Clinical trial NCT04094337: Implementing Internet-Assisted Treatment for Non-Cardiac Chest Pain
Official title: Implementing Internet-Assisted Treatment for Non-Cardiac Chest Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chest Pain
Keywords: non-cardiac chest pain
NCCP
anxiety
internet-assisted treatment
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
First posted: 2019-09-18
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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 Body Sensations Questionnaire (BSQ)
timeFrame: 58 weeks
Secondary outcomes:
measure: Change in Cardiac Anxiety Questionnaire (CAQ)
timeFrame: 58 weeks
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 EQ-5D-5L
timeFrame: 58 weeks
measure: Change in self-developed questions
timeFrame: 58 weeks
Other outcomes:
measure: PHQ-9
timeFrame: 58 weeks
Locations:
city: Kristiansand
country: Norway
facility: Sorlandet Sykehus HF
state: Vest-Agder
Study officials:
affiliation: Head of Clinical Research
name: Frode Gallefoss, PhD
role: STUDY_DIRECTOR
affiliation: Researcher
name: Egil Jonsbu, PhD
role: PRINCIPAL_INVESTIGATOR
References: