Chest PainNCT02336880
Internet-delivered CBT for NCCP-patients - a Pilot Trial
A study testing Internet-delivered cognitive behavioural therapy in people with Chest Pain and Anxiety, run by Linkoeping University at 1 site in Sweden.
Trial summary
This pilot randomized controlled trial (RCT) aims to test the feasibility and effectiveness of a guided internet-delivered cognitive behavioural therapy intervention in the treatment of cardiac anxiety and fear of body sensations in patients with non-cardiac chest pain. The control group will receive care-as-usual. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chest Pain, Anxiety, Fear
- 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
- 15 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2015to Jun 2016
- 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
- recurrent chest pain that has been diagnosed as non-cardiac at least twice during last 6 months
- patients screened positive for avoidance of physical activity due to cardiac anxiety and/or fear of body sensations
Who cannot join
- no regular access to a computer/tablet computer with internet connection
- language difficulties
- not able to perform physical activity/exercise test due to physical constraints
- patients with severe depressive symptoms
- patients with acute ischemic heart disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short-term Internet-delivered Cognitive Behavioural Therapy for Treatment of Cardiac Anxiety and Fear of Body Sensations in Patients With Non-cardiac Chest Pain - a Pilot Randomized Controlled Study
This pilot randomized controlled trial (RCT) aims to test the feasibility and effectiveness of a guided internet-delivered cognitive behavioural therapy intervention in the treatment of cardiac anxiety and fear of body sensations in patients with non-cardiac chest pain. The control group will receive care-as-usual.
Read the detailed description
Despite reassurance, many patients with non-cardiac chest pain (NCCP) think they have an undetected cardiac disease and avoid activities that they think might be harmful to their heart. These patients need help and support to evaluate the way they perceive and handle their chest pain. Therefore, we have developed a 4 session guided intervention based on cognitive behavioural therapy that will be delivered via internet.
The intervention consists of psychoeducation, exposure to physical activity, and a breathing-based relaxation exercise. The goal with the intervention is to help the participants modify their beliefs about chest pain, change their cognitive and behavioural strategies, and give them tools to handle chest pain to prevent them from relapse.
- Conditions
- Chest Pain, Anxiety, Fear
- Being tested
- Internet-delivered cognitive behavioural therapy
- 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.
Internet-delivered cognitive behavioural therapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 4 weeks guided internet-delivered cognitive behavioural therapy program. The program consists of psychoeducation, exposure to physical activity, and a breathing-based relaxation exercise Receives: Behavioral: Internet-delivered cognitive behavioural therapy |
| Control group | No intervention | Care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac anxiety (Data collection)
Data collection will be performed before and after the intervention, and 3 and 12 months after the end of the intervention
Measured: 12 months
Secondary outcomes (3)
Fear of body sensations (Data collection)
Data collection will be performed before and after the intervention, and 3 and 12 months after the end of the intervention
Measured: 12 months
Depressive symptoms (Data collection)
Data collection will be performed before and after the intervention, and 3 and 12 months after the end of the intervention
Measured: 12 months
Healthcare utilization and costs (Data collection)
Data collection will be performed12 months after the end of the intervention
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionMar 2015
- Study completionJun 2016
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 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Collaborators
- Ostergotland County Council, Sweden, Medical Research Council of Southeast Sweden
- Responsible party
- Principal investigator, Ghassan Mourad, Linkoeping University
- Investigators
- Tiny Jaarsma, Professor, Study chair, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02336880
- Sponsor's protocol ID
- I-CBT in NCCP
- Status last verified
- Aug 2016
- First submitted
- 8 Jan 2015
- Last updated
- 22 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Mourad G, Stromberg A, Jonsbu E, Gustafsson M, Johansson P, Jaarsma T. Guided Internet-delivered cognitive behavioural therapy in patients with non-cardiac chest pain - a pilot randomized controlled study. Trials. 2016 Jul 26;17(1):352. doi: 10.1186/s13063-016-1491-1.
PubMed 27456689
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Internet-delivered Cognitive Behavioural Therapy for Treatment of Cardiac Anxiety and Fear of Body Sensations in Patients With Non-cardiac Chest Pain - a Pilot Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02336880
- Acronym / sponsor ID
- I-CBT in NCCP
- Conditions
- Chest Pain, Anxiety, Fear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Collaborators
- Ostergotland County Council, Sweden, Medical Research Council of Southeast Sweden
- Study start
- Jan 2015
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 13 Jan 2015 (estimated)
- 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 pilot randomized controlled trial (RCT) aims to test the feasibility and effectiveness of a guided internet-delivered cognitive behavioural therapy intervention in the treatment of cardiac anxiety and fear of body sensations in patients with non-cardiac chest pain. The control group will receive care-as-usual.
Detailed description
Despite reassurance, many patients with non-cardiac chest pain (NCCP) think they have an undetected cardiac disease and avoid activities that they think might be harmful to their heart. These patients need help and support to evaluate the way they perceive and handle their chest pain. Therefore, we have developed a 4 session guided intervention based on cognitive behavioural therapy that will be delivered via internet.
The intervention consists of psychoeducation, exposure to physical activity, and a breathing-based relaxation exercise. The goal with the intervention is to help the participants modify their beliefs about chest pain, change their cognitive and behavioural strategies, and give them tools to handle chest pain to prevent them from relapse.
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 behavioural therapy4 weeks guided internet-delivered cognitive behavioural therapy program. The program consists of psychoeducation, exposure to physical activity, and a breathing-based relaxation exercise |
| Control group | No intervention | –Care as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- recurrent chest pain that has been diagnosed as non-cardiac at least twice during last 6 months
- patients screened positive for avoidance of physical activity due to cardiac anxiety and/or fear of body sensations
Key exclusion criteria (5 listed)
- no regular access to a computer/tablet computer with internet connection
- language difficulties
- not able to perform physical activity/exercise test due to physical constraints
- patients with severe depressive symptoms
- patients with acute ischemic heart disease
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 therapy | Behavioural | Intervention group |
Primary outcome
Cardiac anxiety (Data collection)
Time frame: 12 months
Data collection will be performed before and after the intervention, and 3 and 12 months after the end of the intervention
3 secondary outcomes
Fear of body sensations (Data collection)
Time frame: 12 months
Depressive symptoms (Data collection)
Time frame: 12 months
Healthcare utilization and costs (Data collection)
Time frame: 12 months
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 22 Aug 2016.
- Derived from this study: PubMed 27456689Mourad G, Stromberg A, Jonsbu E, Gustafsson M, Johansson P, Jaarsma T. Guided Internet-delivered cognitive behavioural therapy in patients with non-cardiac chest pain - a pilot randomized controlled study. Trials. 2016 Jul 26;17(1):352. doi: 10.1186/s13063-016-1491-1.
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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.
Tiny Jaarsma, Professor 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 behavioural therapy in people with Chest Pain and 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 22 Aug 2016. 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 (Data collection) (time frame: 12 months). 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 NCT02336880, 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 22 Aug 2016.