Non-cardiac Chest PainIKSITNCT03336112
Internet-delivered CBT for Patients With NCCP
A study testing Internet-delivered cognitive behavioral therapy (I-CBT) and Information program in people with Non-cardiac Chest Pain and Cardiac Anxiety, run by Linkoeping University at 1 site in Sweden.
Trial summary
Non-cardiac chest pain (NCCP) is common and has substantial impact on patients' psychological wellbeing, quality of life and healthcare use. Although cardiac diagnosis is 'ruled out', many patients think they have an undetected cardiac disease (i.e. they suffer cardiac anxiety) as no other explanation is offered. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-cardiac Chest Pain, Cardiac Anxiety
- What is being tested?
- Internet-delivered cognitive behavioral therapy (I-CBT) and Information program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteSweden
- Study dates
- 1 Nov 2017to 31 Jul 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 2 healthcare visits due to NCCP during the last 6 months
- patients suffering from cardiac anxiety (score ≥ 24 on the Cardiac Anxiety Questionnaire-CAQ)
Who cannot join
- language difficulties
- not able to perform physical activity/exercise due to physical constraints
- patients with severe depressive symptoms
- patients with acute ischemic heart disease
- patients with no access to computer/tablet and/or Internet
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Internet-delivered Cognitive Behavioral Therapy for Treatment of Cardiac Anxiety in Patients With Non-cardiac Chest Pain - a Randomized Controlled Study
Non-cardiac chest pain (NCCP) is common and has substantial impact on patients' psychological wellbeing, quality of life and healthcare use. Although cardiac diagnosis is 'ruled out', many patients think they have an undetected cardiac disease (i.e. they suffer cardiac anxiety) as no other explanation is offered. They therefore avoid activities that they believe might be harmful to their heart, leading to greater ill-health, and increased healthcare use and societal costs. Targeting cardiac anxiety with psychological interventions might break this vicious circle and improve patient outcomes. Patients need to evaluate the way they perceive and handle their chest pain, which can be done with cognitive behavioral therapy (CBT).
The aim of this study is therefore to evaluate the short- and long-term effects of an Internet-delivered CBT (I-CBT) program on psychological distress and other patient-reported outcomes in patients with NCCP. A second aim is to explore factors related to implementation of I-CBT in clinical care. The study has a randomized controlled design comparing I-CBT with Internet-delivered information program. Quantitative methods will be used to evaluate the effectiveness of the I-CBT program. Implementation issues will be evaluated from the perspectives of patients, healthcare professionals and policymakers using qualitative methods.
- Conditions
- Non-cardiac Chest Pain, Cardiac Anxiety
- Being tested
- Internet-delivered cognitive behavioral therapy (I-CBT), Information program
- Keywords
- Non-cardiac chest pain, Psychological distress, I-CBT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-delivered cognitive behavioral therapy (I-CBT)Behavioural
The intervention (I-CBT) will consist of 5 weeks of Internet-delivered cognitive behavioral therapy using three main parts. The first is psychoeducation that aims to educate the patients about chest pain and other causes than the cardiac ones. The other part concerns avoidance and exposure. This includes exposing the patients to physical activities that patients perceive as a threat to the heart. The third part contains awareness (mindfulness) training to teach the patients to have contact with the present moment despite chest pain and not trying to avoid it.
Information programOther
Information program delivered by the Internet during 5 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 5 weeks guided internet-delivered cognitive behavioral therapy program The program consists of psychoeducation, exposure to physical activity, and awareness (mindfulness) training. Receives: Behavioral: Internet-delivered cognitive behavioral therapy (I-CBT) |
| Control group | Active comparator | Information program delivered by the Internet during 5 weeks. Receives: Other: Information program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac anxiety
Cardiac Anxiety Questionnaire (CAQ) will be used before and after the intervention (5 weeks), and 3, 6, 12 months after the end of the intervention to assess changes related to intervention. The CAQ consists of 18 items and a score range between 0 and 72. The higher scores the greater cardiac anxiety.
Measured: 12 months after end of intervention
Secondary outcomes (6)
Fear of body sensations
Body Sensations Questionnaire will be used before and after the intervention (5 weeks), and 3, 6, 12 months after the end of the intervention to assess changes related to intervention. The questionnaire comprises 17 items with scores ranging between 17 and 85 and the higher scores the greater fear of body sensations.
