NCT02541968

Internet-based vs Face-to-face Cognitive Behavioural Therapy for Obsessive-compulsive Disorder

Internet-based vs Face-to-face Cognitive Behavioural Therapy for Obsessive-compulsive Disorder - a Randomized Controlled Non-inferiority Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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?

Conditions

• Obsessive-compulsive Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive-behavioral therapy (face-to-face)
BEHAVIORAL	Internet-based Cognitive-behavioral therapy	With therapist support
BEHAVIORAL	Internet-based Cognitive-behavioral therapy without therapist support

Timeline

• Start date: 2015-09-03
• Primary completion: 2019-05-01
• Completion: 2021-01-31
• First posted: 2015-09-04
• Last updated: 2022-04-22

Locations

1 site across 1 country: Sweden