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

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ClinicalTrials.gov Identifier: NCT02796573
Recruitment Status : Recruiting
First Posted : June 10, 2016
Last Update Posted : May 10, 2018
Sponsor:
Information provided by (Responsible Party):
Kim Mathiasen, 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.


Condition or disease Intervention/treatment Phase
Adult Depression Behavioral: cognitive behavioural therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Blended Cognitive Behavioural Therapy Versus Face-to-face Cognitive Behavioural Therapy: A Randomised Non-inferiority Trial
Study Start Date : March 2016
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: B-CBT
6 face-to-face consultations plus 6 online modules.
Behavioral: cognitive behavioural therapy
Active Comparator: Face-to-Face CBT
12 face-to-face consultations.
Behavioral: cognitive behavioural therapy



Primary Outcome Measures :
  1. Patient Health Questionnaire 9-item change [ Time Frame: Change from Baseline, 3 months, 6 months, 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796573


Contacts
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Contact: Kim Mathiasen, M.Sc., Ph.D. fellow +4520187263 kmathiasen@health.sdu.dk

Locations
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Denmark
Centre for Telepsychiatry Recruiting
Odense, Fyn, Denmark, 5000
Contact: Kim Mathiasen, M.Sc., Ph.D. fellow    +4520187263    kmathiasen@health.sdu.dk   
Sponsors and Collaborators
University of Southern Denmark

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kim Mathiasen, Ph.D. fellow, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT02796573     History of Changes
Other Study ID Numbers: S-20150150
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018

Keywords provided by Kim Mathiasen, University of Southern Denmark:
blended care
CBT
B-CBT
depression

Additional relevant MeSH terms:
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Depression
Behavioral Symptoms