DIgital Online SuPport for COVID-19 StrEss

Study Overview
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Brief Summary
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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.

Detailed Description
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The overall aim of this randomised trial with observational component is to estimate the effects of a guided digital online support program to increase mental health and reduce psychosocial stress in the context of the COVID-19 pandemic. More specifically, the main hypothesis is to estimate whether the improvement in mental health is stronger during the first two weeks of applying the online support program as compared to a two weeks waiting condition (with provision of WHO information on 'coping with stress during the 2019-nCoV' outbreak only). In addition to the randomised control group (second arm: waiting condition, followed by online support program), the study comprises as third arm a non-randomised comparator condition, consisting of subjects not intending to participate in the online support program. Furthermore, our aim is to estimate changes in the outcomes along taking part in the program. Additional research questions are: to compare the intervention effects across modules and chapters of the online support program, including between module comparison with an unspecific, control (comparator) module: general information on the corona virus and its unspecific chapters; to estimate the effects of selected modules on additional outcomes (e.g. physical activity, and schooling related factors); to describe the magnitude and course of psychosocial stress, mental health and related factors in the context of the COVID-19 pandemic; to estimate and predict which subjects profit most from specific parts of the program. Follow-up assessment shall include estimating whether the program prevents the development of detrimental mental health conditions, e.g. depression, anxiety, etc. In order to make first study results available as early as possible, we intend to conduct quick complete analyses (primary outcome and relevant parts of secondary/other outcomes): These analyses will be conducted with data including subjects from the first 4 weeks of recruitment, given that a sample size of at least 300 for the online support program arm and a sample size of at least 300 for the waiting condition is reached; or if not yet reached after 4 weeks of recruitment, as soon as a sample size of at least 300 for the online support program arm and a sample size of at least 300 for the waiting condition is reached. However, we intend to continue recruiting beyond this point in time and sample size (until the COVID-19 pandemic situation has come to an end, i.e., vaccination is broadly available), to allow further, also more detailed analyses at a later point in time, resulting in more precise estimates.

Official Title
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Online Support for Psychosocial Stress in the Context of the COVID-19 Pandemic

Conditions
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COVID-19, Psychosocial Stress, Mental Health

Intervention / Treatment
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* Behavioral: Guided online support program
* Behavioral: WHO recommendations (waiting condition)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria, general: Sufficient German language skills to participate in the assessments. Providing informed consent for participation. Inclusion criteria for the arms Online support program and Waiting condition...: - Having signed up for the online support program provided by selfapy GmbH, Berlin, Germany (www.selfapy.de/corona) aiming at reducing burden in the context of the COVID-19 pandemic. Inclusion criteria for the arm No intervention...: - Not having signed up for the online support program provided by selfapy GmbH, Berlin, Germany (www.selfapy.de/corona) aiming at reducing burden in the context of the COVID-19 pandemic.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Randomized controlled trial with a waiting comparator condition (provision of WHO recommendations, comparable to treatment as usual, TAU), consisting of a two weeks waiting period during which general WHO recommendations how to handle stress in the context of the COVID-19 pandemic will be provided. All subjects in the waiting condition will undergo the intervention following the waiting period. Main assessments will be conducted before the waiting period, before beginning of the intervention, two weeks after beginning of the intervention (+2 weeks), +4 weeks, +12 weeks, and follow ups at +6 months and +12 months.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Online support program<br>Guided online support program, consisting of modules (structured in chapters) aiming at reduce stress related to the COVID-19 pandemic. | Behavioral: Guided online support program<br>* Guided online support program consisting of several modules; Module General information ... is an unspecific control module (providing general information on hygiene etc. with no expected effect on outcomes)<br>* Other names: guided online support;|
| Active Comparator: Waiting period (WHO recommendation)<br>Waiting period (2 weeks duration) during which subjects are provided with the WHO recommendations Coping with stress during the 2019 nCoV outbreak. Following the 2 weeks waiting period, subjects are provided with the guided online support program outlined in the arm 'online support program'. | Behavioral: Guided online support program<br>* Guided online support program consisting of several modules; Module General information ... is an unspecific control module (providing general information on hygiene etc. with no expected effect on outcomes)<br>* Other names: guided online support;Behavioral: WHO recommendations (waiting condition)<br>* During the waiting period, a german translation of the WHO recommendations Coping with stress during the 2019-nCoV outbreak is provided<br>|
| No Intervention: No intervention (natural course)<br>This non-randomised arm (recruited separately; anticipated sample size of 500 subjects, not counted in the overall anticipated sample size) consists of subjects not intending to participate in the Selfapy online support program. Assessment points in this arm are comparable to those in the arm Online support program (in the 'No intervention (natural course)' arm, T1 refers to time of study inclusion). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Short-Form-36 (SF-36) Health Survey - Mental Health Component Summary score | 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. | 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 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-Form-36 (SF-36) Health Survey - Mental Health Component Summary score | mental health related quality of life | T2 (T1+2 weeks) (arm 2 only), T3 (T1+4 weeks), T4 (T1+12 weeks), follow ups: T1+ 6 months, T1+12 months | 
| Chronic stress items (9 items) | Assessing chronic stress (Petrowski et al., 2019) | 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 months | 
| Generalized Anxiety Disorder Scale (GAD-7) | Assessing anxiety symptoms (Löwe et al., 2008) | 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 months | 
| Patient Health Questionnaire (PHQ8) | Assessing depressive symptoms (Kroenke et al., 2001) | 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 months | 
| Somatic Symptom Disorder (SSD-12) | Assessing depressive symptoms (Toussaint et al., 2019) | 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 months | 
| Somatic Symptom Scale (SSS-8) | Assessing somatic symptoms (Gierk et al., 2015) | 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 months | 
| Allgemeine Selbstwirksamkeit Kurzskala (ASKU) | competence expectations to deal with difficulties and obstacles in daily life (Beierlein et al., 2014) | 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 months | 
| Screening Tool for Psychological Distress (STOP-D) - selected items | 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 | 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 intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, SARS-CoV-2, psychosocial stress, online support, guided, mental health, anxiety, depression, somatic symptom disorder