iCBT for Cardiac Anxiety in Patients With NCCP (IKSIT2)

Patient and Societal Benefits of Guided Internet-delivered Cognitive Behavioural Therapy for Cardiac Anxiety in Patients With Non-cardiac Chest Pain

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiac Anxiety; Non-cardiac Chest Pain
• Intervention / Treatment: Behavioral: Internet-delivered cognitive behavioural therapy; Behavioral: Attention control

• Study Type: Interventional
• Enrollment (Estimated): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Linköping, Sweden
    • Linköping University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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; 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.; Other Names: iCBT
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Generalized anxiety	The Generalized Anxiety Disorder 7 (GAD-7) will be used to assess the severity of symptoms in individuals experiencing anxiety. It consists of 7 items with scores ranging between 0 and 21 with higher scores indicating more severe anxiety 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.
Kinesiophobia	The Tampa Scale for Kinesiophobia (TSK) will be used to assess the fear of movement. It consists of 17 items that measure various aspects of kinesiophobia, including avoidance behaviour and the belief that movement may cause harm. Scores range between 17 and 68, with higher scores indicating a higher level of fear of movement.	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	Body Sensations Questionnaire will be used to assess fear of body sensations. The questionnaire comprises 17 items with scores ranging between 17 and 85 and the higher scores the greater 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	Patient Health Questionnaire-9 will be used to assess changes in depressive symptoms related to intervention. This questionnaire comprises 9 items with scores ranging between 0 and 27. Higher scores indicate higher levels of 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	EuroQol-5D (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).	Measurements will be performed before and after the intervention (8 weeks), and 3, 6, 12, and 24 months after the end of the intervention.
Chest pain prevalence	Self-developed open questions will be used to asses the frequency and intensity of perceived chest pain.	Measurements will be performed before and after the intervention (8 weeks), and 3, 6, 12, and 24 months after the end of the intervention.
Illness perception	The Revised Illness Perception Questionnaire (IPQ-R) is designed to assess individuals' perceptions and beliefs about their illness or health condition, i.e. NCCP. It evaluates various components, such as their understanding of the illness, perceived consequences, timeline, personal control, treatment control, and emotional representations related to the illness. The questionnaire helps to understand patients' cognitive and emotional representations of their health condition, which can influence their coping strategies and health-related behaviours.	Measurements will be performed before and after the intervention (8 weeks), and 3, 6, 12, and 24 months after the end of the intervention.
Personality traits	The Ten-Item Personality Inventory (TIPI) is used to assess an individual's personality traits. It consists of ten items, with two items for each of the Big Five personality traits: extraversion, agreeableness, conscientiousness, emotional stability (or neuroticism), and openness to experience. Participants rate themselves on a scale from 1 to 7 for each item, indicating the extent to which they agree or disagree with the statements.	Measurements will be performed before and after the intervention (8 weeks), and 3, 6, 12, and 24 months after the end of the intervention.
Healthcare use	In-patient (hospital admissions and length of stay, and outclinic visits at hospital), and out-patient data (primary care visits/consultations) will be collected frpom data care registries.	Data will be collected one year prior to and one year post intervention
Healthcare costs	Healthcare costs will be collected from cost registers.	Data will be collected one year prior to and one year post intervention

Collaborators and Investigators

• Sponsor: Linkoeping University
• Investigators: Principal Investigator: Ghassan Mourad, Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: November 13, 2023
• First Submitted That Met QC Criteria: November 13, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 29, 2025
• Last Update Submitted That Met QC Criteria: April 28, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Cost-effectiveness; Psychological distress; Cognitive behavioural therapy; Therapeutic alliance; Cardiac anxiety; Internet-delivered; Noncardiac chest pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Mental Disorders; Anxiety Disorders; Chest Pain
• Other Study ID Numbers: iCBT for NCCP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No