Efficacy of Two Internet Delivered Intervention Programs for Depression: Behavioral Activation vs Physical Activity

Study Overview
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Brief Summary
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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
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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).

Official Title
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Treatment of Depression: Efficacy and Efficiency of Two Self-administered Online Intervention Protocols Based on Behavioral Activation and Physical Activity

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Behavioral: Behavioral Activation
* Behavioral: Physical Activity


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral Activation<br>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. | Behavioral: Behavioral Activation<br>* Behavioral Activation intervention promotes the involvement in meaningful activities close to personal values.<br>|
| No Intervention: Waiting list control group<br>In the waiting list control group (WL), subjects will receive no treatment during 8 weeks. We will not interfere but we will monitor carefully through self-report. Then participants will be randomised to the two treatment groups. | |
| Experimental: Physical Activity<br>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: Physical Activity<br>* Physical Activity intervention promotes the gradual increase of the frequency and intensity of PA levels, with special attention to motivational strategies.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Internet based treatment, Depression, Efficacy, Cost-effectiveness, Behavioral Activation, Self-applied, Ecological Momentary Assessment, Physical Activity