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Completed

NCT Number: NCT02361684

e-Compared-S: Comparative Effectiveness Research on Internet-based Depression Treatment - Spanish Trial

To compare the clinical and cost-effectiveness of blended Cognitive Behavioural Therapy (CBT) for adults with major depressive disorder (MDD) with treatment as usual (TAU) in Spanish population.

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Jaume I, Castellon, Castellón, Spain

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About this study

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 than those of standard treatment as usual (TAU), but with similar levels of clinical efficacy and quality of care.

The trials will be conducted in 8 European countries. In Spain the trial will be carried out in routine primary, comparing the clinical and cost-effectiveness of CBT and TAU for adults with major depressive disorder (MDD). Respondents will be followed until 12 months after baseline (measures will be taken at BL, 3 months, 6 months and 12 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 confirmed by MINI International Neuropsychiatric Interview version 5.0
  • a score 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).
  • Not having a Smartphone that is compatible with the mobile component of the intervention that is offered or not willing to carry a Smartphone during the duration of treatment

Treatment and study plan

Blended CBT treatment

Behavioral

Internet based blended CBT depression treatment combines individual face-to-face cognitive behavioural therapy (CBT) with CBT 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 CBT treatment are: (1) psycho-education, (2) cognitive restructuring, (3) behavioural activation, (4) positive psychology, and (5) relapse prevention. These will be delivered over 10 sessions. For this study, the ratio between the number of face-to-face sessions and the number of online module will be 1/3 face-to-face and 2/3 online.

Treatment as Usual

Other

Treatment as usual (TAU) is defined as the routine care that subjects receive when they are diagnosed with depression in the primary care system. In practice, this means that treatment as usual may vary between patients. We will not interfere with treatment as usual but we will monitor carefully which health care services are utilized by usual care patients using patient records and through self-report

Primary outcomes

  1. Change in Patient Health Questionnaire-9

    Time frame: Baseline, 3 months, 6 months and 12 months

    The PHQ-9 is a nine-item mood module that can be used to screen and to diagnose patients with depressive disorders. The 9 items are each scored on a 0-3 scale with the total score ranging from 0-27 and higher scores indicating more severe depression. The PHQ-9 has shown to have good psychometric properties (Wittkampf, Naeije, Schene, Huyser, & van Weert, 2007).

Secondary outcomes

  1. Change in Quick Inventory of Depressive Symptomatology Self-Report (QIDS-16-SR) US Translation

    Time frame: Baseline, 3 months, 6 months and 12 months

    The QIDS is a questionnaire that screens for depressive symptoms and assesses depression severity. The QIDS is available in both clinician-rated (IDS-C) and patient self-report (IDS-SR) forms. The QIDS consists of 16 items (each item scores 0-3) and includes symptom domains of MDD based on DSM-IV and Research Diagnostic Criteria (RDC). The QIDS has shown good psychometric properties.

  2. Change in the MINI International Neuropsychiatric Interview (M.I.N.I) version 5.0

    Time frame: Baseline and 12 months

    The M.I.N.I. is a structured diagnostic interview based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) and on International Classification of Diseases (ICD-10) criteria. The M.I.N.I has been translated to 65 languages and is used for both clinical and research practice. The interview compares well with Structural Clinical Interview for DSM-IV disorders (SCID) (Sheehan et al., 1998) and the Composite International Diagnostic Interview (CIDI) (Lecrubier et al., 1997; Sheehan et al., 1998).

  3. Change in the EQ-5D-5L (EuroQol)

    Time frame: Baseline, 3 months, 6 months and 12 months

    The EQ-5D-5L is a self-report questionnaire which measures health related quality of life and enables conversion to utility scores to calculate Quality-Adjusted Life-Years (QALYs). The EQ-5D-5L consists of five dimensions: mobility, self-care, ordinary activities, discomfort, and mood state related to anxiety or depression. Each item consists of five categories ranging from no problems to a lot of problems (Van Agt, Essink-Bot, Krabbe, & Bonsel, 1994).

  4. Change in the Questionnaires on Costs Associated with Psychiatric Illness (TiC-P; Hakkaart-van Rooijen, van Straten, Donker, Tiemens, 2002)

    Time frame: Baseline, 3 months, 6 months and 12 months

    The TiC-P is a self-report questionnaire and consists of two different parts that can be administrated separately. Part I will be used to assess the participants' healthcare utilization and medication use. Part II (short form health and labor questionnaire [SF-HLQ]) measures lost productivity costs resulting from absenteeism (being absent from work because of illness) and presenteeism (being present at work while ill which may lead to reduced efficiency) and consists of 11 items. Healthcare utilization and productivity losses will be valued using country-specific prices.

  5. Change in the Working Alliance Inventory (WAI-SF)

    Time frame: 3 months

    The WAI-SF is a 12-item self-report questionnaire with responses on a 5-point Likert scale ranging from 1 (never) to 5 (always) (Hatcher & Gillaspy, 2006). The questionnaire covers three dimensions of working alliance: (1) therapeutic goals, (2) tasks, and (3) bond and the subscales have shown to have good internal consistencies. Both the patient and the 10-item therapist version of the questionnaire will be administered

  6. Change in the credibility and expectancy questionnaire (CEQ; Devilly and Borkovec, 2000)

    Time frame: Baseline

    The scale consists of 6 questions, with answer options rated on a 10 point scale and on a 1-100% scale and evaluates 2 factors : credibility and expectancy

  7. Change in the Satisfaction Questionnaire (CSQ-8; Nguyen, Attkinson, & Stegner, 1983)

    Time frame: 3 months

    This questionnaire is used to measure global patient satisfaction. The questionnaire consists of 8 items that are measured on a 4 points scale with total scores ranging from 8 to 32 and has shown good psychometric properties.

  8. Change in the system usability scale (SUS; Brooke, 1996)

    Time frame: 3 months

    SUS is a simple ten item scale giving a global view of subjective assessments of usability of a technology system. All items are measured on a 5-point scale ranging from strongly disagree until strongly agree. Total SUS scores have a range from 0-100.

Sponsors and collaborators

Lead sponsor

Universitat Jaume I

Other

Collaborators

  • University of Valencia

Registry information

Official study title

European Comparative Effectiveness Research on Internet-based Depression Treatment - Spanish Trial

Acronym: E-COMPARED_S

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Feb 12, 2015
Registry last updated
Sep 20, 2019

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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