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

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?

Structured Clinical Interview for DSM-5 (SCID-5) obsessive-compulsive and related disorders Structured Clinical Interview for DSM-5 (SCID-5) obsessive-compulsive and related disorders

Self-rated questionnaire on healthcare utilization and productivity losses in patients with a psychiatric disorder

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.

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Lundstrom L, Flygare O, Andersson E, Enander J, Bottai M, Ivanov VZ, Boberg J, Pascal D, Mataix-Cols D, Ruck C. Effect of Internet-Based vs Face-to-Face Cognitive Behavioral Therapy for Adults With Obsessive-Compulsive Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2022 Mar 1;5(3):e221967. doi: 10.1001/jamanetworkopen.2022.1967. Erratum In: JAMA Netw Open. 2022 Jul 1;5(7):e2222742. JAMA Netw Open. 2023 Jun 1;6(6):e2323948.

Ruck C, Lundstrom L, Flygare O, Enander J, Bottai M, Mataix-Cols D, Andersson E. Study protocol for a single-blind, randomised controlled, non-inferiority trial of internet-based versus face-to-face cognitive behaviour therapy for obsessive-compulsive disorder. BMJ Open. 2018 Sep 5;8(9):e022254. doi: 10.1136/bmjopen-2018-022254.