Implementing Internet-Assisted Treatment for Non-Cardiac Chest Pain

Study Overview
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Brief Summary
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This study aims to test Implementation of Internet-Assisted Treatment for Non-Cardiac Chest Pain at the Cardiac Department at Sørlandet Hospital. The internet-assisted treatment will be delivered by personnel working at the department. Effectiveness will be tested in an randomized controlled trial (RCT). The intervention has been tested in an RCT where the intervention was delivered by a cognitive behavioral therapy (CBT) specialist who also participated in developing the intervention. Presently the investigators will test if personnel working at the department, with minimal training in CBT, can deliver the intervention effectively.

Detailed Description
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Most patients with chest pain referred to hospital do not have a cardiac illness. Non-cardiac chest pain (NCCP) is often followed by persistent distress and reduced quality of life, and societal costs are nearly equal to those of cardiac patients. Research suggests that face-to-face CBT is effective, but this has not been implemented as standard treatment. The investigators plan to test an easily implementable internet-assisted treatment for NCCP patients delivered by personnel already working at the department. Patients will be recruited at the chest pain unit at Sørlandet Hospital, Kristiansand, and will be recruited after they have finished their cardiac examination. The intervention group will receive six web-based sessions, comprising information, exposure to physical activity, how worry can excess pain, physical reactions to pain and worry, consequences of avoidance, and specific panic treatment.

Official Title
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Implementing Internet-Assisted Treatment for Non-Cardiac Chest Pain

Conditions
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Chest Pain

Intervention / Treatment
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* Behavioral: Internet-assisted treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-Cardiac Chest Pain Exclusion Criteria: Language difficulties Unable to perform at least moderate physical activity due to physical constraints Obvious cognitive impairment (e.g mentally retarded, psychotic, dementia or intoxicated) no regular access to a computer/tablet computer with internet connection

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Interventional Model Description: Parallel Assignment Eligible patients will be consecutively included and randomized to two groups, intervention group or control group. The investigators will use a web-based randomisation procedure, conducted at a place remote from where the study takes place.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-assisted treatment<br>The intervention group will receive internet-assisted treatment comprising six web-based sessions, comprising information, exposure to physical activity, how worry can excess pain, physical reactions to pain and worry, consequences of avoidance, and specific panic treatment. The first session will be done at the hospital before discharge, the others at home. Between sessions there will be a brief telephone contact with a project worker. | Behavioral: Internet-assisted treatment<br>* Internet-assisted treatment<br>|
| No Intervention: Control group<br>The control group will receive treatment as usual, which is no specific treatment. The control group can however use the general health system as they like. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Sensations Questionnaire (BSQ) | BSQ is an 17-item self-report-questionnaire which measures fear of different bodily sensations. Each item is rated on a five-point Likert scale ranging from 1 to 5. Total range 17-85 where higher score represents more symptoms. Primary outcome is difference in mean score between intervention arm and control arm for BSQ at end of treatment (6 weeks after randomization for both arms). Difference in mean scores between arms will also be assessed at pretreatment/baseline, and at 3 months and 12 months after end of treatment (18 weeks and 58 weeks after randomization). There is no predefined clinical relevant effect for this measure. The investigators will use a distribution based method. Clinical relevant effect is defined as improvement of more than 0.5 standard deviation compared to baseline. | 58 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cardiac Anxiety Questionnaire (CAQ) | CAQ is an 18-item self-report-questionnaire which measures hearth related anxiety/fear, attention, avoidance and safety seeking behavior. Each item is rated on a five-point Likert scale ranging from 0 to 4. Total range 0-72 where higher score represents more symptoms. Primary outcome is difference in mean score between intervention arm and control arm for CAQ at end of treatment (6 weeks after randomization for both arms). Difference in mean scores between arms will also be assessed at pretreatment/baseline, and at 3 months and 12 months after end of treatment (18 weeks and 58 weeks after randomization). There is no predefined clinical relevant effect for this measure. The investigators will use a distribution based method. Clinical relevant effect is defined as improvement of more than 0.5 standard deviation compared to baseline. | 58 weeks | 
| Change in Brief Illness Perception Questionnaire (BIPQ) | BIPQ is an 8-item self-report-questionnaire which assess the patient's perception/beliefs about their symptoms. Each item is rated on a 0-10 scale. The items represent different components/dimensions. Secondary outcome is difference in mean score between intervention arm and control arm for item 1, 5, 6 and 8 at end of treatment (6 weeks after randomization for both arms). Difference in mean scores between arms will also be assessed for item 1, 5, 6 and 8 at pretreatment/baseline, and at 3 months and 12 months after end of treatment (18 weeks and 58 weeks after randomization). There is no predefined clinical relevant effect for this measure. The investigators will use a distribution based method. Clinical relevant effect is defined as improvement of more than 0.5 standard deviation compared to baseline. | 58 weeks | 
| Change in Patient Health Questionnaire (PHQ-9) | PHQ-9 is an 9 item self-report-questionnaire which assess depression symptoms. Each item is rated on a 0-3 scale. Total range 0-27 where higher score represents more symptoms. Secondary outcome is difference in mean score between intervention arm and control arm for PHQ-9 at end of treatment (6 weeks after randomization for both arms). Difference in mean scores between arms will also be assessed at pretreatment/baseline, and at 3 months and 12 months after end of treatment (18 weeks and 58 weeks after randomization). | 58 weeks | 
| Change in EQ-5D-5L | EQ-5D-5L is an 5 item (plus a visual analog scale) self-report-questionnaire assessing health related quality of life. Secondary outcome is difference in mean score between intervention arm and control arm for EQ-5D-5L at end of treatment (6 weeks after randomization for both arms). Difference in mean scores between arms will also be assessed at pretreatment/baseline, and at 3 months and 12 months after end of treatment (18 weeks and 58 weeks after randomization). Distribution based methods are commonly used, defining improvement of 0.2 or 0.5 standard deviation as clinical relevant. The investigators define a minimal clinical relevant improvement to be 0.2 standard deviation in EQ-5D-5L. | 58 weeks | 
| Change in self-developed questions | Questions regarding: Impact on social, work and Family life Frequency of chest pain Avoidance of physical activity due to chest pain Physical activity level | 58 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-cardiac chest pain, NCCP, anxiety, internet-assisted treatment