A Research Study to Evaluate the Benefits of a Self-management Booklet to Promote Wellbeing During the COVID-19 Pandemic
NCT04408157 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 185
Last updated 2022-10-13
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 [email protected]
Conditions
Interventions
- BEHAVIORAL
-
Self-management booklet (SWitCh: Stay well during COVID-19)
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.
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Federica Picariello, PhD · King's College London
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-05-20
- Primary Completion
- 2021-10-01
- Completion
- 2021-10-01
Countries
- United Kingdom
Study Locations
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