e-Compared-S: Comparative Effectiveness Research on Internet-based Depression Treatment - Spanish Trial
NCT ID: NCT02361684
Last Updated: 2019-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
160 participants
INTERVENTIONAL
2015-02-28
2019-09-30
Brief Summary
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Detailed Description
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Internet-based depression treatment appears a very promising alternative to current routine depression treatment strategies. Meta-analyses have demonstrated the clinical effectiveness and potential cost-effectiveness of Internet-based treatment for depression in controlled research setting. Internet-based treatment thus has the potential to keep depression treatment affordable, as it enables mental health care providers to reach out to large populations needing depression treatment at a better cost-effectiveness than those of standard treatment as usual (TAU), but with similar levels of clinical efficacy and quality of care.
The trials will be conducted in 8 European countries. In Spain the trial will be carried out in routine primary, comparing the clinical and cost-effectiveness of CBT and TAU for adults with major depressive disorder (MDD). Respondents will be followed until 12 months after baseline (measures will be taken at BL, 3 months, 6 months and 12 months).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Blended CBT treatment
Blended CBT treatment
Internet based blended CBT depression treatment combines individual face-to-face cognitive behavioural therapy (CBT) with CBT delivered through an Internet based treatment platform with mobile phone components (either integrated in the treatment platform or as a separate system). The core components of the CBT treatment are: (1) psycho-education, (2) cognitive restructuring, (3) behavioural activation, (4) positive psychology, and (5) relapse prevention. These will be delivered over 10 sessions. For this study, the ratio between the number of face-to-face sessions and the number of online module will be 1/3 face-to-face and 2/3 online.
Treatment as usual
Treatment as usual
Treatment as usual (TAU) is defined as the routine care that subjects receive when they are diagnosed with depression in the primary care system. In practice, this means that treatment as usual may vary between patients. 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
Interventions
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Blended CBT treatment
Internet based blended CBT depression treatment combines individual face-to-face cognitive behavioural therapy (CBT) with CBT delivered through an Internet based treatment platform with mobile phone components (either integrated in the treatment platform or as a separate system). The core components of the CBT treatment are: (1) psycho-education, (2) cognitive restructuring, (3) behavioural activation, (4) positive psychology, and (5) relapse prevention. These will be delivered over 10 sessions. For this study, the ratio between the number of face-to-face sessions and the number of online module will be 1/3 face-to-face and 2/3 online.
Treatment as usual
Treatment as usual (TAU) is defined as the routine care that subjects receive when they are diagnosed with depression in the primary care system. In practice, this means that treatment as usual may vary between patients. 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
Eligibility Criteria
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Inclusion Criteria
* Meet DSM-IV diagnostic criteria for MDD confirmed by MINI International Neuropsychiatric Interview version 5.0
* a score a score of 5 or higher on the PHQ-9 screening questionnaire.
Exclusion Criteria
* 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 language (Spanish)
* Not having access to a PC and fast Internet connection (i.e. broadband or comparable).
* Not having a Smartphone that is compatible with the mobile component of the intervention that is offered or not willing to carry a Smartphone during the duration of treatment
18 Years
ALL
No
Sponsors
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University of Valencia
OTHER
Universitat Jaume I
OTHER
Responsible Party
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Principal Investigators
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Cristina Botella Arbona, PhD
Role: PRINCIPAL_INVESTIGATOR
Universitat Jaume I;CIBERObn ISC III, Castellón de la Plana, Spain
Rosa Baños Rivera, PhD
Role: PRINCIPAL_INVESTIGATOR
Universitat de Valencia; CIBERObn ISC III, Castellón de la Plana, Spain
Azucena García-Palacios, PhD
Role: PRINCIPAL_INVESTIGATOR
Universitat Jaume I;CIBERObn ISC III, Castellón de la Plana, Spain
Ernestina Etchemendy, PhD
Role: PRINCIPAL_INVESTIGATOR
CIBERObn ISC III, Castellón de la Plana, Spain
Rocio Herrero Camarano, PhD
Role: PRINCIPAL_INVESTIGATOR
Universitat Jaume I
Locations
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University Jaume I
Castellon, Castellón, Spain
University of Valencia
Valencia, , Spain
Countries
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References
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Other Identifiers
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UJaumeI07
Identifier Type: -
Identifier Source: org_study_id
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