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

Sponsor

Linkoeping University (Other)

Overall Status

Completed

CT.gov ID

NCT02449447

Collaborator

European Commission (Other)

150

Enrollment

Location

Arms

Actual Duration (Months)

5.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorders	Behavioral: Cognitive behavioral therapy Other: Treatment as usual	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Feb 1, 2015

Actual Primary Completion Date :

Jun 1, 2016

Actual Study Completion Date :

Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Blended treatment 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 CBT based on behavioral activation and cognitive therapy techniques including homework
Active Comparator: Treatment as usual Usual course of antidepressants and management in primary care (e.g medication and supportive counselling).	Other: Treatment as usual Treatment as usual in primary care including antidepressants and counselling

Arm

Intervention/Treatment

Experimental: Blended treatment

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

CBT based on behavioral activation and cognitive therapy techniques including homework

Active Comparator: Treatment as usual

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

Other: Treatment as usual

Treatment as usual in primary care including antidepressants and counselling

Outcome Measures

Primary Outcome Measures

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

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.
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)
System Usability Scale (SUS) [Time Frame: 3 months (post treatment)]
Satisfaction with the internet platform will be evaluated with the system usability scale (SUS)
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.
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)