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

NCT03096925 | Unknown

• 2 other identifiers: 8154432016031
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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).

Conditions

Chest Pain

Keywords

non-cardiac chest pain; anxiety

Outcome Measures

Primary Outcomes (2)

• Change in Cardiac Anxiety Questionnaire (CAQ)

  CAQ is an 18-item self-report-questionnaire which measures hearth related anxiety/fear, attention, avoidance and safety seeking behavior. Each item is rated on a five-point Likert scale ranging from 0 to 4. Total range 0-72 where higher score represents more symptoms. Primary outcome is difference in mean score between intervention arm and control arm for CAQ 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, we use a distribution based method and define clinical relevant effect as improvement of more than 0.5 standard deviation compared to baseline.

  58 weeks

• 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, we use a distribution based method and define clinical relevant effect as improvement of more than 0.5 standard deviation compared to baseline.

  58 weeks

Secondary Outcomes (5)

• Change in Brief Illness Perception Questionnaire (BIPQ)

  58 weeks

• Change in Patient Health Questionnaire (PHQ-9)

  58 weeks

• Change in General perceived Self-Efficacy Scale

  58 weeks

• Change in EQ-5D-5L

  58 weeks

• Health care costs

  58 weeks

Other Outcomes (1)

• Composite measures

  58 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Behavioral: Guided self-help

Control group

NO INTERVENTION

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

Interventions

Guided self-help BEHAVIORAL

Web-based guided self-help intervention

Intervention group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• 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

Related Publications (2)

• 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.

  PMID: 37838653 DERIVED

• 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.

  PMID: 35072641 DERIVED

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, MD, PhD

  Head of Clinical Research, Sørlandet HF.

  STUDY DIRECTOR

• Liv T Walseth, MD, PhD

  Researcher, Sørlandet HF

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

Study Record Dates

• First Submitted: February 16, 2017
• First Posted: March 30, 2017
• Study Start: April 3, 2017
• Primary Completion: December 19, 2019
• Study Completion: January 1, 2024
• Last Updated: February 1, 2023

Record last verified: 2023-01

Locations

NO (1)