Clinical trial NCT03096925: Non-cardiac Chest Pain: Effect of Cognitive Therapy Administered as Guided Self-help
Official title: Non-cardiac Chest Pain: Effect of Cognitive Therapy Administered as Guided Self-help
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chest Pain
Keywords: non-cardiac chest pain
anxiety
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
First posted: 2017-03-30
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Cardiac Anxiety Questionnaire (CAQ)
timeFrame: 58 weeks
measure: Change in Body Sensations Questionnaire (BSQ)
timeFrame: 58 weeks
Secondary outcomes:
measure: Change in Brief Illness Perception Questionnaire (BIPQ)
timeFrame: 58 weeks
measure: Change in Patient Health Questionnaire (PHQ-9)
timeFrame: 58 weeks
measure: Change in General perceived Self-Efficacy Scale
timeFrame: 58 weeks
measure: Change in EQ-5D-5L
timeFrame: 58 weeks
measure: Health care costs
timeFrame: 58 weeks
Other outcomes:
measure: Composite measures
timeFrame: 58 weeks
Locations:
city: Kristiansand
country: Norway
facility: Sorlandet Sykehus HF
state: Vest Agder
Study officials:
affiliation: Head of Clinical Research, Sørlandet HF.
name: Frode Gallefoss, MD, PhD
role: STUDY_DIRECTOR
affiliation: Researcher, Sørlandet HF
name: Liv T Walseth, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.