Clinical trial NCT02336880: Internet-delivered CBT for NCCP-patients - a Pilot Trial
Official title: Short-term Internet-delivered Cognitive Behavioural Therapy for Treatment of Cardiac Anxiety and Fear of Body Sensations in Patients With Non-cardiac Chest Pain - a Pilot Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chest Pain
Anxiety
Fear
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
Collaborators: name: Ostergotland County Council, Sweden
name: Medical Research Council of Southeast Sweden
First posted: 2015-01-13
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This pilot randomized controlled trial (RCT) aims to test the feasibility and effectiveness of a guided internet-delivered cognitive behavioural therapy intervention in the treatment of cardiac anxiety and fear of body sensations in patients with non-cardiac chest pain. The control group will receive care-as-usual.

Detailed description: Despite reassurance, many patients with non-cardiac chest pain (NCCP) think they have an undetected cardiac disease and avoid activities that they think might be harmful to their heart. These patients need help and support to evaluate the way they perceive and handle their chest pain. Therefore, we have developed a 4 session guided intervention based on cognitive behavioural therapy that will be delivered via internet.

The intervention consists of psychoeducation, exposure to physical activity, and a breathing-based relaxation exercise. The goal with the intervention is to help the participants modify their beliefs about chest pain, change their cognitive and behavioural strategies, and give them tools to handle chest pain to prevent them from relapse.

Eligibility criteria: Inclusion Criteria:

* recurrent chest pain that has been diagnosed as non-cardiac at least twice during last 6 months
* patients screened positive for avoidance of physical activity due to cardiac anxiety and/or fear of body sensations

Exclusion Criteria:

* no regular access to a computer/tablet computer with internet connection
* language difficulties
* not able to perform physical activity/exercise test due to physical constraints
* patients with severe depressive symptoms
* patients with acute ischemic heart disease

Primary outcomes:
measure: Cardiac anxiety (Data collection)
timeFrame: 12 months
Secondary outcomes:
measure: Fear of body sensations (Data collection)
timeFrame: 12 months
measure: Depressive symptoms (Data collection)
timeFrame: 12 months
measure: Healthcare utilization and costs (Data collection)
timeFrame: 12 months
Other outcomes:
Locations:
city: Linkoeping
country: Sweden
facility: Linkoeping University
Study officials:
affiliation: Linkoeping University
name: Tiny Jaarsma, Professor
role: STUDY_CHAIR
References:
citation: Mourad G, Stromberg A, Jonsbu E, Gustafsson M, Johansson P, Jaarsma T. Guided Internet-delivered cognitive behavioural therapy in patients with non-cardiac chest pain - a pilot randomized controlled study. Trials. 2016 Jul 26;17(1):352. doi: 10.1186/s13063-016-1491-1.