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Completed

NCT Number: NCT02369393

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Jaume I

Castellon, 12071, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Behavioral Activation

Behavioral

Behavioral Activation intervention promotes the involvement in meaningful activities close to personal values.

Physical activity

Behavioral

Physical Activity intervention promotes the gradual increase of the frequency and intensity of PA levels, with special attention to motivational strategies.

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universitat Jaume I

Other

Collaborators

  • Universitat Politècnica de València
  • University of Valencia

Registry information

Official study title

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

Acronym: PROMETEOII

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Feb 23, 2015
Registry last updated
Jul 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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