Investigating Treatment and Information Processing in Olfactory Reference Syndrome: A Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Yale-Brown Obsessive Compulsive Scale Modified for olfactory reference syndrome (ORS-YBOCS)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Internet-delivered CBT
10 weeks of CBT delivered via the Internet.
Intervention: Cognitive behavioral therapy (Behavioral)
Outcomes
Primary Outcomes
Yale-Brown Obsessive Compulsive Scale Modified for olfactory reference syndrome (ORS-YBOCS)
Time Frame: Change from baseline (week 0) to post-treatment (week 10).
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).
Secondary Outcomes
- The Montgomery Åsberg Depression Rating Scale - self report (MADRS-S)(Change from baseline (week 0) to post-treatment (week 10).)
- Yale-Brown Obsessive Compulsive Scale Modified for olfactory reference syndrome - Self Report (ORS-YBOCS-SR)(Change from baseline (week 0) to post-treatment (week 10).)
Investigators
Volen Ivanov
Principal Investigator
Karolinska Institutet