e-Compared-S: Comparative Effectiveness Research on Internet-based Depression Treatment - Spanish Trial (E-COMPARED_S)

Universitat Jaume I

Status

Completed

Conditions

Major Depressive Disorder

Treatments

Other: Treatment as usual

Behavioral: Blended CBT treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT02361684

UJaumeI07

Details and patient eligibility

About

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.

Full 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).

Enrollment

160 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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