Internet Delivered CBT for Olfactory Reference Syndrome

Sponsor

Volen Ivanov (Other)

Overall Status

Completed

CT.gov ID

NCT03846076

Collaborator

Region Stockholm (Other)

Enrollment

Location

Arm

25.3

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Olfactory Reference Syndrome	Behavioral: Cognitive behavioral therapy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 4, 2019

Actual Primary Completion Date :

Apr 12, 2021

Actual Study Completion Date :

Apr 12, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Internet-delivered CBT 10 weeks of CBT delivered via the Internet.	Behavioral: Cognitive behavioral therapy Cognitive behavioral therapy

Arm

Intervention/Treatment

Experimental: Internet-delivered CBT

10 weeks of CBT delivered via the Internet.

Behavioral: Cognitive behavioral therapy

Cognitive behavioral therapy

Outcome Measures

Primary Outcome Measures

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

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).
The Montgomery Åsberg Depression Rating Scale - self report (MADRS-S) [Change from baseline (week 0) to post-treatment (week 10).]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	M46: Karolinska Universitetssjukhuset, Psykiatri Sydväst Stockholm, Huddinge, Sweden, 141 86	Stockholm		Sweden	141 86

Sponsors and Collaborators

Volen Ivanov
Region Stockholm

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Volen Ivanov, Principal Investigator, Karolinska Institutet

ClinicalTrials.gov Identifier:

NCT03846076

Other Study ID Numbers:

2019-00775

First Posted:

Feb 19, 2019

Last Update Posted:

Nov 2, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Syndrome

Study Results

No Results Posted as of Nov 2, 2021