COVIDSWitChNCT04408157
A Research Study to Evaluate the Benefits of a Self-management Booklet to Promote Wellbeing During the COVID-19 Pandemic
A study testing Self-management booklet (SWitCh: Stay well during COVID-19) in people with COVID, run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID
- What is being tested?
- Self-management booklet (SWitCh: Stay well during COVID-19)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 May 2020to 1 Oct 2021
- 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 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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
Read the 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.
- Conditions
- COVID
- Being tested
- Self-management booklet (SWitCh: Stay well during COVID-19)
- Keywords
- wellbeing; covid19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-management booklet (SWitCh: Stay well during COVID-19)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months post-randomisation
Secondary outcomes (23)
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.
Measured: 4 months post-randomisation
Self-rated health status: Bombak, 2013
validated self-report measure; scores range from 0 to 100 and higher scores indicate better health
Measured: 2 months post-randomisation
Self-rated health status: Bombak, 2013
validated self-report measure; scores range from 0 to 100 and higher scores indicate better health
Measured: 4 months post-randomisation
Brief Resilience Scale (BRS): Smith et al., 2008
validated self-report measure; items are averaged to create a total score, ranging from 1 to 7 and higher total scores indicate higher levels of resilience.
Measured: 2 months post-randomisation
Brief Resilience Scale (BRS): Smith et al., 2008
validated self-report measure; items are averaged to create a total score, ranging from 1 to 7 and higher total scores indicate higher levels of resilience.
Measured: 4 months post-randomisation
Intolerance of Uncertainty Scale (IUS-12): Carleton et al., 2007
validated self-report measure; total scores range from 12 to 60 and higher scores indicate higher intolerance of uncertainty
Measured: 2 months post-randomisation
Intolerance of Uncertainty Scale (IUS-12): Carleton et al., 2007
validated self-report measure; total scores range from 12 to 60 and higher scores indicate higher intolerance of uncertainty
Measured: 4 months post-randomisation
Positive Affect subscale of the Positive and Negative Affect Scale-X (PANAS-X): Watson & Clark, 1999
validated self-report measure; positive affect items (N=27) are rated on a five-point scale (1) very slightly or not at all, (2) a little, (3) moderately, (4) quite a bit, and (5) extremely and can be grouped into subscales according to Watson, D., \& Clark, L. A. (1999). The PANAS-X: Manual for the positive and negative affect schedule-expanded form. Higher scores indicate higher levels of positive affect states.
Measured: 2 months post-randomisation
Positive Affect subscale of the Positive and Negative Affect Scale-X (PANAS-X): Watson & Clark, 1999
validated self-report measure; positive affect items (N=27) are rated on a five-point scale (1) very slightly or not at all, (2) a little, (3) moderately, (4) quite a bit, and (5) extremely and can be grouped into subscales according to Watson, D., \& Clark, L. A. (1999). The PANAS-X: Manual for the positive and negative affect schedule-expanded form. Higher scores indicate higher levels of positive affect states.
Measured: 4 months post-randomisation
UCLA 3 item loneliness scale: Russell, 1996
validated self-report measure; total scores range from 3 to 9 and higher scores indicate higher levels of loneliness
Measured: 2 months post-randomisation
UCLA 3 item loneliness scale: Russell, 1996
validated self-report measure; total scores range from 3 to 9 and higher scores indicate higher levels of loneliness
Measured: 4 months post-randomisation
Multidimensional Scale of Perceived Social Support (MSPSS): Zimet et al., 1988
validated self-report measure; the scale consists of three subscales (family, friends, and significant other) that contain 4 items each; each subscale score can range from 4 to 28. Items are summed, and a total score is also calculated and ranges from 12 to 84. Higher subscale and total scores indicate higher levels of perceived social support.
Measured: 2 months post-randomisation
Multidimensional Scale of Perceived Social Support (MSPSS): Zimet et al., 1988
validated self-report measure; the scale consists of three subscales (family, friends, and significant other) that contain 4 items each; each subscale score can range from 4 to 28. Items are summed, and a total score is also calculated and ranges from 12 to 84. Higher subscale and total scores indicate higher levels of perceived social support.
Measured: 4 months post-randomisation
Subjective Health Complaint Scale (SHC): Eriksen, Ihlebæk, & Ursin, 1999
validated self-report measure; a total score will be obtained for each symptom (severity x duration) with a possible range from 0 to 90, with higher scores indicating greater severity of a symptom, total number of symptoms reported, and a total score from 0 to 84 with higher scores indicating greater severity of somatic complaints.
Measured: 2 months post-randomisation
Subjective Health Complaint Scale (SHC): Eriksen, Ihlebæk, & Ursin, 1999
validated self-report measure; a total score will be obtained for each symptom (severity x duration) with a possible range from 0 to 90, with higher scores indicating greater severity of a symptom, total number of symptoms reported, and a total score from 0 to 84 with higher scores indicating greater severity of somatic complaints.
Measured: 4 months post-randomisation
Leeds Sleep Evaluation Questionnaire (LSEQ): Parrott & Hindmarch, 1980
validated self-report measure; responses are measured using a 100-mm scale and are then averaged to provide a score for each domain and higher scores indicate better sleep.
Measured: 2 months post-randomisation
Leeds Sleep Evaluation Questionnaire (LSEQ): Parrott & Hindmarch, 1980
validated self-report measure; responses are measured using a 100-mm scale and are then averaged to provide a score for each domain and higher scores indicate better sleep.
Measured: 4 months post-randomisation
Self-reported napping: Stone et al., 2018
self-report measure used in Stone et al., 2018; self-reported napping is defined as reporting at least 1 hour of napping each time and responses will be categorised as follows: no napping=coded as 0; <1 hour=coded as 1, 1-2 hours=coded as 2, and >2 hours=coded as 3.
Measured: 2 months post-randomisation
Self-reported napping: Stone et al., 2018
self-report measure used in Stone et al., 2018; self-reported napping is defined as reporting at least 1 hour of napping each time and responses will be categorised as follows: no napping=coded as 0; <1 hour=coded as 1, 1-2 hours=coded as 2, and >2 hours=coded as 3.
Measured: 4 months post-randomisation
Work and Social Adjustment Scale (WSAS): Mundt et al., 2002
validated self-report measure; total scores range from 0 to 40 and higher scores indicate greater impairment
Measured: 2 months post-randomisation
Work and Social Adjustment Scale (WSAS): Mundt et al., 2002
validated self-report measure; total scores range from 0 to 40 and higher scores indicate greater impairment
Measured: 4 months post-randomisation
International Physical Activity Questionnaire -short form (IPAQ-SF): Craig et al., 2003
validated self-report measure; The questionnaire can be scored categorically according to developed cut-offs to classify individuals into low, moderate, or high physical activity groups; or it can be scored continuously. Responses can be converted to Metabolic Equivalent Task minutes per week (METmin/wk), according to the IPAQ scoring protocol. MET scores across the three sub-components can be summed to indicate overall physical activity
Measured: 2 months post-randomisation
International Physical Activity Questionnaire -short form (IPAQ-SF): Craig et al., 2003
validated self-report measure; The questionnaire can be scored categorically according to developed cut-offs to classify individuals into low, moderate, or high physical activity groups; or it can be scored continuously. Responses can be converted to Metabolic Equivalent Task minutes per week (METmin/wk), according to the IPAQ scoring protocol. MET scores across the three sub-components can be summed to indicate overall physical activity
Measured: 4 months post-randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start20 May 2020
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by King's College LondonThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm parallel randomised-controlled trial with nested qualitative study
- Masking
- None (open label)
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Federica Picariello, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04408157
- Sponsor's protocol ID
- v1.1 06.05.2020
- Acronym
- SWitCh
- Status last verified
- Sep 2021
- First submitted
- 26 May 2020
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be confidentially and securely stored for 7 years as per University policy. Anonymised aggregated data will be made available upon request to the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04408157
- Acronym / sponsor ID
- SWitCh / v1.1 06.05.2020
- Conditions
- COVID
- Keywords
- wellbeing; covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 20 May 2020 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 29 May 2020 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm parallel randomised-controlled trial with nested qualitative study
| Arm | Type | Receives |
|---|---|---|
| Self-management booklet | Experimental | Behavioral: Self-management booklet (SWitCh: Stay well during COVID-19)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. |
| 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. |
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 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.
