Olfactory Reference SyndromeNCT03846076
Internet Delivered CBT for Olfactory Reference Syndrome
A study testing Cognitive behavioral therapy in people with Olfactory Reference Syndrome, run by Volen Ivanov at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Olfactory Reference Syndrome
- What is being tested?
- Cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSweden
- Study dates
- 4 Mar 2019to 12 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
M46: Karolinska Universitetssjukhuset, Psykiatri Sydväst Stockholm, Huddinge, Sweden, 141 86
Stockholm, 141 86
About this study
Official title: 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.
- Conditions
- Olfactory Reference Syndrome
- Being tested
- Cognitive behavioral therapy
- Medical subject headings
- olfactory reference syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapyBehavioural
Cognitive behavioral therapy
| Study group | Role | What they receive |
|---|---|---|
| Internet-delivered CBT | Experimental | 10 weeks of CBT delivered via the Internet. Receives: Behavioral: Cognitive behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
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).
Measured: Change from baseline (week 0) to post-treatment (week 10).
The Montgomery Åsberg Depression Rating Scale - self report (MADRS-S)
Measured: Change from baseline (week 0) to post-treatment (week 10).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start4 Mar 2019
- Primary completion12 Apr 2021
- Study completion12 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Olfactory Reference SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Volen Ivanov
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Sponsor-investigator, Volen Ivanov, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03846076
- Sponsor's protocol ID
- 2019-00775
- Other IDs
- 2019
- Status last verified
- Nov 2021
- First submitted
- 16 Feb 2019
- Last updated
- 2 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Treatment and Information Processing in Olfactory Reference Syndrome: A Pilot Study
- ClinicalTrials.gov ID
- NCT03846076
- Acronym / sponsor ID
- 2019-00775
- Conditions
- Olfactory Reference Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Volen IvanovUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 12 Apr 2021 (actual)
- Study completion
- 12 Apr 2021 (actual)
- First posted
- 19 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Internet-delivered CBT | Experimental | Behavioral: Cognitive behavioral therapy10 weeks of CBT delivered via the Internet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavioral therapyCognitive behavioral therapy | Behavioural | Internet-delivered CBT |
Primary outcome
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).
2 secondary outcomes
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 Montgomery Åsberg Depression Rating Scale - self report (MADRS-S)
Time frame: Change from baseline (week 0) to post-treatment (week 10).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral therapy in people with Olfactory Reference Syndrome, run by Volen Ivanov at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yale-Brown Obsessive Compulsive Scale Modified for olfactory reference syndrome (ORS-YBOCS) (time frame: Change from baseline (week 0) to post-treatment (week 10).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2021.