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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03692611

Acronym

STOMP

Enrollment

278

Registered

2018-10-02

Start date

2019-08-14

Completion date

2025-01-06

Last updated

2025-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

Keywords

Chronic pain, HIV, Opioid prescribing, Behavioral clinical trial

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.

Interventions

BEHAVIORALSkills TO Manage Pain (STOMP)

12 week pain self management (PSM) intervention incorporating social cognitive theory constructs.

BEHAVIORALComparison group

Participants in this arm will receive usual care as given by providers but no behavioral PSM intervention.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

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.

Eligibility

Sex/Gender

ALL

Age

18 Years to 89 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Brief Pain Inventory (BPI) Total Score	Immediately postintervention and 3-month follow-up (postintervention)	The Brief Pain Inventory (BPI) is a validated tool measuring pain severity and its impact on daily functioning. It includes 11 items assessing pain severity (worst, least, average, current) and pain interference with general activity, mood, walking, work, relations with others, sleep, and enjoyment of life. Each item is rated from 0 (no pain/no interference) to 10 (worst pain imaginable/complete interference). The Pain Severity Subscore (0-10) is the average of four severity items, the Functional Interference Subscore (0-10) is the average of seven interference items, and the Total Score (0-10) is the average of all 11 items. Higher scores indicate worse pain severity and greater pain interference.

Secondary

Measure	Time frame	Description
Brief Pain Inventory (BPI) Pain Severity Subscore	Immediately postintervention and 3-month follow-up (postintervention)	The Brief Pain Inventory (BPI) is a validated tool measuring pain severity and its impact on daily functioning. It includes 11 items assessing pain severity (worst, least, average, current) and pain interference with general activity, mood, walking, work, relations with others, sleep, and enjoyment of life. Each item is rated from 0 (no pain/no interference) to 10 (worst pain imaginable/complete interference). The Pain Severity Subscore (0-10) is the average of four severity items, the Functional Interference Subscore (0-10) is the average of seven interference items, and the Total Score (0-10) is the average of all 11 items. Higher scores indicate worse pain severity and greater pain interference.
The Pain, Enjoyment and General Activity (PEG) Scale	Immediately postintervention and 3-month follow-up (postintervention)	The Pain, Enjoyment and General Activity (PEG) scale measures pain severity and enjoyment of activities with scores ranging from 0 to 10. Higher scores indicate worse pain and greater interference with daily activities. The total score is the average of 3 items assessing pain intensity, enjoyment of life, and general activity.
Brief Pain Inventory (BPI) Functional Interference Subscore	Immediately postintervention and 3-month follow-up (postintervention)	The Brief Pain Inventory (BPI) is a validated tool measuring pain severity and its impact on daily functioning. It includes 11 items assessing pain severity (worst, least, average, current) and pain interference with general activity, mood, walking, work, relations with others, sleep, and enjoyment of life. Each item is rated from 0 (no pain/no interference) to 10 (worst pain imaginable/complete interference). The Pain Severity Subscore (0-10) is the average of four severity items, the Functional Interference Subscore (0-10) is the average of seven interference items, and the Total Score (0-10) is the average of all 11 items. Higher scores indicate worse pain severity and greater pain interference.
The Patient Health Questionnaire-8 (PHQ-8)	Immediately postintervention and 3-month follow-up (postintervention)	The Patient Health Questionnaire-8 (PHQ-8) is an 8-item self-report measure assessing depressive symptoms over the past two weeks. Each item is rated from 0 to 3, with the total score (0-24) calculated by adding all responses, with higher scores indicating more severe depressive symptoms and a worse mental health outcome.
The Pain Catastrophizing Scale (PCS)	Immediately postintervention and 3-month follow-up (postintervention)	The Pain Catastrophizing Scale (PCS) is a 13-item self-report measure assessing exaggerated negative thoughts and feelings about pain. Each item is rated from 0 to 4, with the total score (0-52) calculated by summing all responses. Higher scores indicate greater pain catastrophizing and worse psychological outcomes related to pain.
The Pain Self-Efficacy Questionnaire (PSEQ)	Immediately postintervention and 3-month follow-up (postintervention)	The Pain Self-Efficacy Questionnaire (PSEQ) assesses an individual's confidence in their ability to perform daily activities despite pain. The total score is the sum of 10 items, each rated from 0 to 6, resulting in a range of 0 to 60. Higher scores indicate greater self-efficacy and a stronger belief in one's ability to manage daily tasks while experiencing pain.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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. Skills TO Manage Pain (STOMP): 12 week pain self management (PSM) intervention incorporating social cognitive theory constructs.	139
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. comparison group: Participants in this arm will receive usual care as given by providers but no behavioral PSM intervention.	139
Total	278

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Found to be ineligible postrandomization	3	0

Baseline characteristics

Characteristic	Skills to Manage Pain (STOMP)	Total	Comparison Group
Age, Customized	53.7 years STANDARD_DEVIATION 9.6	53.5 years STANDARD_DEVIATION 10	53.3 years STANDARD_DEVIATION 10.4
Brief Pain Inventory (BPI) Functional Interference Subscore	6.5 units on a scale STANDARD_DEVIATION 2.2	6.4 units on a scale STANDARD_DEVIATION 2.2	6.4 units on a scale STANDARD_DEVIATION 2.3
Brief Pain Inventory (BPI) Pain Severity Subscore	6.4 units on a scale STANDARD_DEVIATION 1.8	6.5 units on a scale STANDARD_DEVIATION 1.8	6.6 units on a scale STANDARD_DEVIATION 1.8
Brief Pain Inventory (BPI) Total Score	6.3 units on a scale STANDARD_DEVIATION 1.7	6.4 units on a scale STANDARD_DEVIATION 1.7	6.4 units on a scale STANDARD_DEVIATION 1.7
Cocaine use history Current use	4 Participants	6 Participants	2 Participants
Cocaine use history None	69 Participants	127 Participants	58 Participants
Cocaine use history Past use	66 Participants	144 Participants	78 Participants
Cocaine use history Unknown	0 Participants	1 Participants	1 Participants
Currently taking any anti-HIV medications No	4 Participants	6 Participants	2 Participants
Currently taking any anti-HIV medications Unknown	0 Participants	1 Participants	1 Participants
Currently taking any anti-HIV medications Yes	135 Participants	271 Participants	136 Participants
Detectable viral load, >200 copies/mL No	120 Participants	236 Participants	116 Participants
Detectable viral load, >200 copies/mL Unknown	13 Participants	28 Participants	15 Participants
Detectable viral load, >200 copies/mL Yes	6 Participants	14 Participants	8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants	3 Participants	1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	137 Participants	275 Participants	138 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Multisite pain (>3 sites of pain) No	32 Participants	62 Participants	30 Participants
Multisite pain (>3 sites of pain) Yes	107 Participants	216 Participants	109 Participants
Pain locations Abdominal	31 Participants	61 Participants	30 Participants
Pain locations Headache	39 Participants	82 Participants	43 Participants
Pain locations Hip	64 Participants	131 Participants	67 Participants
Pain locations Knee	75 Participants	150 Participants	75 Participants
Pain locations Lower back	109 Participants	210 Participants	101 Participants
Pain locations Numbness or tingling in hands and/or feet	75 Participants	146 Participants	71 Participants
Pain locations Other	65 Participants	135 Participants	70 Participants
Pain locations Pain everywhere in the body	28 Participants	56 Participants	28 Participants
Pain locations Shoulder	64 Participants	121 Participants	57 Participants
Race/Ethnicity, Customized Black or African American	107 Participants	225 Participants	118 Participants
Race/Ethnicity, Customized Other or American Indian/Alaska Native	5 Participants	7 Participants	2 Participants
Race/Ethnicity, Customized White	27 Participants	46 Participants	19 Participants
Region of Enrollment United States	139 participants	278 participants	139 participants
Sex: Female, Male Female	67 Participants	132 Participants	65 Participants
Sex: Female, Male Male	72 Participants	146 Participants	74 Participants
Site University of Alabama at Birmingham	67 Participants	139 Participants	72 Participants
Site University of North Carolina-Chapel Hill	72 Participants	139 Participants	67 Participants
Taken an opioid or narcotic for pain for 3 months or more No	106 Participants	213 Participants	107 Participants
Taken an opioid or narcotic for pain for 3 months or more Yes	33 Participants	65 Participants	32 Participants
The Pain Catastrophizing Scale (PCS)	39.8 units on a scale STANDARD_DEVIATION 13.5	39.8 units on a scale STANDARD_DEVIATION 13.7	39.9 units on a scale STANDARD_DEVIATION 14
The Pain, Enjoyment and General Activity (PEG) scale	7.4 units on a scale STANDARD_DEVIATION 1.6	7.5 units on a scale STANDARD_DEVIATION 1.6	7.5 units on a scale STANDARD_DEVIATION 1.7
The Pain Self-Efficacy Questionnaire (PSEQ)	34.6 units on a scale STANDARD_DEVIATION 13.4	33.6 units on a scale STANDARD_DEVIATION 14.5	32.5 units on a scale STANDARD_DEVIATION 15.4
The Patient Health Questionnaire-8 (PHQ-8)	9.1 units on a scale STANDARD_DEVIATION 5.6	9.1 units on a scale STANDARD_DEVIATION 5.8	9.1 units on a scale STANDARD_DEVIATION 6.1

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 139	0 / 139
other Total, other adverse events	51 / 139	52 / 139
serious Total, serious adverse events	39 / 139	45 / 139

Outcome results

Primary

Brief Pain Inventory (BPI) Total Score

The Brief Pain Inventory (BPI) is a validated tool measuring pain severity and its impact on daily functioning. It includes 11 items assessing pain severity (worst, least, average, current) and pain interference with general activity, mood, walking, work, relations with others, sleep, and enjoyment of life. Each item is rated from 0 (no pain/no interference) to 10 (worst pain imaginable/complete interference). The Pain Severity Subscore (0-10) is the average of four severity items, the Functional Interference Subscore (0-10) is the average of seven interference items, and the Total Score (0-10) is the average of all 11 items. Higher scores indicate worse pain severity and greater pain interference.