Clinical trial NCT02361684: e-Compared-S: Comparative Effectiveness Research on Internet-based Depression Treatment - Spanish Trial
Official title: European Comparative Effectiveness Research on Internet-based Depression Treatment - Spanish Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: cost-effectiveness
blended treatment
Internet based treatment
Efficacy
Depression
cognitive behavioural therapy
Lead sponsor: Universitat Jaume I
Sponsor class: OTHER
Collaborators: name: University of Valencia
First posted: 2015-02-12
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the clinical and cost-effectiveness of blended Cognitive Behavioural Therapy (CBT) for adults with major depressive disorder (MDD) with treatment as usual (TAU) in Spanish population.

Detailed description: Depression is a common mental disorder with a negative impact on mental well-being, quality of life, and social and work-related functioning both in the short and longer term. Additionally, depression is associated with increased morbidity, mortality, health care utilization and health care costs. On a population level, depression is one of the most costly diseases. The economic costs of depression were estimated at €136.3 billion (EU25) in 2010 in the EU and are still rising. European health care systems face the challenge of improving access to cost-effective treatments while simultaneously working to sustain budgetary stability in times of economic austerity.

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).

Eligibility criteria: Inclusion Criteria:

* Being 18 years of age or older
* 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:

* 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 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

Primary outcomes:
measure: Change in Patient Health Questionnaire-9
timeFrame: Baseline, 3 months, 6 months and 12 months
Secondary outcomes:
measure: Change in Quick Inventory of Depressive Symptomatology Self-Report (QIDS-16-SR) US Translation
timeFrame: Baseline, 3 months, 6 months and 12 months
measure: Change in the MINI International Neuropsychiatric Interview (M.I.N.I) version 5.0
timeFrame: Baseline and 12 months
measure: Change in the EQ-5D-5L (EuroQol)
timeFrame: Baseline, 3 months, 6 months and 12 months
measure: Change in the Questionnaires on Costs Associated with Psychiatric Illness (TiC-P; Hakkaart-van Rooijen, van Straten, Donker, Tiemens, 2002)
timeFrame: Baseline, 3 months, 6 months and 12 months
measure: Change in the Working Alliance Inventory (WAI-SF)
timeFrame: 3 months
measure: Change in the credibility and expectancy questionnaire (CEQ; Devilly and Borkovec, 2000)
timeFrame: Baseline
measure: Change in the Satisfaction Questionnaire (CSQ-8; Nguyen, Attkinson, & Stegner, 1983)
timeFrame: 3 months
measure: Change in the system usability scale (SUS; Brooke, 1996)
timeFrame: 3 months
Other outcomes:
Locations:
city: Castelló de la Plana
country: Spain
facility: University Jaume I
state: Castellón
city: Valencia
country: Spain
facility: University of Valencia
Study officials:
affiliation: Universitat Jaume I;CIBERObn ISC III, Castellón de la Plana, Spain
name: Cristina Botella Arbona, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitat de Valencia; CIBERObn ISC III, Castellón de la Plana, Spain
name: Rosa Baños Rivera, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitat Jaume I;CIBERObn ISC III, Castellón de la Plana, Spain
name: Azucena García-Palacios, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CIBERObn ISC III, Castellón de la Plana, Spain
name: Ernestina Etchemendy, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitat Jaume I
name: Rocio Herrero Camarano, PhD
role: PRINCIPAL_INVESTIGATOR
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