Non-cardiac Chest Pain: Effect of Cognitive Therapy Administered as Guided Self-help

NCT ID: NCT03096925

Last Updated: 2023-02-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-03
• Study Completion Date: 2024-01-01

Brief Summary

This study aims to test an easily implementable web-based cognitive behaviour therapy (CBT) self-help intervention designed for non-cardiac chest pain patients, and compare effectiveness and cost-effectiveness to treatment as usual in an randomized controlled trial (RCT).

Detailed Description

Most patients with chest pain referred to hospital do not have a cardiac illness. Non-cardiac chest pain (NCCP) is often followed by persistent distress and reduced quality of life, and societal costs are nearly equal to those of cardiac patients. Research suggests that face-to-face CBT is effective, but this has not been implemented as standard treatment. We plan to test an easily implementable web-based guided self-help intervention for NCCP patients.

Patients will be recruited at the chest pain unit at Sørlandet Hospital, Kristiansand, and will be recruited after they have finished their cardiac examination.

The intervention group will receive six web-based sessions, comprising information, exposure to physical activity, how worry can excess pain, physical reactions to pain and worry, consequences of avoidance, and specific panic treatment.

Conditions

Chest Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

The intervention group will receive guided self-help comprising six web-based sessions, comprising information, exposure to physical activity, how worry can excess pain, physical reactions to pain and worry, consequences of avoidance, and specific panic treatment. The first session will be done at the hospital before discharge, the others at home. Between sessions there will be a brief telephone contact with a project worker.

Group Type: EXPERIMENTAL

Guided self-help

Intervention Type: BEHAVIORAL

Web-based guided self-help intervention

Control group

This group will receive treatment as usual, which is no specific treatment. They can however use the general health system as they like.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Guided self-help

Web-based guided self-help intervention

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Non-Cardiac Chest Pain

Exclusion Criteria

• Language difficulties
• Unable to perform at least moderate physical activity due to physical constraints
• Obvious cognitive impairment (e.g mentally retarded, psychotic, dementia or intoxicated)
• no regular access to a computer/tablet computer with internet connection

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sorlandet Hospital HF

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frode Gallefoss, MD, PhD

Role: STUDY_DIRECTOR

Head of Clinical Research, Sørlandet HF.

Liv T Walseth, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Researcher, Sørlandet HF

Locations

Sorlandet Sykehus HF

Kristiansand, Vest Agder, Norway

Countries

Norway

References

Thesen T, Himle JA, Pripp AH, Sunde T, Walseth LT, Thorup F, Gallefoss F, Jonsbu E. Patients with depression symptoms are more likely to experience improvements of internet-based cognitive behavioral therapy: a secondary analysis of effect modifiers in patients with non-cardiac chest pain in a randomized controlled trial. BMC Psychiatry. 2023 Oct 14;23(1):751. doi: 10.1186/s12888-023-05238-1.

Reference Type: DERIVED

PMID: 37838653 (View on PubMed)

Thesen T, Himle JA, Martinsen EW, Walseth LT, Thorup F, Gallefoss F, Jonsbu E. Effectiveness of Internet-Based Cognitive Behavioral Therapy With Telephone Support for Noncardiac Chest Pain: Randomized Controlled Trial. J Med Internet Res. 2022 Jan 24;24(1):e33631. doi: 10.2196/33631.

Reference Type: DERIVED

PMID: 35072641 (View on PubMed)

Other Identifiers

2016031

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

815443

Identifier Type: -

Identifier Source: org_study_id