Implementing Internet-Assisted Treatment for Non-Cardiac Chest Pain

NCT ID: NCT04094337

Last Updated: 2023-02-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 169 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-26
• Study Completion Date: 2024-01-31

Brief Summary

This study aims to test Implementation of Internet-Assisted Treatment for Non-Cardiac Chest Pain at the Cardiac Department at Sørlandet Hospital. The internet-assisted treatment will be delivered by personnel working at the department. Effectiveness will be tested in an randomized controlled trial (RCT). The intervention has been tested in an RCT where the intervention was delivered by a cognitive behavioral therapy (CBT) specialist who also participated in developing the intervention. Presently the investigators will test if personnel working at the department, with minimal training in CBT, can deliver the intervention effectively.

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. The investigators plan to test an easily implementable internet-assisted treatment for NCCP patients delivered by personnel already working at the department.

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

Internet-assisted treatment

The intervention group will receive internet-assisted treatment 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

Internet-assisted treatment

Intervention Type: BEHAVIORAL

Internet-assisted treatment

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Internet-assisted treatment

Internet-assisted treatment

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: Yes

Sponsors

Sorlandet Hospital HF

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frode Gallefoss, PhD

Role: STUDY_DIRECTOR

Head of Clinical Research

Egil Jonsbu, PhD

Role: PRINCIPAL_INVESTIGATOR

Researcher

Locations

Sorlandet Sykehus HF

Kristiansand, Vest-Agder, Norway

Countries

Norway

Other Identifiers

815486

Identifier Type: -

Identifier Source: org_study_id