iCBT for Cardiac Anxiety in Patients With NCCP

NCT ID: NCT06136494

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-15
• Study Completion Date: 2027-12-31

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

Study Design

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

Study Groups

Intervention group

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

Group Type: EXPERIMENTAL

Internet-delivered cognitive behavioural therapy

Intervention Type: 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.

Control group

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.

Group Type: ACTIVE_COMPARATOR

Attention control

Intervention Type: 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.

Interventions

Internet-delivered cognitive behavioural therapy

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.

Intervention Type: BEHAVIORAL

Attention control

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

iCBT

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

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

Sponsors

Linkoeping University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ghassan Mourad

Senior Associate Professor (Docent)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ghassan Mourad

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Linköping University

Linköping, , Sweden

Countries

Sweden

Other Identifiers

iCBT for NCCP

Identifier Type: -

Identifier Source: org_study_id