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Internet-Based Pain Coping Skills Training for Patients With Lupus (PainCOACH)

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ClinicalTrials.gov Identifier: NCT03933839
Recruitment Status : Recruiting
First Posted : May 1, 2019
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
This is a pilot study of an automated, internet-based pain coping skills training (PCST) program, PainCOACH.

Condition or disease Intervention/treatment Phase
Lupus Erythematosus, Systemic Behavioral: PainCOACH Not Applicable

Detailed Description:

Background and Significance: Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that impacts multiple organ systems. SLE results in a variety of challenging symptoms, including flare-ups and periods of remission that are unpredictable, and it is a complex disease to manage clinically. Because of these factors, SLE often has a major impact on patients' quality of life. Notably, SLE is often associated with pain, fatigue, emotional symptoms like anxiety and depression, and disability. Because of the relatively young average age of SLE onset, many patients must navigate these challenges while maintaining work and / or caring for young children.

Prior studies show that greater use of adaptive coping strategies and greater self-efficacy for coping with SLE-related symptoms are associated with better physical and psychological outcomes. Conversely, maladaptive coping behaviors, particularly pain catastrophizing (e.g., focusing on and exaggerating the threat of pain and negatively evaluating one's ability to deal with pain), are associated with poorer SLE outcomes. Importantly, many studies in other rheumatic conditions have shown that pain coping skills training (PCST) programs can improve coping patterns, as well as physical and psychological health outcomes. However, there have been no trials of PCST among individuals with SLE, who face a unique set of disease-related challenges and are overall younger than patients with many other rheumatic conditions. Delivery of PCST programs to patients with SLE could have a tremendous impact on outcomes and quality of life, but this evidence base needs to be established, including adaptations of current PCST programs that may be important specifically for patients with SLE. Therefore, the objective of this project is to conduct a pilot study of an automated, internet-based PCST program, PainCOACH, that has been shown to improve multiple key outcomes among patients with osteoarthritis

Study Aims: This project has three specific aims: 1) Evaluate the feasibility and acceptability of PainCOACH among patients with SLE. 2) Obtain a preliminary assessment of the efficacy of PainCOACH (relative to a wait list control group) for improving pain interference and other key outcomes among patients with SLE 3) Determine appropriate adaptations to PainCOACH for patients with SLE.

Study Description: Investigators will conduct a randomized pilot study, with N=60 patients age >= 18 years with physician diagnosis of systemic lupus erythematosus (SLE), equally allocated to PainCOACH and a wait list control group that will be offered PainCOACH after completion of the 9 week follow-up assessment. This design will allow a between-group comparison as well as collection of acceptability data from the control group following their completion of PainCOACH. Outcomes will be assessed at baseline and at about 9 week follow-up as PainCOACH is designed for delivery over 8 weeks.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Internet-Based Pain Coping Skills Training (PainCOACH) for Patients With Lupus
Actual Study Start Date : May 20, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Experimental: PainCOACH
This group will take part in an 8-week pain coping skills training (PCST) intervention.
Behavioral: PainCOACH
PainCOACH is an eight-week, automated, internet-based training in specific pain coping skills (such as progressive muscle relaxation, pleasant imagery and activity pacing), and guided practice with each skill.

No Intervention: Wait List Control
The other group will be the wait list group and will receive the pain CST program after completing all study measures.



Primary Outcome Measures :
  1. Change from Baseline to 9 weeks in PROMIS Pain Interference Score [ Time Frame: Baseline and 9 weeks ]
    PROMIS Pain Interference (Short Form 6a) includes 6 items assessing self-reported consequences of pain across aspects of life including social, cognitive, emotional, physical and recreational activities rated on a Likert scale of 1 (not at all) to 5 (very much). Scores are converted to t-scores and higher scores indicate greater pain interference. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like pain interference, a T-score of 60 is one SD worse than average. By comparison, a pain interference T-score of 40 is one SD better than average.


