Advertisement

Heterogeneity of Treatment Effects in a Randomized Trial of Literacy-Adapted Group Cognitive-Behavioral Therapy, Pain Psychoeducation, and Usual Medical Care for Multiply Disadvantaged Patients With Chronic Pain

      Highlights

      • More disadvantaged patients benefited more from cognitive-behavioral therapy.
      • Patients with higher literacy benefited from both psychosocial treatments.
      • Patients with higher working memory benefited from both psychosocial treatments.
      • Patients with higher education benefited from both psychosocial treatments.
      • Simplifying cognitive-behavioral therapy reduces outcome disparities.

      Abstract

      Differences among patients can moderate the impact of evidence-based treatments (ie, heterogeneity of treatment effects), leading patients to get more or less benefit. The Learning About My Pain study was a randomized, comparative effectiveness trial of a 10-week literacy-adapted group cognitive-behavioral therapy for chronic pain (CBT) versus pain psychoeducation groups (EDU) versus usual medical care. We examined potential sociodemographic and cognitive moderators of treatment effect among participants with post-treatment assessments (N = 241). Analyses were conducted using moderation in the PROCESS macro in SPSS and significant interactions were explored further. Education and primary literacy moderated the difference between CBT and EDU on pain intensity, and primary literacy, health literacy, and working memory moderated the difference between CBT and EDU on pain interference. Analyses revealed few significant moderation effects relative to usual medical care. No moderators were identified for depression. Neither sex nor minority status moderated any differences between groups. Patients with lower education, literacy, and working memory gained more benefit from CBT than EDU. When provided sufficient guidance and structure in a way that is meaningfully adapted, highly disadvantaged patients achieved as much benefit as less disadvantaged patients, suggesting that the literacy-adapted CBT more successfully met the needs of this population.

      Trial registration

      clinicaltrials.gov identifier NCT01967342

      Perspective

      This article presents findings related to heterogeneity of treatment effects for simplified group psychosocial treatments for chronic pain. The results suggest that educationally, cognitively, or literacy disadvantaged patients benefit most from the more structured approach of literacy-adapted CBT rather than EDU, whereas less disadvantaged patients benefit from either treatment.

      Key words

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to The Journal of Pain
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Alschuler KN.
        • Jensen MP.
        • Ehde DM
        Defining mild, moderate, and severe pain in persons with multiple sclerosis.
        Pain Med. 2012; 13: 1358-1365
        • Baker D.W.
        • Williams M.V.
        • Parker R.M.
        • Gazmararian J.A
        Development of a brief test to measure functional health literacy.
        Patient Educ Counsel. 1999; 38: 33-42
        • Bann C.M.
        • McCormack L.A.
        • Berkman N.D.
        • Squiers L.B
        The health literacy skills instrument: A 10-item short form.
        J Health Commun. 2012; 17: 191-202
        • Bartley E.J.
        • Fillingim R.B.
        Sex differences in pain: A brief review of clinical and experimental findings.
        Br J Anaesthes. 2013.; 111: 52-58
        • Bonham V
        Race, ethnicity, and pain treatment: Striving to understand the causes and solutions to the disparities in pain treatment.
        J Law Med Ethics. 2001; 29: 52-68
        • Braden J.B.
        • Zhang L.
        • Zimmerman F.J.
        • Sullivan M.D
        Employment outcomes of persons with a mental disorder and comorbid chronic pain.
        Psychiatr Serv. 2008; 59: 78-885https://doi.org/10.1176/appi.ps.59.8.878
        • Breivik H.
        • Collett B.
        • Ventafridda V.
        • Cohen R.
        • Gallacher D
        Survey of chronic pain in Europe: Prevalence, impact on daily life, and treatment.
        Eur J Pain. 2006; 10: 287-333
        • Busse J.W.
        • Craigie S.
        • Juurlink D.N.
        • Buckley D.N.
        • Wang L.
        • Couban R.J.
        • Guyatt G.H
        Guideline for opioid therapy and chronic noncancer pain.
        CMAJ. 2017; 18: 659https://doi.org/10.1503/cmaj.170363
        • Carr J.L.
        • Moffett J.K.
        The impact of social deprivation on chronic back pain outcomes.
        Chronic Illness. 2005; 1: 121-129https://doi.org/10.1179/174239505X44826
        • Cherkin D.C.
        • Sherman K.J.
        • Balderson B.H.
        • Cook A.J.
        • Anderson M.L.
        • Hawkes R.J.
        • Turner J.A.
        Effect of mindfulness-based stress reduction vs cognitive behavioral therapy or usual care on back pain and functional limitations in adults with chronic low back pain: A randomized clinical trial.
        JAMA. 2016; 315: 1240-1249https://doi.org/10.1001/jama.2016.2323
        • Cleeland CS
        • Ryan KM
        Pain assessment: Global use of the Brief Pain Inventory.
        Ann Acad Med Singapore. 1994; 23: 129-138
        • Closs S.J.
        • Staples V.
        • Reid I.
        • Bennett M.I.
        • Briggs M.
        The impact of neuropathic pain on relationships.
        J Adv Nurs. 2009; 65: 402-411https://doi.org/10.1111/j.1365-2648.2008.04892.x
        • Day M.A.
        • Thorn B.E.
        The relationship of demographic and psychosocial variables to pain-related outcomes in a rural chronic pain population.
        Pain. 2010; 151: 467-474
        • Eccleston C.
        • Williams A.D.C.
        • Morley S.
        Psychological therapies for the management of chronic pain (excluding headache) in adults.
        Cochrane Database Syst Rev. 2009; 2: 11
        • Ehde D
        • Jensen M
        • Engel J
        • Hanley M
        • Raichle K
        • Osborne T
        Education Intervention Therapist Manual: Project II: Role of Catastrophizing in Chronic Pain.
        University of Washington, Seattle2005
        • Ehde D.M.
        • Dillworth T.M.
        • Turner J.A.
        Cognitive-behavioral therapy for individuals with chronic pain: Efficacy, innovations, and directions for research.
        Am Psychol. 2014; 69: 153-166
        • Erdemoglu A.K.
        • Koc R
        Brief Pain Inventory score identifying and discriminating neuropathic and nociceptive pain.
        Acta Neurol Scand. 2013; 128: 351-358
        • Eyer J.C.
        • Thorn B.E.
        The Learning About My Pain study protocol: Reducing disparities with literacy-adapted psychosocial treatments for chronic pain, a comparative behavioral trial.
        J Health Psychol. 2016; 21: 2063-2074
        • Gerdle B.
        • Björk J.
        • Cöster L.
        • Henriksson K.
        • Henriksson C.
        • Bengtsson A.
        Prevalence of widespread pain and associations with work status: A population study.
        BMC Musculoskel Disord. 2008.; 9: 102
        • Green C.R.
        • Hart-Johnson T.
        The association between race and neighborhood socioeconomic status in younger Black and White adults with chronic pain.
        J Pain. 2012; 13: 176-186https://doi.org/10.1016/j.jpain.2011.10.008Fill
        • Guzys D.
        • Kenny A.
        • Dickson-Swift V.
        • Threlkeld G.
        A critical review of population health literacy assessment.
        BMC Public Health. 2015; 15: 215https://doi.org/10.1186/s12889-015-1551-6
      1. Hayes AF: Introduction to mediation, moderation, and conditional process analysis: A regression-based approach (2nd ed.), New York, Guilford Press, 2017

