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OpenTrials
Completed

NCT Number: NCT03846076

Internet Delivered CBT for Olfactory Reference Syndrome

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.

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Key information

Conditions

Olfactory Reference Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Stockholm, 141 86, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive behavioral therapy

Behavioral

Cognitive behavioral therapy

Primary outcomes

  1. 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

  1. 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).

  2. The Montgomery Åsberg Depression Rating Scale - self report (MADRS-S)

    Time frame: Change from baseline (week 0) to post-treatment (week 10).

Sponsors and collaborators

Lead sponsor

Volen Ivanov

Other

Collaborators

  • Region Stockholm

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 19, 2019
Registry last updated
Nov 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.