Blended Cognitive Behavioural Therapy Versus Face-to-face Cognitive Behavioural Therapy

Depression is a prevalent and disabling disorder with great cost to the individual and the society. Lately, the use of internet interventions as guided self-help has demonstrated remarkable results. However, certain shortcomings such as lack of personal adaptation has been identified.

The presents study aims to investigate the potential of blending Internet based interventions with face-to-face consultations using cognitive behavioural therapy (B-CBT). The main hypotheses are, that that B-CBT will be as clinically effective as TAU, and that it will be acceptable to patients and clinicians.

The study is designed as a two arm randomised non-inferiority trial comparing internet based B-CBT for depression to treatment as usual (TAU) defined as 12 sessions of face-to-face CBT.

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Key information

Conditions

Adult Depression Behavior Behavioral Symptoms Depression

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Telepsychiatry

Odense, Fyn, 5000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Being 18 years of age or older.
Meet Diagnostic and Statistic Manual of Mental Disorders 4th. edition (DSM-IV) diagnostic criteria for major depressive disorder as confirmed by the telephone administered Mini International Neuropsychiatric Interview version 5.0 (MINI)and a score of 5 or higher on the Patient Health Questionnaire nine items (PHQ-9).

Exclusion criteria

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 computer and fast Internet connection (i.e. broadband or comparable)

Treatment and study plan

Cognitive Behavioural Therapy

Behavioral

Primary outcomes

Patient Health Questionnaire 9-item change

Time frame: Change from Baseline, 3 months, 6 months, 12 months

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Registry information

Official study title

Blended Cognitive Behavioural Therapy Versus Face-to-face Cognitive Behavioural Therapy: A Randomised Non-inferiority Trial

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2020
First posted: Jun 10, 2016
Registry last updated: May 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed