European Comparative Effectiveness Research on Internet-based Depression Treatment in Poland (E-COMPARED)
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|ClinicalTrials.gov Identifier: NCT02389660|
Recruitment Status : Completed
First Posted : March 17, 2015
Last Update Posted : June 29, 2018
Effective, accessible, and affordable depression treatment is of high importance considering the large individual and economic burden of depression. There is ample support for the effectiveness of Internet-based Cognitive Behavioral Therapy (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 European Comparative Effectiveness Research on Internet-based Depression Treatment (E-COMPARED) in Poland aims to compare the clinical and cost-effectiveness of blended CBT for adults with major depressive disorder (MDD) with treatment as usual (TAU). The trial will be conducted in routine mental health care in Poland, and is a part of the bigger project funded by European Commission (Grant Agreement No: 603098). In this randomized controlled trial, a total of 150 patients with MDD will be assigned to one of two conditions: 1) blended CBT, 2) TAU. Respondents in both conditions will be followed until 12 months after baseline (measures will be taken at baseline, 3 months, 6 months and 12 months).
|Condition or disease||Intervention/treatment||Phase|
|Depression||Behavioral: Blended Cognitive Behavioural Therapy (CBT) Behavioral: Treatment as usual||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||84 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||European Comparative Effectiveness Research on Internet-based Depression Treatment in Poland [Europejskie Badania Porównawcze Nad Efektywnością Interwencji Internetowej Dla Osób z Depresją] (E-COMPARED)|
|Actual Study Start Date :||June 2015|
|Actual Primary Completion Date :||June 2018|
|Actual Study Completion Date :||June 2018|
Experimental: Blended CBT
Internet based blended depression treatment combines individual face-to-face cognitive behavioural therapy (CBT) with CBT delivered through an Internet based treatment platform with mobile phone components. The core components of the CBT treatment are: (1) psycho-education, (2) cognitive restructuring, (3) behavioural activation, and (4) relapse prevention. These will be delivered over 13 sessions (6 online and 7 face-to-face, session sequence - alternate, online platform - Moodbuster).
Behavioral: Blended Cognitive Behavioural Therapy (CBT)
Active Comparator: Treatment as usual
Treatment as usual (TAU) will be defined as the routine care CBT that subjects receive when they are diagnosed with depression in the setting of recruitment. We will not interfere with treatment as usual but we will monitor carefully which health care services are utilized by usual care patients using patient records and through self-report (including TIC-P measurements).
Behavioral: Treatment as usual
- Change from Baseline Depression at 12 months [ Time Frame: Baseline, 12 months ]Symptoms of depression will be assessed with the 9-item self-report The Patient Health Questionnaire (PHQ) (Kroenke et. al., 2001).
- Change from Baseline Symptoms of Depression at 12 months [ Time Frame: Baseline, 12 months ]Symptoms of depression will be assessed with the 16-Item Quick Inventory of Depressive Symptomatology (QIDS) (Rush et al., 2003).
- Change from Baseline Diagnosis of Depression at 12 months [ Time Frame: Baseline, 12 months ]A diagnosis of depression will be assessed with the MINI International Neuropsychiatric Interview (M.I.N.I) version 5.0. The M.I.N.I. is a structured diagnostic interview based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) and on International Classification of Diseases (ICD-10) criteria. The interview compares well with Structural Clinical Interview for DSM-IV disorders (SCID) (Sheehan et al., 1998) and the Composite International Diagnostic Interview (CIDI) (Lecrubier et al., 1997; Sheehan et al., 1998).
- Change from Baseline Health Service Uptake and Production Loss Due to Illness at 12 months [ Time Frame: Baseline, 12 months ]Health service uptake and production loss due to illness will be measured with the Trimbos and iMTA Questionnaires on Costs Associated with Psychiatric Illness (TiC-P; Hakkaart-van Rooijen, van Straten, Donker, Tiemens, 2002).
- Therapeutic Alliance [ Time Frame: 3 months ]The therapeutic alliance between therapists and patient will be assessed with the short version of the Working Alliance Inventory (WAI-SF; Hatcher & Gillaspy, 2006).
- Patient's Satisfaction with the Treatment [ Time Frame: 3 months ]Patient's satisfaction with the treatment was assessed with Client Satisfaction Questionnaire (CSQ-8; Nguyen, Attkinson, & Stegner, 1983).
- Satisfaction with the Platform [ Time Frame: 3 months ]Satisfaction with the platform will be evaluated with the System usability scale (SUS; Brooke, 1996).
- Alliance between the Patient and Technologies [ Time Frame: 3 months ]We will assess the alliance between the patient and technologies with an adapted version of the WAI-SF, the Technology Alliance Inventory (TAI-SF).
- Patients' Expectancy of Treatment [ Time Frame: Baseline ]Patients' expectancy of treatment will be assessed with the credibility and expectancy questionnaire of Devilly and Borkovec (2000).
- Change from Quality of Life at 12 months [ Time Frame: Baseline, 12 months ]Quality of life will be assessed with the EQ-5D-5L (EuroQol; Van Agt, Essink-Bot, Krabbe, & Bonsel, 1994).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02389660
|University of Social Sciences and Humanities|
|Warsaw, Poland, 03-815|
|Principal Investigator:||Roman Cieslak, PhD||University of Social Sciences and Humanities|