- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04094337
Implementing Internet-Assisted Treatment for Non-Cardiac Chest Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Vest-Agder
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Kristiansand, Vest-Agder, Norway, 4604
- Sorlandet sykehus HF
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Internet-assisted treatment
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.
|
Internet-assisted treatment
|
No Intervention: Control group
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?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Body Sensations Questionnaire (BSQ)
Time Frame: 58 weeks
|
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)
Time Frame: 58 weeks
|
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)
Time Frame: 58 weeks
|
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)
Time Frame: 58 weeks
|
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
Time Frame: 58 weeks
|
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
Time Frame: 58 weeks
|
Questions regarding:
|
58 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PHQ-9
Time Frame: 58 weeks
|
Total range of PHQ-9 is 0-27. A score of 5 or above is defined as cut-off for mild depressive symptoms. The investigators will sub-group participants with a prescore of 5 or above on PHQ-9 to evaluate if this subgroup has:
|
58 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Frode Gallefoss, PhD, Head of Clinical Research
- Principal Investigator: Egil Jonsbu, PhD, Researcher
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 815486
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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