DIgital Online SuPport for COVID-19 StrEss

NCT04324190 | Unknown

• 1 other identifier: IPUB_2020_01
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

• 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

• 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

• 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

• 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

Other Outcomes (4)

• Physical activity

  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

• Home-schooling

  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

• Information related to COVID-19 and SARS-CoV-2

  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

Study Arms (3)

Online support program

EXPERIMENTAL

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

Waiting period (WHO recommendation)

ACTIVE COMPARATOR

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; Behavioral: WHO recommendations (waiting condition)

No intervention (natural course)

NO INTERVENTION

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).

Interventions

Guided online support program BEHAVIORAL

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)

Also known as: online intervention, guided online support

Online support program; Waiting period (WHO recommendation)

WHO recommendations (waiting condition) BEHAVIORAL

During the waiting period, a german translation of the WHO recommendations "Coping with stress during the 2019-nCoV outbreak" is provided

Waiting period (WHO recommendation)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sufficient German language skills to participate in the assessments.
• Providing informed consent for participation.
• \- 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.
• \- 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.

Sponsors & Collaborators

• Gunther Meinlschmidt: lead
• Selfapy GmbH: collaborator

Study Sites (1)

Selfapy GmbH

Berlin, 10435, Germany

RECRUITING

MeSH Terms

Conditions

COVID-19; Psychological Well-Being; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Personal Satisfaction; Behavior; Mental Disorders; Behavioral Symptoms

Central Study Contacts

Gunther Meinlschmidt, Prof. Dr.

CONTACT

+49 30 300117; gunther.meinlschmidt@ipu-berlin.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Care providers (providing guidance) are not informed about wether participants have been assigned to the online support program condition or the comparator condition, consisting of a waiting period followed by the online support program.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: 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.

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: March 27, 2020
• Study Start: April 8, 2020
• Primary Completion: June 1, 2020
• Study Completion: December 1, 2021
• Last Updated: April 14, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)