Clinical trial NCT02449447: Blended Depression Therapy: Cognitive Behaviour Therapy Face-to-face and Via Internet
Official title: European Comparative Effectiveness Research on Internet-based Depression in Sweden (E-compared) Treatment). A Randomized Controlled Trial Comparing Blended Internet and Face-to-face CBT Against Treatment as Usual
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorders
Keywords: Major Depressive Disorder (MDD)
Blended treatment
Cognitive behavior Therapy (CBT)
Face-to-face
internet-based treatment
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
Collaborators: name: European Commission
First posted: 2015-05-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* depressive symptoms according to DSM-IV
* have access to a computer with internet connection
* have good knowledge of the Swedish language

Exclusion Criteria:

* recent (during last 6 weeks) change in psychiatric medication
* presently in any other psychological treatment
* severe depression
* suicidal ideation

Primary outcomes:
measure: Quick Inventory of Depressive Symptomatology Self-Report (QIDS
timeFrame: Change from baseline in symptoms of depression. Time Frame: 0, 3, 6 and 12 months
Secondary outcomes:
measure: EuroQol-5D (EQ-5D-5L)
timeFrame: Time Frame: 0, 3, 6 and 12 months
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: Time Frame: 3 months (post treatment)
measure: Credibility and Expectancy Questionnaire (CEQ)
timeFrame: Time Frame: 3 months (post treatment)
measure: System Usability Scale (SUS)
timeFrame: Time Frame: 3 months (post treatment)
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Time Frame: 0, 3, 6 and 12 months
measure: Working Alliance Inventory (WAI-SF)
timeFrame: Time Frame: 0 months ( three weeks after started treatment)
measure: Trimbos and iMTA questionnaire on Costs associated with Psychiatric illness (TIC-P)
timeFrame: Time Frame: 0, 3, 6 and 12 months
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Department of Behavioral Sciences and Learning, Linköping University
state: Östergötland
Study officials:
affiliation: VU University of Amsterdam
name: Heleen Riper, 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: 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.
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.