Internet Delivered CBT for Olfactory Reference Syndrome

Not Applicable

Completed

• Conditions: Olfactory Reference Syndrome
• Interventions: Behavioral: Cognitive behavioral therapy

• Registration Number: NCT03846076
• Lead Sponsor: Volen Ivanov

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-16
• Study First Submitted QC: 2019-02-16
• Study First Posted: 2019-02-19
• Study Start: 2019-03-04
• Primary Completion: 2021-04-12
• Study Completion: 2021-04-12
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-01
• Last Update Posted: 2021-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Internet-delivered CBT	Cognitive behavioral therapy	10 weeks of CBT delivered via the Internet.

Primary Outcome Measures

Name	Time	Method
Yale-Brown Obsessive Compulsive Scale Modified for olfactory reference syndrome (ORS-YBOCS)	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 Outcome Measures

Name	Time	Method
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).	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).

Trial Locations

Locations (1)

M46: Karolinska Universitetssjukhuset, Psykiatri Sydväst Stockholm, Huddinge, Sweden, 141 86; 🇸🇪 Stockholm, Sweden