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

N/ACompletedNCT02541968

Karolinska Institutet120 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

120

Conditions

Obsessive-compulsive Disorder

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * ≥ 18 years of age, * Internet access, * primary diagnosis of OCD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), * Written consent of participation in the study. Exclusion Criteria: * Other psychological treatment for OCD during the treatment period, * Adjustment of concurrent psychotropic medication within the last two months, * bipolar disorder, * psychosis, * alcohol or substance dependence, * completed CBT for OCD in the last 12 months, * hoarding disorder or OCD with primary hoarding symptoms, * suicidal ideation, * subjects that lack the ability to read written Swedish or lack the cognitive ability to assimilate to the written material, * Autism spectrum disorder, * organic brain disorder.

Outcomes

Primary Outcomes

Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)

Time frame: Change from baseline to treatmentweek 2, 4, 6, 8, 10 , 12, 15 and 3- and 12-month follow-up.