Internet-delivered CBT for NCCP-patients - a Pilot Trial
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
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 8, 2015
CompletedFirst Posted
Study publicly available on registry
January 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedAugust 22, 2016
August 1, 2016
2 months
January 8, 2015
August 19, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
Fear of body sensations (Data collection)
12 months
Depressive symptoms (Data collection)
12 months
Healthcare utilization and costs (Data collection)
12 months
Study Arms (2)
Intervention group
EXPERIMENTAL4 weeks guided internet-delivered cognitive behavioural therapy program. The program consists of psychoeducation, exposure to physical activity, and a breathing-based relaxation exercise
Control group
NO INTERVENTIONCare as usual
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Linkoeping Universitylead
- Ostergotland County Council, Swedencollaborator
- Medical Research Council of Southeast Swedencollaborator
Study Sites (1)
Linkoeping University
Linköping, Sweden
Related Publications (1)
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.
PMID: 27456689DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Tiny Jaarsma, Professor
Linkoeping University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Junior lecturer, PhD-student
Study Record Dates
First Submitted
January 8, 2015
First Posted
January 13, 2015
Study Start
January 1, 2015
Primary Completion
March 1, 2015
Study Completion
June 1, 2016
Last Updated
August 22, 2016
Record last verified: 2016-08