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| ID | Type | Description | Link |
|---|---|---|---|
| 1R03AG060183-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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Chronic pain impacts a large proportion of aging people living with HIV (aPLWH) and involves factors directly related to HIV (neurotoxicity) and psychosocial co-morbidities common in aPLWH (i.e. social isolation and loneliness). The investigators hypothesize that novel interventions that acknowledge these psychosocial co-morbidities may improve the efficacy of chronic pain management and minimize the use of potentially dangerous medications. This grant proposes to adapt and pilot a pain psychotherapy approach using group acceptance and commitment therapy (ACT) in aPLWH with chronic pain.
Chronic pain affects a very high proportion of aging people living with HIV (aPLWH) and is thought to be related to both direct toxicity of HIV and antiretroviral therapy (ART) and by psychosocial factors that negatively affect pain (i.e. loneliness, HIV stigma). PLWH are also at increased risk for prescription opiate misuse. However as PLWH age, non-opiate medications used for pain can contribute to other negative outcomes such as falls, altered mental status and gastrointestinal bleeding. Thus there is a critical need for the development of novel interventions in the management of chronic pain in aPLWH that consider the psychological co-morbidities of aging with HIV and that can minimize the need for prescription medications. Acceptance and commitment therapy (ACT) has previously been evaluated in older persons with chronic pain and has demonstrated higher levels of satisfaction and efficacy when compared to cognitive behavioral therapy (CBT). ACT has never been evaluated in aPLWH for chronic pain, but has theoretical advantages over CBT for this population. Specifically several negatively modifying factors of CBT efficacy such as cognitive deficits are common in aPLWH.
The overarching objective of this study is to determine the acceptability and feasibility of an ACT intervention for the management of chronic pain adapted to aPLWH. To accomplish this objective the investigators will 1) train lay personnel to perform ACT to determine feasibility of this approach for future implementation, 2) conduct uncontrolled group ACT in aPLWH to generate participant feedback and questionnaire data to inform ACT adaption with the assistance of a steering commitee, and 3) conduct a pilot randomized controlled trial (RCT) evaluating the acceptability of adapted ACT compared to pain education. At completion of this grant the investigators expect to have successfully trained lay personnel to perform group ACT, adapted ACT from quantitative and qualitative data collected from an uncontrolled study of group ACT, and determined whether ACT is acceptable and feasible as an intervention in aPLWH. These expected outcomes may benefit other aging populations with chronic pain that are enriched for psychosocial co-morbidities such as persons who inject drugs, the socioeconomically disadvantaged, and racial or gender minorities. This proposal is aligned with the Office of AIDS Research High Priorities to better understand "HIV-associated comorbidities" which includes pain and to "Reduce Health Disparities in treatment outcomes of those living with HIV/AIDS" and with the National Pain Strategy to "expand investment ... in the development of safe and effective pain treatments."
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acceptance and Commitment Therapy (ACT) | Experimental | The intervention will consists of eight weekly two hour group ACT sessions led by trained lay personnel and followed by homework. ACT is a behavioral therapy. |
|
| Education Control | Experimental | Consists of eight weekly two hour group chronic pain education sessions led by trained lay personnel and followed by homework. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acceptance and Commitment Therapy (ACT) | Behavioral | Empirically based behavioral intervention that encourages acceptance of circumstances with commitment and behavioral change strategies to improve psychological flexibility. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Chronic Pain Acceptance Questionnaire (CPAQ) Week 0 to Week 6 | Change in Chronic Pain Acceptance Questionnaire or CPAQ from study entry to end of intervention. This scale measures acceptance of chronic pain and measures two factors: activity engagement (pursuit of life activities regardless of pain) and pain willingness (recognition that avoidance and control are often unworkable methods of adapting to chronic pain). A total of 20 items represents these two factors and the items are rated on a 7-point scale from 0 (never true) to 6 (always true). Scoring the CPAQ requires adding the summed items for activity engagement and pain willingness for a total score. Thus the range of scores is from 0 (no acceptance) to 120 (full acceptance). Change in scale will be represented by the difference in CPAQ total score from baseline to week 6. