NCT07296822

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
8mo left

Started May 2025

Typical duration for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
May 2025Dec 2026

First Submitted

Initial submission to the registry

May 1, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
8 months until next milestone

First Posted

Study publicly available on registry

December 22, 2025

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

8 months

First QC Date

May 1, 2025

Last Update Submit

December 8, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Study Arms (2)

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.

Behavioral: Intervention

Interventions

InterventionBEHAVIORAL

Participants will receive the internet-based cognitive behavioral therapy (iCBT) intervention prior to undergoing the mock MR examination.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • self-perceived problems with doing MRI examinations

You may not qualify if:

  • difficulty understanding written text
  • severe mental health problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Linköping University

Linköping, 58739, Sweden

RECRUITING

Related Links

MeSH Terms

Conditions

Anxiety DisordersClaustrophobia

Interventions

Methods

Condition Hierarchy (Ancestors)

Mental DisordersPhobic Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Johan Kihlberg, PhD

CONTACT

Tomas Bjerner, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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).
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 1, 2025

First Posted

December 22, 2025

Study Start

May 1, 2025

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

December 22, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

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.

Locations