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CompletedNCT02796573Updated May 19, 2022

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

An interventional study of cognitive behavioural therapy in Adult Depression, sponsored by University of Southern Denmark. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-19.

Sponsored by University of Southern Denmark · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Adult Depression

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Keywords

  • blended care
  • CBT
  • B-CBT
  • depression
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In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 76 is close to the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

University of Southern Denmark is the lead sponsor of 327 studies on the registry; 45 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
76 participants (actual)

Study arms

  • 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

Interventions

  • Behavioralcognitive behavioural therapy
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What researchers measure

Primary outcomes

  1. Patient Health Questionnaire 9-item change

    Time frame: Change from Baseline, 3 months, 6 months, 12 months

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Study locations

1 site
  • Centre for Telepsychiatry
    Odense, Fyn 5000, Denmark
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References and documents

Publications

  • Mathiasen K, Andersen TE, Lichtenstein MB, Ehlers LH, Riper H, Kleiboer A, Roessler KK. The Clinical Effectiveness of Blended Cognitive Behavioral Therapy Compared With Face-to-Face Cognitive Behavioral Therapy for Adult Depression: Randomized Controlled Noninferiority Trial. J Med Internet Res. 2022 Sep 7;24(9):e36577. doi: 10.2196/36577. PubMed 36069798 ↗
  • Mathiasen K, Andersen TE, Riper H, Kleiboer AA, Roessler KK. Blended CBT versus face-to-face CBT: a randomised non-inferiority trial. BMC Psychiatry. 2016 Dec 5;16(1):432. doi: 10.1186/s12888-016-1140-y. PubMed 27919234 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02796573
Lead sponsor
University of Southern Denmark
Responsible party
Kim Mathiasen (Ph.D. fellow, University of Southern Denmark) — Principal investigator
First posted
Jun 10, 2016
Start date
Mar 2016
Primary completion
May 1, 2019
Completion
Jun 2020
Last update
May 19, 2022
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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