Internet Delivered CBT for Olfactory Reference Syndrome

Olfactory Reference Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03846076
• Other study ID #: 2019-00775
• Status: Completed
• Phase: N/A
• Start date: March 4, 2019
• Est. completion date: April 12, 2021

Study information

• Verified date: November 2021
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 12, 2021
• Est. primary completion date: April 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Olfactory Reference Syndrome
• Syndrome

Intervention

Behavioral:
• Cognitive behavioral therapy
Cognitive behavioral therapy

Locations

Country	Name	City	State
Sweden	M46: Karolinska Universitetssjukhuset, Psykiatri Sydväst Stockholm, Huddinge, Sweden, 141 86	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Volen Ivanov	Region Stockholm

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Secondary	The Montgomery Åsberg Depression Rating Scale - self report (MADRS-S)		Change from baseline (week 0) to post-treatment (week 10).