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.
Full Title of Study: “Acceptance and Commitment Therapy to Address the Psychosocial Co-Morbidities of Chronic Pain in Aging People Living With HIV”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: September 1, 2020
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."
- Behavioral: Acceptance and Commitment Therapy (ACT)
- Empirically based behavioral intervention that encourages acceptance of circumstances with commitment and behavioral change strategies to improve psychological flexibility.
- Other: Chronic Pain Education
- Education materials about living with chronic pain developed by Weill Cornell Universitys Translational Research Institute for Pain in Later Life
Arms, Groups and Cohorts
- Experimental: 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.
- Experimental: Education Control
- Consists of eight weekly two hour group chronic pain education sessions led by trained lay personnel and followed by homework.
Clinical Trial Outcome Measures
- Chronic Pain Acceptance Questionnaire (CPAQ)
- Time Frame: 8 weeks
- 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 8.
- Chronic Pain Acceptance Questionnaire
- Time Frame: 4 weeks
- 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 4.
- Brief Pain Inventory Interference subscale
- Time Frame: 8 weeks
- Change in the Brief Pain Inventory (BPI) Interference subscale from week 0 to 8. 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 8.
Participating in This Clinical Trial
- HIV seropositive
- Diagnosis of chronic non cancer pain
- English speaking
- Deemed appropriate for study by primary care provider
- Consents to participation
- Cancer associated pain
- Unwillingness to participate in audio recorded sessions
- Enrollment in hospice
- Moderate to severe neurocognitive deficits (MOCA < 16)
- Currently undergoing other psychotherapy for chronic pain
Gender Eligibility: All
Minimum Age: 50 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- University of California, San Diego
- National Institute on Aging (NIA)
- Provider of Information About this Clinical Study
- Principal Investigator: Maile Young Karris, Associate Professor – University of California, San Diego
- Overall Contact(s)
- Maile Y Karris, MD, 619-543-5039, email@example.com
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.
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. Epub 2004 Aug 16.
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.
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.
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. Review.
Lampe A, Doering S, Rumpold G, Sölder E, Krismer M, Kantner-Rumplmair W, Schubert C, Söllner W. Chronic pain syndromes and their relation to childhood abuse and stressful life events. J Psychosom Res. 2003 Apr;54(4):361-7.
Shippy RA, Karpiak SE. The aging HIV/AIDS population: fragile social networks. Aging Ment Health. 2005 May;9(3):246-54.
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.
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.
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. Erratum in: J Acquir Immune Defic Syndr. 2013 May 1;63(1):e38-9.
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.
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. Review.
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.
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.
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. Review.
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.
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. Review.
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. Review.
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. Review.
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.
Alonso-Fernández M, López-López A, Losada A, González 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.
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.
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.
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.
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.
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.
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.