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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
CBT based on behavioral activation and cognitive therapy techniques including homework
Treatment as usual in primary care including antidepressants and counselling
Department of Behavioral Sciences and Learning, Linköping University
Linköping, Östergötland County, Sweden
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.
Time frame: Change from baseline in symptoms of depression. Time Frame: 0, 3, 6 and 12 months
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: 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: 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: 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: 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: 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).
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Time frame: 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: Time Frame: 0, 3, 6 and 12 months