CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 120 target
Drug / intervention
Cognitive-behavioral therapy (face-to-face) +2 morebehavioral
Likely dose
Not stated in record
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Search/NCT02541968
NCT02541968N/ACompleted

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

Karolinska Institutet·interventional·Posted Sep 4, 2015·Updated Apr 22, 2022

In Brief

A clinical study evaluating Cognitive-behavioral therapy (face-to-face), Internet-based Cognitive-behavioral therapy, and 1 other intervention for Obsessive-compulsive Disorder. Completed, enrolled 120 participants across 1 site.

Detailed 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?

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSweden
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 4, 2015
Enrollment StartSep 3, 2015
Primary CompletionMay 1, 2019
Study CompletionJan 31, 2021
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 10.8 years ago

Interventions

Cognitive-behavioral therapy (face-to-face)behavioral

Internet-based Cognitive-behavioral therapybehavioral

With therapist support

Internet-based Cognitive-behavioral therapy without therapist supportbehavioral