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European Comparative Effectiveness Research on Internet-based Depression Treatment (E-COMPARED)

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ClinicalTrials.gov Identifier: NCT02542891
Recruitment Status : Completed
First Posted : September 7, 2015
Last Update Posted : December 4, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To compare the clinical impact and cost-effectiveness of blended Cognitive Behavioural Therapy (CBT) for adults with major depressive disorder (MDD) with treatment as usual (TAU). Within the French context the TAU is considered as the traditional face to face CBT.

Condition or disease Intervention/treatment
Depressive Disorder Other: Blended CBT Other: Treatment as Usual (TAU)

Detailed Description:

Background:

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.

Objective:

To compare the clinical impact and cost-effectiveness of blended Cognitive Behavioural Therapy (CBT) for adults with major depressive disorder (MDD) with treatments as usual (TAU)-face to face CBT in expert centres specialized in depression.

Study design:

The study is a two-arm randomized controlled non-inferiority and cost-effectiveness trial. The trial will be conducted in expert centres in France. A total of 150 patients with MDD will be assigned to one of two treatment arms: 1) blended CBT, 2) TAU. Respondents in both arms will be followed until 12 months after baseline (measures will be taken at baseline, 3 months, post- treatment (17 weeks), 6 months and 12 months).


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: E-Compared: Comparative Effectiveness Research on Internet Based Depression Treatment- French Trial
Study Start Date : September 2015
Primary Completion Date : October 31, 2016
Arms and Interventions

Arm Intervention/treatment
Experimental: Blended CBT

Internet based blended depression treatment combines individual face-to-face cognitive behavioural therapy (CBT) with CBT delivered through an Internet based treatment platform with smart phone components. The core components of the CBT treatment are: (1) psycho-education, (2) cognitive restructuring, (3) behavioural activation, and (4) relapse prevention. These will be delivered over 16 sessions (8 online and 8 face-to-face), once a week. The online platform is called Moodbuster.

The trial will not interfere with regular medication treatment, and patient's care will be monitored throughout the study.

Other: Blended CBT
Other Name: Moodbuster Platform
Active Comparator: Treament as Usual (TAU)

In order to increase the comparability between the two arms, we defined TAU as a traditional face to face CBT of 16 sessions. These sessions will be administered over a course of 16 weeks.

The trial will not interfere with regular medication treatment, and patient's care will be monitored throughout the study.

Other: Treatment as Usual (TAU)


Outcome Measures

Primary Outcome Measures :
  1. Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: 12 months ]
    The primary outcome measure is symptoms of depression as assessed with Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001). 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 Outcome Measures :
  1. QIDS-SR16 [ Time Frame: 12 months ]
    The 16 item self-report version of the Quick Inventory of Depressive Symptomatology Self-Report (QIDS-16-SR) US Translation (Rush et al., 2003) is used in addition to the PHQ-9 because it is a promising questionnaire for assessing depressive symptoms especially in specialized mental health care whereas the PHQ-9 is developed for use in primary care.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).

  2. M.I.N.I [ Time Frame: 12 months ]
    The full M.I.N.I. 5.0,with exception of section M (Anorexia Nervosa), N (Bulimia nervosa), and P (Antisocial personality disorder), will be assessed at baseline to assess lifetime and current depression, and current comorbid disorders that often co-occur with and predict the onset of depression (anxiety disorders and PTSD) and other comorbid disorders that are an exclusion criteria in this study (i.e. substance dependence, bipolar affective disorder, psychotic illness, and obsessive compulsive disorder). At 12 months follow-up, the depression, anxiety and PTSD sections will be assessed again.

  3. MADRS [ Time Frame: 12 months ]
    The MADRS (Montgomery and Asberg Depression Rating Scale) is a hetero-assessment of depressive symptoms evaluated by clinicians.


Other Outcome Measures:
  1. EQ-5D-5L [ Time Frame: 12 months ]
    Quality of life will be assessed with 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).

  2. AQOL-6D [ Time Frame: 12 months ]
    Health-Related Quality of Life will optionally be measured with the Assessment of Quality of Life instrument (AQoL) (Hawthorne, Richardson, & Osborne, 1999). For the current study the AQoL-6D (Richardson, Peacock, Hawthorne, Lezzi, Elsworth, & Day, 2012) which consists of 20 questions measured on a 5 point scale will be used. The AQoL-6D includes the six dimensions: independent living, mental health, coping, relationships, pain, and senses.

  3. TIC-P [ Time Frame: 12 months ]
    Health service uptake and production loss due to illness will be measured with the Trimbos and iMTA 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.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  • Having a PHQ-9 score greater than 5
  • Having access to a PC and Internet connection
  • Having ( or accepting to be loaned) a smartphone that is compatible with the mobile component of the intervention
  • Understanding of the French language spoken and written

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, and suicide risks, as established at the MINI interview
  • Currently receiving psychological treatment for depression
Contacts and Locations

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): NCT02542891


Locations
France
Centre Hospitalier Charles Perrens
Bordeaux, France, 33076
CHU de Brest
Brest, France
Centre Hospitalier Le Vinatier-
Bron, France, 69678
CHU de Clermont- Ferrnand
Clermont- Ferrand, France, 63003
Hôpital A. Chenevier
Creteil, France, 94010
CHU de Grenoble
Grenoble, France
Hôpital de la conception Pôle Psychiatrie Centre
Marseille, France, 13005
CHRU Lapeyronie
Montpellier, France, 34295
Hôptial Fernand Widal
Paris, France, 75010
CHU de Tours
Tours, France, 37540
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
European Commission
Fondation FondaMental
Assistance Publique - Hôpitaux de Paris
Investigators
Study Director: Karine Chevreul, Dr Institut National de la Santé Et de la Recherche Médicale, France
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT02542891     History of Changes
Other Study ID Numbers: C15-16
First Posted: September 7, 2015    Key Record Dates
Last Update Posted: December 4, 2017
Last Verified: December 2016

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
e-health
depressive disorder
cost-effectiveness
Cognitive behavioral treatment

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders