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

Study Overview
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Brief Summary
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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.

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

Conditions
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Adult Depression

Intervention / Treatment
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* Behavioral: cognitive behavioural therapy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: B-CBT<br>6 face-to-face consultations plus 6 online modules. | Behavioral: cognitive behavioural therapy<br> <br> |
| Active Comparator: Face-to-Face CBT<br>12 face-to-face consultations. | Behavioral: cognitive behavioural therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire 9-item change |  | Change from Baseline, 3 months, 6 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CBT, blended care, B-CBT, depression