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

Major Depressive Disorder Clinical Trial

— PROMETEOII  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02369393
• Other study ID #: UJaimeI06
• Status: Completed
• Phase: N/A
• Start date: November 2, 2021
• Est. completion date: February 1, 2023

Study information

• Verified date: July 2023
• Source: Universitat Jaume I
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 1, 2023
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Spain	University Jaume I	Castelló de la Plana

Sponsors (3)

Lead Sponsor	Collaborator
Universitat Jaume I	Universitat Politècnica de València, University of Valencia

Country where clinical trial is conducted

Spain, 

References & Publications (30)

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Eysenck Personality Questionnaire-Revised Short Form (Neuroticism subscale)		Baseline
Other	Credibility and expectancy questionnaire (CEQ)		2 weeks
Other	Self concordance motivation (SCM)		2 weeks
Other	Working Alliance Inventory (WAI-SF)		3 weeks
Other	System usability scale (SUS)		2 months
Other	Change in preferences for treatment scale (self-applied vs face to face)		Change from baseline to 2 months
Other	Satisfaction with the treatment		2 months
Other	Change in the MINI International Neuropsychiatric Interview (M.I.N.I) version 5.0		Change from baseline to 2 months
Other	Change in Structured Clinical Interview (SCID-I) for Adjustment Disorders		Change from baseline to 2 months
Other	Attitudes towards Psychological Online Interventions Questionnaire (APOI)		Baseline
Other	Semi-structured interview about users´ intervention experience		2 months
Primary	Change in Patient Health Questionnaire-9		Change from baseline to 2 months, 5 months, and 8 months
Primary	Change in the Beck Depression Inventory		Change from baseline to 2 months, 5 months, and 8 months
Secondary	Change in the EQ-5D-5L (EuroQol)		Change from baseline to 2 months, 5 months, and 8 months
Secondary	Change in the Quality of Life (QLI)		Change from baseline to 2 months, 5 months, and 8 months
Secondary	Change in the Overall Anxiety Severity and Impairment Scale (OASIS)		Change from baseline to 2 months, 5 months, and 8 months
Secondary	Change in the Positive and Negative Affect Scale (PANAS)		Change from baseline to 2 months, 5 months, and 8 months
Secondary	Change in the Happiness Scale (Fordyce)		Change from baseline to 2 months, 5 months, and 8 months
Secondary	Change in the Satisfaction with Life Scale (SWLS, Diener)		Change from baseline to 2 months, 5 months, and 8 months
Secondary	Change in the Ryff Scale of Psychological Wellbeing		Change from baseline to 2 months, 5 months, and 8 months
Secondary	Change in the Behavioral Activation for Depression Scale - Short Form (BADS-SF)		Change from baseline to 2 months, 5 months, and 8 months
Secondary	Change in the Environmental Reward Observation Scale (EROS)		Change from baseline to 2 months, 5 months, and 8 months
Secondary	Change in Beck Depression Inventory (BDI-II)		Change from baseline to 2 months, 5 months, and 8 months