To compare the clinical and cost-effectiveness of Behavioral Activation (BA) and Physical Activity (PA) for adults with major depressive disorder (MDD) or adjustment disorder with depressive symptomatology with a wait list control group (WL) in Spanish population.
Research shows that in 2030 (Mathers and Loncar, 2006) depression will become one of the three leading causes of disability. 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, but with similar levels of clinical efficacy and quality of care. In Spain the trial will be carried out in a community sample, comparing the clinical and cost-effectiveness of BA or PA with WL for adults with major depressive disorder (MDD) and adjustment disorder with depressive symptomatology. Respondents will be followed until 6 months after baseline (measures will be taken at BL, 3 months, and 6 months).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
Behavioral Activation intervention promotes the involvement in meaningful activities close to personal values.
Physical Activity intervention promotes the gradual increase of the frequency and intensity of PA levels, with special attention to motivational strategies.
University Jaume I
Castellon, Spain
Change in Patient Health Questionnaire-9
Time frame: Change from baseline to 2 months, 5 months, and 8 months
Change in the Beck Depression Inventory
Time frame: Change from baseline to 2 months, 5 months, and 8 months
Change in the EQ-5D-5L (EuroQol)
Time frame: Change from baseline to 2 months, 5 months, and 8 months
Change in the Quality of Life (QLI)
Time frame: Change from baseline to 2 months, 5 months, and 8 months
Change in the Overall Anxiety Severity and Impairment Scale (OASIS)
Time frame: Change from baseline to 2 months, 5 months, and 8 months
Change in the Positive and Negative Affect Scale (PANAS)
Time frame: Change from baseline to 2 months, 5 months, and 8 months
Change in the Happiness Scale (Fordyce)
Time frame: Change from baseline to 2 months, 5 months, and 8 months
Change in the Satisfaction with Life Scale (SWLS, Diener)
Time frame: Change from baseline to 2 months, 5 months, and 8 months
Change in the Ryff Scale of Psychological Wellbeing
Time frame: Change from baseline to 2 months, 5 months, and 8 months
Change in the Behavioral Activation for Depression Scale - Short Form (BADS-SF)
Time frame: Change from baseline to 2 months, 5 months, and 8 months
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Change in the Environmental Reward Observation Scale (EROS)
Time frame: Change from baseline to 2 months, 5 months, and 8 months
Change in Beck Depression Inventory (BDI-II)
Time frame: Change from baseline to 2 months, 5 months, and 8 months