustment Scale (WSAS): Mundt et al., 2002
timeFrame: 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)
measure: Change from baseline to follow-up on the International Physical Activity Questionnaire -short form (IPAQ-SF): Craig et al., 2003
timeFrame: 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)
measure: Change from baseline to follow-up in self-reported napping: Stone et al., 2018
timeFrame: 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)
measure: Change from baseline to follow-up on the Subjective Health Complaint Scale (SHC): Eriksen, Ihlebæk, & Ursin, 1999
timeFrame: 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)
measure: Change from baseline to follow-up in Positive Affect states on the Positive and Negative Affect Scale-X (PANAS-X): Watson & Clark, 1999
timeFrame: 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)
Locations:
city: London
country: United Kingdom
facility: Online recruitment through Qualtrics
Study officials:
affiliation: King's College London
name: Federica Picariello, PhD
role: PRINCIPAL_INVESTIGATOR
References: