Implementing Internet-Assisted Treatment for Non-Cardiac Chest Pain

Chest Pain Clinical Trial

Official title:

Implementing Internet-Assisted Treatment for Non-Cardiac Chest Pain

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04094337
• Other study ID #: 815486
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 26, 2019
• Est. completion date: January 31, 2024

Study information

• Verified date: January 2023
• Source: Sorlandet Hospital HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 169
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chest Pain

Intervention

Behavioral:
• Internet-assisted treatment
Internet-assisted treatment

Locations

Country	Name	City	State
Norway	Sorlandet Sykehus HF	Kristiansand	Vest-Agder

Sponsors (1)

Lead Sponsor	Collaborator
Sorlandet Hospital HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	PHQ-9	Total range of PHQ-9 is 0-27. A score of 5 or above is defined as cut-off for mild depressive symptoms. The investigators will sub-group participants with a prescore of 5 or above on PHQ-9 to evaluate if this subgroup has: Effect of the intervention on the primary/secondary measures and how this compares to the Whole Group; Evaluate if a score of 5 or above can predict outcome for these patients	58 weeks
Primary	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	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. 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	Change in Brief Illness Perception Questionnaire (BIPQ)	BIPQ is an 8-item self-report-questionnaire which assess the patient's perception/beliefs about their symptoms. Each item is rated on a 0-10 scale. The items represent different components/dimensions. Secondary outcome is difference in mean score between intervention arm and control arm for item 1, 5, 6 and 8 at end of treatment (6 weeks after randomization for both arms). Difference in mean scores between arms will also be assessed for item 1, 5, 6 and 8 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	Change in Patient Health Questionnaire (PHQ-9)	PHQ-9 is an 9 item self-report-questionnaire which assess depression symptoms. Each item is rated on a 0-3 scale. Total range 0-27 where higher score represents more symptoms. Secondary outcome is difference in mean score between intervention arm and control arm for PHQ-9 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).	58 weeks
Secondary	Change in EQ-5D-5L	EQ-5D-5L is an 5 item (plus a visual analog scale) self-report-questionnaire assessing health related quality of life. Secondary outcome is difference in mean score between intervention arm and control arm for EQ-5D-5L 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). Distribution based methods are commonly used, defining improvement of 0.2 or 0.5 standard deviation as clinical relevant. The investigators define a minimal clinical relevant improvement to be 0.2 standard deviation in EQ-5D-5L.	58 weeks
Secondary	Change in self-developed questions	Questions regarding: Impact on social, work and Family life; Frequency of chest pain; Avoidance of physical activity due to chest pain; Physical activity level	58 weeks