NCT02796573

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 10, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

May 19, 2022

Status Verified

May 1, 2022

Enrollment Period

3.2 years

First QC Date

June 1, 2016

Last Update Submit

May 18, 2022

Conditions

Adult Depression

Keywords

blended careCBTB-CBTdepression

Outcome Measures

Primary Outcomes (1)

  • Patient Health Questionnaire 9-item change

    Change from Baseline, 3 months, 6 months, 12 months

Study Arms (2)

B-CBT

EXPERIMENTAL

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

Behavioral: cognitive behavioural therapy

Face-to-Face CBT

ACTIVE COMPARATOR

12 face-to-face consultations.

Behavioral: cognitive behavioural therapy

Interventions

cognitive behavioural therapyBEHAVIORAL
B-CBTFace-to-Face CBT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Telepsychiatry

Odense, Fyn, 5000, Denmark

Location

Related Publications (3)

  • Doukani A, Quartagno M, Sera F, Free C, Kakuma R, Riper H, Kleiboer A, Cerga-Pashoja A, van Schaik A, Botella C, Berger T, Chevreul K, Matynia M, Krieger T, Hazo JB, Draisma S, Titzler I, Topooco N, Mathiasen K, Vernmark K, Urech A, Maj A, Andersson G, Berking M, Banos RM, Araya R. Comparison of the Working Alliance in Blended Cognitive Behavioral Therapy and Treatment as Usual for Depression in Europe: Secondary Data Analysis of the E-COMPARED Randomized Controlled Trial. J Med Internet Res. 2024 May 31;26:e47515. doi: 10.2196/47515.

    PMID: 38819882DERIVED

  • 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.

    PMID: 36069798DERIVED

  • 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.

    PMID: 27919234DERIVED

MeSH Terms

Conditions

Depression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D. fellow

Study Record Dates

First Submitted

June 1, 2016

First Posted

June 10, 2016

Study Start

March 1, 2016

Primary Completion

May 1, 2019

Study Completion

June 1, 2020

Last Updated

May 19, 2022

Record last verified: 2022-05

Locations

DK(1)