Implementing Internet-Assisted Treatment for Non-Cardiac Chest Pain

NCT04094337 | Unknown

• 1 other identifier: 815486
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 1

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.

Conditions

Chest Pain

Keywords

non-cardiac chest pain; NCCP; anxiety; internet-assisted treatment

Outcome Measures

Primary Outcomes (1)

• Change in Body Sensations Questionnaire (BSQ)

  BSQ is an 17-item self-report-questionnaire which measures fear of different bodily sensations. Each item is rated on a five-point Likert scale ranging from 1 to 5. Total range 17-85 where higher score represents more symptoms. Primary outcome is difference in mean score between intervention arm and control arm for BSQ at end of treatment (6 weeks after randomization for both arms). Difference in mean scores between arms will also be assessed at pretreatment/baseline, and at 3 months and 12 months after end of treatment (18 weeks and 58 weeks after randomization). There is no predefined clinical relevant effect for this measure. The investigators will use a distribution based method. Clinical relevant effect is defined as improvement of more than 0.5 standard deviation compared to baseline.

  58 weeks

Secondary Outcomes (5)

• Change in Cardiac Anxiety Questionnaire (CAQ)

  58 weeks

• Change in Brief Illness Perception Questionnaire (BIPQ)

  58 weeks

• Change in Patient Health Questionnaire (PHQ-9)

  58 weeks

• Change in EQ-5D-5L

  58 weeks

• Change in self-developed questions

  58 weeks

Other Outcomes (1)

• PHQ-9

  58 weeks

Study Arms (2)

Internet-assisted treatment

EXPERIMENTAL

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.

Behavioral: Internet-assisted treatment

Control group

NO INTERVENTION

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.

Interventions

Internet-assisted treatment BEHAVIORAL

Internet-assisted treatment

Internet-assisted treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-Cardiac Chest Pain

You may not qualify if:

• 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

Sponsors & Collaborators

• Sorlandet Hospital HF: lead

Study Sites (1)

Sorlandet Sykehus HF

Kristiansand, Vest-Agder, 4604, Norway

Location

MeSH Terms

Conditions

Chest Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Frode Gallefoss, PhD

  Head of Clinical Research

  STUDY DIRECTOR

• Egil Jonsbu, PhD

  Researcher

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Parallel Assignment Eligible patients will be consecutively included and randomized to two groups, intervention group or control group. The investigators will use a web-based randomisation procedure, conducted at a place remote from where the study takes place.

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: September 18, 2019
• Study Start: October 26, 2019
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: February 1, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available within 12 months of study completion.
• Access Criteria: Data Access requests will be reviewed by the science unit at Sørlandet Hospital, Norway. Requestors will be required to sign a Data Access Agreement.

Locations

NO (1)