European Comparative Effectiveness Research on Internet-based Depression Treatment in Poland

NCT02389660 | Completed

• 1 other identifier: W73/7. PR/2014
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

Effective, accessible, and affordable depression treatment is of high importance considering the large individual and economic burden of depression. There is ample support for the effectiveness of Internet-based Cognitive Behavioral Therapy (CBT) for depression which is considered a promising alternative to routine depression treatment strategies. Most evidence comes from randomized controlled trials, however, and not from research in routine practice. The European Comparative Effectiveness Research on Internet-based Depression Treatment (E-COMPARED) in Poland aims to compare the clinical and cost-effectiveness of blended CBT for adults with major depressive disorder (MDD) with treatment as usual (TAU). The trial will be conducted in routine mental health care in Poland, and is a part of the bigger project funded by European Commission (Grant Agreement No: 603098). In this randomized controlled trial, a total of 150 patients with MDD will be assigned to one of two conditions: 1) blended CBT, 2) TAU. Respondents in both conditions will be followed until 12 months after baseline (measures will be taken at baseline, 3 months, 6 months and 12 months).

Conditions

Depression

Keywords

Depression, Blended Cognitive Behavioural Therapy, Internet intervention

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Depression at 12 months

  Symptoms of depression will be assessed with the 9-item self-report The Patient Health Questionnaire (PHQ) (Kroenke et. al., 2001).

  Baseline, 12 months

Secondary Outcomes (9)

• Change from Baseline Symptoms of Depression at 12 months

  Baseline, 12 months

• Change from Baseline Diagnosis of Depression at 12 months

  Baseline, 12 months

• Change from Baseline Health Service Uptake and Production Loss Due to Illness at 12 months

  Baseline, 12 months

• Therapeutic Alliance

  3 months

• Patient's Satisfaction with the Treatment

  3 months

Study Arms (2)

Blended CBT

EXPERIMENTAL

Internet based blended 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) psycho-education, (2) cognitive restructuring, (3) behavioural activation, and (4) relapse prevention. These will be delivered over 13 sessions (6 online and 7 face-to-face, session sequence - alternate, online platform - Moodbuster).

Behavioral: Blended Cognitive Behavioural Therapy (CBT)

Treatment as usual

ACTIVE COMPARATOR

Treatment as usual (TAU) will be defined as the routine care CBT that subjects receive when they are diagnosed with depression in the setting of recruitment. We will not interfere with treatment as usual but we will monitor carefully which health care services are utilized by usual care patients using patient records and through self-report (including TIC-P measurements).

Behavioral: Treatment as usual

Interventions

Blended Cognitive Behavioural Therapy (CBT) BEHAVIORAL

Blended CBT

Treatment as usual BEHAVIORAL

Treatment as usual

Eligibility Criteria

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

You may qualify if:

• Meet DSM-IV diagnostic criteria for MDD as confirmed by the telephone administered MINI International Neuropsychiatric Interview version 5.0 and a score a score of 5 or higher on the PHQ-9 screening questionnaire.

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 in primary or specialised mental health care
• Being unable to comprehend the spoken and written Polish
• Not having access to a PC and fast Internet connection (i.e. broadband or comparable).
• Not having a Smart phone that is compatible with the mobile component of the intervention that is offered or not willing to carry a Smartphone if one is provided with one by the research team for the study duration.

Sponsors & Collaborators

• University of Social Sciences and Humanities, Warsaw: lead
• VU University of Amsterdam: collaborator
• Linkoeping University: collaborator
• University of Erlangen-Nürnberg: collaborator
• London School of Hygiene and Tropical Medicine: collaborator
• GGZ inGeest: collaborator
• Universitat Jaume I: collaborator
• Leuphana Universität Lünenberg: collaborator
• University of Limerick: collaborator
• University of Bern: collaborator
• University of Valencia: collaborator
• Inesc Porto: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• European Commission: collaborator
• Ministry of Science and Higher Education, Poland: collaborator

Study Sites (1)

University of Social Sciences and Humanities

Warsaw, 03-815, Poland

Location

Related Publications (17)

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• 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.

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  PMID: 27488181 DERIVED

MeSH Terms

Conditions

Depression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Roman Cieslak, PhD

  University of Social Sciences and Humanities

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice-Rector for Research

Study Record Dates

• First Submitted: February 18, 2015
• First Posted: March 17, 2015
• Study Start: June 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: June 29, 2018

Record last verified: 2018-06

Locations

PL (1)