Skip to main content
OpenTrials
Completed

NCT Number: NCT02410616

E-Compared-CH: Comparative Effectiveness Research on Internet-based Depression Treatment - Swiss 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 Swiss patients in secondary care

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Depressive Disorder, Major Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sanatorium Kilchberg, Kilchberg, Canton of Zurich, Switzerland

Loading trial locations.

About this study

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 and cost-effectiveness of blended CBT and TAU in secondary care

Methods

In Switzerland, a randomized-controlled trial will be carried out in secondary care, 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, 12 weeks, 18 weeks, 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
  • Informed Consent
  • Having access to a PC and Internet connection
  • Having a Smartphone that is compatible with the mobile component of the intervention
  • Understanding of the German 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, as established at the MINI interview
  • Currently receiving psychological treatment for depression
  • Being unable to comprehend the spoken and written language (German)
  • 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

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. The core components of the CBT treatment are: (1) psychoeducation, (2) behavioural activation, (3) cognitive restructuring, and (4) relapse prevention.

Treatment as Usual

Behavioral

Treatment as usual (TAU) is defined as the routine care that subjects receive when they are diagnosed with depression in the secondary care system. The investigators will not interfere with treatment as usual but they will monitor carefully which health care services are utilized by usual care patients using patient records and through self-report.

Primary outcomes

  1. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: 18 weeks

Secondary outcomes

  1. Assessment of Quality of Life (AQoL-6D)

    Time frame: Baseline, 12 weeks, 18 weeks, 6 months, and 12 months

  2. Quick Inventory of Depressive Symptomatology Self-Report (QIDS-16-SR)

    Time frame: Baseline, 12 weeks, 18 weeks, 6 months, and 12 months

  3. MINI International Neuropsychiatric Interview (M.I.N.I; Ackenheil et al., 1999)

    Time frame: Baseline, 18 weeks, and 12 months

  4. EuroQoL (EQ-5D-5L; Herdman et al., 2011)

    Time frame: Baseline, 12 weeks, 18 weeks, 6 months, and 12 months

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

    Time frame: Baseline, 12 weeks, 18 weeks, 6 months, and 12 months

  6. Client Satisfaction Questionnaire (CSQ-8; Nguyen, Attkinson, & Stegner, 1983)

    Time frame: 12 weeks, and 18 weeks

  7. System Usability Scale (SUS; Brooke, 1996)

    Time frame: 12 weeks, and 18 weeks

  8. Patient Health Questionnaire-9 (PHQ-9)

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

Sponsors and collaborators

Lead sponsor

University of Bern

Other

Registry information

Official study title

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

Acronym: E-COMPARED_CH

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 7, 2015
Registry last updated
Sep 21, 2017

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.