Efficacy of Two Internet Delivered Intervention Programs for Depression: Behavioral Activation vs Physical Activity
- Conditions
- Major Depressive Disorder
- Registration Number
- NCT02369393
- Lead Sponsor
- Universitat Jaume I
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- Being 18 years of age or older
- Meet DSM-IV diagnostic criteria for MDD and adjustment disorder confirmed by MINI International Neuropsychiatric Interview version 5.0 and SCID I
- A score of 5 or higher on the PHQ-9 screening questionnaire.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in Patient Health Questionnaire-9 Change from baseline to 2 months, 5 months, and 8 months Change in the Beck Depression Inventory Change from baseline to 2 months, 5 months, and 8 months
- Secondary Outcome Measures
Name Time Method Change in the Ryff Scale of Psychological Wellbeing Change from baseline to 2 months, 5 months, and 8 months Change in the Environmental Reward Observation Scale (EROS) Change from baseline to 2 months, 5 months, and 8 months Change in the Positive and Negative Affect Scale (PANAS) Change from baseline to 2 months, 5 months, and 8 months Change in the EQ-5D-5L (EuroQol) Change from baseline to 2 months, 5 months, and 8 months Change in the Quality of Life (QLI) Change from baseline to 2 months, 5 months, and 8 months Change in the Overall Anxiety Severity and Impairment Scale (OASIS) Change from baseline to 2 months, 5 months, and 8 months Change in the Happiness Scale (Fordyce) Change from baseline to 2 months, 5 months, and 8 months Change in the Satisfaction with Life Scale (SWLS, Diener) Change from baseline to 2 months, 5 months, and 8 months Change in Beck Depression Inventory (BDI-II) Change from baseline to 2 months, 5 months, and 8 months Change in the Behavioral Activation for Depression Scale - Short Form (BADS-SF) Change from baseline to 2 months, 5 months, and 8 months
Trial Locations
- Locations (1)
University Jaume I
🇪🇸Castelló de la Plana, Spain
University Jaume I🇪🇸Castelló de la Plana, Spain