Clinical trial NCT02410616: E-Compared-CH: Comparative Effectiveness Research on Internet-based Depression Treatment - Swiss Trial
Official title: European Comparative Effectiveness Research on Internet-based Depression Treatment - Swiss Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Disorder, Major
Keywords: Psychotherapy
Comparative Effectiveness Research
Randomized Controlled Trial
Secondary Care
Lead sponsor: University of Bern
Sponsor class: OTHER
First posted: 2015-04-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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 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).

Eligibility 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
* 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

Primary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 18 weeks
Secondary outcomes:
measure: Assessment of Quality of Life (AQoL-6D)
timeFrame: Baseline, 12 weeks, 18 weeks, 6 months, and 12 months
measure: Quick Inventory of Depressive Symptomatology Self-Report (QIDS-16-SR)
timeFrame: Baseline, 12 weeks, 18 weeks, 6 months, and 12 months
measure: MINI International Neuropsychiatric Interview (M.I.N.I; Ackenheil et al., 1999)
timeFrame: Baseline, 18 weeks, and 12 months
measure: EuroQoL (EQ-5D-5L; Herdman et al., 2011)
timeFrame: Baseline, 12 weeks, 18 weeks, 6 months, and 12 months
measure: Questionnaires on Costs Associated with Psychiatric Illness (TiC-P; Hakkaart-van Rooijen, van Straten, Donker, Tiemens, 2002)
timeFrame: Baseline, 12 weeks, 18 weeks, 6 months, and 12 months
measure: Client Satisfaction Questionnaire (CSQ-8; Nguyen, Attkinson, & Stegner, 1983)
timeFrame: 12 weeks, and 18 weeks
measure: System Usability Scale (SUS; Brooke, 1996)
timeFrame: 12 weeks, and 18 weeks
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline, 12 weeks, 6 months, and 12 months
Other outcomes:
Locations:
city: Kilchberg
country: Switzerland
facility: Sanatorium Kilchberg
state: Zurich
city: Bern
country: Switzerland
facility: Department of Clinical Psychology and Psychotherapy
Study officials:
affiliation: University of Bern
name: Thomas Berger, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Genugten CR, Schuurmans J, Hoogendoorn AW, Araya R, Andersson G, Banos R, Botella C, Cerga Pashoja A, Cieslak R, Ebert DD, Garcia-Palacios A, Hazo JB, Herrero R, Holtzmann J, Kemmeren L, Kleiboer A, Krieger T, Smoktunowicz E, Titzler I, Topooco N, Urech A, Smit JH, Riper H. Examining the Theoretical Framework of Behavioral Activation for Major Depressive Disorder: Smartphone-Based Ecological Momentary Assessment Study. JMIR Ment Health. 2021 Dec 6;8(12):e32007. doi: 10.2196/32007.
citation: Kleiboer A, Smit J, Bosmans J, Ruwaard J, Andersson G, Topooco N, Berger T, Krieger T, Botella C, Banos R, Chevreul K, Araya R, Cerga-Pashoja A, Cieslak R, Rogala A, Vis C, Draisma S, van Schaik A, Kemmeren L, Ebert D, Berking M, Funk B, Cuijpers P, Riper H. European COMPARative Effectiveness research on blended Depression treatment versus treatment-as-usual (E-COMPARED): study protocol for a randomized controlled, non-inferiority trial in eight European countries. Trials. 2016 Aug 3;17(1):387. doi: 10.1186/s13063-016-1511-1.