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

Primary Purpose

Chest Pain, Anxiety, Fear

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Internet-delivered cognitive behavioural therapy
Sponsored by
Linkoeping University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chest Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Linkoeping University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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

Care as usual

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
Healthcare utilization and costs (Data collection)
Data collection will be performed12 months after the end of the intervention

Full Information

First Posted
January 8, 2015
Last Updated
August 19, 2016
Sponsor
Linkoeping University
Collaborators
Ostergotland County Council, Sweden, Medical Research Council of Southeast Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT02336880
Brief Title
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

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Linkoeping University
Collaborators
Ostergotland County Council, Sweden, Medical Research Council of Southeast Sweden

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain, Anxiety, Fear

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
4 weeks guided internet-delivered cognitive behavioural therapy program. The program consists of psychoeducation, exposure to physical activity, and a breathing-based relaxation exercise
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Care as usual
Intervention Type
Behavioral
Intervention Name(s)
Internet-delivered cognitive behavioural therapy
Primary Outcome Measure Information:
Title
Cardiac anxiety (Data collection)
Description
Data collection will be performed before and after the intervention, and 3 and 12 months after the end of the intervention
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Fear of body sensations (Data collection)
Description
Data collection will be performed before and after the intervention, and 3 and 12 months after the end of the intervention
Time Frame
12 months
Title
Depressive symptoms (Data collection)
Description
Data collection will be performed before and after the intervention, and 3 and 12 months after the end of the intervention
Time Frame
12 months
Title
Healthcare utilization and costs (Data collection)
Description
Data collection will be performed12 months after the end of the intervention
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tiny Jaarsma, Professor
Organizational Affiliation
Linkoeping University
Official's Role
Study Chair
Facility Information:
Facility Name
Linkoeping University
City
Linkoeping
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
27456689
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.
Results Reference
derived

Learn more about this trial

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

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