NCT03933839

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 1, 2019

Completed
19 days until next milestone

Study Start

First participant enrolled

May 20, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2020

Completed
Last Updated

May 20, 2020

Status Verified

May 1, 2020

Enrollment Period

11 months

First QC Date

April 29, 2019

Last Update Submit

May 18, 2020

Conditions

Lupus Erythematosus, Systemic

Keywords

LupusSystemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline to 9 weeks in PROMIS Pain Interference Score

    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.

    Baseline and 9 weeks

Secondary Outcomes (3)

  • Change from Baseline to 9 weeks in PROMIS-29 Score

    Baseline and 9 weeks

  • Change from Baseline to 9 weeks in Coping Strategies Questionnaire (CSQ) Score

    Baseline and 9 weeks

  • Change from Baseline to 9 weeks in LupusPRO Score

    Baseline and 9 weeks

Study Arms (2)

PainCOACH

EXPERIMENTAL

This group will take part in an 8-week pain coping skills training (PCST) intervention.

Behavioral: PainCOACH

Wait List Control

NO INTERVENTION

The other group will be the wait list group and will receive the pain CST program after completing all study measures.

Interventions

PainCOACHBEHAVIORAL

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.

PainCOACH

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • physician diagnosis of Systemic lupus erythematosus (SLE)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

  • Allen KD, Beauchamp T, Rini C, Keefe FJ, Bennell KL, Cleveland RJ, Grimm K, Huffman K, Hu DG, Santana A, Saxena Beem S, Walker J, Sheikh SZ. Pilot study of an internet-based pain coping skills training program for patients with systemic Lupus Erythematosus. BMC Rheumatol. 2021 Jun 17;5(1):20. doi: 10.1186/s41927-021-00191-6.

    PMID: 34134788DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Kelli D Allen, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2019

First Posted

May 1, 2019

Study Start

May 20, 2019

Primary Completion

April 22, 2020

Study Completion

April 22, 2020

Last Updated

May 20, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
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.

Locations

US(1)