Chest PainNCT03096925
Non-cardiac Chest Pain: Effect of Cognitive Therapy Administered as Guided Self-help
A study testing Guided self-help in people with Chest Pain, run by Sorlandet Hospital HF at 1 site in Norway.
Trial summary
This study aims to test an easily implementable web-based cognitive behaviour therapy (CBT) self-help intervention designed for non-cardiac chest pain patients, and compare effectiveness and cost-effectiveness to treatment as usual in an randomized controlled trial (RCT). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chest Pain
- What is being tested?
- Guided self-help
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteNorway
- Study dates
- 3 Apr 2017to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-Cardiac Chest Pain
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to test an easily implementable web-based cognitive behaviour therapy (CBT) self-help intervention designed for non-cardiac chest pain patients, and compare effectiveness and cost-effectiveness to treatment as usual in an randomized controlled trial (RCT).
Read the 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. We plan to test an easily implementable web-based guided self-help intervention for NCCP patients.
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.
- Conditions
- Chest Pain
- Being tested
- Guided self-help
- Keywords
- non-cardiac chest pain, anxiety
- Medical subject headings
- Chest Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided self-helpBehavioural
Web-based guided self-help intervention
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group will receive guided self-help 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. Receives: Behavioral: Guided self-help |
| Control group | No intervention | This group will receive treatment as usual, which is no specific treatment. They can however use the general health system as they like. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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, we use a distribution based method and define clinical relevant effect as improvement of more than 0.5 standard deviation compared to baseline.
Measured: 58 weeks
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, we use a distribution based method and define clinical relevant effect as improvement of more than 0.5 standard deviation compared to baseline.
Measured: 58 weeks
Secondary outcomes (5)
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 these items, we use a distribution based method and define clinical relevant effect as improvement of more than 0.5 standard deviation compared to baseline.
Measured: 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). We define clinical relevant effect as an absolute drop of 5 points on an individual level, and between groups as an improvement of 3 points.
Measured: 58 weeks
Change in General perceived Self-Efficacy Scale
GSE is an 10 item self-report-questionnaire which assess self-efficacy. Each item is rated on a 1-4 Lickert scale. Total range 10-40 where higher score represents more self-efficacy. Secondary outcome is difference in mean score between intervention arm and control arm for GSE 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, we use a distribution based method and define clinical relevant effect as improvement of more than 0.5 standard deviation compared to baseline. We will also investigate its ability to predict treatment effect.
Measured: 58 weeks
Change in EQ-5D-5L
EQ-5D-5L is an 5 item (plus a VAS 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 SD as clinical relevant. We define a minimal clinical relevant improvement to be 0.2 SD in EQ-5D-5L.
Measured: 58 weeks
Health care costs
Secondary outcome is to calculate the difference in healthcare utilization between intervention and control arm over a period of 12 months after end of treatment. We will collect data on both direct and indirect costs with self-report forms collected every third month, as well as register data. We will compare the costs between the two arms.
Measured: 58 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study start3 Apr 2017
- Primary completion19 Dec 2019
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chest PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible patients will be consecutively included and randomized to two groups, intervention group or control group. We will use a web-based randomisation procedure, conducted at a place remote from where the study takes place.
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Frode Gallefoss, MD, PhD, Study director, Head of Clinical Research, Sørlandet HF.Liv T Walseth, MD, PhD, Principal investigator, Researcher, Sørlandet HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03096925
- Sponsor's protocol ID
- 815443
- Other IDs
- 2016031
- Status last verified
- Jan 2023
- First submitted
- 16 Feb 2017
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Thesen T, Himle JA, Pripp AH, Sunde T, Walseth LT, Thorup F, Gallefoss F, Jonsbu E. Patients with depression symptoms are more likely to experience improvements of internet-based cognitive behavioral therapy: a secondary analysis of effect modifiers in patients with non-cardiac chest pain in a randomized controlled trial. BMC Psychiatry. 2023 Oct 14;23(1):751. doi: 10.1186/s12888-023-05238-1.
PubMed 37838653Thesen T, Himle JA, Martinsen EW, Walseth LT, Thorup F, Gallefoss F, Jonsbu E. Effectiveness of Internet-Based Cognitive Behavioral Therapy With Telephone Support for Noncardiac Chest Pain: Randomized Controlled Trial. J Med Internet Res. 2022 Jan 24;24(1):e33631. doi: 10.2196/33631.
PubMed 35072641
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-cardiac Chest Pain: Effect of Cognitive Therapy Administered as Guided Self-help
- ClinicalTrials.gov ID
- NCT03096925
- Acronym / sponsor ID
- 815443
- Conditions
- Chest Pain
- Keywords
- non-cardiac chest pain, anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 19 Dec 2019 (actual)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 30 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to test an easily implementable web-based cognitive behaviour therapy (CBT) self-help intervention designed for non-cardiac chest pain patients, and compare effectiveness and cost-effectiveness to treatment as usual in an randomized controlled trial (RCT).
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. We plan to test an easily implementable web-based guided self-help intervention for NCCP patients.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eligible patients will be consecutively included and randomized to two groups, intervention group or control group. We will use a web-based randomisation procedure, conducted at a place remote from where the study takes place.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Guided self-helpThe intervention group will receive guided self-help 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. |
| Control group | No intervention | –This group will receive treatment as usual, which is no specific treatment. They can however use the general health system as they like. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Non-Cardiac Chest Pain
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided self-helpWeb-based guided self-help intervention | Behavioural | Intervention group |
Primary outcome
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, we use a distribution based method and define clinical relevant effect as improvement of more than 0.5 standard deviation compared to baseline.
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, we use a distribution based method and define clinical relevant effect as improvement of more than 0.5 standard deviation compared to baseline.
5 secondary outcomes
Change in Brief Illness Perception Questionnaire (BIPQ)
Time frame: 58 weeks
Change in Patient Health Questionnaire (PHQ-9)
Time frame: 58 weeks
Change in General perceived Self-Efficacy Scale
Time frame: 58 weeks
Change in EQ-5D-5L
Time frame: 58 weeks
Health care costs
Time frame: 58 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Derived from this study: PubMed 37838653Thesen T, Himle JA, Pripp AH, Sunde T, Walseth LT, Thorup F, Gallefoss F, Jonsbu E. Patients with depression symptoms are more likely to experience improvements of internet-based cognitive behavioral therapy: a secondary analysis of effect modifiers in patients with non-cardiac chest pain in a randomized controlled trial. BMC Psychiatry. 2023 Oct 14;23(1):751. doi: 10.1186/s12888-023-05238-1.
- Derived from this study: PubMed 35072641Thesen T, Himle JA, Martinsen EW, Walseth LT, Thorup F, Gallefoss F, Jonsbu E. Effectiveness of Internet-Based Cognitive Behavioral Therapy With Telephone Support for Noncardiac Chest Pain: Randomized Controlled Trial. J Med Internet Res. 2022 Jan 24;24(1):e33631. doi: 10.2196/33631.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frode Gallefoss, MD, PhD study director
Head of Clinical Research, Sørlandet HF.
Liv T Walseth, MD, PhD principal investigator
Researcher, Sørlandet HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided self-help in people with Chest Pain, run by Sorlandet Hospital HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cardiac Anxiety Questionnaire (CAQ) (time frame: 58 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03096925, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.