iCBT for Cardiac Anxiety in Patients With NCCP

NCT06136494 | Active Not Recruiting

• 1 other identifier: iCBT for NCCP
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

Non-cardiac chest pain (NCCP) is a common condition that significantly affects patients' mental well-being, overall quality of life, and healthcare use. Even after ruling out cardiac issues, many patients still worry about having an undiagnosed cardiac illness, leading to cardiac anxiety since no other explanation is provided. Consequently, they avoid activities they believe might harm their heart, worsening their overall health and resulting in increased healthcare visits and societal costs. Addressing cardiac anxiety through psychological interventions could help break this viscious cycle and enhance patient outcomes. Internet-delivered cognitive behavioural therapy (iCBT) can assist patients in reassessing their perceptions, emotions and behaviours in order to handle their chest pain and therby reduce their cardiac anxiety. The aim of this study is to evaluate the short- and long-term effects of a guided 8-week iCBT program on cardiac anxiety, generalized anxiety, kinesiophobia, fear of body sensations, depressive symptoms, health-related quality of life, chest pain frequency and illness perception. Also to examine how participants' personality traits influence the effectiveness of the iCBT program. Furthermore, to assess the cost-effectiveness of the iCBT program compared to attention control. In addition, we will explore the perceptions of participants regarding the therapeutic alliance during the treatment.

Conditions

Non-cardiac Chest Pain; Cardiac Anxiety

Keywords

Cardiac anxiety; Cognitive behavioural therapy; Internet-delivered; Noncardiac chest pain; Psychological distress; Cost-effectiveness; Therapeutic alliance

Outcome Measures

Primary Outcomes (1)

• Cardiac Anxiety

  Cardiac Anxiety Questionnaire (CAQ) will be used to assess the short- and long-term effects of the intervention on cardiac anxiety. The CAQ consists of 18 items and a score range between 0 and 72. The higher scores the greater cardiac anxiety.

  Measurements will be performed before and after the intervention (8 weeks), and 3, 6, 12, and 24 months after the end of the intervention.

Secondary Outcomes (10)

• Generalized anxiety

  Measurements will be performed before and after the intervention (8 weeks), and 3, 6, 12, and 24 months after the end of the intervention.

• Kinesiophobia

  Measurements will be performed before and after the intervention (8 weeks), and 3, 6, 12, and 24 months after the end of the intervention.

• Fear of body sensations

  Measurements will be performed before and after the intervention (8 weeks), and 3, 6, 12, and 24 months after the end of the intervention.

• Depressive symptoms

  Measurements will be performed before and after the intervention (8 weeks), and 3, 6, 12, and 24 months after the end of the intervention.

• Health-related quality of life

  Measurements will be performed before and after the intervention (8 weeks), and 3, 6, 12, and 24 months after the end of the intervention.

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group will receive an 8-week guided iCBT-program including goal setting, psychoeducation, physical activity, exposure, mindfulness, and acceptance.

Behavioral: Internet-delivered cognitive behavioural therapy

Control group

ACTIVE COMPARATOR

The control group will receive general support via weekly email contact to check how they are feeling and how they are dealing with their situation. The control group will be offered iCBT after 3 months.

Behavioral: Attention control

Interventions

Internet-delivered cognitive behavioural therapy BEHAVIORAL

Psychoeducation aims at teaching patients about chest pain and anxiety and their impact on daily life. Mindfulness is used to raise awareness of what is going on in the body and emotions and to learn how to relate to chest pain. Physical activity consists of psychoeducation and recommendations regarding physical activity with the goal to get patients to learn that their heart tolerates physical activity and to reduce cardiac anxiety and avoidance of physical activity. Avoidance/exposure is to teach patients how avoidance and safety behaviours can maintain/exacerbate chest pain and negatively impact daily life. Acceptance is about learning to accept having the chest pain without letting it take over one's life. The participants will have weekly assignments with weekly feedback and advice. Reminders and encouraging messages will be sent to motivate participants to complete the intervention. The treatment will be carried out through our own web platform.

Also known as: iCBT

Intervention group

Attention control BEHAVIORAL

General support via weekly email contact to check how participants are feeling and how they are dealing with their situation. iCBT will be offered after 3 months.

Control group

Eligibility Criteria

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

You may qualify if:

• experience of non-cardiac chest pain
• exhibiting cardiac anxiety (score ≥24 on the Cardiac Anxiety Questionnaire, CAQ)

You may not qualify if:

• language difficulties
• patients with no access to computer/tablet and/or Internet
• not able to perform physical activity/exercise due to physical constraints
• severe psychological disorders or chronic somatic illness assessed to be requiring acute treatment or to hinder participation

Sponsors & Collaborators

• Linkoeping University: lead

Study Sites (1)

Linköping University

Linköping, Sweden

Location

Study Officials

• Ghassan Mourad

  Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Associate Professor (Docent)

Model Details: iCBT versus attention control

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 18, 2023
• Study Start: March 15, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)