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

Not Applicable

Completed

• Conditions: Major Depressive Disorders

• Registration Number: NCT02449447
• Lead Sponsor: Linkoeping University

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.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-03-30
• Study First Submitted QC: 2015-05-16
• Study First Posted: 2015-05-20
• Primary Completion: 2016-06
• Study Completion: 2017-06
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-19
• Last Update Posted: 2017-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Quick Inventory of Depressive Symptomatology Self-Report (QIDS	Change from baseline in symptoms of depression. Time Frame: 0, 3, 6 and 12 months	Symptoms of depression measured by the QIDS. The QIDS is a questionnaire that screens for depressive symptoms and assesses depression severity.

Secondary Outcome Measures

Name	Time	Method
Client Satisfaction Questionnaire (CSQ-8)	Time Frame: 3 months (post treatment)	Patient's satisfaction with the treatment is assessed with Client Satisfaction Questionnaire (CSQ-8)
Credibility and Expectancy Questionnaire (CEQ)	Time Frame: 3 months (post treatment)	Patients' expectancy of treatment will be assessed with the credibility and expectancy questionnaire (CEQ)
Patient Health Questionnaire (PHQ-9)	Time Frame: 0, 3, 6 and 12 months	The PHQ-9 is a nine-item mood module that can be used to screen and to diagnose patients with depressive disorders.
EuroQol-5D (EQ-5D-5L)	Time Frame: 0, 3, 6 and 12 months	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.
System Usability Scale (SUS)	Time Frame: 3 months (post treatment)	Satisfaction with the internet platform will be evaluated with the system usability scale (SUS)
Working Alliance Inventory (WAI-SF)	Time Frame: 0 months ( three weeks after started treatment)	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)	Time Frame: 0, 3, 6 and 12 months	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)

Trial Locations

Locations (1)

Department of Behavioral Sciences and Learning, Linköping University; 🇸🇪 Linköping, Östergötland, Sweden