DIgital Online SuPport for COVID-19 StrEss

COVID-19 Clinical Trial

— DISPOSE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04324190
• Other study ID #: IPUB_2020_01
• Status: Recruiting
• Phase: N/A
• Start date: April 8, 2020
• Est. completion date: December 2021

Study information

• Verified date: April 2020
• Source: International Psychoanalytic University Berlin
• Contact: Gunther Meinlschmidt, Prof. Dr.
• Phone: +49 30 300117
• Email: gunther.meinlschmidt[@]ipu-berlin.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 2021
• Est. primary completion date: June 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Mental Health
• Psychosocial Stress

Intervention

Behavioral:
• Guided online support program
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)
• WHO recommendations (waiting condition)
During the waiting period, a german translation of the WHO recommendations "Coping with stress during the 2019-nCoV outbreak" is provided

Locations

Country	Name	City	State
Germany	Selfapy GmbH	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Gunther Meinlschmidt	Selfapy GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physical activity	Vigorous, moderate, and walking activity (minutes/day)	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
Other	Home-schooling	Questions related to home-schooling related stress & learning	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
Other	Information related to COVID-19 and SARS-CoV-2	Questions related to COVID-19 and SARS-CoV-2 symptoms, disease, and testing, anxiety, stressors	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
Other	Unintended effects	Unintended effects of online support program	only after undergoing online support program: T1+2 weeks, T1+4 weeks, T1+12 weeks, follow ups: T1+ 6 months, T1+12 months
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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