DIgital Online SuPport for COVID-19 StrEss (DISPOSE)

Gunther Meinlschmidt

Status: Unknown

Conditions: COVID-19; Psychosocial Stress; Mental Health

Treatments: Behavioral: Guided online support program; Behavioral: WHO recommendations (waiting condition)

Study type: Interventional

Funder types: Other

Identifiers

NCT04324190

IPUB_2020_01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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600 participants in 3 patient groups

Online support program

Experimental group

Description:

Guided online support program, consisting of modules (structured in chapters) aiming at reduce stress related to the COVID-19 pandemic.

Treatment:

Behavioral: Guided online support program

Waiting period (WHO recommendation)

Active Comparator group

Description:

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'.

Treatment:

Behavioral: Guided online support program

Behavioral: WHO recommendations (waiting condition)

No intervention (natural course)

No Intervention group

Description:

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).