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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2020-06-30

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.

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Detailed Description

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Conditions

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Adult Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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B-CBT

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

Group Type EXPERIMENTAL

cognitive behavioural therapy

Intervention Type BEHAVIORAL

Face-to-Face CBT

12 face-to-face consultations.

Group Type ACTIVE_COMPARATOR

cognitive behavioural therapy

Intervention Type BEHAVIORAL

Interventions

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cognitive behavioural therapy

Intervention Type BEHAVIORAL

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No