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

NCT ID: NCT02336880

Last Updated: 2016-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-06-30

Brief Summary

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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

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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.

Conditions

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Chest Pain Anxiety Fear

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Internet-delivered cognitive behavioural therapy

Intervention Type BEHAVIORAL

Control group

Care as usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Internet-delivered cognitive behavioural therapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ostergotland County Council, Sweden

OTHER

Sponsor Role collaborator

Medical Research Council of Southeast Sweden

OTHER_GOV

Sponsor Role collaborator

Linkoeping University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Ghassan Mourad

Junior lecturer, PhD-student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tiny Jaarsma, Professor

Role: STUDY_CHAIR

Linkoeping University

Locations

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Linkoeping University

Linköping, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 27456689 (View on PubMed)

Other Identifiers

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I-CBT in NCCP

Identifier Type: -

Identifier Source: org_study_id

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