Major Depressive Disorder
Conditions
Keywords
Internet based treatment, Depression, Efficacy, Cost-effectiveness, Behavioral Activation, Self-applied, Ecological Momentary Assessment, Physical Activity
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).
Interventions
BEHAVIORALBehavioral Activation
Behavioral Activation intervention promotes the involvement in meaningful activities close to personal values.
BEHAVIORALPhysical Activity
Physical Activity intervention promotes the gradual increase of the frequency and intensity of PA levels, with special attention to motivational strategies.
Sponsors
University of Valencia
Universitat Politècnica de València
Universitat Jaume I
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 Positive and Negative Affect Scale (PANAS) | 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 the Ryff Scale of Psychological Wellbeing | 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 |
| Change in the Environmental Reward Observation Scale (EROS) | 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 |
Other
| Measure | Time frame |
|---|---|
| Eysenck Personality Questionnaire-Revised Short Form (Neuroticism subscale) | Baseline |
| Credibility and expectancy questionnaire (CEQ) | 2 weeks |
| Self concordance motivation (SCM) | 2 weeks |
| Working Alliance Inventory (WAI-SF) | 3 weeks |
| System usability scale (SUS) | 2 months |
| Change in preferences for treatment scale (self-applied vs face to face) | Change from baseline to 2 months |
| Change in the MINI International Neuropsychiatric Interview (M.I.N.I) version 5.0 | Change from baseline to 2 months |
| Change in Structured Clinical Interview (SCID-I) for Adjustment Disorders | Change from baseline to 2 months |
| Attitudes towards Psychological Online Interventions Questionnaire (APOI) | Baseline |
| Semi-structured interview about users´ intervention experience | 2 months |
| Satisfaction with the treatment | 2 months |
Countries
Spain
Outcome results
None listed