NCT02410616

Brief Summary

To compare the clinical and cost-effectiveness of blended Cognitive Behavioural Therapy (CBT) for adults with major depressive disorder (MDD) with treatment as usual (TAU) in Swiss patients in secondary care

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 2, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 7, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

September 21, 2017

Status Verified

September 1, 2017

Enrollment Period

2.3 years

First QC Date

April 2, 2015

Last Update Submit

September 20, 2017

Conditions

Depressive Disorder, Major

Keywords

PsychotherapyComparative Effectiveness ResearchRandomized Controlled TrialSecondary Care

Outcome Measures

Primary Outcomes (1)

  • Patient Health Questionnaire-9 (PHQ-9)

    18 weeks

Secondary Outcomes (8)

  • Assessment of Quality of Life (AQoL-6D)

    Baseline, 12 weeks, 18 weeks, 6 months, and 12 months

  • Quick Inventory of Depressive Symptomatology Self-Report (QIDS-16-SR)

    Baseline, 12 weeks, 18 weeks, 6 months, and 12 months

  • MINI International Neuropsychiatric Interview (M.I.N.I; Ackenheil et al., 1999)

    Baseline, 18 weeks, and 12 months

  • EuroQoL (EQ-5D-5L; Herdman et al., 2011)

    Baseline, 12 weeks, 18 weeks, 6 months, and 12 months

  • Questionnaires on Costs Associated with Psychiatric Illness (TiC-P; Hakkaart-van Rooijen, van Straten, Donker, Tiemens, 2002)

    Baseline, 12 weeks, 18 weeks, 6 months, and 12 months

  • +3 more secondary outcomes

Study Arms (2)

Blended CBT

EXPERIMENTAL

Internet based blended CBT depression treatment combines individual face-to-face cognitive behavioural therapy (CBT) with CBT delivered through an Internet based treatment platform with mobile phone components. The core components of the CBT treatment are: (1) psychoeducation, (2) behavioural activation, (3) cognitive restructuring, and (4) relapse prevention.

Behavioral: Blended CBT

Treatment as usual

ACTIVE COMPARATOR

Treatment as usual (TAU) is defined as the routine care that subjects receive when they are diagnosed with depression in the secondary care system. The investigators will not interfere with treatment as usual but they will monitor carefully which health care services are utilized by usual care patients using patient records and through self-report.

Behavioral: Treatment as usual

Interventions

Blended CBTBEHAVIORAL

Internet based blended CBT depression treatment combines individual face-to-face cognitive behavioural therapy (CBT) with CBT delivered through an Internet based treatment platform with mobile phone components. The core components of the CBT treatment are: (1) psychoeducation, (2) behavioural activation, (3) cognitive restructuring, and (4) relapse prevention.

Blended CBT
Treatment as usualBEHAVIORAL

Treatment as usual (TAU) is defined as the routine care that subjects receive when they are diagnosed with depression in the secondary care system. The investigators will not interfere with treatment as usual but they will monitor carefully which health care services are utilized by usual care patients using patient records and through self-report.

Treatment as usual

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 DSM-IV diagnostic criteria for MDD confirmed by MINI International Neuropsychiatric Interview version 5.0
  • Informed Consent
  • Having access to a PC and Internet connection
  • Having a Smartphone that is compatible with the mobile component of the intervention
  • Understanding of the German language spoken and written

You may not qualify if:

  • Current high risk for suicide according to the MINI Interview section C
  • Serious psychiatric co-morbidity: substance dependence, bipolar affective disorder, psychotic illness, obsessive compulsive disorder, as established at the MINI interview
  • Currently receiving psychological treatment for depression
  • Being unable to comprehend the spoken and written language (German)
  • Not having access to a PC and fast Internet connection (i.e. broadband or comparable).
  • Not having a Smartphone that is compatible with the mobile component of the intervention that is offered or not willing to carry a Smartphone during the duration of treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sanatorium Kilchberg

Kilchberg, Canton of Zurich, 8802, Switzerland

Location

Department of Clinical Psychology and Psychotherapy

Bern, 3014, Switzerland

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

  • van Genugten CR, Schuurmans J, Hoogendoorn AW, Araya R, Andersson G, Banos R, Botella C, Cerga Pashoja A, Cieslak R, Ebert DD, Garcia-Palacios A, Hazo JB, Herrero R, Holtzmann J, Kemmeren L, Kleiboer A, Krieger T, Smoktunowicz E, Titzler I, Topooco N, Urech A, Smit JH, Riper H. Examining the Theoretical Framework of Behavioral Activation for Major Depressive Disorder: Smartphone-Based Ecological Momentary Assessment Study. JMIR Ment Health. 2021 Dec 6;8(12):e32007. doi: 10.2196/32007.

    PMID: 34874888DERIVED

  • Kleiboer A, Smit J, Bosmans J, Ruwaard J, Andersson G, Topooco N, Berger T, Krieger T, Botella C, Banos R, Chevreul K, Araya R, Cerga-Pashoja A, Cieslak R, Rogala A, Vis C, Draisma S, van Schaik A, Kemmeren L, Ebert D, Berking M, Funk B, Cuijpers P, Riper H. European COMPARative Effectiveness research on blended Depression treatment versus treatment-as-usual (E-COMPARED): study protocol for a randomized controlled, non-inferiority trial in eight European countries. Trials. 2016 Aug 3;17(1):387. doi: 10.1186/s13063-016-1511-1.

    PMID: 27488181DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Thomas Berger, PhD

    University of Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2015

First Posted

April 7, 2015

Study Start

March 1, 2015

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

September 21, 2017

Record last verified: 2017-09

Locations

CH(2)