Short summary

Depression is a serious and prevalent disorder with high costs for the patient and for society. However, only about half of the patients in need of treatment have any contact with the health care system. In combination with budgetary constraints and an increase in demand for depression treatment the need for novel innovative treatment approaches is immense. The current study aims to investigate the possibility of blending traditional psychotherapy with online treatment modules.

Rationale

Background: Depression is a serious disorder with a lifetime prevalence of approximately 17%, ranking third as cause of burden of disease globally. Internet-based cognitive behavioral therapy (iCBT) has been demonstrated to be effective, with treatment effect comparable to traditional face-to-face CBT. However, it is a low-intensity treatment format, presupposing a high degree of autonomy from the patients. Combining iCBT with traditional consultations in a blended CBT format (B-CBT), may increase treatment adherence and -effect.

Aim: To investigate whether delivery of CBT in two novel formats using an internet based treatment platform in two different treatment intensities (iCBT and B-CBT) are clinical- and cost-effective.

Method: Using the treatment platform for depression developed by Internetpsykiatrien, Telepsykiatrisk Center, Odense, a treatment will be set up blending the 6-8 online modules with 6 face-to-face consultations (B-CBT). This will be tested in a randomised non-inferiority trial comparing the B-CBT treatment with treatment as usual defined as 12 sessions of face-to-face CBT. The trial is affiliated to the EU project E-compared.

Description of the cohort

All participants will be able adults.

Inclusion criteria:

• Being 18 years of age or older.
• Meet DSM-IV diagnostic criteria for MDD as confirmed by the video-conference administered MINI International Neuropsychiatric Interview version 5.0 and a score of 5 or higher on the PHQ-9 screening questionnaire. 

Exclusion criteria are:

• Current high risk of suicide according to the MINI Interview section C.
• Co-morbid substance dependence, bipolar affective disorder, psychotic illness, obsessive compulsive disorder, as established at the MINI interview.
• Currently receiving psychological treatment for depression in primary or specialised mental health care
• Being unable to comprehend the spoken and written language of Danish.
• Not having access to a PC and fast Internet connection (i.e. broadband or comparable).

Recruitment

Participants will be recruited from Internetpsykiatrien, which is a clinic at the Center for Tele-Psychiatry at the Mental Health Services of Southern Denmark.

Data and biological material

Data from the study comprise questionnaire data from patients and clinicians and data from interviews with clinicians.

Primary outcome: Symptomatic level of depression (PHQ-9)

Secondary outcomes:

M.I.N.I., QIDS-16-SR, EQ-5D-5L, TiC-P, CSQ-8, Wai-SF, SUS. 

Collaborating researchers and departments

The Research Unit for E-mental Health, University of Southern Denmark

• Psychologist Kim Mathiasen, PhD

Department of Psychology, University of Southern Denmark

• Professor and main supervisor Kirsten Kaya Roessler
• Associate professor Tonny E. Andersen

Department of Clinical Psychology, Vrije Universiteit Amsterdam

• Professor and co-supervisor Heleen Riper