        • Hayes A.F.
        • Rockwood N.J.
        Regression-based statistical mediation and moderation analysis in clinical research: Observations, recommendations, and implementation.
        Behav Res Ther. 2017; 98: 39-57
        • Hedges LV
        Effect sizes in cluster-randomized designs.
        J Educ Behav Stat. 2007; 32: 341-370
        • Hughes L.S.
        • Clark J.
        • Colclough J.A.
        • Dale E.
        • McMillan D
        Acceptance and commitment therapy (ACT) for chronic pain: A systematic review and meta-analyses.
        Clin J Pain. 2017; 33: 552-568https://doi.org/10.1097/AJP.0000000000000425
        • IBM Corporation
        SPSS Statistics for Mac, version 24.0.
        IBM Corporation, Armonk, NY2016
        • Institute of Medicine [IOM]
        Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research.
        The National Academies Press, Washington, DC2011
        • Johannes C.B.
        • Le T.K.
        • Zhou X.
        • Johnston J.A.
        • Dworkin R.H.
        The prevalence of chronic pain in United States adults: Results of an Internet-based survey.
        J Pain. 2010; 11: 1230-1239
        • Keefe F.J.
        • Buffington A.L.
        • Studts J.L.
        • Rumble M.E.
        Behavioral medicine: 2002 and beyond.
        J Consult Clin Psychol. 2002; 70: 852
        • Kennedy B.M.
        • Paeratakul S.
        • Ryan D.H.
        • Bray G.A.
        Socioeconomic status and health disparity in the United States.
        J Human Behav Soc Environ. 2007; 15: 13-23https://doi.org/10.1300/J137v15n02_02
        • Keogh E.
        • Bond F.W.
        • Hanmer R.
        • Tilston J.
        Comparing acceptance- and control-based coping instructions on the cold-pressor pain experiences of healthy men and women.
        Eur J Pain. 2005; 9 (591–591.)
        • Kessler R.C.
        • van Loo H.M.
        • Wardenaar K.J.
        • Bossarte R.M.
        • Brenner L.A.
        • Ebert D.D.
        • Zaslavsky A.M.
        Using patient self-reports to study heterogeneity of treatment effects in major depressive disorder.
        Epidemiol Psychiatr Sci. 2017; 26: 22-36https://doi.org/10.1017/S2045796016000020
        • Kroenke K
        • Spitzer RL
        • Williams JB
        The PHQ-9: Validity of a brief depression severity measure.
        J Gen Intern Med. 2001; 16: 606-613
        • Kuhajda M.C.
        • Thorn B.E.
        • Gaskins S.W.
        • Day M.A.
        • Cabbil C.M.
        Literacy and cultural adaptations for cognitive behavioral therapy in a rural pain population.
        Transl Behav Med. 2011; 1: 216-223
        • Leo R.J
        Chronic pain and comorbid depression.
        Curr Treat Option Neurol. 2005; 7: 403-412
        • Lezak MD
        Neuropsychological Assessment.
        Oxford University Press, New York1995
        • Li K.K.
        • Harris K.
        • Hadi S.
        • Chow E.
        What should be the optimal cut points for mild, moderate, and severe pain?.
        J Palliat Med. 2007; 10: 1338-1346
        • McCracken L.M.
        • Turk D.C.
        Behavioral and cognitive–behavioral treatment for chronic pain: Outcome, predictors of outcome, and treatment process.
        Spine. 2002; 27: 2564-2573
        • Means-Christensen A.J.
        • Roy-Byrne P.P.
        • Sherbourne C.D.
        • Craske M.G.
        • Stein M.B.
        Relationships among pain, anxiety, and depression in primary care.
        Depression Anxiety. 2008; 25: 593-600https://doi.org/10.1002/da.20342
        • Newman A.K.
        • Van Dyke B.P.
        • Torres C.A.
        • Baxter J.W.
        • Eyer J.C.
        • Kapoor S.
        • Thorn B.E.
        The relationship of sociodemographic and psychological variables with chronic pain variables in a low-income population.
        Pain. 2017; 158: 1687-1696
        • Nicassio P.M.
        • Meyerowitz B.E.
        • Kerns R.D.
        The future of health psychology interventions.
        Health Psychol. 2004; 23: 132
        • Pfeiffer E.
        A short portable mental status questionnaire for the assessment of organic brain deficit in elderly patients.
        J Am Geriatr Soc. 1975; 23: 433-441
        • Pieh C.
        • Altmeppen J.
        • Neumeier S.
        • Loew T.
        • Angerer M.
        • Lahmann C.
        Gender differences in outcomes of a multimodal pain management program.
        Pain. 2012.; 153: 197-202
        • Saper R.B.
        • Lemaster C.
        • Delitto A.
        • Sherman K.J.
        • Herman P.M.
        • Sadikova E.
        • Roseen E.J.
        Yoga, physical therapy, or education for chronic low back pain: A randomized noninferiority trial.
        Ann Intern Med. 2017; 167: 85-94
        • Shi Q.
        • Mendoza T.R.
        • Dueck A.C.
        • Ma H.
        • Zhang J.
        • Qian Y.
        • Cleeland C.S.
        Determination of mild, moderate, and severe pain interference in patients with cancer.
        Pain. 2017; 158: 1108-1112
        • Simon C.B.
        • Lentz T.A.
        • Bishop M.D.
        • Riley III, J.L.
        • Fillingim R.B.
        • George S.Z.
        Comparative associations of working memory and pain catastrophizing with chronic low back pain intensity.
        Phys Ther. 2016; 96: 1049-1056
        • Tait R.C.
        • Chibnall J.T.
        • Krause S.
        The pain disability index: Psychometric properties.
        Pain. 1990; 40: 171-182
        • Tait R.C.
        • Chibnall J.T.
        Racial/ethnic disparities in the assessment and treatment of pain: Psychosocial perspectives.
        Am Psychol. 2014; 69: 131-141https://doi.org/10.1037/a0035204
        • Thorn B.E.
        Cognitive Therapy for Chronic Pain: A Step-by-Step Guide.
        Guilford Press, New York2004
        • Thorn B.E.
        • Day M.A.
        • Burns J.
        • Kuhajda M.C.
        • Gaskins S.W.
        • Sweeney K.
        • Cabbil C.
        Randomized trial of group cognitive behavioral therapy compared with a pain education control for low-literacy rural people with chronic pain.
        Pain. 2011; 152: 2710-2720
        • Thorn B.E.
        • Eyer J.C.
        • Van Dyke B.P.
        • Torres C.A.
        • Burns J.W.
        • Kim M.
        • Tucker D.H.
        Literacy-adapted cognitive behavioral therapy versus education for chronic pain at low-income clinics.
        Ann Intern Med. 2018; 168: 471-480
        • Turk D.C.
        Clinical effectiveness and cost-effectiveness of treatments for patients with chronic pain.
        Clin J Pain. 2002; 18: 355-365https://doi.org/10.1097/00002508-200211000-00003
        • Turner B.J.
        • Liang Y.
        • Simmonds M.J.
        • Rodriguez N.
        • Bobadilla R.
        • Yin Z.
        Randomized trial of chronic pain self-management program in the community or clinic for low-income primary care patients.
        J Gen Intern Med. 2018.; 33: 668-677
        • Vlaeyen J.S.
        • Linton S.J.
        Fear-avoidance and its consequences in chronic musculoskeletal pain: A state of the art.
        Pain. 2000; 85: 317-332https://doi.org/10.1016/S0304-3959(99)00242-0
        • Vliegenthart J.
        • Noppe G.
        • van Rossum E.F.C.
        • Koper J.W.
        • Raat H.
        • van den Akker E.L.T.
        Socioeconomic status in children is associated with hair cortisol levels as a biological measure of chronic stress.
        Psychoneuroendocrinology. 2016; 65: 9-14
        • Waters G.S.
        • Caplan D.
        The reliability and stability of verbal working memory measures.
        Behav Res Methods Instrum Comput. 2003; 35: 550-564
        • Wilkinson GS
        • Robertson GJ
        Wide Range Achievement Test 4 (WRAT4).
        Psychological Assessment and Resources, Inc, Lutz, FL2006
        • Williams A.C.
        • Eccleston C.
        • Morley S.
        Psychological therapies for the management of chronic pain (excluding headache) in adults.
        Cochrane Database Syst Rev. 2012.; 11: CD007407
        • Zhang Z.
        • Wang C.
        • Nie L.
        • Soon G.
        Assessing the heterogeneity of treatment effects via potential outcomes of individual patients.
        J Roy Stat Soc C Appl Stat. 2013; 62: 687-704