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Completed

NCT Number: NCT02336880

Internet-delivered CBT for NCCP-patients - a Pilot Trial

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.

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Key information

Conditions

Chest Pain Anxiety Anxiety Disorders Fear Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Linkoeping University

Linköping, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Internet-delivered cognitive behavioural therapy

Behavioral

Primary outcomes

  1. Cardiac anxiety (Data collection)

    Time frame: 12 months

    Data collection will be performed before and after the intervention, and 3 and 12 months after the end of the intervention

Secondary outcomes

  1. Fear of body sensations (Data collection)

    Time frame: 12 months

    Data collection will be performed before and after the intervention, and 3 and 12 months after the end of the intervention

  2. Depressive symptoms (Data collection)

    Time frame: 12 months

    Data collection will be performed before and after the intervention, and 3 and 12 months after the end of the intervention

  3. Healthcare utilization and costs (Data collection)

    Time frame: 12 months

    Data collection will be performed12 months after the end of the intervention

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Collaborators

  • Medical Research Council of Southeast Sweden
  • Ostergotland County Council, Sweden

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Jan 13, 2015
Registry last updated
Aug 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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