Internet-Based Cognitive Behavioral Therapy for MRI-Related Anxiety (MRTightxiety)

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.

Study Overview

• Status: Recruiting
• Conditions: Anxiety; Claustrophobia; Magnetic Resonance Imaging (MRI)
• Intervention / Treatment: Behavioral: Intervention

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Johan Kihlberg, PhD; Phone Number: +461038902; Email: johan.kihlberg@liu.se
• Study Contact Backup: Name: Tomas Bjerner, PhD; Email: tomas.bjerner@liu.se

Study Locations

• Sweden
  • Linköping, Sweden, 58739
    • Recruiting
    • Linköping University
    • Contact: Johan Kihlberg; Phone Number: 73929; Email: johan.kihlberg@liu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• self-perceived problems with doing MRI examinations

Exclusion Criteria:

• difficulty understanding written text
• severe mental health problems

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Controls; Participants will receive the same iCBT intervention after completing the mock MR examination.
Experimental: Intervention; Participants will receive the internet-based cognitive behavioral therapy (iCBT) intervention prior to undergoing the mock MR examination.	Behavioral: Intervention; Participants will receive the internet-based cognitive behavioral therapy (iCBT) intervention prior to undergoing the mock MR examination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and within two days of the mock MRI examination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline and within two days of the mock MRI examination

Collaborators and Investigators

• Sponsor: Johan Kihlberg
• Collaborators: Linkoeping University; Region Östergötland; Region Jönköping County; Landstinget i Kalmar Län

Publications and helpful links

Helpful Links

• Study information for patients
• Study information

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: May 1, 2025
• First Submitted That Met QC Criteria: December 8, 2025
• First Posted (Actual): December 22, 2025

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Phobic Disorders; Anxiety Disorders; Claustrophobia; Investigative Techniques; Methods
• Other Study ID Numbers: EPM Dnr 2024-00435-01; Dnr 2024-00435-01 (Other Identifier: Swedish Ethical Review Authority)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No