Clinical trial NCT04324190: DIgital Online SuPport for COVID-19 StrEss
Official title: Online Support for Psychosocial Stress in the Context of the COVID-19 Pandemic
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Psychosocial Stress
Mental Health
Keywords: COVID-19
SARS-CoV-2
psychosocial stress
online support
guided
mental health
anxiety
depression
somatic symptom disorder
Lead sponsor: International Psychoanalytic University Berlin
Sponsor class: OTHER
Collaborators: name: Selfapy GmbH
First posted: 2020-03-27
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Short-Form-36 (SF-36) Health Survey - Mental Health Component Summary score
timeFrame: 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 outcomes:
measure: Short-Form-36 (SF-36) Health Survey - Mental Health Component Summary score
timeFrame: T2 (T1+2 weeks) (arm 2 only), T3 (T1+4 weeks), T4 (T1+12 weeks), follow ups: T1+ 6 months, T1+12 months
measure: Chronic stress items (9 items)
timeFrame: 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
measure: Generalized Anxiety Disorder Scale (GAD-7)
timeFrame: 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
measure: Patient Health Questionnaire (PHQ8)
timeFrame: 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
measure: Somatic Symptom Disorder (SSD-12)
timeFrame: 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
measure: Somatic Symptom Scale (SSS-8)
timeFrame: 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
measure: Allgemeine Selbstwirksamkeit Kurzskala (ASKU)
timeFrame: 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
measure: Screening Tool for Psychological Distress (STOP-D) - selected items
timeFrame: 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
Other outcomes:
measure: Physical activity
timeFrame: 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 pandemic
measure: Home-schooling
timeFrame: 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 pandemic
measure: Information related to COVID-19 and SARS-CoV-2
timeFrame: 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 intervention
measure: Unintended effects
timeFrame: only after undergoing online support program: T1+2 weeks, T1+4 weeks, T1+12 weeks, follow ups: T1+ 6 months, T1+12 months
Locations:
city: Berlin
country: Germany
facility: Selfapy GmbH
Study officials:
References: