Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of the Efficacy and Mechanisms of a Novel Intervention for Chronic Pain Tailored to People Living With HIV (STOMP)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03692611
Recruitment Status : Recruiting
First Posted : October 2, 2018
Last Update Posted : August 9, 2019
Sponsor:
Collaborators:
University of Alabama at Birmingham
University of California, San Diego
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Jessica Merlin, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE September 7, 2018
First Posted Date  ICMJE October 2, 2018
Last Update Posted Date August 9, 2019
Estimated Study Start Date  ICMJE December 2019
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2018)
Brief Pain Inventory (BPI) score immediately post intervention [ Time Frame: BPI will be conducted at baseline and immediately after the intervention ]
the BPI asks 11 questions about pain severity (pain at its worst, least, average, and right now) and the interference of pain in several aspects of patients' lives (activity, mood, walking ability, work, relations with other people, sleep, and enjoyment of life) on a scale of 0 (no pain/does not interfere) to 10 (pain as bad as you imagine/completely interferes). The BPI-Total score is the average score across all 11 questions.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03692611 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Efficacy and Mechanisms of a Novel Intervention for Chronic Pain Tailored to People Living With HIV
Official Title  ICMJE Evaluation of the Efficacy and Mechanisms of a Novel Intervention for Chronic Pain Tailored to People Living With HIV
Brief Summary Due to its prevalence and impact on quality of life and overall health, the National Academy of Medicine has called chronic pain a "public health crisis." Therefore, this proposal is relevant to public health because it seeks to improve chronic pain treatment in accordance with the approach recommended by the Department of Health and Human Services National Pain Strategy: to develop and test Pain Self-Management interventions tailored to the needs of vulnerable populations, particularly people living with HIV (PLWH). Chronic pain is an important and understudied comorbidity among PLWH; therefore, this proposal is responsive to the NIH's HIV Research Priorities, which identify comorbidities as a high priority research topic.
Detailed Description Behavioral interventions for chronic pain among people living with HIV (PLWH) are an understudied area, with great potential to improve pain and function. Chronic pain is an important comorbidity that affects between 30% and 85% of PLWH and is associated with greater odds of functional impairment, increased emergency room utilization, suboptimal retention in HIV care, and failure to achieve virologic suppression. What is not known is how to optimally address chronic pain in this population. Opioids are a commonly used treatment for chronic pain, particularly in PLWH. Opioid prescribing for chronic pain often does not result in substantial improvement in outcomes and contributes to the growing epidemic of opioid addiction and overdose. In contrast, behavioral interventions are among the most effective and safest treatments for chronic pain in the general population. Pain Self-Management (PSM) is a Social Cognitive Theory (SCT)-based behavioral approach that involves pain-related skill acquisition and goal setting. PSM interventions have been promoted by the 2016 Department of Health and Human Services National Pain Strategy (DHHS NPS) as an effective, scalable approach to chronic pain management. Especially given the current opioid crisis, the DHHS NPS underscored the urgent need to develop and test PSM interventions tailored to the unique needs of vulnerable populations, particularly PLWH, that can be implemented and disseminated nationwide. Until an effective and scalable PSM intervention for chronic pain in PLWH is developed, reducing the burden of chronic pain safely and effectively in this population will not be possible. The overall objective of this proposal is to evaluate a novel theory-based PSM intervention, "Skills TO Manage Pain" (STOMP), developed for and tailored to PLWH. The investigators will accomplish the overall objective with the following primary specific aim: 1) Evaluate the efficacy of STOMP, a theory-based intervention tailored to improving chronic pain in PLWH. Given the investigators' rigorous intervention development process and promising pilot trial results, the working hypothesis is that STOMP will decrease pain and improve function in PLWH. Investigators also propose the following secondary aims: 2) Conduct exploratory analyses of the impact of STOMP on HIV outcomes associated with chronic pain (i.e. retention in care, virologic suppression), and 3) Investigate proximal outcomes as potential mediators of STOMP's impact on chronic pain. This approach is innovative because it incorporates novel peer co-led group sessions that were created based on the investigators' formative intervention development work, includes patients with comorbidities (e.g., depressive symptoms, addiction history) common among PLWH but typically excluded from chronic pain studies, and investigates the impact of a chronic pain intervention on disease-specific HIV outcomes in addition to pain and function. The proposed research will be significant because if successful, it will pave the way for future dissemination and implementation studies that have the potential to dramatically change chronic pain treatment for PLWH.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This is a randomized controlled trial to discover whether STOMP is an efficacious Pain Self-Management (PSM) intervention, mediated by the hypothesized Social Cognitive Theory (SCT) constructs.
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Pain
Intervention  ICMJE
  • Behavioral: Skills TO Manage Pain (STOMP)
    12 week pain self management (PSM) intervention incorporating social cognitive theory constructs.
  • Behavioral: comparison group
    Participants in this arm will receive usual care as given by providers but no behavioral PSM intervention.
    Other Name: active comparator
Study Arms  ICMJE
  • Experimental: Skills to Manage Pain (STOMP)
    The intervention group will receive treatment as usual plus the STOMP behavioral intervention. The STOMP behavioral intervention consists of 12 intervention sessions (6 group and 6 individual sessions). The sessions will be completed over a period of 12-16 weeks from enrollment. The first intervention session will be a group session for all participants followed by individual and then alternating group and individual sessions for the rest of the intervention. The intervention group will utilize a study manual on pain management in which they will use with each session.
    Intervention: Behavioral: Skills TO Manage Pain (STOMP)
  • Active Comparator: comparison group
    The comparison group will receive treatment as usual.The comparison group will also be provided with the intervention manual, however, no additional treatment will be provided to participants allocated to the control group. The group will not receive the PSM intervention.
    Intervention: Behavioral: comparison group
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 28, 2018)
280
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2022
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Enrolled in CNICS
  2. Age ≥ 18 years
  3. English-speaking
  4. Chronic pain (Brief Chronic Pain Screening Questionnaire (BCPQ) = at least moderate pain for at least 3 months)
  5. Moderately severe and impairing chronic pain (PEG pain questionnaire = average of all three items is 4 or greater)
  6. Ability and willingness to attend the group sessions at the date/time specified
  7. No plans for major surgery during the study period that would interfere with study procedures.

Exclusion Criteria:

  1. Do not speak or understand English
  2. Are planning a new pain treatment like surgery
  3. Cannot attend the group sessions
  4. Had previously participated in the pilot study (STOMP)
  5. Unwilling to provide informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Alissa Eugeni 412-383-0618 ale64@pitt.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03692611
Other Study ID Numbers  ICMJE PRO18060101
1R01MH115754-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jessica Merlin, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE
  • University of Alabama at Birmingham
  • University of California, San Diego
  • National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Jessica Merlin, MD PhD MBA Univ of Pittsburgh
PRS Account University of Pittsburgh
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP