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

Anxiety Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02336880
• Other study ID #: I-CBT in NCCP
• Status: Completed
• Phase: N/A
• First received: January 8, 2015
• Last updated: August 19, 2016
• Start date: January 2015
• Est. completion date: June 2016

Study information

• Verified date: August 2016
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2016
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Chest Pain
• Fear

Intervention

Behavioral:
• Internet-delivered cognitive behavioural therapy

Locations

Country	Name	City	State
Sweden	Linkoeping University	Linkoeping

Sponsors (3)

Lead Sponsor	Collaborator
Linkoeping University	Medical Research Council of Southeast Sweden, Ostergotland County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac anxiety (Data collection)	Data collection will be performed before and after the intervention, and 3 and 12 months after the end of the intervention	12 months	No
Secondary	Fear of body sensations (Data collection)	Data collection will be performed before and after the intervention, and 3 and 12 months after the end of the intervention	12 months	No
Secondary	Depressive symptoms (Data collection)	Data collection will be performed before and after the intervention, and 3 and 12 months after the end of the intervention	12 months	No
Secondary	Healthcare utilization and costs (Data collection)	Data collection will be performed12 months after the end of the intervention	12 months	No