<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04408157</url>
  </required_header>
  <id_info>
    <org_study_id>v1.1 06.05.2020</org_study_id>
    <nct_id>NCT04408157</nct_id>
  </id_info>
  <brief_title>A Research Study to Evaluate the Benefits of a Self-management Booklet to Promote Wellbeing During the COVID-19 Pandemic</brief_title>
  <acronym>SWitCh</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King's College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King's College London</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background The immediate psychological impact of COVID-19 is already emerging. The&#xD;
      investigators are interested in the benefits of a self-management booklet focused on the&#xD;
      current circumstances in response to the COVID-19 pandemic on people's physical and mental&#xD;
      wellbeing.&#xD;
&#xD;
      Who can participate? The investigators are looking for participants aged 18 and over who live&#xD;
      in the UK and can read and write in English, without any current serious mental health&#xD;
      problems (e.g. bipolar disorder, PTSD, active thoughts of self-harm, or severe&#xD;
      anxiety/depression), and who feel that their physical and/or mental wellbeing have been&#xD;
      affected since the COVID-19 pandemic.&#xD;
&#xD;
      What does the study involve? Eligible participants will complete questionnaires at baseline&#xD;
      following which they will be randomly allocated to either receive the self-management booklet&#xD;
      right away (via email) or after 4 months (waiting-list, in the meantime participants will be&#xD;
      provided a link to educational materials). Participants will not be able to choose whether&#xD;
      they will receive the self-management booklet right away or be in the waiting-list as a&#xD;
      computer system (Qualtrics randomiser) will allocate them to one of the two groups at random.&#xD;
      Participants in both conditions will be asked to complete online questionnaires at multiple&#xD;
      time points, 2-months and 4-months after allocation. Participants in the waiting-list&#xD;
      condition will also be asked to complete the same set of questionnaires at 6- and 8-months&#xD;
      after allocation to assess how beneficial they found the self-management booklet.&#xD;
&#xD;
      Participants will also be invited to take part in an audio-recorded interview after T2 to&#xD;
      tell us more about how they found the self-management booklet or the educational materials.&#xD;
      The investigators will select 30 participants (15 from each condition) for the interview out&#xD;
      of those who opt-in to capture a wide range of experiences and backgrounds.&#xD;
&#xD;
      What are the possible benefits and risks of participating? Risks to participants are small.&#xD;
      Participants may find reflecting on the impact of COVID-19 on their lives distressing.&#xD;
      However, these effects are anticipated to be short lived, as participants will learn&#xD;
      psychological techniques during the intervention that can help them manage better in the&#xD;
      current circumstances and improve their wellbeing.&#xD;
&#xD;
      Where is the study run from? The lead site is King's College London. The study is run online&#xD;
      via Qualtrics.&#xD;
&#xD;
      When is the study starting and how long is it expected to run for? May 2020 to May 2021&#xD;
&#xD;
      Who is the main contact? Dr Federica Picariello federica.picariello@kcl.ac.uk&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the UK, over 4 in 5 Britons are worried about the effect COVID-19 is having on their life,&#xD;
      with over half reporting that their wellbeing has been affected. Providing support for&#xD;
      individuals to build optimal structures to maintain their physical and mental wellbeing is&#xD;
      key to mitigate the consequences of the pandemic on day-to-day life and in the longer term.&#xD;
      The investigators would like to conduct a randomised-controlled trial to test the efficacy of&#xD;
      a theory-based self-management booklet to improve physical and mental wellbeing versus&#xD;
      education alone. The trial will include a nested qualitative study to explore in a subgroup&#xD;
      of participants their experiences of the self-management booklet or education alone. The&#xD;
      primary objective is to examine the efficacy of the self-management booklet at improving&#xD;
      wellbeing as compared to the waiting-list control arm 2-months post-randomisation. The&#xD;
      investigators also want to explore the treatment effects of the self-management booklet on&#xD;
      secondary outcomes (health status, day-to-day activities, resilience, intolerance of&#xD;
      uncertainty, loneliness, social support, sleep quality, napping, sedentary behaviour,&#xD;
      physical activity, and COVID-19-related behaviours, symptom complaints). Tertiary objectives&#xD;
      include exploring changes in self-reported primary and secondary outcomes over time in a&#xD;
      non-randomised analysis combining data from both arms and qualitatively exploring&#xD;
      participants' perceptions of the acceptability and usefulness of the self-management booklet.&#xD;
      These objectives will be addressed by a two-armed parallel randomised controlled trial (RCT)&#xD;
      with a nested qualitative study. The study will be conducted through Qualitrics (including&#xD;
      recruitment, randomisation, and data collection). Participants in both arms will be&#xD;
      followed-up at 2 and 4 months post-randomisation. Additionally, participants in the control&#xD;
      arm will receive the self-management booklet after the 4-months follow-up assessment and will&#xD;
      be followed-up at 6 and 8 months post-randomisation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 20, 2020</start_date>
  <completion_date type="Actual">October 1, 2021</completion_date>
  <primary_completion_date type="Actual">October 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Two-arm parallel randomised-controlled trial with nested qualitative study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Blinding not possible as passive control arm and using self-report outcomes.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS): Tennant et al., 2007</measure>
    <time_frame>2 months post-randomisation</time_frame>
    <description>validated self-report measure; scores range from 14 to 70 and higher scores indicate greater positive mental wellbeing.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS): Tennant et al., 2007</measure>
    <time_frame>4 months post-randomisation</time_frame>
    <description>validated self-report measure; scores range from 14 to 70 and higher scores indicate greater positive mental wellbeing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-rated health status: Bombak, 2013</measure>
    <time_frame>2 months post-randomisation</time_frame>
    <description>validated self-report measure; scores range from 0 to 100 and higher scores indicate better health</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-rated health status: Bombak, 2013</measure>
    <time_frame>4 months post-randomisation</time_frame>
    <description>validated self-report measure; scores range from 0 to 100 and higher scores indicate better health</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Resilience Scale (BRS): Smith et al., 2008</measure>
    <time_frame>2 months post-randomisation</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Resilience Scale (BRS): Smith et al., 2008</measure>
    <time_frame>4 months post-randomisation</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intolerance of Uncertainty Scale (IUS-12): Carleton et al., 2007</measure>
    <time_frame>2 months post-randomisation</time_frame>
    <description>validated self-report measure; total scores range from 12 to 60 and higher scores indicate higher intolerance of uncertainty</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intolerance of Uncertainty Scale (IUS-12): Carleton et al., 2007</measure>
    <time_frame>4 months post-randomisation</time_frame>
    <description>validated self-report measure; total scores range from 12 to 60 and higher scores indicate higher intolerance of uncertainty</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive Affect subscale of the Positive and Negative Affect Scale-X (PANAS-X): Watson &amp; Clark, 1999</measure>
    <time_frame>2 months post-randomisation</time_frame>
    <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., &amp; 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive Affect subscale of the Positive and Negative Affect Scale-X (PANAS-X): Watson &amp; Clark, 1999</measure>
    <time_frame>4 months post-randomisation</time_frame>
    <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., &amp; 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>UCLA 3 item loneliness scale: Russell, 1996</measure>
    <time_frame>2 months post-randomisation</time_frame>
    <description>validated self-report measure; total scores range from 3 to 9 and higher scores indicate higher levels of loneliness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>UCLA 3 item loneliness scale: Russell, 1996</measure>
    <time_frame>4 months post-randomisation</time_frame>
    <description>validated self-report measure; total scores range from 3 to 9 and higher scores indicate higher levels of loneliness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multidimensional Scale of Perceived Social Support (MSPSS): Zimet et al., 1988</measure>
    <time_frame>2 months post-randomisation</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multidimensional Scale of Perceived Social Support (MSPSS): Zimet et al., 1988</measure>
    <time_frame>4 months post-randomisation</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Health Complaint Scale (SHC): Eriksen, Ihlebæk, &amp; Ursin, 1999</measure>
    <time_frame>2 months post-randomisation</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Health Complaint Scale (SHC): Eriksen, Ihlebæk, &amp; Ursin, 1999</measure>
    <time_frame>4 months post-randomisation</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Leeds Sleep Evaluation Questionnaire (LSEQ): Parrott &amp; Hindmarch, 1980</measure>
    <time_frame>2 months post-randomisation</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Leeds Sleep Evaluation Questionnaire (LSEQ): Parrott &amp; Hindmarch, 1980</measure>
    <time_frame>4 months post-randomisation</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported napping: Stone et al., 2018</measure>
    <time_frame>2 months post-randomisation</time_frame>
    <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; &lt;1 hour=coded as 1, 1-2 hours=coded as 2, and &gt;2 hours=coded as 3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported napping: Stone et al., 2018</measure>
    <time_frame>4 months post-randomisation</time_frame>
    <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; &lt;1 hour=coded as 1, 1-2 hours=coded as 2, and &gt;2 hours=coded as 3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Work and Social Adjustment Scale (WSAS): Mundt et al., 2002</measure>
    <time_frame>2 months post-randomisation</time_frame>
    <description>validated self-report measure; total scores range from 0 to 40 and higher scores indicate greater impairment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Work and Social Adjustment Scale (WSAS): Mundt et al., 2002</measure>
    <time_frame>4 months post-randomisation</time_frame>
    <description>validated self-report measure; total scores range from 0 to 40 and higher scores indicate greater impairment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>International Physical Activity Questionnaire -short form (IPAQ-SF): Craig et al., 2003</measure>
    <time_frame>2 months post-randomisation</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>International Physical Activity Questionnaire -short form (IPAQ-SF): Craig et al., 2003</measure>
    <time_frame>4 months post-randomisation</time_frame>
    <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</description>
  </secondary_outcome>
  <other_outcome>
    <measure>COVID-related behaviours</measure>
    <time_frame>Baseline (before randomisation), 2 and 4 months post-randomisation both arms, and 6 and 8 months post-randomisation control arm only.</time_frame>
    <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)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline to follow-up on the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS): Tennant et al., 2007</measure>
    <time_frame>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)</time_frame>
    <description>validated self-report measure; scores range from 14 to 70 and higher scores indicate greater positive mental wellbeing.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline to follow-up on the Self-rated health status: Bombak, 2013</measure>
    <time_frame>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)</time_frame>
    <description>validated self-report measure; scores range from 0 to 100 and higher scores indicate better health</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline to follow-up on the Brief Resilience Scale (BRS): Smith et al., 2008</measure>
    <time_frame>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)</time_frame>
    <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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline to follow-up on the Intolerance of Uncertainty Scale (IUS-12): Carleton et al., 2007</measure>
    <time_frame>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)</time_frame>
    <description>validated self-report measure; total scores range from 12 to 60 and higher scores indicate higher intolerance of uncertainty</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline to follow-up on the UCLA 3 item loneliness scale: Russell, 1996</measure>
    <time_frame>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)</time_frame>
    <description>validated self-report measure; total scores range from 3 to 9 and higher scores indicate higher levels of loneliness</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline to follow-up on the Multidimensional Scale of Perceived Social Support (MSPSS): Zimet et al., 1988</measure>
    <time_frame>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)</time_frame>
    <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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline to follow-up on the Leeds Sleep Evaluation Questionnaire (LSEQ): Parrott &amp; Hindmarch, 1980</measure>
    <time_frame>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)</time_frame>
    <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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline to follow-up on the Work and Social Adjustment Scale (WSAS): Mundt et al., 2002</measure>
    <time_frame>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)</time_frame>
    <description>validated self-report measure; total scores range from 0 to 40 and higher scores indicate greater impairment</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline to follow-up on the International Physical Activity Questionnaire -short form (IPAQ-SF): Craig et al., 2003</measure>
    <time_frame>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)</time_frame>
    <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</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline to follow-up in self-reported napping: Stone et al., 2018</measure>
    <time_frame>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)</time_frame>
    <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; &lt;1 hour=coded as 1, 1-2 hours=coded as 2, and &gt;2 hours=coded as 3.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline to follow-up on the Subjective Health Complaint Scale (SHC): Eriksen, Ihlebæk, &amp; Ursin, 1999</measure>
    <time_frame>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)</time_frame>
    <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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline to follow-up in Positive Affect states on the Positive and Negative Affect Scale-X (PANAS-X): Watson &amp; Clark, 1999</measure>
    <time_frame>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)</time_frame>
    <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., &amp; 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.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">185</enrollment>
  <condition>COVID</condition>
  <arm_group>
    <arm_group_label>Self-management booklet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Education only (waiting-list)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Self-management booklet (SWitCh: Stay well during COVID-19)</intervention_name>
    <description>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.</description>
    <arm_group_label>Self-management booklet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18 and over who live in the UK and can read and write in English, without any&#xD;
             current serious mental health problems (e.g. bipolar disorder, PTSD, active thoughts&#xD;
             of self-harm, or severe anxiety/depression) and who feel that their physical and/or&#xD;
             mental wellbeing have been affected since the COVID-19 pandemic.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any current serious mental health problems (e.g. bipolar disorder, PTSD, active&#xD;
             thoughts of self-harm, or severe anxiety/depression) or who feel that their physical&#xD;
             and/or mental wellbeing have not been affected by COVID-19&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Federica Picariello, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>King's College London</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Online recruitment through Qualtrics</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>October 12, 2022</last_update_submitted>
  <last_update_submitted_qc>October 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>wellbeing; covid19</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>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.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04408157
org study id: v1.1 06.05.2020
nct id: NCT04408157
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Two-arm parallel randomised-controlled trial with nested qualitative study
primary purpose: Treatment
masking: None (Open Label)
masking description: Blinding not possible as passive control arm and using self-report outcomes.
measure: Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS): Tennant et al., 2007
time frame: 2 months post-randomisation
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 frame: 4 months post-randomisation
description: validated self-report measure; scores range from 14 to 70 and higher scores indicate greater positive mental wellbeing.
