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Trial record 12 of 174 for:    Recruiting, Not yet recruiting, Available Studies | Chest pain

Internet-delivered CBT for Patients With NCCP (IKSIT)

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ClinicalTrials.gov Identifier: NCT03336112
Recruitment Status : Recruiting
First Posted : November 8, 2017
Last Update Posted : February 26, 2019
Sponsor:
Collaborator:
Ostergotland County Council, Sweden
Information provided by (Responsible Party):
Ghassan Mourad, Linkoeping University

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Non-cardiac Chest Pain Cardiac Anxiety Behavioral: Internet-delivered cognitive behavioral therapy (I-CBT) Other: Information program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Internet-delivered Cognitive Behavioral Therapy for Treatment of Cardiac Anxiety in Patients With Non-cardiac Chest Pain - a Randomized Controlled Study
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Chest Pain

Arm Intervention/treatment
Experimental: Intervention group
5 weeks guided internet-delivered cognitive behavioral therapy program The program consists of psychoeducation, exposure to physical activity, and awareness (mindfulness) training.
Behavioral: 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.

Active Comparator: Control group
Information program delivered by the Internet during 5 weeks.
Other: Information program
Information program delivered by the Internet during 5 weeks.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Fear of body sensations [ Time Frame: 12 months after end of intervention ]
    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.

  2. Depressive symptoms [ Time Frame: 12 months after end of intervention ]
    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.

  3. Quality of life [ Time Frame: 12 months after end of intervention ]
    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).

  4. Chest pain frequency [ Time Frame: 12 months after end of intervention ]
    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.

  5. Healthcare use [ Time Frame: 12 months after end of intervention ]
    Care Data Warehouse (Register), data will be collected 12 months after the end of the intervention to assess changes related to intervention.

  6. Societal costs [ Time Frame: 12 months after end of intervention ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03336112


Contacts
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Contact: Ghassan Mourad, PhD +4611363514 ghassan.mourad@liu.se
Contact: Peter Johansson, assist. prof +4611363185 peter.b.johansson@liu.se

Locations
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Sweden
Linköping University Recruiting
Linköping, Sweden
Contact: Ghassan Mourad, PhD    +4611363514    ghassan.mourad@liu.se   
Contact: Peter Johansson, Professor    +4611363185    peter.b.johansson@liu.se   
Sponsors and Collaborators
Linkoeping University
Ostergotland County Council, Sweden
Investigators
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Study Chair: Ghassan Mourad, PhD Linkoeping University

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Responsible Party: Ghassan Mourad, Senior lecturer, Linkoeping University
ClinicalTrials.gov Identifier: NCT03336112     History of Changes
Other Study ID Numbers: I-CBT for NCCP
First Posted: November 8, 2017    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ghassan Mourad, Linkoeping University:
Non-cardiac chest pain
Psychological distress
I-CBT
Additional relevant MeSH terms:
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Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms