AnxietyMRTightxietyNCT07296822
Internet-Based Cognitive Behavioral Therapy for MRI-Related Anxiety
A study testing Intervention in people with Anxiety and Claustrophobia, run by Johan Kihlberg at 1 site in Sweden.
Trial summary
The aim of the study is to investigate whether internet-based cognitive behavioural therapy (iCBT) can help patients who have difficulty undergoing magnetic resonance imaging (MRI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Claustrophobia, Magnetic Resonance Imaging (MRI)
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 1 May 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- self-perceived problems with doing MRI examinations
Who cannot join
- difficulty understanding written text
- severe mental health problems
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tomas Bjerner, PhD contact
Sweden1 site, 1 recruiting
- Recruiting
Linköping University
Linköping, 58739
Johan Kihlberg, 73929, johan.kihlberg@liu.se
About this study
Official title: A Randomized Controlled Trial of Internet-Based Cognitive Behavioral Therapy for MRI-Related Anxiety
The aim of the study is to investigate whether internet-based cognitive behavioural therapy (iCBT) can help patients who have difficulty undergoing magnetic resonance imaging (MRI). The main question to be answered is
- Can patients undergo MRI with less anxiety using iCBT?
The patients will undergo a four-week treatment that includes information about MRI, anxiety management, relaxation and retention. The end goal is to simulate an MRI scan in a mock scanner where participants can report their anxiety. Half of the participants will be randomized to receive the treatment before (intervention group) the simulated MRI scan and half will receive the treatment after the simulated MRI scan (control group). Up to 60 patients will be included plus some pilot patients.
- Conditions
- Anxiety, Claustrophobia, Magnetic Resonance Imaging (MRI)
- Being tested
- Intervention
- Medical subject headings
- Anxiety Disorders, Claustrophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
Participants will receive the internet-based cognitive behavioral therapy (iCBT) intervention prior to undergoing the mock MR examination.
| Study group | Role | What they receive |
|---|---|---|
| Controls | No intervention | Participants will receive the same iCBT intervention after completing the mock MR examination. |
| Intervention | Experimental | Participants will receive the internet-based cognitive behavioral therapy (iCBT) intervention prior to undergoing the mock MR examination. Receives: Behavioral: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI-related anxiety
MRI-related anxiety using the Magnetic Resonance Imaging Anxiety Questionnaire (MRI-AQ) measured before and after the mock MRI examination. Higher value means increased symptoms. Can give between 15-60 points.
Measured: Baseline and within two days of the mock MRI examination
Secondary outcomes (3)
Anxiety
Anxiety using Generalized Anxiety Disorder Seven Item Scale (GAD-7) measured before and after the mock MRI examination. Higher value means increased symptoms. Can give between 0-27 points.
Measured: Baseline and within two days of the mock MRI examination
Claustrophobia
Claustrophobia using a Swedish validated translation of The Claustrophobia Questionnaire (CLQ) measured before and after the mock MRI examination. Higher value means increased symptoms. Can give between 0-48 points.
Measured: Baseline and within two days of the mock MRI examination
Mental health
Mental health using the Patient Health Questionnaire-9 (PHQ-9) measured before and after the mock MRI examination. Higher value means increased symptoms. Can give between 0-27 points.
Measured: Baseline and within two days of the mock MRI examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start1 May 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Randomised
- Intervention model
- Crossover
- Model description
- The patients will undergo a four-week treatment that includes information about MRI, anxiety management, relaxation and retention. The end goal is to simulate an MRI scan in a mock scanner where participants can report their anxiety. Half of the participants will be randomized to receive the treatment before (intervention group) the simulated MRI scan and half will receive the treatment after the simulated MRI scan (control group).
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johan Kihlberg
- Sponsor type
- Other government
- Collaborators
- Linkoeping University, Region Östergötland, Region Jönköping County, Landstinget i Kalmar Län
- Responsible party
- Sponsor-investigator, Johan Kihlberg, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07296822
- Sponsor's protocol ID
- EPM Dnr 2024-00435-01
- Other IDs
- Dnr 2024-00435-01
- Acronym
- MRTightxiety
- Status last verified
- Dec 2025
- First submitted
- 1 May 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Collected data will be stored at Linköping University, which the entire research group has full access to. No unauthorized persons will have access to the data. This is a research project with a quantitative method where the results are reported in aggregated form. The data is reported completely anonymized and only at the group level.
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Internet-Based Cognitive Behavioral Therapy for MRI-Related Anxiety
- ClinicalTrials.gov ID
- NCT07296822
- Acronym / sponsor ID
- MRTightxiety / EPM Dnr 2024-00435-01
- Conditions
- Anxiety, Claustrophobia, Magnetic Resonance Imaging (MRI)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Johan KihlbergOther government
- Collaborators
- Linkoeping University, Region Östergötland, Region Jönköping County, Landstinget i Kalmar Län
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Dec 2025 (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 aim of the study is to investigate whether internet-based cognitive behavioural therapy (iCBT) can help patients who have difficulty undergoing magnetic resonance imaging (MRI). The main question to be answered is
- Can patients undergo MRI with less anxiety using iCBT?
The patients will undergo a four-week treatment that includes information about MRI, anxiety management, relaxation and retention. The end goal is to simulate an MRI scan in a mock scanner where participants can report their anxiety. Half of the participants will be randomized to receive the treatment before (intervention group) the simulated MRI scan and half will receive the treatment after the simulated MRI scan (control group). Up to 60 patients will be included plus some pilot patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The patients will undergo a four-week treatment that includes information about MRI, anxiety management, relaxation and retention. The end goal is to simulate an MRI scan in a mock scanner where participants can report their anxiety. Half of the participants will be randomized to receive the treatment before (intervention group) the simulated MRI scan and half will receive the treatment after the simulated MRI scan (control group).
| Arm | Type | Receives |
|---|---|---|
| Controls | No intervention | –Participants will receive the same iCBT intervention after completing the mock MR examination. |
| Intervention | Experimental | Behavioral: InterventionParticipants will receive the internet-based cognitive behavioral therapy (iCBT) intervention prior to undergoing the mock MR examination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- self-perceived problems with doing MRI examinations
Key exclusion criteria (2 listed)
- difficulty understanding written text
- severe mental health problems
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 |
|---|---|---|
| InterventionParticipants will receive the internet-based cognitive behavioral therapy (iCBT) intervention prior to undergoing the mock MR examination. | Behavioural | Intervention |
Primary outcome
MRI-related anxiety
Time frame: Baseline and within two days of the mock MRI examination
MRI-related anxiety using the Magnetic Resonance Imaging Anxiety Questionnaire (MRI-AQ) measured before and after the mock MRI examination. Higher value means increased symptoms. Can give between 15-60 points.
3 secondary outcomes
Anxiety
Time frame: Baseline and within two days of the mock MRI examination
Claustrophobia
Time frame: Baseline and within two days of the mock MRI examination
Mental health
Time frame: Baseline and within two days of the mock MRI examination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Study information for patientsLink provided by the sponsor.
- Study informationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Collected data will be stored at Linköping University, which the entire research group has full access to. No unauthorized persons will have access to the data. This is a research project with a quantitative method where the results are reported in aggregated form. The data is reported completely anonymized and only at the group level.
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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.
Tomas Bjerner, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Anxiety and Claustrophobia, run by Johan Kihlberg 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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 22 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johan Kihlberg, PhD (+461038902, johan.kihlberg@liu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI-related anxiety (time frame: Baseline and within two days of the mock MRI examination). 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 22 Dec 2025.