Measured: 12 months after end of intervention
Depressive symptoms
Patient Health Questionnaire-9 will be used before and after the intervention (5 weeks), and 3, 6, 12 months after the end of the intervention to assess changes related to intervention. This questionnaire comprises 9 items with scores ranging between 0 and 27. Higher scores indicate higher levels of depressive symptoms. A cut-off of 10 demonstrates moderate levels and will be used in this study.
Measured: 12 months after end of intervention
Health-related quality of life
EuroQol-5D (EQ-5D) will be used before and after the intervention (5 weeks), and 3, 6, 12 months after the end of the intervention to assess changes related to intervention. The EQ-5D includes five dimensions of Health-related quality of life: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has five levels corresponding to: no problems, slight problems, moderate problems, severe problems and extreme problems/unable. The questionnaire also includes an EQ-VAS, which is a visual analogue scale ranging from 0 (worst health you can imagine) to 100 (best health you can imagine).
Measured: 12 months after end of intervention
Chest pain frequency
Self-developed open questions will be used before and after the intervention (5 weeks), and 3, 6, 12 months after the end of the intervention to assess changes in chest pain related to intervention.
Measured: 12 months after end of intervention
Healthcare use
Care Data Warehouse (Register), data will be collected 12 months after the end of the intervention to assess changes related to intervention.
Measured: 12 months after end of intervention
Societal costs
Cost per patient register and Social Insurance Office register, data will be collected 12 months after the end of the intervention to assess changes related to intervention.
Measured: 12 months after end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start1 Nov 2017
- Primary completion9 Oct 2020
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Non-cardiac Chest PainStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Collaborators
- Ostergotland County Council, Sweden
- Responsible party
- Principal investigator, Ghassan Mourad, Linkoeping University
- Investigators
- Ghassan Mourad, PhD, Study chair, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03336112
- Sponsor's protocol ID
- I-CBT for NCCP
- Acronym
- IKSIT
- Status last verified
- Mar 2023
- First submitted
- 25 Oct 2017
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Eriksson-Liebon M, Karner Kohler A, Johansson P, Mourad G. Living with non-cardiac chest pain - An inductive qualitative interview study of spouses' perspectives. Nurs Open. 2024 May;11(5):e2189. doi: 10.1002/nop2.2189.
PubMed 38794988Eriksson-Liebon M, Westas M, Johansson P, Mourad G. Long-term effects and predictors of change of internet-delivered cognitive behavioural therapy on cardiac anxiety in patients with non-cardiac chest pain: a randomized controlled trial. BMC Psychiatry. 2024 Mar 19;24(1):216. doi: 10.1186/s12888-024-05661-y.
PubMed 38504157Eriksson-Liebon M, Lundgren J, Rytterstrom P, Johansson P, Mourad G. Experience of internet-delivered cognitive behavioural therapy among patients with non-cardiac chest pain. J Clin Nurs. 2023 Jul;32(13-14):4060-4069. doi: 10.1111/jocn.16565. Epub 2022 Oct 27.
PubMed 36303332Mourad G, Eriksson-Liebon M, Karlstrom P, Johansson P. The Effect of Internet-Delivered Cognitive Behavioral Therapy Versus Psychoeducation Only on Psychological Distress in Patients With Noncardiac Chest Pain: Randomized Controlled Trial. J Med Internet Res. 2022 Jan 28;24(1):e31674. doi: 10.2196/31674.
PubMed 35089153
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-delivered Cognitive Behavioral Therapy for Treatment of Cardiac Anxiety in Patients With Non-cardiac Chest Pain - a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03336112
- Acronym / sponsor ID
- IKSIT / I-CBT for NCCP
- Conditions
- Non-cardiac Chest Pain, Cardiac Anxiety
- Keywords
- Non-cardiac chest pain, Psychological distress, I-CBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Collaborators
- Ostergotland County Council, Sweden
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 9 Oct 2020 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 8 Nov 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.
Non-cardiac chest pain (NCCP) is common and has substantial impact on patients' psychological wellbeing, quality of life and healthcare use. Although cardiac diagnosis is 'ruled out', many patients think they have an undetected cardiac disease (i.e. they suffer cardiac anxiety) as no other explanation is offered. They therefore avoid activities that they believe might be harmful to their heart, leading to greater ill-health, and increased healthcare use and societal costs. Targeting cardiac anxiety with psychological interventions might break this vicious circle and improve patient outcomes. Patients need to evaluate the way they perceive and handle their chest pain, which can be done with cognitive behavioral therapy (CBT).
