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

University of Southern Denmark (SDU)

Status: Completed

Conditions: Adult Depression

Treatments: Behavioral: cognitive behavioural therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02796573

S-20150150

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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76 participants in 2 patient groups

B-CBT

Experimental group

Description:

6 face-to-face consultations plus 6 online modules.

Treatment:

Behavioral: cognitive behavioural therapy

Face-to-Face CBT

Active Comparator group

Description:

12 face-to-face consultations.

Treatment:

Behavioral: cognitive behavioural therapy