Clinical trial NCT02796573: Blended Cognitive Behavioural Therapy Versus Face-to-face Cognitive Behavioural Therapy
Official title: Blended Cognitive Behavioural Therapy Versus Face-to-face Cognitive Behavioural Therapy: A Randomised Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adult Depression
Keywords: blended care
CBT
B-CBT
depression
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2016-06-10
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Patient Health Questionnaire 9-item change
timeFrame: Change from Baseline, 3 months, 6 months, 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Centre for Telepsychiatry
state: Fyn
Study officials:
References:
citation: 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.
citation: 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.