Internet Delivered CBT for Olfactory Reference Syndrome

Study Overview
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Brief Summary
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The primary aim of the study is to test the feasibility and efficacy of, a manual based, Internet-delivered, cognitive behaviour therapy (CBT) for patients with Olfactory Reference Syndrome (ORS) who live in Sweden. The secondary aim is to investigate smell sensitivity and body odor in these ORS-patients.

Official Title
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Investigating Treatment and Information Processing in Olfactory Reference Syndrome: A Pilot Study

Conditions
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Olfactory Reference Syndrome

Intervention / Treatment
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* Behavioral: Cognitive behavioral therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary diagnosis of ORS Outpatients Male or female Signed informed consent Have regular access to a computer with Internet access and skills to use the web Exclusion Criteria: Not able to read or understand the basics of the ICBT self-help material Psychotropic medication changes within two months prior to treatment Completed CBT for ORS within last 12 months Ongoing substance dependence or misuse Lifetime bipolar disorder or psychosis Suicidal ideation Axis II diagnosis that could jeopardize treatment participation Serious physical illness that will be an obstacle in ICBT Other ongoing psychological treatments that could affect ORS symptoms Epilepsia

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-delivered CBT<br>10 weeks of CBT delivered via the Internet. | Behavioral: Cognitive behavioral therapy<br>* Cognitive behavioral therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yale-Brown Obsessive Compulsive Scale Modified for olfactory reference syndrome (ORS-YBOCS) | The instrument is a 12-item clinician-administered scale rating the severity of ORS symptoms during the past week. Each item is scored along a Likert scale ranging from 0 (least extreme) to 4 (most extreme), with higher total scores indicating more severe ORS symptoms (range 0-48). | Change from baseline (week 0) to post-treatment (week 10). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yale-Brown Obsessive Compulsive Scale Modified for olfactory reference syndrome - Self Report (ORS-YBOCS-SR) | The instrument is a12-item self-administered scale rating the severity of ORS symptoms during the past week. Each item is scored along a Likert scale ranging from 0 (least extreme) to 4 (most extreme), with higher total scores indicating more severe ORS symptoms (range 0-48). | Change from baseline (week 0) to post-treatment (week 10). | 
| The Montgomery Åsberg Depression Rating Scale - self report (MADRS-S) |  | Change from baseline (week 0) to post-treatment (week 10). |