Internet-delivered CBT for Patients With NCCP

Non-cardiac Chest Pain Clinical Trial

— IKSIT  

Official title:

Internet-delivered Cognitive Behavioral Therapy for Treatment of Cardiac Anxiety in Patients With Non-cardiac Chest Pain - a Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03336112
• Other study ID #: I-CBT for NCCP
• Status: Completed
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: July 31, 2021

Study information

• Verified date: March 2023
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: July 31, 2021
• Est. primary completion date: October 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Anxiety
• Chest Pain
• Non-cardiac Chest Pain

Intervention

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.

Other:
• Information program
Information program delivered by the Internet during 5 weeks.

Locations

Country	Name	City	State
Sweden	Linköping University	Linköping

Sponsors (2)

Lead Sponsor	Collaborator
Linkoeping University	Ostergotland County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Fear of body sensations	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.	12 months after end of intervention
Secondary	Depressive symptoms	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.	12 months after end of intervention
Secondary	Health-related quality of life	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).	12 months after end of intervention
Secondary	Chest pain frequency	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.	12 months after end of intervention
Secondary	Healthcare use	Care Data Warehouse (Register), data will be collected 12 months after the end of the intervention to assess changes related to intervention.	12 months after end of intervention
Secondary	Societal costs	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.	12 months after end of intervention