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

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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

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.

Condition or disease Intervention/treatment Phase
Chronic Pain Behavioral: Skills TO Manage Pain (STOMP) Behavioral: comparison group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
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
Official Title: Evaluation of the Efficacy and Mechanisms of a Novel Intervention for Chronic Pain Tailored to People Living With HIV
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Behavioral: Skills TO Manage Pain (STOMP)
12 week pain self management (PSM) intervention incorporating social cognitive theory constructs.

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.
Behavioral: comparison group
Participants in this arm will receive usual care as given by providers but no behavioral PSM intervention.
Other Name: active comparator




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03692611


Contacts
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Contact: Alissa Eugeni 412-383-0618 ale64@pitt.edu

Locations
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United States, Alabama
University of Alabama Recruiting
Birmingham, Alabama, United States, 352940
Contact: Michael Mugavero, MD    205-975-1274    mmugavero@uabmc.edu   
Principal Investigator: Michael Mugavero, MD         
Sponsors and Collaborators
University of Pittsburgh
University of Alabama at Birmingham
University of California, San Diego
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Jessica Merlin, MD PhD MBA Univ of Pittsburgh
  Study Documents (Full-Text)

Documents provided by Jessica Merlin, University of Pittsburgh:
Study Protocol  [PDF] August 1, 2018


Publications:

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Responsible Party: Jessica Merlin, Visiting Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03692611     History of Changes
Other Study ID Numbers: PRO18060101
1R01MH115754-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 2, 2018    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Jessica Merlin, University of Pittsburgh:
chronic pain
hiv
opioid prescribing
behavioral clinical trial
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms