iCBT for Cardiac Anxiety in Patients With NCCP (IKSIT2)

Linköping University (LiU)

Status: Active, not recruiting

Conditions: Non-cardiac Chest Pain; Cardiac Anxiety

Treatments: Behavioral: Internet-delivered cognitive behavioural therapy; Behavioral: Attention control

Study type: Interventional

Funder types: Other

Identifiers

NCT06136494

iCBT for NCCP

Details and patient eligibility

About

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.

Enrollment: 126 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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126 participants in 2 patient groups

Intervention group

Experimental group

Description:

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

Treatment:

Behavioral: Internet-delivered cognitive behavioural therapy

Control group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Attention control