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

Not Applicable

Completed

• Conditions: Adult Depression
• Interventions: Behavioral: cognitive behavioural therapy

• Registration Number: NCT02796573
• Lead Sponsor: University of Southern Denmark

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-06-01
• Study First Submitted QC: 2016-06-06
• Study First Posted: 2016-06-10
• Primary Completion: 2019-05-01
• Study Completion: 2020-06
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-18
• Last Update Posted: 2022-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Face-to-Face CBT	cognitive behavioural therapy	12 face-to-face consultations.
B-CBT	cognitive behavioural therapy	6 face-to-face consultations plus 6 online modules.

Primary Outcome Measures

Name	Time	Method
Patient Health Questionnaire 9-item change	Change from Baseline, 3 months, 6 months, 12 months

Trial Locations

Locations (1)

Centre for Telepsychiatry; 🇩🇰 Odense, Fyn, Denmark