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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH115754-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Alabama at Birmingham | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
| University of North Carolina, Chapel Hill | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Skills to Manage Pain (STOMP) | Experimental | 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. |
|
| comparison group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Skills TO Manage Pain (STOMP) | Behavioral | 12 week pain self management (PSM) intervention incorporating social cognitive theory constructs. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately postintervention and 3-month follow-up (postintervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Pain Inventory (BPI) Functional Interference Subscore | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica Merlin, MD PhD MBA | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 352940 | United States | ||
| University of North Carolina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22766967 | Background | Merlin JS, Westfall AO, Raper JL, Zinski A, Norton WE, Willig JH, Gross R, Ritchie CS, Saag MS, Mugavero MJ. Pain, mood, and substance abuse in HIV: implications for clinic visit utilization, antiretroviral therapy adherence, and virologic failure. J Acquir Immune Defic Syndr. 2012 Oct 1;61(2):164-70. doi: 10.1097/QAI.0b013e3182662215. | |
| 28880698 | Background | Merlin JS, Westfall AO, Johnson MO, Kerns RD, Bair MJ, Kertesz S, Turan JM, Clay OJ, Starrels JL, Kilgore M. Cost-effectiveness of a chronic pain intervention for people living with HIV (PLWH). J Med Econ. 2018 Feb;21(2):122-126. doi: 10.1080/13696998.2017.1377719. Epub 2017 Sep 18. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Immediately postintervention and 3-month follow-up (postintervention) |
|
2 years, 7 months
Participants reported adverse events (AEs) during routine assessments and indicated if they were study-related. Study-related AEs were adjudicated by the site PI. All AEs were reported and reviewed in meetings. Events were classified by type (hospitalization, illness, injury) and grouped by severity: mild, moderate, severe, or very severe (see Adverse Event Term Additional Description). AEs were recorded based on participant descriptions rather than predefined Adverse Event Terms.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Very Severe | General disorders | Systematic Assessment | Life-threatening, disabling, fatal event |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Moderate | General disorders | Systematic Assessment | Event resolved with treatment; normal activities conducted with some limitations. |
Limitations include a specific population (people with HIV and chronic pain), limiting generalizability to other groups. Short follow-up (3 months) restricts insight into long-term effects. Women were slightly underrepresented, reducing applicability to chronic pain populations where women are more common. Participants were not blinded, possibly introducing bias, though staff and investigators remained blinded. Addressing these in future trials can improve applicability and robustness.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jessica Merlin | University of Pittsburgh | (412) 383-0617 | merlinjs@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 1, 2019 | Mar 1, 2025 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
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| Comparison group | Behavioral | Participants in this arm will receive usual care as given by providers but no behavioral PSM intervention. |
|
|
| Immediately postintervention and 3-month follow-up (postintervention) |
| Brief Pain Inventory (BPI) Pain Severity Subscore | 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. | Immediately postintervention and 3-month follow-up (postintervention) |
| The Pain, Enjoyment and General Activity (PEG) Scale | 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. | Immediately postintervention and 3-month follow-up (postintervention) |
| The Pain Self-Efficacy Questionnaire (PSEQ) | 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. | Immediately postintervention and 3-month follow-up (postintervention) |
| The Patient Health Questionnaire-8 (PHQ-8) | 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. | Immediately postintervention and 3-month follow-up (postintervention) |
| The Pain Catastrophizing Scale (PCS) | 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. | Immediately postintervention and 3-month follow-up (postintervention) |
| Chapel Hill |
| North Carolina |
| 27599 |
| United States |
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| 40748350 | Derived | McGill LS, Clay OJ, Edwards KA, Jones KF, Long DM, Johnson MO, Bair MJ, Browne LE, Liebschutz JM, Demonte W, Agil D, Burkholder G, Durr AL, Farel CE, Johnson B, Orris SM, Napravnik S, Thomas T, Merlin JS. Trajectories of Pain Impact and Pain Self-Efficacy in People With HIV and Chronic Pain: Extending Findings From the Skills TO Manage Pain Randomized Clinical Trial. J Acquir Immune Defic Syndr. 2025 Dec 1;100(4):347-354. doi: 10.1097/QAI.0000000000003739. |
| 40530923 | Derived | Edwards KA, Long D, Jones KF, Durr AL, Farel CE, Liebschutz JM, Bair MJ, Agil D, Napravnik S, Browne L, Johnson B, Thomas T, Burkholder G, Clay OJ, Demonte W, Orris SM, Johnson MO, Merlin J. The Skills to Manage Pain Randomized Trial: Results of Antiretroviral Therapy Adherence, HIV Primary Care Retention, and Virologic Suppression Outcomes. J Acquir Immune Defic Syndr. 2025 Oct 1;100(2):180-185. doi: 10.1097/QAI.0000000000003706. |
| 40179206 | Derived | Edwards KA, Smith KJ, Jones KF, Bair MJ, Liebschutz JM, McGill LS, Agil D, Johnson MO, Thomas T, Clay OJ, Farel CE, Napravnik S, Long D, Burkholder G, Browne L, Durr AL, Johnson B, Demonte W, Orris SM, Merlin JS. Cost-Effectiveness of a Tailored Pain Self-Management Intervention Compared With Enhanced Usual Care Among People With HIV and Chronic Pain: An Economic Evaluation. J Acquir Immune Defic Syndr. 2025 Aug 1;99(4):341-348. doi: 10.1097/QAI.0000000000003671. |
| 39008317 | Derived | Jones KF, Long DM, Bair MJ, Agil D, Browne L, Burkholder G, Clay OJ, Conder K, Durr AL, Farel CE, King K, Johnson B, Liebschutz JM, Demonte W, Leone M, Mullen L, Orris SM, Thomas T, Johnson M, Napravnik S, Merlin JS. Efficacy of a Pain Self-Management Intervention Tailored to People With HIV: A Randomized Clinical Trial. JAMA Intern Med. 2024 Sep 1;184(9):1074-1082. doi: 10.1001/jamainternmed.2024.3071. |
| 36958702 | Derived | Jones KF, Bair MJ, Orris SM, Johnson M, Liebschutz JM, Demonte W, Clay OJ, Durr AL, Farel CE, Agil D, Burkholder G, Johnson B, Conder K, Leone M, Napravnik S, Thomas T, Browne L, King K, Mullen L, Merlin J. Evaluation of the efficacy and mechanisms of a novel intervention for chronic pain tailored to people with HIV: The STOMP protocol. Contemp Clin Trials. 2023 Jun;129:107163. doi: 10.1016/j.cct.2023.107163. Epub 2023 Mar 21. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Site | Count of Participants | Participants |
|
| Detectable viral load, >200 copies/mL | Count of Participants | Participants |
|
| Currently taking any anti-HIV medications | Count of Participants | Participants |
|
| Brief Pain Inventory (BPI) Total Score | The Brief Pain Inventory measures pain severity and impact on daily functioning. Includes 4 items assessing pain severity (worst/least/average/current) and 7 items assessing pain interference with general activity, mood, walking, work, relations with others, sleep, and life enjoyment. Each item and measure is rated from 0-10 with higher scores indicating worse pain severity and greater pain interference. The Pain Severity Subscore is the average of 4 severity items, the Functional Interference Subscore is the average of 7 interference items, and the Total Score is the average of all 11 items. | Mean | Standard Deviation | units on a scale |
|
| Brief Pain Inventory (BPI) Pain Severity Subscore | The Brief Pain Inventory measures pain severity and impact on daily functioning. Includes 4 items assessing pain severity (worst/least/average/current) and 7 items assessing pain interference with general activity, mood, walking, work, relations with others, sleep, and life enjoyment. Each item and measure is rated from 0-10 with higher scores indicating worse pain severity and greater pain interference. The Pain Severity Subscore is the average of 4 severity items, the Functional Interference Subscore is the average of 7 interference items, and the Total Score is the average of all 11 items. | Mean | Standard Deviation | units on a scale |
|
| Brief Pain Inventory (BPI) Functional Interference Subscore | The Brief Pain Inventory measures pain severity and impact on daily functioning. Includes 4 items assessing pain severity (worst/least/average/current) and 7 items assessing pain interference with general activity, mood, walking, work, relations with others, sleep, and life enjoyment. Each item and measure is rated from 0-10 with higher scores indicating worse pain severity and greater pain interference. The Pain Severity Subscore is the average of 4 severity items, the Functional Interference Subscore is the average of 7 interference items, and the Total Score is the average of all 11 items. | Mean | Standard Deviation | units on a scale |
|
| Taken an opioid or narcotic for pain for 3 months or more | Count of Participants | Participants |
|
| Multisite pain (>3 sites of pain) | Count of Participants | Participants |
|
| Pain locations | Count of Participants | Participants |
|
| Cocaine use history | Count of Participants | Participants |
|
| The Pain, Enjoyment and General Activity (PEG) scale | 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. | Mean | Standard Deviation | units on a scale |
|
| The Pain Self-Efficacy Questionnaire (PSEQ) | 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. | Mean | Standard Deviation | units on a scale |
|
| The Patient Health Questionnaire-8 (PHQ-8) | 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. | Mean | Standard Deviation | units on a scale |
|
| The Pain Catastrophizing Scale (PCS) | 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. | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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. |
|
|
| Secondary | Brief Pain Inventory (BPI) Functional Interference Subscore | 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. | Posted | Mean | Standard Deviation | score on a scale | Immediately postintervention and 3-month follow-up (postintervention) |
|
|
|
| Secondary | Brief Pain Inventory (BPI) Pain Severity Subscore | 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. | Posted | Mean | Standard Deviation | score on a scale | Immediately postintervention and 3-month follow-up (postintervention) |
|
|
|
| Secondary | The Pain, Enjoyment and General Activity (PEG) Scale | 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. | Posted | Mean | Standard Deviation | score on a scale | Immediately postintervention and 3-month follow-up (postintervention) |
|
|
|
| Secondary | The Pain Self-Efficacy Questionnaire (PSEQ) | 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. | Posted | Mean | Standard Deviation | score on a scale | Immediately postintervention and 3-month follow-up (postintervention) |
|
|
|
| Secondary | The Patient Health Questionnaire-8 (PHQ-8) | 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. | Posted | Mean | Standard Deviation | score on a scale | Immediately postintervention and 3-month follow-up (postintervention) |
|
|
|
| Secondary | The Pain Catastrophizing Scale (PCS) | 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. | Posted | Mean | Standard Deviation | score on a scale | Immediately postintervention and 3-month follow-up (postintervention) |
|
|
|
| 0 |
| 139 |
| 39 |
| 139 |
| 51 |
| 139 |
| EG001 | 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. | 0 | 139 | 45 | 139 | 52 | 139 |
|
| Severe | General disorders | Systematic Assessment | Event required extensive medical attention; unable to carry out normal activities. |
|
|
| Mild | General disorders | Systematic Assessment | Event required no or minimal treatment; able to carry out normal activities |
|
Not provided
Not provided
Not provided