E-Compared-CH: Comparative Effectiveness Research on Internet-based Depression Treatment - Swiss Trial

Depressive Disorder, Major Clinical Trial

— E-COMPARED_CH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02410616
• Other study ID #: 001/15
• Status: Completed
• Phase: N/A
• First received: April 2, 2015
• Last updated: September 20, 2017
• Start date: March 2015
• Est. completion date: July 2017

Study information

• Verified date: September 2017
• Source: University of Bern
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 Swiss patients in secondary care

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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Behavioral:
• Blended CBT
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
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.

Locations

Country	Name	City	State
Switzerland	Department of Clinical Psychology and Psychotherapy	Bern
Switzerland	Sanatorium Kilchberg	Kilchberg	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Health Questionnaire-9 (PHQ-9)		18 weeks
Secondary	Assessment of Quality of Life (AQoL-6D)		Baseline, 12 weeks, 18 weeks, 6 months, and 12 months
Secondary	Quick Inventory of Depressive Symptomatology Self-Report (QIDS-16-SR)		Baseline, 12 weeks, 18 weeks, 6 months, and 12 months
Secondary	MINI International Neuropsychiatric Interview (M.I.N.I; Ackenheil et al., 1999)		Baseline, 18 weeks, and 12 months
Secondary	EuroQoL (EQ-5D-5L; Herdman et al., 2011)		Baseline, 12 weeks, 18 weeks, 6 months, and 12 months
Secondary	Questionnaires on Costs Associated with Psychiatric Illness (TiC-P; Hakkaart-van Rooijen, van Straten, Donker, Tiemens, 2002)		Baseline, 12 weeks, 18 weeks, 6 months, and 12 months
Secondary	Client Satisfaction Questionnaire (CSQ-8; Nguyen, Attkinson, & Stegner, 1983)		12 weeks, and 18 weeks
Secondary	System Usability Scale (SUS; Brooke, 1996)		12 weeks, and 18 weeks
Secondary	Patient Health Questionnaire-9 (PHQ-9)		Baseline, 12 weeks, 6 months, and 12 months