The aim of this study is therefore to evaluate the short- and long-term effects of an Internet-delivered CBT (I-CBT) program on psychological distress and other patient-reported outcomes in patients with NCCP. A second aim is to explore factors related to implementation of I-CBT in clinical care. The study has a randomized controlled design comparing I-CBT with Internet-delivered information program. Quantitative methods will be used to evaluate the effectiveness of the I-CBT program. Implementation issues will be evaluated from the perspectives of patients, healthcare professionals and policymakers using qualitative methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Internet-delivered cognitive behavioral therapy (I-CBT)5 weeks guided internet-delivered cognitive behavioral therapy program The program consists of psychoeducation, exposure to physical activity, and awareness (mindfulness) training. |
| Control group | Active comparator | Other: Information programInformation program delivered by the Internet during 5 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- at least 2 healthcare visits due to NCCP during the last 6 months
- patients suffering from cardiac anxiety (score ≥ 24 on the Cardiac Anxiety Questionnaire-CAQ)
Key exclusion criteria (5 listed)
- language difficulties
- not able to perform physical activity/exercise due to physical constraints
- patients with severe depressive symptoms
- patients with acute ischemic heart disease
- patients with no access to computer/tablet and/or Internet
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 |
|---|---|---|
| Internet-delivered cognitive behavioral therapy (I-CBT)The intervention (I-CBT) will consist of 5 weeks of Internet-delivered cognitive behavioral therapy using three main parts. The first is psychoeducation that aims to educate the patients about chest pain and other causes than the cardiac ones. The other part concerns avoidance and exposure. This includes exposing the patients to physical activities that patients perceive as a threat to the heart. The third part contains awareness (mindfulness) training to teach the patients to have contact with the present moment despite chest pain and not trying to avoid it. | Behavioural | Intervention group |
| Information programInformation program delivered by the Internet during 5 weeks. | Other | Control group |
Primary outcome
Cardiac anxiety
Time frame: 12 months after end of intervention
Cardiac Anxiety Questionnaire (CAQ) will be used before and after the intervention (5 weeks), and 3, 6, 12 months after the end of the intervention to assess changes related to intervention. The CAQ consists of 18 items and a score range between 0 and 72. The higher scores the greater cardiac anxiety.
6 secondary outcomes
Fear of body sensations
Time frame: 12 months after end of intervention
Depressive symptoms
Time frame: 12 months after end of intervention
Health-related quality of life
Time frame: 12 months after end of intervention
Chest pain frequency
Time frame: 12 months after end of intervention
Healthcare use
Time frame: 12 months after end of intervention
Societal costs
Time frame: 12 months after end of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Derived from this study: PubMed 38794988Eriksson-Liebon M, Karner Kohler A, Johansson P, Mourad G. Living with non-cardiac chest pain - An inductive qualitative interview study of spouses' perspectives. Nurs Open. 2024 May;11(5):e2189. doi: 10.1002/nop2.2189.
- Derived from this study: PubMed 38504157Eriksson-Liebon M, Westas M, Johansson P, Mourad G. Long-term effects and predictors of change of internet-delivered cognitive behavioural therapy on cardiac anxiety in patients with non-cardiac chest pain: a randomized controlled trial. BMC Psychiatry. 2024 Mar 19;24(1):216. doi: 10.1186/s12888-024-05661-y.
- Derived from this study: PubMed 36303332Eriksson-Liebon M, Lundgren J, Rytterstrom P, Johansson P, Mourad G. Experience of internet-delivered cognitive behavioural therapy among patients with non-cardiac chest pain. J Clin Nurs. 2023 Jul;32(13-14):4060-4069. doi: 10.1111/jocn.16565. Epub 2022 Oct 27.
- Derived from this study: PubMed 35089153Mourad G, Eriksson-Liebon M, Karlstrom P, Johansson P. The Effect of Internet-Delivered Cognitive Behavioral Therapy Versus Psychoeducation Only on Psychological Distress in Patients With Noncardiac Chest Pain: Randomized Controlled Trial. J Med Internet Res. 2022 Jan 28;24(1):e31674. doi: 10.2196/31674.
- 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.
Ghassan Mourad, PhD study chair
Linkoeping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-delivered cognitive behavioral therapy (I-CBT) and Information program in people with Non-cardiac Chest Pain and Cardiac Anxiety, run by Linkoeping University at 1 site in Sweden.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 8 Mar 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cardiac anxiety (time frame: 12 months after end of intervention). 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 NCT03336112, which also lists 4 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 8 Mar 2023.