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Chronic Pain Acceptance Questionnaire Week 0 to Week 3 | Change in Chronic Pain Acceptance Questionnaire or CPAQ from study entry to end of intervention. This scale measures acceptance of chronic pain and measures two factors: activity engagement (pursuit of life activities regardless of pain) and pain willingness (recognition that avoidance and control are often unworkable methods of adapting to chronic pain). A total of 20 items represents these two factors and the items are rated on a 7-point scale from 0 (never true) to 6 (always true). Scoring the CPAQ requires adding the summed items for activity engagement and pain willingness for a total score. Thus the range of scores is from 0 (no acceptance) to 120 (full acceptance). Change in scale will be represented by the difference in CPAQ total score from baseline to week 3. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AntiViral Research Center | San Diego | California | 92103-8208 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22115794 | Background | Merlin JS, Cen L, Praestgaard A, Turner M, Obando A, Alpert C, Woolston S, Casarett D, Kostman J, Gross R, Frank I. Pain and physical and psychological symptoms in ambulatory HIV patients in the current treatment era. J Pain Symptom Manage. 2012 Mar;43(3):638-45. doi: 10.1016/j.jpainsymman.2011.04.019. Epub 2011 Nov 23. | |
| 15356788 | Background | Silverberg MJ, Gore ME, French AL, Gandhi M, Glesby MJ, Kovacs A, Wilson TE, Young MA, Gange SJ. Prevalence of clinical symptoms associated with highly active antiretroviral therapy in the Women's Interagency HIV Study. Clin Infect Dis. 2004 Sep 1;39(5):717-24. doi: 10.1086/423181. Epub 2004 Aug 16. |
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De-identified individual participant data including quantitative (questionnaires, baseline data) and qualitative (focus group) data will be stored in our secure database and made available to researchers upon request.
Data will be available twelve months after study has ended and for five years.
Contact PI and submission of brief proposal to minimize duplication of effort and ensure research questions are answerable using IPD available.
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All participants were randomized to groups shortly after enrollment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Acceptance and Commitment Therapy (ACT) | The intervention will consists of eight weekly two hour group ACT sessions led by trained lay personnel and followed by homework. ACT is a behavioral therapy. Acceptance and Commitment Therapy (ACT): Empirically based behavioral intervention that encourages acceptance of circumstances with commitment and behavioral change strategies to improve psychological flexibility. |
| FG001 | Education Control | Consists of eight weekly two hour group chronic pain education sessions led by trained lay personnel and followed by homework. Chronic Pain Education: Education materials about living with chronic pain developed by Weill Cornell Universitys Translational Research Institute for Pain in Later Life |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
These participants were randomized, however once the intervention or control started several participants opted to no longer continue
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| ID | Title | Description |
|---|---|---|
| BG000 | Acceptance and Commitment Therapy (ACT) | The intervention will consists of eight weekly two hour group ACT sessions led by trained lay personnel and followed by homework. ACT is a behavioral therapy. Acceptance and Commitment Therapy (ACT): Empirically based behavioral intervention that encourages acceptance of circumstances with commitment and behavioral change strategies to improve psychological flexibility. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Change in Chronic Pain Acceptance Questionnaire (CPAQ) Week 0 to Week 6 | Change in Chronic Pain Acceptance Questionnaire or CPAQ from study entry to end of intervention. This scale measures acceptance of chronic pain and measures two factors: activity engagement (pursuit of life activities regardless of pain) and pain willingness (recognition that avoidance and control are often unworkable methods of adapting to chronic pain). A total of 20 items represents these two factors and the items are rated on a 7-point scale from 0 (never true) to 6 (always true). Scoring the CPAQ requires adding the summed items for activity engagement and pain willingness for a total score. Thus the range of scores is from 0 (no acceptance) to 120 (full acceptance). Change in scale will be represented by the difference in CPAQ total score from baseline to week 6. | Posted | Median | Inter-Quartile Range | score on a scale | 6 weeks |
|
2 years
Adverse events would be defined as events reported by participants and study staff
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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 | Acceptance and Commitment Therapy (ACT) | The intervention will consists of eight weekly two hour group ACT sessions led by trained lay personnel and followed by homework. ACT is a behavioral therapy. Acceptance and Commitment Therapy (ACT): Empirically based behavioral intervention that encourages acceptance of circumstances with commitment and behavioral change strategies to improve psychological flexibility. |
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We hypothesize our ability to recruit and engage participants was impaired by the COVID-19 pandemic. Barriers included halting of non-covid studies, IRB approval for remote delivery of the intervention, disinterest in research participation in the context of COVID, lack of access to reliable internet connectivity and unfamiliarity with video visits.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maile Young Karris | University of California San Diego | 1-619-543-5039 | m1young@health.ucsd.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 | May 22, 2020 | Oct 5, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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Not provided
| ID | Term |
|---|---|
| D064869 | Acceptance and Commitment Therapy |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Chronic Pain Education | Other | Education materials about living with chronic pain developed by Weill Cornell Universitys Translational Research Institute for Pain in Later Life |
|
| 3 weeks |
| Brief Pain Inventory Interference Subscale | Change in the Brief Pain Inventory (BPI) Interference subscale from week 0 to 6. The BPI allows persons to rate the severity of their pain (pain severity subscale) and the degree to which their pain interferes with feeling and function (interference subscale). The severity scale assess pain at its "worst, least, average and now". These 4 items are ranked from 0 (no pain) to 10 (pain as bad as you can imagine). Most commonly single items of "worst" and "average" are used to represent severity. A composite of the four items (mean severity score) is often also presented. Pain interference has 7 items "general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life" and is scored from 0 (does not interfere) to 10 (completely interferes). Pain interference subscale is scored as the mean of the seven interference items. Change in BPI interference subscale will be represented by the difference in mean interference from baseline to week 6. | 6 weeks |
| Change in Pain Education Score | Difference from Week 0 to 6 in proportion of pain knowledge questions answered correctly. | Week 0 to Week 6 |
| 20210870 | Background | Cervia LD, McGowan JP, Weseley AJ. Clinical and demographic variables related to pain in HIV-infected individuals treated with effective, combination antiretroviral therapy (cART). Pain Med. 2010 Apr;11(4):498-503. doi: 10.1111/j.1526-4637.2010.00802.x. Epub 2010 Mar 4. |
| 21174240 | Background | Heaton RK, Franklin DR, Ellis RJ, McCutchan JA, Letendre SL, Leblanc S, Corkran SH, Duarte NA, Clifford DB, Woods SP, Collier AC, Marra CM, Morgello S, Mindt MR, Taylor MJ, Marcotte TD, Atkinson JH, Wolfson T, Gelman BB, McArthur JC, Simpson DM, Abramson I, Gamst A, Fennema-Notestine C, Jernigan TL, Wong J, Grant I; CHARTER Group; HNRC Group. HIV-associated neurocognitive disorders before and during the era of combination antiretroviral therapy: differences in rates, nature, and predictors. J Neurovirol. 2011 Feb;17(1):3-16. doi: 10.1007/s13365-010-0006-1. Epub 2010 Dec 21. |
| 9186019 | Background | Fishbain DA, Cutler R, Rosomoff HL, Rosomoff RS. Chronic pain-associated depression: antecedent or consequence of chronic pain? A review. Clin J Pain. 1997 Jun;13(2):116-37. doi: 10.1097/00002508-199706000-00006. |
| 12670615 | Background | Lampe A, Doering S, Rumpold G, Solder E, Krismer M, Kantner-Rumplmair W, Schubert C, Sollner W. Chronic pain syndromes and their relation to childhood abuse and stressful life events. J Psychosom Res. 2003 Apr;54(4):361-7. doi: 10.1016/s0022-3999(02)00399-9. |
| 16019278 | Background | Shippy RA, Karpiak SE. The aging HIV/AIDS population: fragile social networks. Aging Ment Health. 2005 May;9(3):246-54. doi: 10.1080/13607860412331336850. |
| 22894702 | Background | Balderson BH, Grothaus L, Harrison RG, McCoy K, Mahoney C, Catz S. Chronic illness burden and quality of life in an aging HIV population. AIDS Care. 2013;25(4):451-8. doi: 10.1080/09540121.2012.712669. Epub 2012 Aug 15. |
| 23759460 | Background | Moore RC, Moore DJ, Thompson WK, Vahia IV, Grant I, Jeste DV. A case-controlled study of successful aging in older HIV-infected adults. J Clin Psychiatry. 2013 May;74(5):e417-23. doi: 10.4088/JCP.12m08100. |
| 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. |
| 25107312 | Background | Vijayaraghavan M, Freitas D, Bangsberg DR, Miaskowski C, Kushel MB. Non-medical use of non-opioid psychotherapeutic medications in a community-based cohort of HIV-infected indigent adults. Drug Alcohol Depend. 2014 Oct 1;143:263-7. doi: 10.1016/j.drugalcdep.2014.06.044. Epub 2014 Jul 27. |
| 22112599 | Background | Green TC, McGowan SK, Yokell MA, Pouget ER, Rich JD. HIV infection and risk of overdose: a systematic review and meta-analysis. AIDS. 2012 Feb 20;26(4):403-17. doi: 10.1097/QAD.0b013e32834f19b6. |
| 23551857 | Background | Merlin JS, Zinski A, Norton WE, Ritchie CS, Saag MS, Mugavero MJ, Treisman G, Hooten WM. A conceptual framework for understanding chronic pain in patients with HIV. Pain Pract. 2014 Mar;14(3):207-16. doi: 10.1111/papr.12052. Epub 2013 Apr 1. |
| 26446832 | Background | By the American Geriatrics Society 2015 Beers Criteria Update Expert Panel. American Geriatrics Society 2015 Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. J Am Geriatr Soc. 2015 Nov;63(11):2227-46. doi: 10.1111/jgs.13702. Epub 2015 Oct 8. |
| 8892142 | Background | Keefe FJ, Kashikar-Zuck S, Opiteck J, Hage E, Dalrymple L, Blumenthal JA. Pain in arthritis and musculoskeletal disorders: the role of coping skills training and exercise interventions. J Orthop Sports Phys Ther. 1996 Oct;24(4):279-90. doi: 10.2519/jospt.1996.24.4.279. |
| 1853989 | Background | Sotsky SM, Glass DR, Shea MT, Pilkonis PA, Collins JF, Elkin I, Watkins JT, Imber SD, Leber WR, Moyer J, et al. Patient predictors of response to psychotherapy and pharmacotherapy: findings in the NIMH Treatment of Depression Collaborative Research Program. Am J Psychiatry. 1991 Aug;148(8):997-1008. doi: 10.1176/ajp.148.8.997. |
| 24581630 | Background | McCracken LM, Morley S. The psychological flexibility model: a basis for integration and progress in psychological approaches to chronic pain management. J Pain. 2014 Mar;15(3):221-34. doi: 10.1016/j.jpain.2013.10.014. |
| 24547803 | Background | McCracken LM, Vowles KE. Acceptance and commitment therapy and mindfulness for chronic pain: model, process, and progress. Am Psychol. 2014 Feb-Mar;69(2):178-87. doi: 10.1037/a0035623. |
| 17904260 | Background | Hofmann SG, Asmundson GJG. Acceptance and mindfulness-based therapy: new wave or old hat? Clin Psychol Rev. 2008 Jan;28(1):1-16. doi: 10.1016/j.cpr.2007.09.003. Epub 2007 Sep 18. |
| 21488484 | Background | Prevedini AB, Presti G, Rabitti E, Miselli G, Moderato P. Acceptance and commitment therapy (ACT): the foundation of the therapeutic model and an overview of its contribution to the treatment of patients with chronic physical diseases. G Ital Med Lav Ergon. 2011 Jan-Mar;33(1 Suppl A):A53-63. |
| 26304771 | Background | Alonso-Fernandez M, Lopez-Lopez A, Losada A, Gonzalez JL, Wetherell JL. Acceptance and Commitment Therapy and Selective Optimization with Compensation for Institutionalized Older People with Chronic Pain. Pain Med. 2016 Feb;17(2):264-77. doi: 10.1111/pme.12885. |
| 26216753 | Background | Wetherell JL, Petkus AJ, Alonso-Fernandez M, Bower ES, Steiner AR, Afari N. Age moderates response to acceptance and commitment therapy vs. cognitive behavioral therapy for chronic pain. Int J Geriatr Psychiatry. 2016 Mar;31(3):302-8. doi: 10.1002/gps.4330. Epub 2015 Jul 28. |
| 26997859 | Background | Petkus AJ, M A, Wetherell JL. Acceptance and Commitment Therapy with Older Adults: Rationale and Considerations. Cogn Behav Pract. 2013 Feb;20(1):47-56. doi: 10.1016/j.cbpra.2011.07.004. |
| 21732897 | Background | Moitra E, Herbert JD, Forman EM. Acceptance-based behavior therapy to promote HIV medication adherence. AIDS Care. 2011 Dec;23(12):1660-7. doi: 10.1080/09540121.2011.579945. Epub 2011 Jul 7. |
| 22523308 | Background | Chen EK, Reid MC, Parker SJ, Pillemer K. Tailoring evidence-based interventions for new populations: a method for program adaptation through community engagement. Eval Health Prof. 2013 Mar;36(1):73-92. doi: 10.1177/0163278712442536. Epub 2012 Apr 19. |
| 18562251 | Background | McGrath PJ, Walco GA, Turk DC, Dworkin RH, Brown MT, Davidson K, Eccleston C, Finley GA, Goldschneider K, Haverkos L, Hertz SH, Ljungman G, Palermo T, Rappaport BA, Rhodes T, Schechter N, Scott J, Sethna N, Svensson OK, Stinson J, von Baeyer CL, Walker L, Weisman S, White RE, Zajicek A, Zeltzer L; PedIMMPACT. Core outcome domains and measures for pediatric acute and chronic/recurrent pain clinical trials: PedIMMPACT recommendations. J Pain. 2008 Sep;9(9):771-83. doi: 10.1016/j.jpain.2008.04.007. Epub 2008 Jun 17. |
| BG001 | Education Control | Consists of eight weekly two hour group chronic pain education sessions led by trained lay personnel and followed by homework. Chronic Pain Education: Education materials about living with chronic pain developed by Weill Cornell Universitys Translational Research Institute for Pain in Later Life |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Years living with HIV | Years participant has been living with HIV. Participant reported, at least from date of diagnosis | Median | Inter-Quartile Range | years |
|
| Years on antiretroviral therapy | Years that participant has been taking antiretroviral therapy for HIV | Median | Inter-Quartile Range | years |
|
| Current HIV Viral Load | Viral load is measured in blood and represented as "x" copies/mL. Of note we used "0" for undetectable or < 20 copies/mL | Median | Inter-Quartile Range | HIV copies/mL |
|
| Current CD4 T cell count | CD4+ T cells, total number of cells per m3 | Median | Inter-Quartile Range | cells/m3 |
|
| Veterans Aging Cohort Study Index | The VACS 1.0 Index characterize the 5 year mortality risk in people with HIV. This Index incorporates age, CD4 T cell count, HIV-1 RNA, hemoglobin, Fib-4 index, eGRF, and Hepatitis C coinfection to create a total score (score range 0 to 164). A score of 0 equates to 1.8% predicted all cause 5-year mortality; a 164 has >85.8% predicted all cause 5-year mortality. This means the higher the VACS index the higher the probability of 5-year mortality due to all causes. | Median | Inter-Quartile Range | units on a scale |
|
| Total # pain medications | We added unique medications (prescribed and over the counter) that participants stated they used daily for pain management including opioids, muscle relaxants, medications for neuropathy, NSAIDS, acetaminophen etc. | Median | Inter-Quartile Range | number of medications |
|
| Total # of opioid/opiates prescribed | Total number of unique prescribed opioid/opiates participants were taking. We did not calculate morphine miligram equivalents. | Median | Inter-Quartile Range | total # of opioid/opiates prescribed |
|
| Baseline CPAQ-R Activity Engagement | The 20 item Chronic Pain Acceptance Questionnaire-Revised measures acceptance of pain. There are two factors 1) activity engagement (pursuit of life activities regardless of pain) and 2) pain willingness (the recognition that avoidance and control are often unworkable methods of adapting to chronic pain). Higher scores indicate higher levels of acceptance The activity engagement scale has 11 items each rated from 0 (never true) to 6 (always true). Scores are added and the range of the activity engagement scale is 0 (no acceptance of pain) to 66 (high acceptance of pain). | Median | Inter-Quartile Range | units on a scale |
|
| Baseline CPAQ-R Pain Willingness | The 20 item Chronic Pain Acceptance Questionnaire-Revised measures acceptance of pain in regards to 1) activity engagement (pursuit of life activities regardless of pain) and 2) pain willingness (the recognition that avoidance and control are often unworkable methods of adapting to chronic pain). Higher scores indicate higher levels of acceptance The pain willingness scale includes 9 items and all items are rated from 0 (never true) to 6 (always true). Scores are added and the range is 0 (no acceptance of pain) to 54 (high acceptance of pain). | Median | Inter-Quartile Range | units on a scale |
|
| Baseline CPAQ-R (revised) Total Score | The 20 item Chronic Pain Acceptance Questionnaire-Revised (CPAQ-R) is designed to measure acceptance of pain. There are two factors identified 1) Activity engagement (pursuit of life activities regardless of pain) and 2) pain willingness (the recognition that avoidance and control are often unworkable methods of adapting to chronic pain). Higher scores indicate higher levels of acceptance. Range is 0 (no acceptance) to 120 (high acceptance) | Median | Inter-Quartile Range | units on a scale |
|
| Brief Pain Inventory: Pain Severity (worse) | Brief Pain Inventory (BPI) short form measures two domains 1) pain intensity (severity) and 2) the impact of pain on functioning (interference). The BPI does not have a scoring algorithm. Most researcher use ratings of "worse" and "average" pain scores to describe pain intensity. The range is from 0 (no pain) to 10 (pain as bad as you can imagine. | Median | Inter-Quartile Range | units on a scale |
|
| Brief Pain Inventory: Pain Severity (average) | Brief Pain Inventory (BPI) short form measures two domains 1) pain intensity (severity) and 2) the impact of pain on functioning (interference). The BPI does not have a scoring algorithm. Most researcher use ratings of "worse" and "average" pain scores to describe pain intensity. The range is from 0 (no pain) to 10 (pain as bad as you can imagine. | Median | Inter-Quartile Range | units on a scale |
|
| Brief Pain Inventory: Pain interference | Brief Pain Inventory short form also measures the impact of pain on functioning (interference). Seven questions inquire about the how much pain interferes with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Each of these areas are scored from 0 (does not interfere) to 10 (completely interferes). Pain interference is reported as a mean of these 7 unique areas. | Median | Inter-Quartile Range | units on a scale |
|
| Pain Knowledge Test % Correct | To evaluate the impact or not of the control (pain education) a general pain knowledge test was provided to all participants. We then provide the median of the % of questions that participants answered correctly on the test. | Median | Inter-Quartile Range | % questions answered correctly |
|
The intervention will consists of six weekly two hour group ACT sessions led by trained lay personnel and followed by homework. ACT is a behavioral therapy.
Acceptance and Commitment Therapy (ACT): Empirically based behavioral intervention that encourages acceptance of circumstances with commitment and behavioral change strategies to improve psychological flexibility.
| OG001 | Education Control | Consists of six weekly two hour group chronic pain education sessions led by trained lay personnel and followed by homework. Chronic Pain Education: Education materials about living with chronic pain developed by Weill Cornell Universitys Translational Research Institute for Pain in Later Life |
|
|
| Secondary | Change in Chronic Pain Acceptance Questionnaire Week 0 to Week 3 | Change in Chronic Pain Acceptance Questionnaire or CPAQ from study entry to end of intervention. This scale measures acceptance of chronic pain and measures two factors: activity engagement (pursuit of life activities regardless of pain) and pain willingness (recognition that avoidance and control are often unworkable methods of adapting to chronic pain). A total of 20 items represents these two factors and the items are rated on a 7-point scale from 0 (never true) to 6 (always true). Scoring the CPAQ requires adding the summed items for activity engagement and pain willingness for a total score. Thus the range of scores is from 0 (no acceptance) to 120 (full acceptance). Change in scale will be represented by the difference in CPAQ total score from baseline to week 3. | Posted | Median | Inter-Quartile Range | change in score from 0 to 6 weeks. | 3 weeks |
|
|
|
| Secondary | Brief Pain Inventory Interference Subscale | Change in the Brief Pain Inventory (BPI) Interference subscale from week 0 to 6. The BPI allows persons to rate the severity of their pain (pain severity subscale) and the degree to which their pain interferes with feeling and function (interference subscale). The severity scale assess pain at its "worst, least, average and now". These 4 items are ranked from 0 (no pain) to 10 (pain as bad as you can imagine). Most commonly single items of "worst" and "average" are used to represent severity. A composite of the four items (mean severity score) is often also presented. Pain interference has 7 items "general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life" and is scored from 0 (does not interfere) to 10 (completely interferes). Pain interference subscale is scored as the mean of the seven interference items. Change in BPI interference subscale will be represented by the difference in mean interference from baseline to week 6. | Posted | Median | Inter-Quartile Range | score on a scale | 6 weeks |
|
|
|
| Secondary | Change in Pain Education Score | Difference from Week 0 to 6 in proportion of pain knowledge questions answered correctly. | Posted | Median | Inter-Quartile Range | proportion of correct answers | Week 0 to Week 6 |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Education Control | Consists of eight weekly two hour group chronic pain education sessions led by trained lay personnel and followed by homework. Chronic Pain Education: Education materials about living with chronic pain developed by Weill Cornell Universitys Translational Research Institute for Pain in Later Life | 0 | 3 | 0 | 3 | 0 | 3 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |