European Comparative Effectiveness Research on Internet-based Depression Treatment

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00006866
• Date of registration: 02/12/2014
• Prospective Registration: Yes
• Primary sponsor: Lehrstuhl für Klinische Psychologie und Psychotherapie Friedrich-Alexander Universität Erlangen-Nürnberg
• Public title: European Comparative Effectiveness Research on Internet-based Depression Treatment
• Scientific title: European Comparative Effectiveness Research on Internet-based Depression Treatment - E-Compared Germany
• Date of first enrolment: 11/03/2015
• Target sample size: 1200
• Recruitment status: Complete
• URL: http://drks.de/search/en/trial/DRKS00006866
• Study type: interventional
• Study design: Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: active; Assignment: other; Study design purpose: treatment
• Phase: N/A

Countries of recruitment

Denmark, France, Germany, Netherlands, Poland, Spain, Sweden, Switzerland, United Kingdom

Contacts

• Name: Ingrid Titzler
• Affiliation: Lehrstuhl für Klinische Psychologie und Psychotherapie Friedrich-Alexander Universität Erlangen-Nürnberg

• Name: Ingrid Titzler
• Affiliation: Lehrstuhl für Klinische Psychologie und PsychotherapieFriedrich-Alexander Universität Erlangen-Nürnberg

Key inclusion & exclusion criteria

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).

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.

Age minimum: 18 Years
Age maximum: None
Gender: All

Health Condition(s) or Problem(s) studied

Depressive episode

Recurrent depressive disorder

F32
F33

Intervention(s)

Group 1: 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 wishe

Primary Outcome(s)

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.

Secondary Outcome(s)

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.

Secondary ID(s)

U1111-1163-4113

Source(s) of Monetary Support

European UnionCORDISProject E-COMPARED, Proposal No: 603098-2

Ethics review

Status: Approved
Approval date: 10/11/2014
Contact:

[e-mail]

Ethik-Kommission der DGPs Fachbereich I Psychologie [Die Ethikkommission (EK) der Deutschen Gesellschaft für Psychologie ist ein Angebot des Zentrum für wissenschaftlich-psychologische Dienstleistungen (DGPs) der TransMIT GmbH. ]

[e-mail]

Results

• Date Completed: 30/06/2017
• URL: http://drks.de/search/en/trial/DRKS00006866#studyResults