Efficacy of Two Internet Delivered Intervention Programs for Depression: Behavioral Activation vs Physical Activity
NCT ID: NCT02369393
Last Updated: 2023-07-11
Study Results
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Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2021-11-02
2023-02-01
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Behavioral Activation
Behavioral Activation intervention promotes the involvement in meaningful activities close to personal values.
Waiting list control group
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.
No interventions assigned to this group
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.
Physical Activity
Physical Activity intervention promotes the gradual increase of the frequency and intensity of PA levels, with special attention to motivational strategies.
Interventions
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Behavioral Activation
Behavioral Activation intervention promotes the involvement in meaningful activities close to personal values.
Physical Activity
Physical Activity intervention promotes the gradual increase of the frequency and intensity of PA levels, with special attention to motivational strategies.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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University of Valencia
OTHER
Universitat Politècnica de València
OTHER
Universitat Jaume I
OTHER
Responsible Party
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Principal Investigators
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Cristina Botella, PhD
Role: PRINCIPAL_INVESTIGATOR
Universitat Jaume I;CIBERObn ISC III, Spain
Rosa Baños, PhD
Role: PRINCIPAL_INVESTIGATOR
Universitat de Valencia; CIBERObn ISC III, Spain
Locations
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University Jaume I
Castellon, , Spain
Countries
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References
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Other Identifiers
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UJaimeI06
Identifier Type: -
Identifier Source: org_study_id
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