Internet-delivered CBT for Patients With NCCP

Not Applicable

Completed

• Conditions: Cardiac Anxiety; Non-cardiac Chest Pain
• Interventions: Other: Information program; Behavioral: Internet-delivered cognitive behavioral therapy (I-CBT)

• Registration Number: NCT03336112
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-25
• Study Start: 2017-11-01
• Study First Submitted QC: 2017-11-03
• Study First Posted: 2017-11-08
• Primary Completion: 2020-10-09
• Study Completion: 2021-07-31
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-07
• Last Update Posted: 2023-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Information program	Information program delivered by the Internet during 5 weeks.
Intervention group	Internet-delivered cognitive behavioral therapy (I-CBT)	5 weeks guided internet-delivered cognitive behavioral therapy program The program consists of psychoeducation, exposure to physical activity, and awareness (mindfulness) training.

Primary Outcome Measures

Name	Time	Method
Cardiac anxiety	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

Name	Time	Method
Fear of body sensations	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.
Depressive symptoms	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.
Health-related quality of life	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).
Chest pain frequency	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.
Societal costs	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.
Healthcare use	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.

Trial Locations

Locations (1)

Linköping University; 🇸🇪 Linköping, Sweden