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| Name | Class |
|---|---|
| European Commission | OTHER |
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To asses the clinical effectiveness of blended cognitive behavior therapy (CBT): face-to-face and internet-based treatment for adults with Major Depressive Disorder (MDD) in primary care compared to treatment as usual.
The study is part of a EU-project. Participants are recruited via regular routes from primary care settings. Following the Mini International Neuropsychiatric Interview (M.I.N.I.) participants will be randomly allocated to either blended treatment for 10 sessions/weeks or to treatment as usual. We will include 150 participants in total.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blended treatment | Experimental | 10 weeks of four face-to-face Cognitive behavioral therapy sessions and internet-based CBT as a complement and support to the four sessions. |
|
| Treatment as usual | Active Comparator | Usual course of antidepressants and management in primary care (e.g medication and supportive counselling). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive behavioral therapy | Behavioral | CBT based on behavioral activation and cognitive therapy techniques including homework |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quick Inventory of Depressive Symptomatology Self-Report (QIDS | Symptoms of depression measured by the QIDS. The QIDS is a questionnaire that screens for depressive symptoms and assesses depression severity. | Change from baseline in symptoms of depression. Time Frame: 0, 3, 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| EuroQol-5D (EQ-5D-5L) | Quality of life will be assessed with the EQ-5D-5L (EuroQol). The EQ-5D-5L is a self-report questionnaire which measures health related quality of life. | Time Frame: 0, 3, 6 and 12 months |
| Client Satisfaction Questionnaire (CSQ-8) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heleen Riper, PhD | VU University of Amsterdam | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Behavioral Sciences and Learning, Linköping University | Linköping | Östergötland County | 58183 | Sweden |
| 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 |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Treatment as usual | Other | Treatment as usual in primary care including antidepressants and counselling |
|
Patient's satisfaction with the treatment is assessed with Client Satisfaction Questionnaire (CSQ-8) |
| Time Frame: 3 months (post treatment) |
| Credibility and Expectancy Questionnaire (CEQ) | Patients' expectancy of treatment will be assessed with the credibility and expectancy questionnaire (CEQ) | Time Frame: 3 months (post treatment) |
| System Usability Scale (SUS) | Satisfaction with the internet platform will be evaluated with the system usability scale (SUS) | Time Frame: 3 months (post treatment) |
| Patient Health Questionnaire (PHQ-9) | The PHQ-9 is a nine-item mood module that can be used to screen and to diagnose patients with depressive disorders. | Time Frame: 0, 3, 6 and 12 months |
| Working Alliance Inventory (WAI-SF) | The therapeutic alliance between therapists and patient will be assessed with the short version of the Working Alliance Inventory (WAI-SF). | Time Frame: 0 months ( three weeks after started treatment) |
| Trimbos and iMTA questionnaire on Costs associated with Psychiatric illness (TIC-P) | Health service uptake and production loss due to illness will be measured with the Trimbos and iMTA Questionnaires on Costs Associated with Psychiatric Illness (TiC-P) | Time Frame: 0, 3, 6 and 12 months |
| 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. |
| 30372653 | Derived | Vernmark K, Hesser H, Topooco N, Berger T, Riper H, Luuk L, Backlund L, Carlbring P, Andersson G. Working alliance as a predictor of change in depression during blended cognitive behaviour therapy. Cogn Behav Ther. 2019 Jul;48(4):285-299. doi: 10.1080/16506073.2018.1533577. Epub 2018 Oct 29. |
| 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. |