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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
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blended CBT | Experimental | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire-9 (PHQ-9) | 18 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Berger, PhD | University of Bern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanatorium Kilchberg | Kilchberg | Canton of Zurich | 8802 | Switzerland | ||
| Department of Clinical Psychology and Psychotherapy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38819882 | Derived | Doukani A, Quartagno M, Sera F, Free C, Kakuma R, Riper H, Kleiboer A, Cerga-Pashoja A, van Schaik A, Botella C, Berger T, Chevreul K, Matynia M, Krieger T, Hazo JB, Draisma S, Titzler I, Topooco N, Mathiasen K, Vernmark K, Urech A, Maj A, Andersson G, Berking M, Banos RM, Araya R. Comparison of the Working Alliance in Blended Cognitive Behavioral Therapy and Treatment as Usual for Depression in Europe: Secondary Data Analysis of the E-COMPARED Randomized Controlled Trial. J Med Internet Res. 2024 May 31;26:e47515. doi: 10.2196/47515. | |
| 34874888 |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| 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. |
|
| 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 |
| Bern |
| 3014 |
| Switzerland |
| Derived |
| 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. |
| 27488181 | Derived | 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. |