DIgital Online SuPport for COVID-19 StrEss
- Conditions
- Mental HealthCOVID-19Psychosocial Stress
- Interventions
- Behavioral: Guided online support programBehavioral: WHO recommendations (waiting condition)
- Registration Number
- NCT04324190
- Lead Sponsor
- Gunther Meinlschmidt
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 600
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Waiting period (WHO recommendation) Guided online support program 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'. Online support program Guided online support program Guided online support program, consisting of modules (structured in chapters) aiming at reduce stress related to the COVID-19 pandemic. Waiting period (WHO recommendation) WHO recommendations (waiting condition) 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'.
- Primary Outcome Measures
Name Time Method Change in Short-Form-36 (SF-36) Health Survey - Mental Health Component Summary score 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 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.
- Secondary Outcome Measures
Name Time Method Somatic Symptom Disorder (SSD-12) 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 Assessing depressive symptoms (Toussaint et al., 2019)
Allgemeine Selbstwirksamkeit Kurzskala (ASKU) 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 competence expectations to deal with difficulties and obstacles in daily life (Beierlein et al., 2014)
Short-Form-36 (SF-36) Health Survey - Mental Health Component Summary score T2 (T1+2 weeks) (arm 2 only), T3 (T1+4 weeks), T4 (T1+12 weeks), follow ups: T1+ 6 months, T1+12 months mental health related quality of life
Chronic stress items (9 items) 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 Assessing chronic stress (Petrowski et al., 2019)
Generalized Anxiety Disorder Scale (GAD-7) 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 Assessing anxiety symptoms (Löwe et al., 2008)
Patient Health Questionnaire (PHQ8) 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 Assessing depressive symptoms (Kroenke et al., 2001)
Somatic Symptom Scale (SSS-8) 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 Assessing somatic symptoms (Gierk et al., 2015)
Screening Tool for Psychological Distress (STOP-D) - selected items 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 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
Trial Locations
- Locations (1)
Selfapy GmbH
🇩🇪Berlin, Germany