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Major Depressive DisorderE-COMPARED_SNCT02361684

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

A study testing Blended CBT treatment and Treatment as usual in people with Major Depressive Disorder, run by Universitat Jaume I at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Major Depressive Disorder
What is being tested?
Blended CBT treatment and Treatment as usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
2 sitesSpain
Study dates
Feb 2015to Sep 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • University Jaume I

    Castellon, Castellón, 12071

  • University of Valencia

    Valencia, 46010

Other trials in Spain

About this study

Official title: European 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.

Read the detailed description

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).

Being tested
Blended CBT treatment, Treatment as usual
Keywords
cost-effectiveness, blended treatment, Internet based treatment, Efficacy, Depression, cognitive behavioural therapy
Medical subject headings
Depressive Disorder, Major, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blended CBT treatmentBehavioural

    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 usualOther

    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

Study groups in NCT02361684
Study groupRoleWhat they receive
Blended CBT treatmentExperimentalNot described
Receives: Behavioral: Blended CBT treatment
Treatment as usualActive comparatorNot described
Receives: Other: Treatment as usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Patient Health Questionnaire-9

    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).

    Measured: Baseline, 3 months, 6 months and 12 months

Secondary outcomes (8)

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

    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.

    Measured: Baseline, 3 months, 6 months and 12 months

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

    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).

    Measured: Baseline and 12 months

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

    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).

    Measured: Baseline, 3 months, 6 months and 12 months

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

    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.

    Measured: Baseline, 3 months, 6 months and 12 months

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

    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

    Measured: 3 months

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

    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

    Measured: Baseline

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

    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.

    Measured: 3 months

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

    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.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completionJun 2019
  4. Study completionSep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02361684
Sponsor's protocol ID
UJaumeI07
Acronym
E-COMPARED_S
Status last verified
Sep 2019
First submitted
8 Jan 2015
Last updated
20 Sep 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Corruble E, Legrand JM, Zvenigorowski H, Duret C, Guelfi JD. Concordance between self-report and clinician's assessment of depression. J Psychiatr Res. 1999 Sep-Oct;33(5):457-65. doi: 10.1016/s0022-3956(99)00011-4.

    PubMed 10504014

  • World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.

    PubMed 24141714

  • van Agt HM, Essink-Bot ML, Krabbe PF, Bonsel GJ. Test-retest reliability of health state valuations collected with the EuroQol questionnaire. Soc Sci Med. 1994 Dec;39(11):1537-44. doi: 10.1016/0277-9536(94)90005-1.

    PubMed 7817218

  • Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.

    PubMed 9881538

  • Rush AJ, Trivedi MH, Ibrahim HM, Carmody TJ, Arnow B, Klein DN, Markowitz JC, Ninan PT, Kornstein S, Manber R, Thase ME, Kocsis JH, Keller MB. The 16-Item Quick Inventory of Depressive Symptomatology (QIDS), clinician rating (QIDS-C), and self-report (QIDS-SR): a psychometric evaluation in patients with chronic major depression. Biol Psychiatry. 2003 Sep 1;54(5):573-83. doi: 10.1016/s0006-3223(02)01866-8.

    PubMed 12946886

  • Rush AJ, Carmody T, Reimitz PE. (2000). The Inventory of Depressive Symptomatology (IDS): Clinician (IDS-C) and Self-Report (IDS-SR) ratings of depressive symptoms. International Journal of Methods in Psychiatric Research, 9(2), 45-59.

  • Richardson JR, Peacock SJ, Hawthorne G, Iezzi A, Elsworth G, Day NA. Construction of the descriptive system for the Assessment of Quality of Life AQoL-6D utility instrument. Health Qual Life Outcomes. 2012 Apr 17;10:38. doi: 10.1186/1477-7525-10-38.

    PubMed 22507254

  • Pinninti NR, Madison H, Musser E, Rissmiller D. MINI International Neuropsychiatric Schedule: clinical utility and patient acceptance. Eur Psychiatry. 2003 Nov;18(7):361-4. doi: 10.1016/j.eurpsy.2003.03.004.

    PubMed 14643565

  • Nguyen TD, Attkisson CC, Stegner BL. Assessment of patient satisfaction: development and refinement of a service evaluation questionnaire. Eval Program Plann. 1983;6(3-4):299-313. doi: 10.1016/0149-7189(83)90010-1.

    PubMed 10267258

  • Lecrubier Y, Sheehan DV, Weiller E, Amorim P, Bonora I, Harnett Sheehan K, Dunbar GC. (1997). The Mini International Neuropsychiatric Interview (MINI). A short diagnostic structured interview: reliability and validity according to the CIDI. European Psychiatry, 12(5), 224-231.

  • Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

    PubMed 11556941

  • Konig HH, Born A, Gunther O, Matschinger H, Heinrich S, Riedel-Heller SG, Angermeyer MC, Roick C. Validity and responsiveness of the EQ-5D in assessing and valuing health status in patients with anxiety disorders. Health Qual Life Outcomes. 2010 May 5;8:47. doi: 10.1186/1477-7525-8-47.

    PubMed 20444251

  • Hawthorne G, Richardson J, Osborne R. The Assessment of Quality of Life (AQoL) instrument: a psychometric measure of health-related quality of life. Qual Life Res. 1999 May;8(3):209-24. doi: 10.1023/a:1008815005736.

    PubMed 10472152

  • Hatcher RL, Gillaspy JA. (2007). Development and validation of a revised short version of the working alliance inventory. Psychother Res, 16:12-25.

  • Hakkaart-van Rooijen L, van Straten A, Donker M, Tiemans B. (2002). Manual Trimbos/iMTA questionnaire for costs associated with psychiatric illness (TIC-P). Rotterdam: Institute for Medical Technology Assessment.

Questions about this trial

What is this clinical trial studying?

A study testing Blended CBT treatment and Treatment as usual in people with Major Depressive Disorder, run by Universitat Jaume I at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Patient Health Questionnaire-9 (time frame: Baseline, 3 months, 6 months and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02361684, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2019.

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