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

Major Depressive Disorders Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02449447
• Other study ID #: E-compared
• Status: Completed
• Phase: N/A
• First received: March 30, 2015
• Last updated: September 19, 2017
• Start date: February 2015
• Est. completion date: June 2017

Study information

• Verified date: September 2017
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorders

Intervention

Behavioral:
• Cognitive behavioral therapy
CBT based on behavioral activation and cognitive therapy techniques including homework

Other:
• Treatment as usual
Treatment as usual in primary care including antidepressants and counselling

Locations

Country	Name	City	State
Sweden	Department of Behavioral Sciences and Learning, Linköping University	Linköping	Östergötland

Sponsors (2)

Lead Sponsor	Collaborator
Linkoeping University	European Commission

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline in symptoms of depression. Time Frame: 0, 3, 6 and 12 months
Secondary	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.	Time Frame: 0, 3, 6 and 12 months
Secondary	Client Satisfaction Questionnaire (CSQ-8)	Patient's satisfaction with the treatment is assessed with Client Satisfaction Questionnaire (CSQ-8)	Time Frame: 3 months (post treatment)
Secondary	Credibility and Expectancy Questionnaire (CEQ)	Patients' expectancy of treatment will be assessed with the credibility and expectancy questionnaire (CEQ)	Time Frame: 3 months (post treatment)
Secondary	System Usability Scale (SUS)	Satisfaction with the internet platform will be evaluated with the system usability scale (SUS)	Time Frame: 3 months (post treatment)
Secondary	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.	Time Frame: 0, 3, 6 and 12 months
Secondary	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).	Time Frame: 0 months ( three weeks after started treatment)
Secondary	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)	Time Frame: 0, 3, 6 and 12 months