Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03096925
Recruitment Status : Active, not recruiting
First Posted : March 30, 2017
Last Update Posted : December 31, 2018
Sponsor:
Information provided by (Responsible Party):
Sorlandet Hospital HF

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).

Condition or disease Intervention/treatment Phase
Chest Pain Behavioral: Guided self-help Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Non-cardiac Chest Pain: Effect of Cognitive Therapy Administered as Guided Self-help
Actual Study Start Date : April 3, 2017
Estimated Primary Completion Date : July 15, 2019
Estimated Study Completion Date : December 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Chest Pain

Arm Intervention/treatment
Experimental: Intervention group
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
Web-based guided self-help intervention

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



Primary Outcome Measures :
  1. Change in Cardiac Anxiety Questionnaire (CAQ) [ Time Frame: 58 weeks ]
    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.

  2. Change in Body Sensations Questionnaire (BSQ) [ Time Frame: 58 weeks ]
    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.


Secondary Outcome Measures :
  1. Change in Brief Illness Perception Questionnaire (BIPQ) [ Time Frame: 58 weeks ]
    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 these items, we use a distribution based method and define clinical relevant effect as improvement of more than 0.5 standard deviation compared to baseline.

  2. Change in Patient Health Questionnaire (PHQ-9) [ Time Frame: 58 weeks ]
    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). We define clinical relevant effect as an absolute drop of 5 points on an individual level, and between groups as an improvement of 3 points.

  3. Change in General perceived Self-Efficacy Scale [ Time Frame: 58 weeks ]
    GSE is an 10 item self-report-questionnaire which assess self-efficacy. Each item is rated on a 1-4 Lickert scale. Total range 10-40 where higher score represents more self-efficacy. Secondary outcome is difference in mean score between intervention arm and control arm for GSE 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. We will also investigate its ability to predict treatment effect.

  4. Change in EQ-5D-5L [ Time Frame: 58 weeks ]
    EQ-5D-5L is an 5 item (plus a VAS 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 SD as clinical relevant. We define a minimal clinical relevant improvement to be 0.2 SD in EQ-5D-5L.

  5. Health care costs [ Time Frame: 58 weeks ]
    Secondary outcome is to calculate the difference in healthcare utilization between intervention and control arm over a period of 12 months after end of treatment. We will collect data on both direct and indirect costs with self-report forms collected every third month, as well as register data. We will compare the costs between the two arms.


Other Outcome Measures:
  1. Composite measures [ Time Frame: 58 weeks ]
    If the primary and secondary outcomes surprisingly do not show difference of statistical significance and clinical relevance, the study data will be searched for composite measures showing clinically and statistical relevance



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03096925


Locations
Layout table for location information
Norway
Sorlandet Sykehus HF
Kristiansand, Vest Agder, Norway, 4604
Sponsors and Collaborators
Sorlandet Hospital HF
Investigators
Layout table for investigator information
Study Director: Frode Gallefoss, MD, PhD Head of Clinical Research, Sørlandet HF.
Principal Investigator: Liv T Walseth, MD, PhD Researcher, Sørlandet HF

Layout table for additonal information
Responsible Party: Sorlandet Hospital HF
ClinicalTrials.gov Identifier: NCT03096925     History of Changes
Other Study ID Numbers: 815443
2016031 ( Other Grant/Funding Number: Helse Sør-Øst )
First Posted: March 30, 2017    Key Record Dates
Last Update Posted: December 31, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sorlandet Hospital HF:
non-cardiac chest pain
anxiety
Additional relevant MeSH terms:
Layout table for MeSH terms
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms