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

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ClinicalTrials.gov Identifier: NCT02369393
Recruitment Status : Recruiting
First Posted : February 23, 2015
Last Update Posted : October 25, 2018
Sponsor:
Collaborators:
University of Valencia
Universitat Politècnica de València
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Behavioral: Behavioral Activation Behavioral: Physical Activity Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Depression: Efficacy and Efficiency of Two Self-administered Online Intervention Protocols Based on Behavioral Activation and Physical Activity
Actual Study Start Date : April 2, 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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: Behavioral Activation
Behavioral Activation intervention promotes the involvement in meaningful activities close to personal values.

No Intervention: 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.
Experimental: 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: Physical Activity
Physical Activity intervention promotes the gradual increase of the frequency and intensity of PA levels, with special attention to motivational strategies.




Primary Outcome Measures :
  1. Change in Patient Health Questionnaire-9 [ Time Frame: Change from baseline to 2 months, 5 months, and 8 months ]
  2. Change in the Beck Depression Inventory [ Time Frame: Change from baseline to 2 months, 5 months, and 8 months ]

Secondary Outcome Measures :
  1. Change in the EQ-5D-5L (EuroQol) [ Time Frame: Change from baseline to 2 months, 5 months, and 8 months ]
  2. Change in the Quality of Life (QLI) [ Time Frame: Change from baseline to 2 months, 5 months, and 8 months ]
  3. Change in the Overall Anxiety Severity and Impairment Scale (OASIS) [ Time Frame: Change from baseline to 2 months, 5 months, and 8 months ]
  4. Change in the Positive and Negative Affect Scale (PANAS) [ Time Frame: Change from baseline to 2 months, 5 months, and 8 months ]
  5. Change in the Happiness Scale (Fordyce) [ Time Frame: Change from baseline to 2 months, 5 months, and 8 months ]
  6. Change in the Satisfaction with Life Scale (SWLS, Diener) [ Time Frame: Change from baseline to 2 months, 5 months, and 8 months ]
  7. Change in the Ryff Scale of Psychological Wellbeing [ Time Frame: Change from baseline to 2 months, 5 months, and 8 months ]
  8. Change in the Behavioral Activation for Depression Scale - Short Form (BADS-SF) [ Time Frame: Change from baseline to 2 months, 5 months, and 8 months ]
  9. Change in the Environmental Reward Observation Scale (EROS) [ Time Frame: Change from baseline to 2 months, 5 months, and 8 months ]
  10. Change in Beck Depression Inventory (BDI-II) [ Time Frame: Change from baseline to 2 months, 5 months, and 8 months ]

Other Outcome Measures:
  1. Eysenck Personality Questionnaire-Revised Short Form (Neuroticism subscale) [ Time Frame: Baseline ]
  2. Credibility and expectancy questionnaire (CEQ) [ Time Frame: 2 weeks ]
  3. Self concordance motivation (SCM) [ Time Frame: 2 weeks ]
  4. Working Alliance Inventory (WAI-SF) [ Time Frame: 3 weeks ]
  5. System usability scale (SUS) [ Time Frame: 2 months ]
  6. Change in preferences for treatment scale (self-applied vs face to face) [ Time Frame: Change from baseline to 2 months ]
  7. Satisfaction with the treatment [ Time Frame: 2 months ]
  8. Change in the MINI International Neuropsychiatric Interview (M.I.N.I) version 5.0 [ Time Frame: Change from baseline to 2 months ]
  9. Change in Structured Clinical Interview (SCID-I) for Adjustment Disorders [ Time Frame: Change from baseline to 2 months ]
  10. Attitudes towards Psychological Online Interventions Questionnaire (APOI) [ Time Frame: Baseline ]
  11. Semi-structured interview about users´ intervention experience [ Time Frame: 2 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02369393


Contacts
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Contact: Cristina Botella, PhD +34 964 38 76 39 ext 7639 botella@uji.es
Contact: Guadalupe Molinari, MA +34 964 38 76 45 guadalupemolinari@gmail.com

Locations
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Spain
University Jaume I Recruiting
Castelló de la Plana, Spain, 12071
Contact: Cristina Botella Arbona, PhD    +34 964 38 76 39 ext 76 39    botella@uji.es   
Contact: Guadalupe Molinari, MA    +34 964 38 76 45 ext 76 45    guadalupemolinari@gmail.com   
Principal Investigator: Cristina Botella Arbona, PhD         
Principal Investigator: Rosa Baños Rivera, PhD         
Sub-Investigator: Macarena Espinoza, PhD         
Sub-Investigator: Guadalupe Molinari, MA         
Sponsors and Collaborators
Universitat Jaume I
University of Valencia
Universitat Politècnica de València
Investigators
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Principal Investigator: Cristina Botella, PhD Universitat Jaume I;CIBERObn ISC III, Spain
Principal Investigator: Rosa Baños, PhD Universitat de Valencia; CIBERObn ISC III, Spain

Publications:

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Responsible Party: Universitat Jaume I
ClinicalTrials.gov Identifier: NCT02369393     History of Changes
Other Study ID Numbers: UJaimeI06
First Posted: February 23, 2015    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universitat Jaume I:
Internet based treatment
Depression
Efficacy
Cost-effectiveness
Behavioral Activation
Self-applied
Ecological Momentary Assessment
Physical Activity
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders