Obsessive-compulsive Disorder
Conditions
Brief 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?
Interventions
BEHAVIORALCognitive-behavioral therapy (face-to-face)
With therapist support
BEHAVIORALInternet-based Cognitive-behavioral therapy without therapist support
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Change from baseline to treatmentweek 15, 3- and 12-month follow-up. | Diagnostic status |
| 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 - Severity (CGI-S) | Change from baseline to 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 | Treatmentweek 0, 15, 3- and 12-month follow-up. | Self-rated questionnaire on healthcare utilization and productivity losses in patients with a psychiatric disorder |
| 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 | — |
| Clinical Global Impression - Improvement (CGI-I) | Treatmentweek 15, 3- and 12-month follow-up. | — |
Countries
Sweden
Outcome results
None listed