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

Not Applicable

Completed

• Conditions: Major Depressive Disorders
• Interventions: Other: Treatment as usual; Behavioral: Cognitive behavioral therapy

• 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

Arm && Interventions

Group	Intervention	Description
Treatment as usual	Treatment as usual	Usual course of antidepressants and management in primary care (e.g medication and supportive counselling).
Blended treatment	Cognitive behavioral therapy	10 weeks of four face-to-face Cognitive behavioral therapy sessions and internet-based CBT as a complement and support to the four sessions.

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