Name (Synonyms) | Correlation | |
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drug328 | Guided online support program Wiki | 1.00 |
drug9 | 1: Usual practice Wiki | 1.00 |
drug15 | 2: Usual practice + SYMBICORT RAPIHALER Wiki | 1.00 |
Name (Synonyms) | Correlation | |
---|---|---|
D012120 | Respiration Disorders NIH | 0.50 |
D012140 | Respiratory Tract Diseases NIH | 0.38 |
D003141 | Communicable Diseases NIH | 0.12 |
D007239 | Infection NIH | 0.08 |
Name (Synonyms) | Correlation |
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There is one clinical trial.
The COVID-19 pandemic leads to a greatly increased risk of substantial psychological stress worldwide. We intend to evaluate an online support program aiming at reducing stress in the context of the COVID-19 pandemic. The program consists of twelve modules that participants undergo, covering a broad range of topics related to stress in the context of the COVID-19 pandemic. It has been developed together with and is provided by Selfapy GmbH, Berlin. The aim of this randomised clinical trial with observational components is to estimate the effects of the intervention as a whole, as well as individual modules and selected chapters. Further, follow-up assessments as well as information on risks and the long-term course of COVID pandemic-related stress may help to elucidate COVID-19 pandemic stress across time and what we can do to prevent long-term negative consequences.
Description: The SF-36 is a widely used patient-reported outcome assessment tool to measure health-related quality of life and has high acceptability. The SF-36 is a standardised questionnaire with good psychometric properties.
Measure: Change in Short-Form-36 (SF-36) Health Survey - Mental Health Component Summary score Time: Change from T1 (baseline before online support - day 1) to T2 (T1 + 2 weeks) in arm 1, versus change from T0 (baseline before waiting) to T1 (baseline before online support) in arm 2Description: mental health related quality of life
Measure: Short-Form-36 (SF-36) Health Survey - Mental Health Component Summary score Time: T2 (T1+2 weeks) (arm 2 only), T3 (T1+4 weeks), T4 (T1+12 weeks), follow ups: T1+ 6 months, T1+12 monthsDescription: Assessing chronic stress (Petrowski et al., 2019)
Measure: Chronic stress items (9 items) Time: baseline before waiting (T0, arm 2 only); baseline before online support (day 1, T1), T2 (T1+2 weeks), T3 (T1+4 weeks), T4 (T1+12 weeks), follow ups: T1+ 6 months, T1+12 monthsDescription: Assessing anxiety symptoms (Löwe et al., 2008)
Measure: Generalized Anxiety Disorder Scale (GAD-7) Time: baseline before waiting (T0, arm 2 only); baseline before online support (day 1, T1), T2 (T1+2 weeks), T3 (T1+4 weeks), T4 (T1+12 weeks), follow ups: T1+ 6 months, T1+12 monthsDescription: Assessing depressive symptoms (Kroenke et al., 2001)
Measure: Patient Health Questionnaire (PHQ8) Time: baseline before waiting (T0, arm 2 only); baseline before online support (day 1, T1), T2 (T1+2 weeks), T3 (T1+4 weeks), T4 (T1+12 weeks), follow ups: T1+ 6 months, T1+12 monthsDescription: Assessing depressive symptoms (Toussaint et al., 2019)
Measure: Somatic Symptom Disorder (SSD-12) Time: baseline before waiting (T0, arm 2 only); baseline before online support (day 1, T1), T2 (T1+2 weeks), T3 (T1+4 weeks), T4 (T1+12 weeks), follow ups: T1+ 6 months, T1+12 monthsDescription: Assessing somatic symptoms (Gierk et al., 2015)
Measure: Somatic Symptom Scale (SSS-8) Time: baseline before waiting (T0, arm 2 only); baseline before online support (day 1, T1), T2 (T1+2 weeks), T3 (T1+4 weeks), T4 (T1+12 weeks), follow ups: T1+ 6 months, T1+12 monthsDescription: competence expectations to deal with difficulties and obstacles in daily life (Beierlein et al., 2014)
Measure: Allgemeine Selbstwirksamkeit Kurzskala (ASKU) Time: baseline before waiting (T0, arm 2 only); baseline before online support (day 1, T1), T2 (T1+2 weeks), T3 (T1+4 weeks), T4 (T1+12 weeks), follow ups: T1+ 6 months, T1+12 monthsDescription: stress, anxiety, depression, social support - single item assessments to be applied repeatedly along the online support intervention (Young, Ignaszewski, Fofonoff, Kaan; 2007), including stress of children and anticipation
Measure: Screening Tool for Psychological Distress (STOP-D) - selected items Time: baseline before waiting (T0, arm 2 only); baseline before online support (day 1, T1), T1+2 weeks, T1+4 weeks, T1+12 weeks, follow ups: T1+ 6 months, T1+12 months; before & after each module of the online interventionDescription: Vigorous, moderate, and walking activity (minutes/day)
Measure: Physical activity Time: baseline before waiting (T0, arm 2 only); baseline before online support (day 1, T1), T1+2 weeks, T1+4 weeks, T1+12 weeks, follow ups: T1+ 6 months, T1+12 months; before & after sports and physical activity module; at baseline: before COVID-19 pandemicDescription: Questions related to home-schooling related stress & learning
Measure: Home-schooling Time: baseline before waiting (T0, arm 2 only); baseline before online support (day 1, T1), T1+2 weeks, T1+4 weeks, T1+12 weeks, follow ups: T1+ 6 months, T1+12 months; before & after sports and physical activity module; at baseline: before COVID-19 pandemicDescription: Questions related to COVID-19 and SARS-CoV-2 symptoms, disease, and testing, anxiety, stressors
Measure: Information related to COVID-19 and SARS-CoV-2 Time: baseline before waiting (T0, arm 2 only); baseline before online support (day 1, T1), T1+2 weeks, T1+4 weeks, T1+12 weeks, follow ups: T1+ 6 months, T1+12 months; before & after the sports and physical activity module of the online interventionDescription: Unintended effects of online support program
Measure: Unintended effects Time: only after undergoing online support program: T1+2 weeks, T1+4 weeks, T1+12 weeks, follow ups: T1+ 6 months, T1+12 months