Overview

This trial is active, not recruiting.

Condition major depressive disorders
Treatments cognitive behavioral therapy, treatment as usual
Sponsor Linkoeping University
Collaborator European Commission
Start date February 2015
End date December 2016
Trial size 150 participants
Trial identifier NCT02449447, E-compared

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(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.
cognitive behavioral therapy
CBT based on behavioral activation and cognitive therapy techniques including homework
(Active Comparator)
Usual course of antidepressants and management in primary care (e.g medication and supportive counselling).
treatment as usual
Treatment as usual in primary care including antidepressants and counselling

Primary Outcomes

Measure
Quick Inventory of Depressive Symptomatology Self-Report (QIDS
time frame: Change from baseline in symptoms of depression. Time Frame: 0, 3, 6 and 12 months

Secondary Outcomes

Measure
EuroQol-5D (EQ-5D-5L)
time frame: Time Frame: 0, 3, 6 and 12 months
Client Satisfaction Questionnaire (CSQ-8)
time frame: Time Frame: 3 months (post treatment)
Credibility and Expectancy Questionnaire (CEQ)
time frame: Time Frame: 3 months (post treatment)
System Usability Scale (SUS)
time frame: Time Frame: 3 months (post treatment)
Patient Health Questionnaire (PHQ-9)
time frame: Time Frame: 0, 3, 6 and 12 months
Working Alliance Inventory (WAI-SF)
time frame: Time Frame: 0 months ( three weeks after started treatment)
Trimbos and iMTA questionnaire on Costs associated with Psychiatric illness (TIC-P)
time frame: Time Frame: 0, 3, 6 and 12 months

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

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
Principal investigator Heleen Riper, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Linkoeping University.