Internet Delivered CBT for Olfactory Reference Syndrome
Investigating Treatment and Information Processing in Olfactory Reference Syndrome: A Pilot Study
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2019
CompletedFirst Posted
Study publicly available on registry
February 19, 2019
CompletedStudy Start
First participant enrolled
March 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 12, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 12, 2021
CompletedNovember 2, 2021
November 1, 2021
2.1 years
February 16, 2019
November 1, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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 Montgomery Åsberg Depression Rating Scale - self report (MADRS-S)
Change from baseline (week 0) to post-treatment (week 10).
Study Arms (1)
Internet-delivered CBT
EXPERIMENTAL10 weeks of CBT delivered via the Internet.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Volen Ivanovlead
- Region Stockholmcollaborator
Study Sites (1)
M46: Karolinska Universitetssjukhuset, Psykiatri Sydväst Stockholm, Huddinge, Sweden, 141 86
Stockholm, 141 86, Sweden
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 16, 2019
First Posted
February 19, 2019
Study Start
March 4, 2019
Primary Completion
April 12, 2021
Study Completion
April 12, 2021
Last Updated
November 2, 2021
Record last verified: 2021-11