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Clinical Trials/NCT07296822
NCT07296822
Recruiting
Not Applicable

A Randomized Controlled Trial of Internet-Based Cognitive Behavioral Therapy for MRI-Related Anxiety

Johan Kihlberg1 site in 1 country60 target enrollmentStarted: May 1, 2025Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Sponsor
Johan Kihlberg
Enrollment
60
Locations
1
Primary Endpoint
MRI-related anxiety

Overview

Brief 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). 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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • self-perceived problems with doing MRI examinations

Exclusion Criteria

  • difficulty understanding written text
  • severe mental health problems

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Anxiety(Baseline and within two days of the mock MRI examination)
  • Claustrophobia(Baseline and within two days of the mock MRI examination)
  • Mental health(Baseline and within two days of the mock MRI examination)

Investigators

Sponsor
Johan Kihlberg
Sponsor Class
Other Gov
Responsible Party
Sponsor Investigator
Principal Investigator

Johan Kihlberg

Associate Professor

Linkoeping University

Study Sites (1)

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