iCBT for Cardiac Anxiety in Patients With NCCP
- Conditions
- Cardiac AnxietyNon-cardiac Chest Pain
- Interventions
- Behavioral: Internet-delivered cognitive behavioural therapyBehavioral: Attention control
- Registration Number
- NCT06136494
- Lead Sponsor
- Linkoeping University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 126
- experience of non-cardiac chest pain
- exhibiting cardiac anxiety (score ≥24 on the Cardiac Anxiety Questionnaire, CAQ)
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Intervention group Internet-delivered cognitive behavioural therapy The intervention group will receive an 8-week guided iCBT-program including goal setting, psychoeducation, physical activity, exposure, mindfulness, and acceptance. Control group Attention control 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.
- Primary Outcome Measures
Name Time Method 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. 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.
- Secondary Outcome Measures
Name Time Method 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. 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.
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. 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.
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. 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.
Chest pain prevalence Measurements will be performed before and after the intervention (8 weeks), and 3, 6, 12, and 24 months after the end of the intervention. Self-developed open questions will be used to asses the frequency and intensity of perceived chest pain.
Personality traits Measurements will be performed before and after the intervention (8 weeks), and 3, 6, 12, and 24 months after the end of the intervention. 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.
Healthcare use Data will be collected one year prior to and one year post intervention 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.
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. 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.
Illness perception Measurements will be performed before and after the intervention (8 weeks), and 3, 6, 12, and 24 months after the end of the intervention. 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.
Healthcare costs Data will be collected one year prior to and one year post intervention Healthcare costs will be collected from cost registers.
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. 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).
Trial Locations
- Locations (1)
Linköping University
🇸🇪Linköping, Sweden