COVID-19DISPOSENCT04324190
DIgital Online SuPport for COVID-19 StrEss
A study testing Guided online support program and WHO recommendations (waiting condition) in people with COVID-19 and Psychosocial Stress, run by Gunther Meinlschmidt at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Psychosocial Stress, Mental Health
- What is being tested?
- Guided online support program and WHO recommendations (waiting condition)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteGermany
- Study dates
- 8 Apr 2020to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Selfapy GmbH
Berlin, 10435
Kati Bermbach, +49 (0) 30 - 3982031 ext. 20, contact@selfapy.com
About this study
Official title: Online Support for Psychosocial Stress in the Context of the COVID-19 Pandemic
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.
Read the 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.
- Conditions
- COVID-19, Psychosocial Stress, Mental Health
- Being tested
- Guided online support program, WHO recommendations (waiting condition)
- Keywords
- COVID-19, SARS-CoV-2, psychosocial stress, online support, guided, mental health, anxiety, depression, somatic symptom disorder
- Medical subject headings
- COVID-19, Psychological Well-Being, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided online support programBehavioural
Also called online intervention, guided online support
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)Behavioural
During the waiting period, a german translation of the WHO recommendations "Coping with stress during the 2019-nCoV outbreak" is provided
| Study group | Role | What they receive |
|---|---|---|
| Online support program | Experimental | Guided online support program, consisting of modules (structured in chapters) aiming at reduce stress related to the COVID-19 pandemic. Receives: 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'. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
mental health related quality of life
Measured: 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)
Assessing chronic stress (Petrowski et al., 2019)
Measured: 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)
Assessing anxiety symptoms (Löwe et al., 2008)
Measured: 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)
Assessing depressive symptoms (Kroenke et al., 2001)
Measured: 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)
Assessing depressive symptoms (Toussaint et al., 2019)
Measured: 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 Scale (SSS-8)
Assessing somatic symptoms (Gierk et al., 2015)
Measured: 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
Allgemeine Selbstwirksamkeit Kurzskala (ASKU)
competence expectations to deal with difficulties and obstacles in daily life (Beierlein et al., 2014)
Measured: 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
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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start8 Apr 2020
- Primary completionJun 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- 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.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gunther Meinlschmidt
- Sponsor type
- University, hospital or other
- Collaborators
- Selfapy GmbH
- Responsible party
- Sponsor-investigator, Gunther Meinlschmidt, International Psychoanalytic University Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04324190
- Sponsor's protocol ID
- IPUB_2020_01
- Acronym
- DISPOSE
- Status last verified
- Apr 2020
- First submitted
- 26 Mar 2020
- Last updated
- 14 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Support for Psychosocial Stress in the Context of the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04324190
- Acronym / sponsor ID
- DISPOSE / IPUB_2020_01
- Conditions
- COVID-19, Psychosocial Stress, Mental Health
- Keywords
- COVID-19, SARS-CoV-2, psychosocial stress, online support, guided, mental health, anxiety, depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Gunther MeinlschmidtUniversity, hospital or other
- Collaborators
- Selfapy GmbH
- Study start
- 8 Apr 2020 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 27 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (care provider)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Online support program | Experimental | Behavioral: Guided online support programGuided online support program, consisting of modules (structured in chapters) aiming at reduce stress related to the COVID-19 pandemic. |
| Waiting period (WHO recommendation) | Active comparator | Behavioral: Guided online support program, Behavioral: 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'. |
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided online support programAlso: online intervention, guided online supportGuided 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) | Behavioural | Online support program, Waiting period (WHO recommendation) |
| 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 | Behavioural | Waiting period (WHO recommendation) |
Primary outcome
Change in Short-Form-36 (SF-36) Health Survey - Mental Health Component Summary score
Time frame: 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.
8 secondary outcomes
Short-Form-36 (SF-36) Health Survey - Mental Health Component Summary score
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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 Scale (SSS-8)
Time frame: 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
Allgemeine Selbstwirksamkeit Kurzskala (ASKU)
Time frame: 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
Screening Tool for Psychological Distress (STOP-D) - selected items
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided online support program and WHO recommendations (waiting condition) in people with COVID-19 and Psychosocial Stress, run by Gunther Meinlschmidt at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gunther Meinlschmidt, Prof. Dr. (+49 30 300117 ext. 710, gunther.meinlschmidt@ipu-berlin.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Short-Form-36 (SF-36) Health Survey - Mental Health Component Summary score (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2020.