Blended Depression Therapy: Cognitive Behaviour Therapy Face-to-face and Via Internet (E-compared)

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

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorders
• Intervention / Treatment: Behavioral: Cognitive behavioral therapy; Other: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Östergötland
    • Linköping, Östergötland, Sweden, 58183
      • Department of Behavioral Sciences and Learning, Linköping University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Blended treatment; 10 weeks of four face-to-face Cognitive behavioral therapy sessions and internet-based CBT as a complement and support to the four sessions.	Behavioral: Cognitive behavioral therapy; CBT based on behavioral activation and cognitive therapy techniques including homework
Active Comparator: Treatment as usual; Usual course of antidepressants and management in primary care (e.g medication and supportive counselling).	Other: Treatment as usual; Treatment as usual in primary care including antidepressants and counselling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Linkoeping University
• Collaborators: European Commission
• Investigators: Principal Investigator: Heleen Riper, PhD, VU University of Amsterdam

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: March 30, 2015
• First Submitted That Met QC Criteria: May 16, 2015
• First Posted (Estimate): May 20, 2015

Study Record Updates

• Last Update Posted (Actual): September 20, 2017
• Last Update Submitted That Met QC Criteria: September 19, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Major Depressive Disorder (MDD); Face-to-face; Blended treatment; Cognitive behavior Therapy (CBT); internet-based treatment
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: E-compared