Internet-delivered CBT for NCCP-patients - a Pilot Trial

Study Overview
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Brief Summary
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This pilot randomized controlled trial (RCT) aims to test the feasibility and effectiveness of a guided internet-delivered cognitive behavioural therapy intervention in the treatment of cardiac anxiety and fear of body sensations in patients with non-cardiac chest pain. The control group will receive care-as-usual.

Detailed Description
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Despite reassurance, many patients with non-cardiac chest pain (NCCP) think they have an undetected cardiac disease and avoid activities that they think might be harmful to their heart. These patients need help and support to evaluate the way they perceive and handle their chest pain. Therefore, we have developed a 4 session guided intervention based on cognitive behavioural therapy that will be delivered via internet. The intervention consists of psychoeducation, exposure to physical activity, and a breathing-based relaxation exercise. The goal with the intervention is to help the participants modify their beliefs about chest pain, change their cognitive and behavioural strategies, and give them tools to handle chest pain to prevent them from relapse.

Official Title
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Short-term Internet-delivered Cognitive Behavioural Therapy for Treatment of Cardiac Anxiety and Fear of Body Sensations in Patients With Non-cardiac Chest Pain - a Pilot Randomized Controlled Study

Conditions
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Chest Pain, Anxiety, Fear

Intervention / Treatment
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* Behavioral: Internet-delivered cognitive behavioural therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: recurrent chest pain that has been diagnosed as non-cardiac at least twice during last 6 months patients screened positive for avoidance of physical activity due to cardiac anxiety and/or fear of body sensations Exclusion Criteria: no regular access to a computer/tablet computer with internet connection language difficulties not able to perform physical activity/exercise test due to physical constraints patients with severe depressive symptoms patients with acute ischemic heart disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>4 weeks guided internet-delivered cognitive behavioural therapy program. The program consists of psychoeducation, exposure to physical activity, and a breathing-based relaxation exercise | Behavioral: Internet-delivered cognitive behavioural therapy<br> <br> |
| No Intervention: Control group<br>Care as usual | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac anxiety (Data collection) | Data collection will be performed before and after the intervention, and 3 and 12 months after the end of the intervention | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fear of body sensations (Data collection) | Data collection will be performed before and after the intervention, and 3 and 12 months after the end of the intervention | 12 months | 
| Depressive symptoms (Data collection) | Data collection will be performed before and after the intervention, and 3 and 12 months after the end of the intervention | 12 months | 
| Healthcare utilization and costs (Data collection) | Data collection will be performed12 months after the end of the intervention | 12 months |