Internet-delivered CBT for Patients With NCCP

NCT03336112 | Completed

• 1 other identifier: I-CBT for NCCP
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

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

Keywords

Non-cardiac chest pain; Psychological distress; I-CBT

Outcome Measures

Primary Outcomes (1)

• Cardiac anxiety

  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.

  12 months after end of intervention

Secondary Outcomes (6)

• Fear of body sensations

  12 months after end of intervention

• Depressive symptoms

  12 months after end of intervention

• Health-related quality of life

  12 months after end of intervention

• Chest pain frequency

  12 months after end of intervention

• Healthcare use

  12 months after end of intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

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)

Control group

ACTIVE COMPARATOR

Information program delivered by the Internet during 5 weeks.

Other: Information program

Interventions

Internet-delivered cognitive behavioral therapy (I-CBT) 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.

Intervention group

Information program OTHER

Information program delivered by the Internet during 5 weeks.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Linkoeping University: lead
• Ostergotland County Council, Sweden: collaborator

Study Sites (1)

Linköping University

Linköping, Sweden

Location

Related Publications (3)

• 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.

  PMID: 38504157 DERIVED

• 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.

  PMID: 36303332 DERIVED

• 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.

  PMID: 35089153 DERIVED

Study Officials

• Ghassan Mourad, PhD

  Linkoeping University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior lecturer

Study Record Dates

• First Submitted: October 25, 2017
• First Posted: November 8, 2017
• Study Start: November 1, 2017
• Primary Completion: October 9, 2020
• Study Completion: July 31, 2021
• Last Updated: March 8, 2023

Record last verified: 2023-03

Locations

SE (1)