Secondary Outcome Measures :
  1. Change from Baseline to 9 weeks in PROMIS-29 Score [ Time Frame: Baseline and 9 weeks ]
    PROMIS-29 includes 29 items covering 7 domains of self-reported health rated on a 5 point Likert scale. There is also one 11-point rating scale for pain intensity. Norm-based scores have been calculated for each domain on the PROMIS measures, so that a score of 50 represents the mean or average of the reference population. A score of 60 means that the person is one standard deviation above the reference population (standard deviation = 10).High scores represent more of the domain being measured. Thus, on symptom oriented domains of PROMIS-29 (anxiety, depression, fatigue, pain interference, and sleep disturbance), higher scores represent worse symptomatology. On the function oriented domains (physical functioning and social role) higher scores represent better functioning.

  2. Change from Baseline to 9 weeks in Coping Strategies Questionnaire (CSQ) Score [ Time Frame: Baseline and 9 weeks ]
    CSQ includes 48 items that assess 6 cognitive domains (Catastrophizing, Diverting Attention, Ignoring Sensations, Coping Self-Statements, Reinterpreting Pain Sensations, Praying-Hoping) and 1 behavioral domain (Increasing Behavioral Activities). Each domain includes 6 items, and participants rate the frequency of their use of specific coping strategies on a 7-point Likert scale from 0 ("Never do that") to 6 ("Always do that"). A Total Coping Attempts score was created, which includes 5 cognitive domains and 1 behavioral domain but excludes the Catastrophizing domain, similar to prior studies. Total range is 252, with higher scores indicating more coping attempts.

  3. Change from Baseline to 9 weeks in LupusPRO Score [ Time Frame: Baseline and 9 weeks ]

    LupusPRO (v1.8) includes 43 items with domains of Lupus Symptoms, Lupus Medication, Physical Health, Emotional Health, Pain, Sleep, Procreation, Cognition, Body Image, Desires-Goals, Coping, Social Support and Satisfaction with Care rated on a 5 point Likert scale, where 0=None of the time/not applicable, 1= A little of the time, 2= Some of the time, 3=Most of the time, 4= All of the time, 5= Not applicable.

    Total scores measure health (HRQOL) and non-health related quality of life (Non HRQOL). Item scores are totaled for each domain item and the mean domain score is obtained by dividing the total score by the number of items in that domain. The mean raw domain score is transformed to scores ranging from 0 (worst QOL) to 100 (best QOL) by dividing by 4 (the number of Likert responses {5 responses} minus 1) and then multiplying by 100. Total HRQOL and N-HRQOL scores are obtained by averaging the transformed domain scores within each construct.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • physician diagnosis of Systemic lupus erythematosus (SLE)

Exclusion Criteria:

  • significant memory loss
  • active psychosis or substance abuse
  • neuropsychiatric SLE
  • severe hearing impairment
  • inability to speak English
  • pregnant or planning to become pregnant in the next 3 months
  • current participation in another SLE-related trial

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): NCT03933839


Contacts
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Contact: Kelli D Allen, PhD 919-966-0558 kdallen@email.unc.edu
Contact: Saira Sheikh, MD 919-843-6619 szsheikh@email.unc.edu

Locations
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United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Kelli D Allen, PhD    919-966-0558    kdallen@email.unc.edu   
Contact: Kimberlea Grimm, MHS    919-843-9256    kimberlea_grimm@med.unc.edu   
Principal Investigator: Kelli D Allen, PhD         
Sub-Investigator: Saira Sheikh, MD         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
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Principal Investigator: Kelli D Allen, PhD University of North Carolina, Chapel Hill

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03933839     History of Changes
Other Study ID Numbers: 19-0600
First Posted: May 1, 2019    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified individual data that supports the results will be shared following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: Data will become available following publication of primary and secondary outcomes, and data will be available until the study is closed with the local IRB.
Access Criteria: Data will be accessible following publication of study results and will be available until the study is closed with the local IRB.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of North Carolina, Chapel Hill:
Lupus
Systemic Lupus Erythematosus

Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases