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| ID | Type | Description | Link |
|---|---|---|---|
| Dnr 2024-00435-01 | Other Identifier | Swedish Ethical Review Authority |
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| Name | Class |
|---|---|
| Linkoeping University | OTHER_GOV |
| Region Östergötland | OTHER |
| Region Jönköping County | OTHER_GOV |
| Landstinget i Kalmar Län |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention | Behavioral | Participants will receive the internet-based cognitive behavioral therapy (iCBT) intervention prior to undergoing the mock MR examination. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Johan Kihlberg, PhD | Contact | +461038902 | johan.kihlberg@liu.se | |
| Tomas Bjerner, PhD | Contact | tomas.bjerner@liu.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linköping University | Recruiting | Linköping | 58739 | Sweden |
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| Label | URL |
|---|---|
| Study information for patients | View source |
| Study information | View source |
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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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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D000098452 | Claustrophobia |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D010698 | Phobic Disorders |
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| ID | Term |
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| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| OTHER |
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).
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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 |