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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
Sponsor:
Collaborators:
VU University of Amsterdam
Linkoeping University
University of Erlangen-Nürnberg
London School of Hygiene and Tropical Medicine
GGZ inGeest
Universitat Jaume I
Leuphana Universität Lünenberg
University of Limerick
University of Bern
University of Valencia
Inesc Porto
Institut National de la Santé Et de la Recherche Médicale, France
European Commission
Ministry of Science and Higher Education, Poland
Information provided by (Responsible Party):
Roman Cieslak, University of Social Sciences and Humanities, Warsaw

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. Satisfaction with the Platform [ Time Frame: 3 months ]
    Satisfaction with the platform will be evaluated with the System usability scale (SUS; Brooke, 1996).

  7. 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).

  8. 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).

  9. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meet DSM-IV diagnostic criteria for MDD as confirmed by the telephone administered MINI International Neuropsychiatric Interview version 5.0 and a score a score of 5 or higher on the PHQ-9 screening questionnaire.

Exclusion Criteria:

  • Current high risk for suicide according to the MINI Interview section C
  • Serious psychiatric co-morbidity: substance dependence, bipolar affective disorder, psychotic illness, obsessive compulsive disorder, as established at the MINI interview
  • Currently receiving psychological treatment for depression in primary or specialised mental health care
  • Being unable to comprehend the spoken and written Polish
  • Not having access to a PC and fast Internet connection (i.e. broadband or comparable).
  • Not having a Smart phone that is compatible with the mobile component of the intervention that is offered or not willing to carry a Smartphone if one is provided with one by the research team for the study duration.

Information from the National Library of Medicine

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


Locations
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Poland
University of Social Sciences and Humanities
Warsaw, Poland, 03-815
Sponsors and Collaborators
University of Social Sciences and Humanities, Warsaw
VU University of Amsterdam
Linkoeping University
University of Erlangen-Nürnberg
London School of Hygiene and Tropical Medicine
GGZ inGeest
Universitat Jaume I
Leuphana Universität Lünenberg
University of Limerick
University of Bern
University of Valencia
Inesc Porto
Institut National de la Santé Et de la Recherche Médicale, France
European Commission
Ministry of Science and Higher Education, Poland
Investigators
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Principal Investigator: Roman Cieslak, PhD University of Social Sciences and Humanities

Publications:
Hatcher R, Gillaspy J. Development and validation of a revised short version of the working alliance inventory. Psychotherapy Research 16(1): 12-25, 2006.
Lecrubier Y, Sheehan DV, Weiller E, Amorim P, Bonora I, Harnett Sheehan K, Dunbar GC. The Mini International Neuropsychiatric Interview (MINI). A short diagnostic structured interview: reliability and validity according to the CIDI. European Psychiatry, 12(5): 224-231, 1997.
Hakkaart-van Rooijen L, van Straten A, Donker M, Tiemans B. Manual Trimbos/iMTA questionnaire for costs associated with psychiatric illness (TIC-P). Rotterdam: Institute for Medical Technology Assessment. 2002
Brooke J. SUS-a quick and dirty usability scale. In Usability Eval Ind. Volume 189. Edited by Jordan PW, Thomas B, Weerdmeester BA, McClelland IL. London: Taylor & Francis Ltd; 1996:189-194.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Roman Cieslak, Vice-Rector for Research, University of Social Sciences and Humanities, Warsaw
ClinicalTrials.gov Identifier: NCT02389660     History of Changes
Other Study ID Numbers: W73/7. PR/2014
First Posted: March 17, 2015    Key Record Dates
Last Update Posted: June 29, 2018
Last Verified: June 2018

Keywords provided by Roman Cieslak, University of Social Sciences and Humanities, Warsaw:
Depression, Blended Cognitive Behavioural Therapy, Internet intervention

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders