Internet-delivered CBT for Patients With NCCP

NCT ID: NCT03336112

Last Updated: 2023-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 109 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2021-07-31

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.

Conditions

Non-cardiac Chest Pain; Cardiac Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

5 weeks guided internet-delivered cognitive behavioral therapy program The program consists of psychoeducation, exposure to physical activity, and awareness (mindfulness) training.

Group Type: EXPERIMENTAL

Internet-delivered cognitive behavioral therapy (I-CBT)

Intervention Type: BEHAVIORAL

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.

Control group

Information program delivered by the Internet during 5 weeks.

Group Type: ACTIVE_COMPARATOR

Information program

Intervention Type: OTHER

Information program delivered by the Internet during 5 weeks.

Interventions

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.

Intervention Type: BEHAVIORAL

Information program

Information program delivered by the Internet during 5 weeks.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ostergotland County Council, Sweden

OTHER

Sponsor Role: collaborator

Linkoeping University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ghassan Mourad

Senior lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ghassan Mourad, PhD

Role: STUDY_CHAIR

Linkoeping University

Locations

Linköping University

Linköping, , Sweden

Countries

Sweden

References

Eriksson-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.

Reference Type: DERIVED

PMID: 38504157 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36303332 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35089153 (View on PubMed)

Other Identifiers

I-CBT for NCCP

Identifier Type: -

Identifier Source: org_study_id