Clinical trial NCT03336112: Internet-delivered CBT for Patients With NCCP
Official title: Internet-delivered Cognitive Behavioral Therapy for Treatment of Cardiac Anxiety in Patients With Non-cardiac Chest Pain - a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-cardiac Chest Pain
Cardiac Anxiety
Keywords: Non-cardiac chest pain
Psychological distress
I-CBT
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
Collaborators: name: Ostergotland County Council, Sweden
First posted: 2017-11-08
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Cardiac anxiety
timeFrame: 12 months after end of intervention
Secondary outcomes:
measure: Fear of body sensations
timeFrame: 12 months after end of intervention
measure: Depressive symptoms
timeFrame: 12 months after end of intervention
measure: Health-related quality of life
timeFrame: 12 months after end of intervention
measure: Chest pain frequency
timeFrame: 12 months after end of intervention
measure: Healthcare use
timeFrame: 12 months after end of intervention
measure: Societal costs
timeFrame: 12 months after end of intervention
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Linköping University
Study officials:
affiliation: Linkoeping University
name: Ghassan Mourad, PhD
role: STUDY_CHAIR
References:
citation: Eriksson-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.
citation: Mourad 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.