Covid 19 Research using Clinical Trials (Home Page)
Self-management booklet (SWitCh: Stay well during COVID-19)Wiki
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (1)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug348 | Biological sample and clinical data collection Wiki | 1.00 |
Correlated HPO Terms (0)
| Name (Synonyms) | Correlation |
|---|
There is one clinical trial.
Clinical Trials
1 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. 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
NCT04408157 COVID Behavioral: Self-management booklet (SWitCh: Stay well during COVID-19)
Primary Outcomes
Description: validated self-report measure; scores range from 14 to 70 and higher scores indicate greater positive mental wellbeing.
Measure: Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS): Tennant et al., 2007 Time: 2 months post-randomisationSecondary Outcomes
Description: validated self-report measure; scores range from 14 to 70 and higher scores indicate greater positive mental wellbeing.
Measure: Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS): Tennant et al., 2007 Time: 4 months post-randomisationDescription: validated self-report measure; scores range from 0 to 100 and higher scores indicate better health
Measure: Self-rated health status: Bombak, 2013 Time: 2 months post-randomisationDescription: validated self-report measure; scores range from 0 to 100 and higher scores indicate better health
Measure: Self-rated health status: Bombak, 2013 Time: 4 months post-randomisationDescription: 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.
Measure: Brief Resilience Scale (BRS): Smith et al., 2008 Time: 2 months post-randomisationDescription: 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.
Measure: Brief Resilience Scale (BRS): Smith et al., 2008 Time: 4 months post-randomisationDescription: validated self-report measure; total scores range from 12 to 60 and higher scores indicate higher intolerance of uncertainty
Measure: Intolerance of Uncertainty Scale (IUS-12): Carleton et al., 2007 Time: 2 months post-randomisationDescription: validated self-report measure; total scores range from 12 to 60 and higher scores indicate higher intolerance of uncertainty
Measure: Intolerance of Uncertainty Scale (IUS-12): Carleton et al., 2007 Time: 4 months post-randomisationDescription: 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.
Measure: Positive Affect subscale of the Positive and Negative Affect Scale-X (PANAS-X): Watson & Clark, 1999 Time: 2 months post-randomisationDescription: 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.
Measure: Positive Affect subscale of the Positive and Negative Affect Scale-X (PANAS-X): Watson & Clark, 1999 Time: 4 months post-randomisationDescription: validated self-report measure; total scores range from 3 to 9 and higher scores indicate higher levels of loneliness
Measure: UCLA 3 item loneliness scale: Russell, 1996 Time: 2 months post-randomisationDescription: validated self-report measure; total scores range from 3 to 9 and higher scores indicate higher levels of loneliness
Measure: UCLA 3 item loneliness scale: Russell, 1996 Time: 4 months post-randomisationDescription: 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.
Measure: Multidimensional Scale of Perceived Social Support (MSPSS): Zimet et al., 1988 Time: 2 months post-randomisationDescription: 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.
Measure: Multidimensional Scale of Perceived Social Support (MSPSS): Zimet et al., 1988 Time: 4 months post-randomisationDescription: 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.
Measure: Subjective Health Complaint Scale (SHC): Eriksen, Ihlebæk, & Ursin, 1999 Time: 2 months post-randomisationDescription: 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.
Measure: Subjective Health Complaint Scale (SHC): Eriksen, Ihlebæk, & Ursin, 1999 Time: 4 months post-randomisationDescription: 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.
Measure: Leeds Sleep Evaluation Questionnaire (LSEQ): Parrott & Hindmarch, 1980 Time: 2 months post-randomisationDescription: 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.
Measure: Leeds Sleep Evaluation Questionnaire (LSEQ): Parrott & Hindmarch, 1980 Time: 4 months post-randomisationDescription: 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.
Measure: Self-reported napping: Stone et al., 2018 Time: 2 months post-randomisationDescription: 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.
Measure: Self-reported napping: Stone et al., 2018 Time: 4 months post-randomisationDescription: validated self-report measure; total scores range from 0 to 40 and higher scores indicate greater impairment
Measure: Work and Social Adjustment Scale (WSAS): Mundt et al., 2002 Time: 2 months post-randomisationDescription: validated self-report measure; total scores range from 0 to 40 and higher scores indicate greater impairment
Measure: Work and Social Adjustment Scale (WSAS): Mundt et al., 2002 Time: 4 months post-randomisationDescription: 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
Measure: International Physical Activity Questionnaire -short form (IPAQ-SF): Craig et al., 2003 Time: 2 months post-randomisationDescription: 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
Measure: International Physical Activity Questionnaire -short form (IPAQ-SF): Craig et al., 2003 Time: 4 months post-randomisationOther Outcomes
Description: non-validated self-report items (such as following guidelines with regards to social distancing, rated from 0 to 10 with higher scores indicating better adherence to guidelines)
Measure: COVID-related behaviours Time: Baseline (before randomisation), 2 and 4 months post-randomisation both arms, and 6 and 8 months post-randomisation control arm only.Description: validated self-report measure; scores range from 14 to 70 and higher scores indicate greater positive mental wellbeing.
Measure: Change from baseline to follow-up on the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS): Tennant et al., 2007 Time: 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)Description: validated self-report measure; scores range from 0 to 100 and higher scores indicate better health
Measure: Change from baseline to follow-up on the Self-rated health status: Bombak, 2013 Time: 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)Description: 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.
Measure: Change from baseline to follow-up on the Brief Resilience Scale (BRS): Smith et al., 2008 Time: 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)Description: validated self-report measure; total scores range from 12 to 60 and higher scores indicate higher intolerance of uncertainty
Measure: Change from baseline to follow-up on the Intolerance of Uncertainty Scale (IUS-12): Carleton et al., 2007 Time: 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)Description: validated self-report measure; total scores range from 3 to 9 and higher scores indicate higher levels of loneliness
Measure: Change from baseline to follow-up on the UCLA 3 item loneliness scale: Russell, 1996 Time: 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)Description: 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.
Measure: Change from baseline to follow-up on the Multidimensional Scale of Perceived Social Support (MSPSS): Zimet et al., 1988 Time: 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)Description: 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.
Measure: Change from baseline to follow-up on the Leeds Sleep Evaluation Questionnaire (LSEQ): Parrott & Hindmarch, 1980 Time: 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)Description: validated self-report measure; total scores range from 0 to 40 and higher scores indicate greater impairment
Measure: Change from baseline to follow-up on the Work and Social Adjustment Scale (WSAS): Mundt et al., 2002 Time: 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)Description: 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
Measure: Change from baseline to follow-up on the International Physical Activity Questionnaire -short form (IPAQ-SF): Craig et al., 2003 Time: 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)Description: 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.
Measure: Change from baseline to follow-up in self-reported napping: Stone et al., 2018 Time: 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)Description: 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.
Measure: Change from baseline to follow-up on the Subjective Health Complaint Scale (SHC): Eriksen, Ihlebæk, & Ursin, 1999 Time: 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)Description: 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.
Measure: Change from baseline to follow-up in Positive Affect states on the Positive and Negative Affect Scale-X (PANAS-X): Watson & Clark, 1999 Time: 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)