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Implementing Internet-Assisted Treatment for Non-Cardiac Chest Pain

Primary Purpose

Chest Pain

Status
Active
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Internet-assisted treatment
Sponsored by
Sorlandet Hospital HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chest Pain focused on measuring non-cardiac chest pain, NCCP, anxiety, internet-assisted treatment

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Sorlandet Sykehus HF

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Internet-assisted treatment

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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).
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.
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

Full Information

First Posted
September 12, 2019
Last Updated
January 31, 2023
Sponsor
Sorlandet Hospital HF
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1. Study Identification

Unique Protocol Identification Number
NCT04094337
Brief Title
Implementing Internet-Assisted Treatment for Non-Cardiac Chest Pain
Official Title
Implementing Internet-Assisted Treatment for Non-Cardiac Chest Pain
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 26, 2019 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sorlandet Hospital HF

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain
Keywords
non-cardiac chest pain, NCCP, anxiety, internet-assisted treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
169 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Internet-assisted treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Internet-assisted treatment
Intervention Description
Internet-assisted treatment
Primary Outcome Measure Information:
Title
Change in Body Sensations Questionnaire (BSQ)
Description
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.
Time Frame
58 weeks
Secondary Outcome Measure Information:
Title
Change in Cardiac Anxiety Questionnaire (CAQ)
Description
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.
Time Frame
58 weeks
Title
Change in Brief Illness Perception Questionnaire (BIPQ)
Description
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.
Time Frame
58 weeks
Title
Change in Patient Health Questionnaire (PHQ-9)
Description
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).
Time Frame
58 weeks
Title
Change in EQ-5D-5L
Description
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.
Time Frame
58 weeks
Title
Change in self-developed questions
Description
Questions regarding: Impact on social, work and Family life Frequency of chest pain Avoidance of physical activity due to chest pain Physical activity level
Time Frame
58 weeks
Other Pre-specified Outcome Measures:
Title
PHQ-9
Description
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
Time Frame
58 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frode Gallefoss, PhD
Organizational Affiliation
Head of Clinical Research
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Egil Jonsbu, PhD
Organizational Affiliation
Researcher
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sorlandet Sykehus HF
City
Kristiansand
State/Province
Vest-Agder
ZIP/Postal Code
4604
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data for all primary and secondary outcome measures will be made available.
IPD Sharing Time Frame
Data will be available within 12 months of study completion.
IPD Sharing 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.

Learn more about this trial

Implementing Internet-Assisted Treatment for Non-Cardiac Chest Pain

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