Randomized Controlled Trial of a Cognitive-Behavioral Intervention for HIV-Positive Persons: An Investigation of Treatment Effects on Psychosocial Adjustment
Questions remain regarding the clinical utility of psychological interventions for HIV-positive persons because randomized controlled trials have utilized stringent inclusion criteria and focused extensively on gay men. The present randomized controlled trial examined the efficacy of a 15-session, individually delivered cognitive-behavioral intervention (n = 467) compared to a wait-list control (n = 469) in a diverse sample of HIV-positive persons who reported HIV transmission risk behavior. Five intervention sessions that dealt with executing effective coping responses were delivered between baseline and the 5 months post-randomization. Additional assessments were completed through 25 months post-randomization. Despite previously documented reductions in HIV transmission risk, no intervention-related changes in psychosocial adjustment were observed across the 25-month investigation period. In addition, there were no intervention effects on psychosocial adjustment among individuals who presented with mild to moderate depressive symptoms. More intensive mental health interventions may be necessary to improve psychosocial adjustment among HIV-positive individuals.
KeywordsAIDS Anxiety Depression HIV Intervention Positive affect
This research was funded by National Institute of Mental Health grants U10-MH57636, U10- MH57631, U10-MH57616, and U10-MH57615; and NIMH center grants P30-MH058107 (Mary Jane Rotheram-Borus, Ph.D., PI), P30-MH57226 (Jeffrey A. Kelly, Ph.D., PI), P30-MH43520 (Anke A. Ehrhardt, Ph.D., PI), and P30-MH062246 (Thomas J. Coates, Ph.D., PI). Additional support was provided by a Ruth L. Kirschstein National Research Service Award (T32-MH019391).
The authors thank those at NIMH: Ellen Stover, Ph.D, and Willo Pequegnat, Ph.D., for their technical assistance in developing the study and Christopher M. Gordon, Ph.D., and Dianne Rausch, Ph.D., for their support of this research. Gratitude is also given to Susan Tross, Ph.D. and Gary Dowsett, Ph.D. for methodological guidance; to the assessors in each city who conducted the interviews, to our clinic and community based organization collaborators, to all other support staff involved in the project, and to the men and women who participated in the interviews.
This study was conducted by the NIMH Healthy Living Trial Group. Research Steering Committee (site principal investigators and NIMH staff collaborator): Margaret A. Chesney, Ph.D.1, Anke A. Ehrhardt, Ph.D.2, Jeffrey A. Kelly, Ph.D.3, Willo Pequegnat, Ph.D.4, Mary Jane Rotheram-Borus, Ph.D.5 Collaborating Scientists, Co-Principal Investigators, and Investigators: Eric G. Benotsch, Ph.D.3, Michael J. Brondino, Ph.D.3, Sheryl L. Catz, Ph.D.3, Edwin D. Charlebois, Ph.D., M.P.H.1, Don C. DesJarlais, Ph.D.6, Naihua Duan, Ph.D.5, Theresa M. Exner, Ph.D.2, Rise B. Goldstein, Ph.D., M.P.H.5, Cheryl Gore-Felton, Ph.D.3, A. Elizabeth Hirky, Ph.D.2, Mallory O. Johnson, Ph.D.1, Robert M. Kertzner, M.D.2, Sheri B. Kirshenbaum, Ph.D.2, Lauren E. Kittel, Psy.D.2, Robert Klitzman, M.D.2, Martha Lee, Ph.D.5, Bruce Levin, Ph.D.2, Marguerita Lightfoot, Ph.D.5, Stephen F. Morin, Ph.D.1, Steven D. Pinkerton, Ph.D.3, Robert H. Remien, Ph.D.2, Fen Rhodes, Ph.D.5, Susan Tross, Ph.D.2, Lance S. Weinhardt, Ph.D.3, Robert Weiss, Ph.D.5, Hannah Wolfe, Ph.D.7, Rachel Wolfe, Ph.D.7, Lennie Wong, Ph.D.5 Data Management and Analytic Support: Philip Batterham, M.A.5, Tyson Rogers, M.A.5 Site Project Coordinators: Kristin Hackl, M.S.W.3, Daniel Hong, M.A.5, Karen Huchting, B.A.5, Joanne D. Mickalian, M.A.1, Margaret Peterson, M.S.W.3, NIMH: Christopher M. Gordon, Ph.D.4, Dianne Rausch, Ph.D.4, Ellen Stover, Ph.D.4
1 University of California, San Francisco; 2 New York State Psychiatric Institute/Columbia University, New York; 3 Medical College of Wisconsin, Milwaukee; 4 National Institute of Mental Health, Bethesda, Maryland; 5 University of California, Los Angeles; 6 Beth Israel Medical Center, New York; 7 St. Luke’s-Roosevelt Medical Center, New York.
- Antoni, M. H., Carrico, A. W., Duran, R. E., Spitzer, S., Penedo, F., Ironson, G., et al. (2006). Randomized clinical trial of cognitive behavioral stress management on human immunodeficiency virus viral load in gay men treated with highly active antiretroviral therapy. Psychosomatic Medicine, 68, 143–151. doi: 10.1097/01.psy.0000195749.60049.63.PubMedCrossRefGoogle Scholar
- Antoni, M. H., Cruess, D. G., Klimas, N., Carrico, A. W., Maher, K., Cruess, S., et al. (2005). Increases in a marker of immune system reconstitution are predated by decreases in 24-h urinary cortisol output and depressed mood during a 10-week stress management intervention in symptomatic HIV-infected men. Journal of Psychosomatic Research, 58, 3–13. doi: 10.1016/j.jpsychores.2004.05.010.PubMedCrossRefGoogle Scholar
- Bing, E. G., Burnam, M. A., Longshore, D., Fleishman, J. A., Sherbourne, C. D., London, A. S., et al. (2001). Psychiatric disorders and drug use among human immunodeficiency virus-infected adults in the United States. Archives of General Psychiatry, 58, 721–728. doi: 10.1001/archpsyc.58.8.721.PubMedCrossRefGoogle Scholar
- Carrico, A. W., Antoni, M. H., Duran, R. E., Ironson, G., Penedo, F., Fletcher, M. A., et al. (2006). Reductions in depressed mood and denial coping during cognitive behavioral stress management with HIV-Positive gay men treated with HAART. Annals of Behavioral Medicine, 31, 155–164. doi: 10.1207/s15324796abm3102_7.PubMedCrossRefGoogle Scholar
- Chesney, M. A., Chambers, D. B., Taylor, J. M., Johnson, L. M., & Folkman, S. (2003). Coping effectiveness training for men living with HIV: results from a randomized clinical trial testing a group-based intervention. Psychosomatic Medicine, 65(6), 1038–1046. doi: 10.1097/01.PSY.0000097344.78697.ED.PubMedCrossRefGoogle Scholar
- Crepaz, N., Passin, W. F., Herbst, J. H., Rama, S. M., Malow, R. M., Purcell, D. W., et al. (2008). Meta-analysis of cognitive-behavioral interventions on HIV-positive persons’ mental health and immune functioning. Health Psychology, 27(1), 4–14. doi: 10.1037/0278-6188.8.131.52.PubMedCrossRefGoogle Scholar
- Dimidjian, S., Hollon, S. D., Dobson, K. S., Schmaling, K. B., Kohlenberg, R. J., Addis, M. E., et al. (2006). Randomized trial of behavioral activation, cognitive therapy, and antidepressant medication in the acute treatment of adults with major depression. Journal of Consulting and Clinical Psychology, 74(4), 658–670. doi: 10.1037/0022-006X.74.4.658.PubMedCrossRefGoogle Scholar
- Gore-Felton, C., Rotheram-Borus, M. J., Weinhardt, L. S., Kelly, J. A., Lightfoot, M., & Kirshenbaum, S. B. (2005). The healthy living project: An individually tailored, multidimensional intervention for HIV-infected persons. AIDS Education and Prevention, 17(Supp. A), 21–39. doi: 10.1521/aeap.184.108.40.206691.PubMedCrossRefGoogle Scholar
- Healthy Living Project Team. (2007). Effects of a behavioral intervention to reduce risk of transmission among people living with HIV: The healthy living project randomized controlled study. Journal of Acquired Immune Deficiency Syndromes, 44, 213–221. doi: 10.1097/QAI.0b013e31802c0cae.CrossRefGoogle Scholar
- Heckman, T. G., Anderson, E. S., Sikkema, K. J., Kochman, A., Kalichman, S. C., & Anderson, T. (2004). Emotional distress in nonmetropolitan persons living with HIV disease enrolled in a telephone-delivered, coping improvement group intervention. Health Psychology, 23(1), 94–100. doi: 10.1037/0278-6220.127.116.11.PubMedCrossRefGoogle Scholar
- Johnson, M. O., Catz, S. L., Remien, R. H., Rotheram-Borus, M. J., Morin, S. F., Charlebois, E., et al. (2003). Theory-guided, empirically supported avenues for intervention on HIV medication nonadherence: Findings from the Healthy Living Project. AIDS Patient Care and STDs, 17(12), 645–656. doi: 10.1089/108729103771928708.PubMedCrossRefGoogle Scholar
- Markowitz, J. C., Kocsis, J. H., Fishman, B., Spielman, L. A., Jacobsberg, L. B., Frances, A. J., et al. (1998). Treatment of depressive symptoms in human immunodeficiency virus-positive patients. Archives of General Psychiatry, 55(5), 452–457. doi: 10.1001/archpsyc.55.5.452.PubMedCrossRefGoogle Scholar
- Safren, S., O’Cleirigh, C., Tan, J., Raminani, S., Reilly, L., Otto, M. W., et al. (in press). Cognitive behavioral therapy for adherence and depression (CBT-AD) in HIV-infected individuals. Health Psychology.Google Scholar
- Sikkema, K. J., Hansen, M. B., Meade, C. S., Kochman, A., & Fox, A. M. (2007). Psychosocial predictors of sexual HIV transmission risk behavior among HIV-positive adults with a sexual abuse history in childhood. Archives of Sexual Behavior. doi: 10.1007/s10508-007-9238-4.
- Spielberger, C., Gorsuch, R., & Lushene, R. (1974). STAI manual for the state-trait anxiety inventory. Palo Alto: CA Consulting Psychologists Press.Google Scholar
- Ware, J. (1993). SF-36 health survey: Manual and interpretation guide. Lincoln, RI: Quality Metric.Google Scholar
- Weaver, K. E., Llabre, M. M., Duran, R. E., Antoni, M. H., Ironson, G., Penedo, F. J., et al. (2005). A stress and coping model of medication adherence and viral load in HIV-positive men and women on highly active antiretroviral therapy (HAART). Health Psychology, 24(4), 385–392. doi: 10.1037/0278-618.104.22.1685.PubMedCrossRefGoogle Scholar
- Weinhardt, L. S., Kelly, J. A., Brondino, M. J., Rotheram-Borus, M. J., Kirshenbaum, S. B., & Chesney, M. A. (2004). HIV transmission risk behavior among men and women: Living with HIV in Four U.S. cities. Journal of Acquired Immune Deficiency Syndromes, 36(5), 1057–1066. doi: 10.1097/00126334-200408150-00009.PubMedCrossRefGoogle Scholar