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| 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. | Behavioural | Self-management booklet |
Primary outcome
Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS): Tennant et al., 2007
Time frame: 2 months post-randomisation
validated self-report measure; scores range from 14 to 70 and higher scores indicate greater positive mental wellbeing.
23 secondary outcomes
Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS): Tennant et al., 2007
Time frame: 4 months post-randomisation
Self-rated health status: Bombak, 2013
Time frame: 2 months post-randomisation
Self-rated health status: Bombak, 2013
Time frame: 4 months post-randomisation
Brief Resilience Scale (BRS): Smith et al., 2008
Time frame: 2 months post-randomisation
Brief Resilience Scale (BRS): Smith et al., 2008
Time frame: 4 months post-randomisation
Intolerance of Uncertainty Scale (IUS-12): Carleton et al., 2007
Time frame: 2 months post-randomisation
Intolerance of Uncertainty Scale (IUS-12): Carleton et al., 2007
Time frame: 4 months post-randomisation
Positive Affect subscale of the Positive and Negative Affect Scale-X (PANAS-X): Watson & Clark, 1999
Time frame: 2 months post-randomisation
Positive Affect subscale of the Positive and Negative Affect Scale-X (PANAS-X): Watson & Clark, 1999
Time frame: 4 months post-randomisation
UCLA 3 item loneliness scale: Russell, 1996
Time frame: 2 months post-randomisation
UCLA 3 item loneliness scale: Russell, 1996
Time frame: 4 months post-randomisation
Multidimensional Scale of Perceived Social Support (MSPSS): Zimet et al., 1988
Time frame: 2 months post-randomisation
Multidimensional Scale of Perceived Social Support (MSPSS): Zimet et al., 1988
Time frame: 4 months post-randomisation
Subjective Health Complaint Scale (SHC): Eriksen, Ihlebæk, & Ursin, 1999
Time frame: 2 months post-randomisation
Subjective Health Complaint Scale (SHC): Eriksen, Ihlebæk, & Ursin, 1999
Time frame: 4 months post-randomisation
Leeds Sleep Evaluation Questionnaire (LSEQ): Parrott & Hindmarch, 1980
Time frame: 2 months post-randomisation
Leeds Sleep Evaluation Questionnaire (LSEQ): Parrott & Hindmarch, 1980
Time frame: 4 months post-randomisation
Self-reported napping: Stone et al., 2018
Time frame: 2 months post-randomisation
Self-reported napping: Stone et al., 2018
Time frame: 4 months post-randomisation
Work and Social Adjustment Scale (WSAS): Mundt et al., 2002
Time frame: 2 months post-randomisation
Work and Social Adjustment Scale (WSAS): Mundt et al., 2002
Time frame: 4 months post-randomisation
International Physical Activity Questionnaire -short form (IPAQ-SF): Craig et al., 2003
Time frame: 2 months post-randomisation
International Physical Activity Questionnaire -short form (IPAQ-SF): Craig et al., 2003
Time frame: 4 months post-randomisation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Individual participant dataSharing planned: No. Data will be confidentially and securely stored for 7 years as per University policy. Anonymised aggregated data will be made available upon request to the corresponding author.
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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.
Federica Picariello, PhD principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-management booklet (SWitCh: Stay well during COVID-19) in people with COVID, run by King's College London 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: finished, as of the sponsor's last update on 13 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS): Tennant et al., 2007 (time frame: 2 months post-randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2022.