measure: Self-rated health status: Bombak, 2013
time frame: 2 months post-randomisation
description: validated self-report measure; scores range from 0 to 100 and higher scores indicate better health
measure: Self-rated health status: Bombak, 2013
time frame: 4 months post-randomisation
description: validated self-report measure; scores range from 0 to 100 and higher scores indicate better health
measure: Brief Resilience Scale (BRS): Smith et al., 2008
time frame: 2 months post-randomisation
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: Brief Resilience Scale (BRS): Smith et al., 2008
time frame: 4 months post-randomisation
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: Intolerance of Uncertainty Scale (IUS-12): Carleton et al., 2007
time frame: 2 months post-randomisation
description: 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 frame: 4 months post-randomisation
description: validated self-report measure; total scores range from 12 to 60 and higher scores indicate higher intolerance of uncertainty
measure: Positive Affect subscale of the Positive and Negative Affect Scale-X (PANAS-X): Watson & Clark, 1999
time frame: 2 months post-randomisation
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: Positive Affect subscale of the Positive and Negative Affect Scale-X (PANAS-X): Watson & Clark, 1999
time frame: 4 months post-randomisation
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: UCLA 3 item loneliness scale: Russell, 1996
time frame: 2 months post-randomisation
description: 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 frame: 4 months post-randomisation
description: validated self-report measure; total scores range from 3 to 9 and higher scores indicate higher levels of loneliness
measure: Multidimensional Scale of Perceived Social Support (MSPSS): Zimet et al., 1988
time frame: 2 months post-randomisation
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: Multidimensional Scale of Perceived Social Support (MSPSS): Zimet et al., 1988
time frame: 4 months post-randomisation
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: Subjective Health Complaint Scale (SHC): Eriksen, Ihlebæk, & Ursin, 1999
time frame: 2 months post-randomisation
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: Subjective Health Complaint Scale (SHC): Eriksen, Ihlebæk, & Ursin, 1999
time frame: 4 months post-randomisation
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: Leeds Sleep Evaluation Questionnaire (LSEQ): Parrott & Hindmarch, 1980
time frame: 2 months post-randomisation
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: Leeds Sleep Evaluation Questionnaire (LSEQ): Parrott & Hindmarch, 1980
time frame: 4 months post-randomisation
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: Self-reported napping: Stone et al., 2018
time frame: 2 months post-randomisation
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: Self-reported napping: Stone et al., 2018
time frame: 4 months post-randomisation
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: Work and Social Adjustment Scale (WSAS): Mundt et al., 2002
time frame: 2 months post-randomisation
description: 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 frame: 4 months post-randomisation
description: validated self-report measure; total scores range from 0 to 40 and higher scores indicate greater impairment
measure: International Physical Activity Questionnaire -short form (IPAQ-SF): Craig et al., 2003
time frame: 2 months post-randomisation
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: International Physical Activity Questionnaire -short form (IPAQ-SF): Craig et al., 2003
time frame: 4 months post-randomisation
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: COVID-related behaviours
time frame: Baseline (before randomisation), 2 and 4 months post-randomisation both arms, and 6 and 8 months post-randomisation control arm only.
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: Change from baseline to follow-up on the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS): Tennant et al., 2007
time frame: 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 14 to 70 and higher scores indicate greater positive mental wellbeing.
measure: Change from baseline to follow-up on the Self-rated health status: Bombak, 2013
time frame: 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 Brief Resilience Scale (BRS): Smith et al., 2008
time frame: 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 Intolerance of Uncertainty Scale (IUS-12): Carleton et al., 2007
time frame: 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 UCLA 3 item loneliness scale: Russell, 1996
time frame: 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 Multidimensional Scale of Perceived Social Support (MSPSS): Zimet et al., 1988
time frame: 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 Leeds Sleep Evaluation Questionnaire (LSEQ): Parrott & Hindmarch, 1980
time frame: 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 Work and Social Adjustment Scale (WSAS): Mundt et al., 2002
time frame: 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 International Physical Activity Questionnaire -short form (IPAQ-SF): Craig et al., 2003
time frame: 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 in self-reported napping: Stone et al., 2018
time frame: 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 on the Subjective Health Complaint Scale (SHC): Eriksen, Ihlebæk, & Ursin, 1999
time frame: 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 in Positive Affect states on the Positive and Negative Affect Scale-X (PANAS-X): Watson & Clark, 1999
time frame: 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.
arm group label: Self-management booklet
arm group type: Experimental
description: 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.
arm group label: Education only (waiting-list)
arm group type: No Intervention
description: 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.
intervention type: Behavioral
intervention name: Self-management booklet (SWitCh: Stay well during COVID-19)
description: 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.
arm group label: Self-management booklet
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Federica Picariello, PhD
role: Principal Investigator
affiliation: King's College London
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No
ipd description: 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.