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Blended Depression Therapy: Cognitive Behaviour Therapy Face-to-face and Via Internet (E-compared)

Primary Purpose

Major Depressive Disorders

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Cognitive behavioral therapy

Treatment as usual

About this trial

This is an interventional treatment trial for Major Depressive Disorders focused on measuring Major Depressive Disorder (MDD), Blended treatment, Cognitive behavior Therapy (CBT), Face-to-face, internet-based treatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Behavioral Sciences and Learning, Linköping University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Blended treatment

Treatment as usual

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

EuroQol-5D (EQ-5D-5L)

Quality of life will be assessed with the EQ-5D-5L (EuroQol). The EQ-5D-5L is a self-report questionnaire which measures health related quality of life.

Client Satisfaction Questionnaire (CSQ-8)

Patient's satisfaction with the treatment is assessed with Client Satisfaction Questionnaire (CSQ-8)

Credibility and Expectancy Questionnaire (CEQ)

Patients' expectancy of treatment will be assessed with the credibility and expectancy questionnaire (CEQ)

System Usability Scale (SUS)

Satisfaction with the internet platform will be evaluated with the system usability scale (SUS)

Patient Health Questionnaire (PHQ-9)

The PHQ-9 is a nine-item mood module that can be used to screen and to diagnose patients with depressive disorders.

Working Alliance Inventory (WAI-SF)

The therapeutic alliance between therapists and patient will be assessed with the short version of the Working Alliance Inventory (WAI-SF).

Trimbos and iMTA questionnaire on Costs associated with Psychiatric illness (TIC-P)

Health service uptake and production loss due to illness will be measured with the Trimbos and iMTA Questionnaires on Costs Associated with Psychiatric Illness (TiC-P)

Full Information

NCT ID

NCT02449447

First Posted

March 30, 2015

Last Updated

September 19, 2017

Sponsor

Linkoeping University

Collaborators

European Commission

1. Study Identification

Unique Protocol Identification Number

NCT02449447

Brief Title

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

Acronym

E-compared

Official Title

European Comparative Effectiveness Research on Internet-based Depression in Sweden (E-compared) Treatment). A Randomized Controlled Trial Comparing Blended Internet and Face-to-face CBT Against Treatment as Usual

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

February 2015 (Actual)

Primary Completion Date

June 2016 (Actual)

Study Completion Date

June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Linkoeping University

Collaborators

European Commission

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorders

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Blended treatment

Arm Type

Experimental

Arm Description

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

Arm Title

Treatment as usual

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Cognitive behavioral therapy

Intervention Description

CBT based on behavioral activation and cognitive therapy techniques including homework

Intervention Type

Other

Intervention Name(s)

Treatment as usual

Intervention Description

Treatment as usual in primary care including antidepressants and counselling

Primary Outcome Measure Information:

Title

Quick Inventory of Depressive Symptomatology Self-Report (QIDS

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

EuroQol-5D (EQ-5D-5L)

Description

Quality of life will be assessed with the EQ-5D-5L (EuroQol). The EQ-5D-5L is a self-report questionnaire which measures health related quality of life.

Time Frame

Time Frame: 0, 3, 6 and 12 months

Title

Client Satisfaction Questionnaire (CSQ-8)

Description

Patient's satisfaction with the treatment is assessed with Client Satisfaction Questionnaire (CSQ-8)

Time Frame

Time Frame: 3 months (post treatment)

Title

Credibility and Expectancy Questionnaire (CEQ)

Description

Patients' expectancy of treatment will be assessed with the credibility and expectancy questionnaire (CEQ)

Time Frame

Time Frame: 3 months (post treatment)

Title

System Usability Scale (SUS)

Description

Satisfaction with the internet platform will be evaluated with the system usability scale (SUS)

Time Frame

Time Frame: 3 months (post treatment)

Title

Patient Health Questionnaire (PHQ-9)

Description

The PHQ-9 is a nine-item mood module that can be used to screen and to diagnose patients with depressive disorders.

Time Frame

Time Frame: 0, 3, 6 and 12 months

Title

Working Alliance Inventory (WAI-SF)

Description

The therapeutic alliance between therapists and patient will be assessed with the short version of the Working Alliance Inventory (WAI-SF).

Time Frame

Time Frame: 0 months ( three weeks after started treatment)

Title

Trimbos and iMTA questionnaire on Costs associated with Psychiatric illness (TIC-P)

Description

Health service uptake and production loss due to illness will be measured with the Trimbos and iMTA Questionnaires on Costs Associated with Psychiatric Illness (TiC-P)

Time Frame

Time Frame: 0, 3, 6 and 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Heleen Riper, PhD

Organizational Affiliation

VU University of Amsterdam

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Behavioral Sciences and Learning, Linköping University

City

Linköping

State/Province

Östergötland

ZIP/Postal Code

58183

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

34874888

Citation

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.

Results Reference

derived

PubMed Identifier

30372653

Citation

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.

Results Reference

derived

PubMed Identifier

27488181

Citation

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.

Results Reference

derived

Learn more about this trial

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

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