Non-cardiac Chest PainIKSIT2NCT06136494
iCBT for Cardiac Anxiety in Patients With NCCP
A study testing Internet-delivered cognitive behavioural therapy 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 a common condition that significantly affects patients' mental well-being, overall quality of life, and healthcare use. Even after ruling out cardiac issues, many patients still worry about having an undiagnosed cardiac illness, leading to cardiac anxiety since no other explanation is… 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 behavioural therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteSweden
- Study dates
- 15 Mar 2024to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- experience of non-cardiac chest pain
- exhibiting cardiac anxiety (score ≥24 on the Cardiac Anxiety Questionnaire, CAQ)
Who cannot join
- language difficulties
- patients with no access to computer/tablet and/or Internet
- not able to perform physical activity/exercise due to physical constraints
- severe psychological disorders or chronic somatic illness assessed to be requiring acute treatment or to hinder participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient and Societal Benefits of Guided Internet-delivered Cognitive Behavioural Therapy for Cardiac Anxiety in Patients With Non-cardiac Chest Pain
Non-cardiac chest pain (NCCP) is a common condition that significantly affects patients' mental well-being, overall quality of life, and healthcare use. Even after ruling out cardiac issues, many patients still worry about having an undiagnosed cardiac illness, leading to cardiac anxiety since no other explanation is provided. Consequently, they avoid activities they believe might harm their heart, worsening their overall health and resulting in increased healthcare visits and societal costs. Addressing cardiac anxiety through psychological interventions could help break this viscious cycle and enhance patient outcomes. Internet-delivered cognitive behavioural therapy (iCBT) can assist patients in reassessing their perceptions, emotions and behaviours in order to handle their chest pain and therby reduce their cardiac anxiety.
The aim of this study is to evaluate the short- and long-term effects of a guided 8-week iCBT program on cardiac anxiety, generalized anxiety, kinesiophobia, fear of body sensations, depressive symptoms, health-related quality of life, chest pain frequency and illness perception. Also to examine how participants' personality traits influence the effectiveness of the iCBT program. Furthermore, to assess the cost-effectiveness of the iCBT program compared to attention control. In addition, we will explore the perceptions of participants regarding the therapeutic alliance during the treatment.
- Conditions
- Non-cardiac Chest Pain, Cardiac Anxiety
- Being tested
- Internet-delivered cognitive behavioural therapy, Attention control
- Keywords
- Cardiac anxiety, Cognitive behavioural therapy, Internet-delivered, Noncardiac chest pain, Psychological distress, Cost-effectiveness, Therapeutic alliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-delivered cognitive behavioural therapyBehavioural
Also called iCBT
Psychoeducation aims at teaching patients about chest pain and anxiety and their impact on daily life. Mindfulness is used to raise awareness of what is going on in the body and emotions and to learn how to relate to chest pain. Physical activity consists of psychoeducation and recommendations regarding physical activity with the goal to get patients to learn that their heart tolerates physical activity and to reduce cardiac anxiety and avoidance of physical activity. Avoidance/exposure is to teach patients how avoidance and safety behaviours can maintain/exacerbate chest pain and negatively impact daily life. Acceptance is about learning to accept having the chest pain without letting it take over one's life. The participants will have weekly assignments with weekly feedback and advice. Reminders and encouraging messages will be sent to motivate participants to complete the intervention. The treatment will be carried out through our own web platform.
Attention controlBehavioural
General support via weekly email contact to check how participants are feeling and how they are dealing with their situation. iCBT will be offered after 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group will receive an 8-week guided iCBT-program including goal setting, psychoeducation, physical activity, exposure, mindfulness, and acceptance. Receives: Behavioral: Internet-delivered cognitive behavioural therapy |
| Control group | Active comparator | The control group will receive general support via weekly email contact to check how they are feeling and how they are dealing with their situation. The control group will be offered iCBT after 3 months. Receives: Behavioral: Attention control |
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 to assess the short- and long-term effects of the intervention on cardiac anxiety. The CAQ consists of 18 items and a score range between 0 and 72. The higher scores the greater cardiac anxiety.
Measured: Measurements will be performed before and after the intervention (8 weeks), and 3, 6, 12, and 24 months after the end of the intervention.
Secondary outcomes (10)
Generalized anxiety
The Generalized Anxiety Disorder 7 (GAD-7) will be used to assess the severity of symptoms in individuals experiencing anxiety. It consists of 7 items with scores ranging between 0 and 21 with higher scores indicating more severe anxiety symptoms.
Measured: Measurements will be performed before and after the intervention (8 weeks), and 3, 6, 12, and 24 months after the end of the intervention.
Kinesiophobia
The Tampa Scale for Kinesiophobia (TSK) will be used to assess the fear of movement. It consists of 17 items that measure various aspects of kinesiophobia, including avoidance behaviour and the belief that movement may cause harm. Scores range between 17 and 68, with higher scores indicating a higher level of fear of movement.
Measured: Measurements will be performed before and after the intervention (8 weeks), and 3, 6, 12, and 24 months after the end of the intervention.
Fear of body sensations
Body Sensations Questionnaire will be used to assess fear of body sensations. The questionnaire comprises 17 items with scores ranging between 17 and 85 and the higher scores the greater fear of body sensations.
Measured: Measurements will be performed before and after the intervention (8 weeks), and 3, 6, 12, and 24 months after the end of the intervention.
Depressive symptoms
Patient Health Questionnaire-9 will be used to assess changes in depressive symptoms related to intervention. This questionnaire comprises 9 items with scores ranging between 0 and 27. Higher scores indicate higher levels of depressive symptoms.
Measured: Measurements will be performed before and after the intervention (8 weeks), and 3, 6, 12, and 24 months after the end of the intervention.
Health-related quality of life
EuroQol-5D (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: Measurements will be performed before and after the intervention (8 weeks), and 3, 6, 12, and 24 months after the end of the intervention.
Chest pain prevalence
Self-developed open questions will be used to asses the frequency and intensity of perceived chest pain.
Measured: Measurements will be performed before and after the intervention (8 weeks), and 3, 6, 12, and 24 months after the end of the intervention.
Illness perception
The Revised Illness Perception Questionnaire (IPQ-R) is designed to assess individuals' perceptions and beliefs about their illness or health condition, i.e. NCCP. It evaluates various components, such as their understanding of the illness, perceived consequences, timeline, personal control, treatment control, and emotional representations related to the illness. The questionnaire helps to understand patients' cognitive and emotional representations of their health condition, which can influence their coping strategies and health-related behaviours.
Measured: Measurements will be performed before and after the intervention (8 weeks), and 3, 6, 12, and 24 months after the end of the intervention.
Personality traits
The Ten-Item Personality Inventory (TIPI) is used to assess an individual's personality traits. It consists of ten items, with two items for each of the Big Five personality traits: extraversion, agreeableness, conscientiousness, emotional stability (or neuroticism), and openness to experience. Participants rate themselves on a scale from 1 to 7 for each item, indicating the extent to which they agree or disagree with the statements.
Measured: Measurements will be performed before and after the intervention (8 weeks), and 3, 6, 12, and 24 months after the end of the intervention.
Healthcare use
In-patient (hospital admissions and length of stay, and outclinic visits at hospital), and out-patient data (primary care visits/consultations) will be collected frpom data care registries.
Measured: Data will be collected one year prior to and one year post intervention
Healthcare costs
Healthcare costs will be collected from cost registers.
Measured: Data will be collected one year prior to and one year post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start15 Mar 2024
- Primary completion1 Jun 2026
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Crossover
- Model description
- iCBT versus attention control
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ghassan Mourad, Linkoeping University
- Investigators
- Ghassan Mourad, Principal investigator, Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06136494
- Sponsor's protocol ID
- iCBT for NCCP
- Acronym
- IKSIT2
- Status last verified
- Aug 2026
- First submitted
- 13 Nov 2023
- Last updated
- 27 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ang NH, Sarnholm J, Andersson G, Johansson P, Mourad G. Therapeutic alliance in guided internet-delivered cognitive behavioural therapy: a thematic analysis of patients with non-cardiac chest pain. BMC Psychol. 2026 Jul 15;14(1):1050. doi: 10.1186/s40359-026-05179-w.
PubMed 42458648
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient and Societal Benefits of Guided Internet-delivered Cognitive Behavioural Therapy for Cardiac Anxiety in Patients With Non-cardiac Chest Pain
- ClinicalTrials.gov ID
- NCT06136494
- Acronym / sponsor ID
- IKSIT2 / iCBT for NCCP
- Conditions
- Non-cardiac Chest Pain, Cardiac Anxiety
- Keywords
- Cardiac anxiety, Cognitive behavioural therapy, Internet-delivered, Noncardiac chest pain, Psychological distress, Cost-effectiveness, Therapeutic alliance
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- Sep 2027 (estimated)
- First posted
- 18 Nov 2023 (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 a common condition that significantly affects patients' mental well-being, overall quality of life, and healthcare use. Even after ruling out cardiac issues, many patients still worry about having an undiagnosed cardiac illness, leading to cardiac anxiety since no other explanation is provided. Consequently, they avoid activities they believe might harm their heart, worsening their overall health and resulting in increased healthcare visits and societal costs. Addressing cardiac anxiety through psychological interventions could help break this viscious cycle and enhance patient outcomes. Internet-delivered cognitive behavioural therapy (iCBT) can assist patients in reassessing their perceptions, emotions and behaviours in order to handle their chest pain and therby reduce their cardiac anxiety.
The aim of this study is to evaluate the short- and long-term effects of a guided 8-week iCBT program on cardiac anxiety, generalized anxiety, kinesiophobia, fear of body sensations, depressive symptoms, health-related quality of life, chest pain frequency and illness perception. Also to examine how participants' personality traits influence the effectiveness of the iCBT program. Furthermore, to assess the cost-effectiveness of the iCBT program compared to attention control. In addition, we will explore the perceptions of participants regarding the therapeutic alliance during the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- iCBT versus attention control
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Internet-delivered cognitive behavioural therapyThe intervention group will receive an 8-week guided iCBT-program including goal setting, psychoeducation, physical activity, exposure, mindfulness, and acceptance. |
| Control group | Active comparator | Behavioral: Attention controlThe control group will receive general support via weekly email contact to check how they are feeling and how they are dealing with their situation. The control group will be offered iCBT after 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- experience of non-cardiac chest pain
- exhibiting cardiac anxiety (score ≥24 on the Cardiac Anxiety Questionnaire, CAQ)
Key exclusion criteria (4 listed)
- language difficulties
- patients with no access to computer/tablet and/or Internet
- not able to perform physical activity/exercise due to physical constraints
- severe psychological disorders or chronic somatic illness assessed to be requiring acute treatment or to hinder participation
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 behavioural therapyAlso: iCBTPsychoeducation aims at teaching patients about chest pain and anxiety and their impact on daily life. Mindfulness is used to raise awareness of what is going on in the body and emotions and to learn how to relate to chest pain. Physical activity consists of psychoeducation and recommendations regarding physical activity with the goal to get patients to learn that their heart tolerates physical activity and to reduce cardiac anxiety and avoidance of physical activity. Avoidance/exposure is to teach patients how avoidance and safety behaviours can maintain/exacerbate chest pain and negatively impact daily life. Acceptance is about learning to accept having the chest pain without letting it take over one's life. The participants will have weekly assignments with weekly feedback and advice. Reminders and encouraging messages will be sent to motivate participants to complete the intervention. The treatment will be carried out through our own web platform. | Behavioural | Intervention group |
| Attention controlGeneral support via weekly email contact to check how participants are feeling and how they are dealing with their situation. iCBT will be offered after 3 months. | Behavioural | Control group |
Primary outcome
Cardiac Anxiety
Time frame: Measurements will be performed before and after the intervention (8 weeks), and 3, 6, 12, and 24 months after the end of the intervention.
Cardiac Anxiety Questionnaire (CAQ) will be used to assess the short- and long-term effects of the intervention on cardiac anxiety. The CAQ consists of 18 items and a score range between 0 and 72. The higher scores the greater cardiac anxiety.
10 secondary outcomes
Generalized anxiety
Time frame: Measurements will be performed before and after the intervention (8 weeks), and 3, 6, 12, and 24 months after the end of the intervention.
Kinesiophobia
Time frame: Measurements will be performed before and after the intervention (8 weeks), and 3, 6, 12, and 24 months after the end of the intervention.
Fear of body sensations
Time frame: Measurements will be performed before and after the intervention (8 weeks), and 3, 6, 12, and 24 months after the end of the intervention.
Depressive symptoms
Time frame: Measurements will be performed before and after the intervention (8 weeks), and 3, 6, 12, and 24 months after the end of the intervention.
Health-related quality of life
Time frame: Measurements will be performed before and after the intervention (8 weeks), and 3, 6, 12, and 24 months after the end of the intervention.
Chest pain prevalence
Time frame: Measurements will be performed before and after the intervention (8 weeks), and 3, 6, 12, and 24 months after the end of the intervention.
Illness perception
Time frame: Measurements will be performed before and after the intervention (8 weeks), and 3, 6, 12, and 24 months after the end of the intervention.
Personality traits
Time frame: Measurements will be performed before and after the intervention (8 weeks), and 3, 6, 12, and 24 months after the end of the intervention.
Healthcare use
Time frame: Data will be collected one year prior to and one year post intervention
Healthcare costs
Time frame: Data will be collected one year prior to and one year post intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Derived from this study: PubMed 42458648Ang NH, Sarnholm J, Andersson G, Johansson P, Mourad G. Therapeutic alliance in guided internet-delivered cognitive behavioural therapy: a thematic analysis of patients with non-cardiac chest pain. BMC Psychol. 2026 Jul 15;14(1):1050. doi: 10.1186/s40359-026-05179-w.
- Individual participant dataSharing planned: No
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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 principal investigator
Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden
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 behavioural therapy 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 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: under way, not looking for participants, as of the sponsor's last update on 27 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
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: Measurements will be performed before and after the intervention (8 weeks), and 3, 6, 12, and 24 months after the end of the 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 NCT06136494, which also lists 1 linked publication.
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 27 Aug 2026.