MedDataX Logo

Blended Depression Therapy: Cognitive Behaviour Therapy Face-to-face and Via Internet

NCT ID: NCT02449447

Last Updated: 2017-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2017-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To asses the clinical effectiveness of blended cognitive behavior therapy (CBT): face-to-face and internet-based treatment for adults with Major Depressive Disorder (MDD) in primary care compared to treatment as usual.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study is part of a EU-project. Participants are recruited via regular routes from primary care settings. Following the Mini International Neuropsychiatric Interview (M.I.N.I.) participants will be randomly allocated to either blended treatment for 10 sessions/weeks or to treatment as usual. We will include 150 participants in total.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Major Depressive Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Blended treatment

10 weeks of four face-to-face Cognitive behavioral therapy sessions and internet-based CBT as a complement and support to the four sessions.

Group Type EXPERIMENTAL

Cognitive behavioral therapy

Intervention Type BEHAVIORAL

CBT based on behavioral activation and cognitive therapy techniques including homework

Treatment as usual

Usual course of antidepressants and management in primary care (e.g medication and supportive counselling).

Group Type ACTIVE_COMPARATOR

Treatment as usual

Intervention Type OTHER

Treatment as usual in primary care including antidepressants and counselling

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cognitive behavioral therapy

CBT based on behavioral activation and cognitive therapy techniques including homework

Intervention Type BEHAVIORAL

Treatment as usual

Treatment as usual in primary care including antidepressants and counselling

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* depressive symptoms according to DSM-IV
* have access to a computer with internet connection
* have good knowledge of the Swedish language

Exclusion Criteria

* recent (during last 6 weeks) change in psychiatric medication
* presently in any other psychological treatment
* severe depression
* suicidal ideation
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

European Commission

OTHER

Sponsor Role collaborator

Linkoeping University

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gerhard Andersson

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Heleen Riper, PhD

Role: PRINCIPAL_INVESTIGATOR

VU University of Amsterdam

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Behavioral Sciences and Learning, Linköping University

Linköping, Östergötland County, Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 38819882 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34874888 (View on PubMed)

Vernmark K, Hesser H, Topooco N, Berger T, Riper H, Luuk L, Backlund L, Carlbring P, Andersson G. Working alliance as a predictor of change in depression during blended cognitive behaviour therapy. Cogn Behav Ther. 2019 Jul;48(4):285-299. doi: 10.1080/16506073.2018.1533577. Epub 2018 Oct 29.

Reference Type DERIVED
PMID: 30372653 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27488181 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

E-compared

Identifier Type: -

Identifier Source: org_study_id