Internet Delivered CBT for Olfactory Reference Syndrome

November 1, 2021 updated by: Volen Ivanov

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 141 86
        • M46: Karolinska Universitetssjukhuset, Psykiatri Sydväst Stockholm, Huddinge, Sweden, 141 86

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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)
Time Frame: 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).
Change from baseline (week 0) to post-treatment (week 10).
The Montgomery Åsberg Depression Rating Scale - self report (MADRS-S)
Time Frame: Change from baseline (week 0) to post-treatment (week 10).
Change from baseline (week 0) to post-treatment (week 10).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Volen Ivanov

Collaborators

Region Stockholm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2019

Primary Completion (Actual)

April 12, 2021

Study Completion (Actual)

April 12, 2021

Study Registration Dates

First Submitted

February 16, 2019

First Submitted That Met QC Criteria

February 16, 2019

First Posted (Actual)

February 19, 2019

Study Record Updates

Last Update Posted (Actual)

November 2, 2021

Last Update Submitted That Met QC Criteria

November 1, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-00775

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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