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

Study Overview
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Brief Summary
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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?

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

Conditions
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Obsessive-compulsive Disorder

Intervention / Treatment
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* Behavioral: Cognitive-behavioral therapy (face-to-face)
* Behavioral: Internet-based Cognitive-behavioral therapy
* Behavioral: Internet-based Cognitive-behavioral therapy without therapist support


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Face-to-face CBT<br>16 sessions of individual CBT delivered in 14 weeks. | Behavioral: Cognitive-behavioral therapy (face-to-face)<br> <br> * Other names: CBT;|
| Experimental: Internet-based CBT<br>Internet-based CBT (ICBT) with therapist support (14 weeks). | Behavioral: Internet-based Cognitive-behavioral therapy<br>* With therapist support<br>* Other names: ICBT;|
| Experimental: ICBT without therapist support<br>Internet-based CBT without therapist support (14 weeks). | Behavioral: Internet-based Cognitive-behavioral therapy without therapist support<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) |  | Change from baseline to treatmentweek 2, 4, 6, 8, 10 , 12, 15 and 3- and 12-month follow-up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression - Severity (CGI-S) |  | Change from baseline to treatmentweek 15, 3- and 12-month follow-up. | 
| Global Assessment of Functioning (GAF) |  | Change from baseline to treatmentweek 15, 3- and 12-month follow-up. | 
| 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 | Diagnostic status | Change from baseline to treatmentweek 15, 3- and 12-month follow-up. | 
| Yale-Brown Obsessive-Compulsive Scale - self-rated (Y-BOCS) |  | Change from baseline to treatmentweek 15, 3- and 12-month follow-up. | 
| Obsessive-Compulsive Inventory - Revised (OCI-R) |  | Change from baseline to treatmentweek 15, 3- and 12-month follow-up. | 
| Sheehan Disability Scale (SDS) |  | Change from baseline to treatmentweek 15, 3- and 12-month follow-up. | 
| Montgomery-Åsberg Depression Rating Scale - self-rated (MADRS-S) |  | Change from baseline to treatmentweek 15, 3- and 12-month follow-up. | 
| Euroqol (EQ-5D) |  | Change from baseline to treatmentweek 15, 3- and 12-month follow-up. | 
| Clinical Global Impression - Improvement (CGI-I) |  | Treatmentweek 15, 3- and 12-month follow-up. | 
| Insomnia Severity Index (ISI) |  | Treatmentweek 15, 3- and 12-month follow-up. | 
| Treatment credibility scale |  | Change from baseline to treatmentweek 2. | 
| Satisfaction with treatment scale |  | Treatmentweek 15 | 
| TiC-P | Self-rated questionnaire on healthcare utilization and productivity losses in patients with a psychiatric disorder | Treatmentweek 0, 15, 3- and 12-month follow-up. | 
| Safety Monitoring Uniform Report Form (SMURF) |  | Treatmentweek 2, 4, 6, 8, 10 , 12, 15 and 3- and 12-month follow-up. | 
| Patient EX/RP Adherence Scale (PEAS) |  | Treatmentweek 6 and 15 | 
| Working Alliance Inventory - short revised |  | Change from baseline to treatment week 6 and 15 |