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Clinical Trial Summary

Randomized controlled non-inferiority trial comparing therapist-guided Internet-based Cognitive behavioral therapy (ICBT), self-guided ICBT, and individual face-to-face (f2f) CBT for Obsessive-Compulsive Disorder (OCD) in adults. The primary objective is to evaluate whether ICBT is a non-inferior treatment option compared to the best possible available treatment for OCD, individual face to face (f2f) CBT. A second objective is to compare the efficacy of self-guided vs. therapist-guided ICBT. As this question has cost implications for the health system, a third objective is to carry out a health economic evaluation of both forms of ICBT, in relation to the gold standard f2f CBT. A fourth objective is to explore whether ICBT is equally suited for clinic-referred cases compared to self-referred patients. Finally, a fifth objective is to investigate whether genetic markers, in combination with clinical variables, can be employed to predict treatment outcomes with CBT in general. Research Questions: Q1: Is therapist-guided internet-based CBT (ICBT) for OCD non-inferior to face-to-face (f2f) CBT with regard to OCD symptoms, function and quality of life? Q2: Is entirely self-guided ICBT non-inferior to f2f CBT with regard to OCD symptoms, function and quality of life? Q3: Is ICBT a cost-effective treatment, compared to f2f CBT? Q4: Is there a difference in treatment outcome between self-referred and clinical referred patients? Q5: Can clinical variables and genetic markers be useful to predict which patients will benefit from CBT?


Clinical Trial Description

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Study Design


Related Conditions & MeSH terms


NCT number NCT02541968
Study type Interventional
Source Karolinska Institutet
Contact
Status Completed
Phase N/A
Start date September 3, 2015
Completion date January 31, 2021

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