Trial document




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  DRKS00006866

Trial Description

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Title

European Comparative Effectiveness Research on Internet-based Depression Treatment

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Trial Acronym

E-Compared Germany

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URL of the Trial

http://www.e-compared.eu

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Brief Summary in Lay Language

Background:
Depressiveness, lethargy and joylessness...
Depression is one of the most serious and common deseases of our time. In 2010, 30 million Europeans were affected by depression and their number is still growing. Half of Europeans in need of mental care for depression do not have access to care services, do not always receive evidence-based treatments, are confronted with long waiting lists or high care expenditures. Internet-based treatment has the potential to addresses the drawbacks of standard care and keep depression treatment of high quality and affordable in Germany and the rest of Europe.

Objective:
We evaluate the clinical and cost-effectiveness of blended internet-based depression treatment as compared to treatment-as-usual (TAU) in routine primary healthcare and specialised mental health service centres. We want to determine what treatment works best, for whom, and under what circumstances.

State of Research:
There is ample support for the effectiveness of Internet-based CBT for depression which is considered a promising alternative to routine depression treatment strategies. Most evidence comes from randomized controlled trials, however, and not from research in routine practice. The E-COMPARED project aims to gain knowledge on the clinical and cost-effectiveness of blended CBT depression treatment as compared to treatment as usual in routine care.

The project:
E-Compared (European Comparative Effectiveness Researchon Internet-based Depression Treatment) is a 3,5-year Europe-wide health research project funded by the European Commission. It is the first project to evaluate this kind of intervention across European countries to optimize mental health care systems.
Visit www.e-compared.eu for more information.

Intervention:
Participants will be randomized to two groups:
A. treatment-as-usaul by their general practitioner with later participation in the internet-based intervention after the end of the study
B. direct participation in the blended internet-based intervention
Blended treatment entails a combination of internet and mobile-based, and face-to-face interventions.

Participants:
Participants will be recruited from routine mental healthcare settings.
Inclusion criteria include age above 18, a diagnosed major depressive disorder, availability of fast internet on PC and smartphone and the motivation to be treated for 10-13 weeks. Participation is not possible if there is a current psychotherapeutic treatment or if there are so many comorbidities or suicide intention that a more intensive treatment is appropriate.

Benefit:
For patients:
Participation is free of charge. Our intervention can help to reduce depressive symptoms and to gain more quality in life. Our participants receive a qualified clinical diagnostic interview. The internet- and mobile-components of Moodbuster can be used at any time or place. There will be up to 90€ compensation for expanses such as time for assessments.

We invite general practitioners to cooperate with us in recruiting patients for our study. Contact us for more information!

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Brief Summary in Scientific Language

Background:
In 2010, 30 million Europeans were affected by depression and their number is still growing. Half of Europeans in need of mental care for depression do not have access to care services, do not always receive evidence-based treatments, are confronted with long waiting lists or high care expenditures. Internet-based treatment has the potential to addresses the drawbacks of standard care and keep depression treatment of high quality and affordable.

Objective:
E-COMPARED aims to provide mental healthcare stakeholders with evidence-based information and recommendations about the clinical and cost-effectiveness of blended depression treatment. The goal is to evaluate the clinical and cost-effectiveness of blended Cognitive Behavioural Therapy (CBT) for adults with major depressive disorder (MDD) as compared to TAU in routine primary healthcare and specialised mental health service centres. Therefore we perform a two armed, randomised controlled non-inferiority and cost-effectiveness trial in different European countries. The trials will be conducted in routine primary or specialised mental health care. Respondents in both conditions will be followed up to 12 months after baseline (measures will be taken at BL, 3 months, 6 months and 12 months).

Participants:
Patients will be recruited from routine clinical practice and will receive either depression treatment as usual or blended CBT depression treatment. Specific recruitment procedures depend on the country and the setting. In all settings consecutive patients that visit the GP (primary care) or the mental health specialist (secondary care) with major depressive disorder will be invited to take part in the study.

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Organizational Data

  •   DRKS00006866
  •   2014/12/02
  •   [---]*
  •   yes
  •   Approved
  •   MB 102014, Die Ethikkommission (EK) der Deutschen Gesellschaft für Psychologie ist ein Angebot des Zentrum für wissenschaftlich-psychologische Dienstleistungen (DGPs) der TransMIT GmbH.
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Secondary IDs

  •   U1111-1163-4113 
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Health Condition or Problem studied

  •   F32 -  Depressive episode
  •   F33 -  Recurrent depressive disorder
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Interventions/Observational Groups

  •   bCBT:
    A blended cognitive behavioral therapy combines individual face-to-face cognitive behavioural therapy (CBT) with CBT delivered through an Internet based treatment platform with mobile phone components.

    Moodbuster Website and App:
    The treatment platform Moodbuster/ICT4D has been developed and evaluated in an earlier finished FP7 project and afterwards optimized in content and technique for the project E-Compared. Moodbuster (platform hosted by INESC Porto, Portugal) will be used in Germany, the Netherlands, France, Poland and England. Its platform is the interface that participants will use the Internet based CBT content – consisting of five modules – to get information on depression or work on therapeutic exercises (e.g. list of pleasant activities, ideas on problem solving). These exercises are only part of the treatment not of the data assessment for evaluation. Patients will also rate their mood, sleep and activities on a smartphone App to supervise their own treatment progress. All content that participants add to the platform or the App will only be read by their therapist. For every finished module participants receive one to two feedback e-mails from their therapist.

    Therapists:
    Therapists plan and lead the face-to-face sessions according to the bCBT manual. They schedule meetings and online-feedback e-mails, control the treatment progress of the patients and write feedback. They support their patients also between the sessions in case of unexpected problems. Every message will be send via the contact option (SSL secured connection) on the Moodbuster website. Therapists have to document everything carefully, abide to data security and professional secrecy obligations and have to write a treatment report to the general practitioner if so wished by the patient. Therapists are psychologist in advanced training to become psychological psychotherapists under constantly supervision from experts.

    Content:
    The core components of the bCBT treatment are (1) psycho-education, (2) cognitive restructuring, (3) behavioural activation, and (4) relapse prevention. Additionally there is content on problem solving and physical activation.

    Duration:
    There are ten online sessions (including 10 online-feedback e-mails) with one session per week and five face-to-face sessions every two weeks. There is also an additional technical introduction in a face-to-face meeting with the therapist. The bCBT will go for a period of ten to thirteen weeks. Each session is scheduled for 50 minutes.
  •   Treatment as usual
    Treatment as usual (TAU) will be defined as the routine care that subjects receive when they are diagnosed with depression. In practice, this means that treatment as usual may vary between countries, setting, and among patients. We will not interfere with treatment as usual but we will monitor carefully what type of treatment subjects that are randomised to treatment as usual have received from the patient records and through self-report (including TIC-P measurements). Patients receiving TAU will also complete ecological momentary assessments (EMA) at the same time points as the patients randomised to blended care. However, this is not deemed part of their usual care treatment, this is considered assessment, although we acknowledge that the monitoring itself may have a small positive effect.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   Active control (effective treament of control group)
  •   Treatment
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

The project E-Compared ends on June, the 30st in 2017. The study E-Compared Germany ends with the last interview of the last participant - at the latest in September 2017. The last assessment for all study participants is the M.I.N.I. 5.0. After the last assessment the TAU group gets access to the bCBT.

Process:
0. Pre-Screening (PHQ-9)
1. First Online-Questionnaire + Baseline Interview
- Treatment -
2. Second Online-Questionnaire (3 months after baseline)
3. Third Online-Questionnaire (6 months after baseline)
4. Fourth Online-Questionnaire + Follow-Up Interview (12 months after baseline)

All questionnaires will be assessed via online-testplatform (www.unipark.de). Baseline is the date of the randomisation on individual patient level.

Symptomspecific Questionnaires - primary outcome:
The primary outcome is the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001).

PHQ-9 will be assessed to all 4 measurement points.

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Secondary Outcome

Symptomspecific Questionnaires - Secondary Outcome:
In addition to the PHQ-9 we use the 16 item version of the Quick Inventory of Depressive Symptomatology Self-Report (QIDS-16-SR) in the US translation (Rush et al., 2003). The diagnosis of depression will be assessed via M.I.N.I. International Neuropsychiatric Interview (M.I.N.I) version 5.0 on telephone. QUIDS and M.I.N.I. are considered as secondary outcomes.

Cost effectiveness:
To calculate cost effectiveness according to Quality-adjusted-life-years (QALY’s) we use the EQ-5D-5L (EuroQol) and in addition Trimbos andiMTA Questionnaires on Costs Associated with Psychiatric Illness (TiC-P; Hakkaart-van Rooijen, van Straten, Donker, Tiemens, 2002) as well as the Assessment of Quality of Life instrument (AQoL) (Hawthorne, Richardson, & Osborne, 1999).

QUIDS-16-SR, EQ-5D-5L, TiC-P & AQoL will be assessed to all 4 measurement points. TheM.I.N.I. will be assised at Baseline and in the 12 month follow up.

Additional measurements:
Demographic variables, treatment history, treatment expectancies via das Credibility and Expectancy Questionnaire (Devilly and Borkovec, 2000) will be assessed at basline in the online-questionnaire.
3 month after baseline we also use the Client Satisfaction Questionnaire (CSQ-8; Nguyen, Attkinson, & Stegner, 1983), the System Usability Scale (SUS; Brooke, 1996), the short version of the Working Alliance Inventory (WAI-SF; Hatcher & Gillaspy, 2006) for patients and therapists as well as the technologic alliance in the WAI ONline Therapy (Labpsitec, 2014).
In Germany there were a few more additional quantitative and qualitative measurement to different measurement points. A table showing all measurements can be asked for via mail.

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Countries of Recruitment

  •   Germany
  •   United Kingdom
  •   Poland
  •   Sweden
  •   Spain
  •   Switzerland
  •   France
  •   Netherlands
  •   Denmark
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2015/03/11
  •   1200
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

Patients will be included, if they
a. are 18 years of age or older
b. meet DSM-IV diagnostic criteria for MDD as confirmed by the telephone administered M.I.N.I. International Neuropsychiatric Interview version 5.0 and have a score of 5 or higher on the PHQ-9 screening questionnaire.
c. provide written informed consent in the study, audio- and video assessment and data usage (including data security).

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Exclusion Criteria

Patients will be exluded, if they
a. report a current high risk for suicide according to the M.I.N.I. Interview section C,
b. have a serious psychiatric co-morbidity that needs a more specific treatment as substance dependence, bipolar affective disorder, psychotic illness, obsessive compulsive disorder established at the MINI interview,
c. currently receive psychological treatment for depression in primary or specialised mental health care,
d. are unable to comprehend the spoken and written language of the country where the study is conducted (i.e. German in Germany),
e. do not have access to a PC and fast Internet connection (i.e. broadband or comparable) or
f. do not have a Smart phone that is compatible with the mobile component of the intervention that is offered or not willing to carry a Smart phone during the duration of treatment (participants without a Smartphone will be provided with one by the research team).

Excluded persons will be informed of other treatment possibilities. In the case of an increased suicide risk special preventive measurements will be taken.

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Addresses

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    • Lehrstuhl für Klinische Psychologie und Psychotherapie Friedrich-Alexander Universität Erlangen-Nürnberg
    • Mr.  Prof. Dr.  Matthias  Berking 
    • Nägelsbachstraße 25a
    • 91052  Erlangen
    • Germany
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    • VU University AmsterdamFaculty of PsychologyDept. Clinical Psychology
    • Ms.  Prof.  Heleen  Riper 
    • Van der Boechorststraat 1
    • 1081  BT Amsterdam
    • Netherlands
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    • Lehrstuhl für Klinische Psychologie und Psychotherapie Friedrich-Alexander Universität Erlangen-Nürnberg
    • Ms.  M.Sc.-Psych.  Ingrid  Titzler 
    • Nägelsbachstraße 25a
    • 91052  Erlangen
    • Germany
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    • Lehrstuhl für Klinische Psychologie und PsychotherapieFriedrich-Alexander Universität Erlangen-Nürnberg
    • Ms.  M.Sc.-Psych.  Ingrid  Titzler 
    • Nägelsbachstraße 25a
    • 91052  Erlangen
    • Germany
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Sources of Monetary or Material Support

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    • European UnionCORDISProject E-COMPARED, Proposal No: 603098-2
    • 2, rue Mercier
    • 2985  Luxembourg
    • Luxembourg
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Status

  •   Recruiting complete, follow-up complete
  •   2017/06/30
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* This entry means the parameter is not applicable or has not been set.