Clinical trial NCT06136494: iCBT for Cardiac Anxiety in Patients With NCCP
Official title: Patient and Societal Benefits of Guided Internet-delivered Cognitive Behavioural Therapy for Cardiac Anxiety in Patients With Non-cardiac Chest Pain
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Non-cardiac Chest Pain
Cardiac Anxiety
Keywords: Cardiac anxiety
Cognitive behavioural therapy
Internet-delivered
Noncardiac chest pain
Psychological distress
Cost-effectiveness
Therapeutic alliance
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2023-11-18
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: iCBT versus attention control
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Cardiac Anxiety
timeFrame: 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:
measure: Generalized anxiety
timeFrame: Measurements will be performed before and after the intervention (8 weeks), and 3, 6, 12, and 24 months after the end of the intervention.
measure: Kinesiophobia
timeFrame: Measurements will be performed before and after the intervention (8 weeks), and 3, 6, 12, and 24 months after the end of the intervention.
measure: Fear of body sensations
timeFrame: Measurements will be performed before and after the intervention (8 weeks), and 3, 6, 12, and 24 months after the end of the intervention.
measure: Depressive symptoms
timeFrame: Measurements will be performed before and after the intervention (8 weeks), and 3, 6, 12, and 24 months after the end of the intervention.
measure: Health-related quality of life
timeFrame: Measurements will be performed before and after the intervention (8 weeks), and 3, 6, 12, and 24 months after the end of the intervention.
measure: Chest pain prevalence
timeFrame: Measurements will be performed before and after the intervention (8 weeks), and 3, 6, 12, and 24 months after the end of the intervention.
measure: Illness perception
timeFrame: Measurements will be performed before and after the intervention (8 weeks), and 3, 6, 12, and 24 months after the end of the intervention.
measure: Personality traits
timeFrame: Measurements will be performed before and after the intervention (8 weeks), and 3, 6, 12, and 24 months after the end of the intervention.
measure: Healthcare use
timeFrame: Data will be collected one year prior to and one year post intervention
measure: Healthcare costs
timeFrame: Data will be collected one year prior to and one year post intervention
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Linköping University
Study officials:
affiliation: Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden
name: Ghassan Mourad
role: PRINCIPAL_INVESTIGATOR
References: