Trial document




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  DRKS00021301

Trial Description

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Title

An e-Mental Health Intervention to Support burdened People in Times of the COVID-19 pandemic: CoPE It

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Trial Acronym

[---]*

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URL of the Trial

https://cope-corona.de/

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Brief Summary in Lay Language

The rapid spread of the corona virus (COVID-19) confronts many people with special challenges, especially psychological ones. Unfortunately, there is no sufficient support available yet to deal with the difficulties during this pandemic. The online training CoPE It is intended to provide support in coping with corona specific stresses and feelings. With the help of CoPE It, participants can work out helpful coping strategies individually over the course of 2 weeks (a new session of 30 minutes each is activated every 48 hours) and learn background information on psychological topics such as feelings, sources of strength, stress management, and self-awareness.

The aim of the study is to find out whether participants show less psychological burdens (measured with a questionnaire) after completion of the training. Furthermore, we want to measure the system usability and the satisfaction with CoPE It.

Participants receive free access to CoPE It and can use it within the study. To achieve the objectives of the study, participants will fill in questionnaires before the training, after the training and at two fixed times (1 and 3 months later) after the training.

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Brief Summary in Scientific Language

Background:
Despite the rapid growth of literature on COVID-19, there is still a lack of research on the effects of the virus on mental health and the needs of those affected. There are also no guidelines for telephone/video-based support services in pandemic situations. Surveys of the specific burden and needs of those using such services are also not available. Self-responsible eHealth approaches such as the developed CoPE It attempt to close this gap. This low-threshold psychological online offer is intended to support burdened citizens in dealing independently and effectively with corona-specific challenges and burdens.

Methods/design:
The self-dependent, web-based CoPE It training covers important aspects of cognitive behavioural therapy and mindfulness teaching. The training comprises four modules over a period of two weeks, each module taking about 30 minutes. This observational study will include all citizens over 18 years of age with sufficient knowledge of German, regardless of demographic or medical characteristics. Participants complete various online questionnaires before the training (T0), immediately after the training (T1), one (T2) and three months (T3) after the training. Patients are recruited via the CoPE hotline of the Essen citizen telephone. We will conduct descriptive analyses of socio-demographic data, mean value comparisons, and regression analyses.

Discussion:
The psychological eHealth intervention CoPE It tries to expand the development of possible specific psychosomatic-psychotherapeutic media interventions. This self-dependent, web-based training is cost and time efficient and offers a new approach to psychological support in the current times. This study provides us with first statements about a change in the longitudinal section on different parameters. Furthermore, we will examine CoPE It with regard to usability and satisfaction.

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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

Data sharing will be in accordance to the ICMJE guidelines. Data collected from the trial will be anonymously available on request after the major results are published. Additionally, the study protocol will be published in an open access journal, and the statistical analysis plan and all relevant documents will be stored and made available by request. To all researchers or other parties who provide a methodologically sound proposal the stored data and documents will be made available. Proposals should be directed to alexander.baeuerle@uni-due.de. To gain access, data requestors will need to sign a data access agreement.

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Organizational Data

  •   DRKS00021301
  •   2020/04/16
  •   [---]*
  •   yes
  •   Approved
  •   20-9243-BO, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   psychological burden caused by COVID-19
  •   U07.1 -  Emergency use of U07.1
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Interventions/Observational Groups

  •   All participating subjects conduct the web-based psychological CoPE It training over a period of two weeks. Every 48 hours a new session (á 30 minutes) is activated for the patients. The CoPE It training can be conducted on the PC, tablet or smartphone of the participating person.

    The four modules of the CoPE It training include stress-related sessions with instructional videos, audio files, interactive worksheets, personal skills box, and the resulting final material for everyday use.

    The contents of the modules are based on established elements and methods from cognitive behavioural therapy and the field of mindfulness teaching.
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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The primary outcome is psychological distress measured with the German Version of the Perceived Stress Questionnaire [PSQ] (Fliege et al., 2001) at measurement time T1.

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Secondary Outcome

Of interest is whether the patients have changed in terms of various parameters (anxiety, depression, mindfulness, distress, quality of life, and self-efficacy) after the training.
The patients are interviewed at the following time points with the help of selected questionnaires.

Before the training (T0)
After the training (T1)
One month after training (T2)
Three months after training (T3)

Generalized Anxiety Disorder Scale [GAD-7] (Spitzer, Kroenke, Williams, & Löwe, 2006)

Patient Health Questionnaire Depression Scale [PHQ-8] (Kroenke et al., 2009)

German Version of the Perceived Stress Questionnaire [PSQ] (Fliege et al., 2001)

Scale for the general expectation of self-efficacy [SWE] (Schwarzer, & Jerusalem, 1981)

Freiburg Mindfulness Inventory [FMI] (Walach et al., 2006)

EQ-5D-3L = European Quality of Life 5 Dimensions 3 Level Version;

In addition, data on usability, feasibility and sustainability will be collected. For this purpose, the System Usability Scale [SUS] (Brooke, 1996), the Client Satisfaction Questionnaire adapted to Internet-based interventions [CSQ-I] (Boß et al., 2016), as well as self-generated items will be queried after completion of the training (T1).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2020/06/04
  •   240
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

18 years or older,
consent to the study conditions,
sufficient knowledge of German,
internet access and sufficient computer skills

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Exclusion Criteria

under 18 years of age
no internet access
insufficient knowledge of the German language

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Addresses

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Sources of Monetary or Material Support

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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

  • [---]*
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* This entry means the parameter is not applicable or has not been set.