Internet-Based Cognitive Behavioral Therapy for MRI-Related Anxiety
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohan Kihlberg
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
self-perceived problems with doing MRI examinations
Disqualifiers
difficulty understanding written text
severe mental health problems
Trial design
Design model
Crossover
Treatments tested in this trial
Intervention
BehavioralParticipants will receive the internet-based cognitive behavioral therapy (iCBT) intervention prior to undergoing the mock MR examination.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: ControlsNo intervention 0 interventions
Group B: InterventionExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Baseline and within two days of the mock MRI examinationSecondary outcomes
1
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.
Time frame
Baseline and within two days of the mock MRI examination2
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.
Time frame
Baseline and within two days of the mock MRI examination3
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.
Time frame
Baseline and within two days of the mock MRI examinationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Johan Kihlberg
Lead sponsor
Linkoeping University
Sponsor institution
Linkoeping University
Collaborator
Region Östergötland
Collaborator
Region Jönköping County
Collaborator
Landstinget i Kalmar Län
Collaborator
Source ClinicalTrials.gov