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

August 19, 2016 updated by: Ghassan Mourad, Linkoeping University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Linkoeping, Sweden
        • Linkoeping University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Care as usual
Experimental: Intervention group
4 weeks guided internet-delivered cognitive behavioural therapy program. The program consists of psychoeducation, exposure to physical activity, and a breathing-based relaxation exercise
Behavioral: Internet-delivered cognitive behavioural therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months
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
12 months
Healthcare utilization and costs (Data collection)
Time Frame: 12 months
Data collection will be performed12 months after the end of the intervention
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Linkoeping University

Collaborators

Ostergotland County Council, Sweden
Medical Research Council of Southeast Sweden

Investigators

  • Study Chair: Tiny Jaarsma, Professor, Linkoeping University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

January 8, 2015

First Submitted That Met QC Criteria

January 12, 2015

First Posted (Estimate)

January 13, 2015

Study Record Updates

Last Update Posted (Estimate)

August 22, 2016

Last Update Submitted That Met QC Criteria

August 19, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I-CBT in NCCP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chest Pain

Clinical Trials on Internet-delivered cognitive behavioural therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe