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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Major Depressive Disorders

Intervention / Treatment
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* Behavioral: Cognitive behavioral therapy
* Other: Treatment as usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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) | 
| 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) | 
| System Usability Scale (SUS) | Satisfaction with the internet platform will be evaluated with the system usability scale (SUS) | Time Frame: 3 months (post treatment) | 
| 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 | 
| 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) | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Major Depressive Disorder (MDD), Blended treatment, Cognitive behavior Therapy (CBT), Face-to-face, internet-based treatment