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

NCT02449447 | Completed DMC

• 1 other identifier: E-compared
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Major Depressive Disorders

Keywords

Major Depressive Disorder (MDD); Blended treatment; Cognitive behavior Therapy (CBT); Face-to-face; internet-based treatment

Outcome Measures

Primary Outcomes (1)

• Quick Inventory of Depressive Symptomatology Self-Report (QIDS

  Symptoms of depression measured by the QIDS. The QIDS is a questionnaire that screens for depressive symptoms and assesses depression severity.

  Change from baseline in symptoms of depression. Time Frame: 0, 3, 6 and 12 months

Secondary Outcomes (7)

• EuroQol-5D (EQ-5D-5L)

  Time Frame: 0, 3, 6 and 12 months

• Client Satisfaction Questionnaire (CSQ-8)

  Time Frame: 3 months (post treatment)

• Credibility and Expectancy Questionnaire (CEQ)

  Time Frame: 3 months (post treatment)

• System Usability Scale (SUS)

  Time Frame: 3 months (post treatment)

• Patient Health Questionnaire (PHQ-9)

  Time Frame: 0, 3, 6 and 12 months

Study Arms (2)

Blended treatment

EXPERIMENTAL

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

Behavioral: Cognitive behavioral therapy

Treatment as usual

ACTIVE COMPARATOR

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

Other: Treatment as usual

Interventions

Cognitive behavioral therapy BEHAVIORAL

CBT based on behavioral activation and cognitive therapy techniques including homework

Blended treatment

Treatment as usual OTHER

Treatment as usual in primary care including antidepressants and counselling

Treatment as usual

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Linkoeping University: lead
• European Commission: collaborator

Study Sites (1)

Department of Behavioral Sciences and Learning, Linköping University

Linköping, Östergötland County, 58183, Sweden

Location

Related Publications (4)

• 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: 38819882 DERIVED

• 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: 34874888 DERIVED

• 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.

  PMID: 30372653 DERIVED

• 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: 27488181 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Cognitive Behavioral Therapy; Therapeutics

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Heleen Riper, PhD

  VU University of Amsterdam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 30, 2015
• First Posted: May 20, 2015
• Study Start: February 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2017
• Last Updated: September 20, 2017

Record last verified: 2017-09

Locations

SE (1)