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

Study Overview
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Brief Summary
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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

Detailed Description
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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).

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

Conditions
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Depressive Disorder, Major

Intervention / Treatment
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* Behavioral: Blended CBT
* Behavioral: Treatment as usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blended CBT<br>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. | Behavioral: Blended CBT<br>* 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.<br>|
| Active Comparator: Treatment as usual<br>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. | Behavioral: Treatment as usual<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire-9 (PHQ-9) |  | 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Quality of Life (AQoL-6D) |  | Baseline, 12 weeks, 18 weeks, 6 months, and 12 months | 
| Quick Inventory of Depressive Symptomatology Self-Report (QIDS-16-SR) |  | Baseline, 12 weeks, 18 weeks, 6 months, and 12 months | 
| MINI International Neuropsychiatric Interview (M.I.N.I; Ackenheil et al., 1999) |  | Baseline, 18 weeks, and 12 months | 
| EuroQoL (EQ-5D-5L; Herdman et al., 2011) |  | Baseline, 12 weeks, 18 weeks, 6 months, and 12 months | 
| 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 | 
| Client Satisfaction Questionnaire (CSQ-8; Nguyen, Attkinson, & Stegner, 1983) |  | 12 weeks, and 18 weeks | 
| System Usability Scale (SUS; Brooke, 1996) |  | 12 weeks, and 18 weeks | 
| Patient Health Questionnaire-9 (PHQ-9) |  | Baseline, 12 weeks, 6 months, and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychotherapy, Comparative Effectiveness Research, Randomized Controlled Trial, Secondary Care