Efficacy of Two Internet Delivered Intervention Programs for Depression: Behavioral Activation vs Physical Activity
- Conditions
- Major Depressive Disorder
- Interventions
- Behavioral: Physical ActivityBehavioral: Behavioral Activation
- 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
- Arm && Interventions
Group Intervention Description Physical Activity Physical Activity There is evidence to suggest that the addition of cognitive behavioral therapies, specifically exercise, can improve treatment outcomes for many patients. Exercise is a behavioral intervention that has shown great promise in alleviating symptoms of depression. The treatment will be 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 PA treatment are: 1) psychoeducation: understand the mental health benefits of physical activity, 2) learn about the types and amounts of physical activity recommended, 3) motivation to perform and maintain physical activities, 4) relapse prevention. These will be delivered over 4 modules. There will be a minimal therapist support. Behavioral Activation Behavioral Activation BA treatment for depression is a simple, cost-effective method. There is evidence that the behavioral component may be the active mechanism of change in cognitive-behavioral treatments of clinical depression. One of the main objectives of the treatment is to systematically increase exposure to positive activities, and thereby improve affect and corresponding cognitions. Treatment will be 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 are: 1) psycho-education, 2) identifying important values and significant activities, 3) activity structuring and scheduling, 4) relapse prevention. These will be delivered over 4 modules. There will be a minimal therapist support.
- 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