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

Not Applicable

Completed

• Conditions: Fear; Chest Pain; Anxiety
• Interventions: Behavioral: Internet-delivered cognitive behavioural therapy

• Registration Number: NCT02336880
• Lead Sponsor: Linkoeping University

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.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-08
• Study First Submitted QC: 2015-01-12
• Study First Posted: 2015-01-13
• Primary Completion: 2015-03
• Study Completion: 2016-06
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-19
• Last Update Posted: 2016-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Internet-delivered cognitive behavioural therapy	4 weeks guided internet-delivered cognitive behavioural therapy program. The program consists of psychoeducation, exposure to physical activity, and a breathing-based relaxation exercise

Primary Outcome Measures

Name	Time	Method
Cardiac anxiety (Data collection)	12 months	Data collection will be performed before and after the intervention, and 3 and 12 months after the end of the intervention

Secondary Outcome Measures

Name	Time	Method
Healthcare utilization and costs (Data collection)	12 months	Data collection will be performed12 months after the end of the intervention
Fear of body sensations (Data collection)	12 months	Data collection will be performed before and after the intervention, and 3 and 12 months after the end of the intervention
Depressive symptoms (Data collection)	12 months	Data collection will be performed before and after the intervention, and 3 and 12 months after the end of the intervention

Trial Locations

Locations (1)

Linkoeping University; 🇸🇪 Linkoeping, Sweden