Development and pilot-testing of a cognitive behavioral coping skills group intervention for patients with chronic hepatitis C
Open accessAbstract
Psychosocial interventions for patients with chronic hepatitis C viral (HCV) infection are needed to attenuate the impact of extrahepatic symptoms, comorbid conditions, and treatment side effects on HCV health outcomes. We adapted empirically-supported interventions for similar patient populations to develop a Cognitive Behavioral Coping Skills group intervention for HCV patients (CBCS-HCV) undergoing treatment. The objectives of this paper are to describe the research activities associated with CBCS-HCV development and pilot testing, including: (1) formative work leading to intervention development; (2) preliminary study protocol; and (3) pilot feasibility testing of the intervention and study design. Formative work included a literature review, qualitative interviews, and adaption, development, and review of study materials. A preliminary study protocol is described. We evaluate the feasibility of conducting a randomized controlled trial (RCT) of the CBCS-HCV with 12 study participants in Wave 1 testing to examine: (a) feasibility of intervention delivery; (b) patient acceptability; (c) recruitment, enrollment, retention; (d) feasibility of conducting a RCT; (d) therapist protocol fidelity; and (e) feasibility of data collection. Numerous lessons were learned. We found very high rates of data collection, participant attendance, engagement, retention and acceptability, and therapist protocol fidelity. We conclude that many aspects of the CBCS-HCV intervention and study protocol were highly feasible. The greatest challenge during this Wave 1 pilot study was efficiency of participant enrollment due to changes in standard of care treatment. These findings informed two additional waves of pilot testing to examine effect sizes and potential improvements in clinical outcomes, with results forthcoming.
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We have completed two pilot feasibility studies with three waves of participants and examined various elements of feasibility, patient acceptability, and effect size estimates of clinical improvements in PROs that may be achieved with the CBCS-HCV.
“In conclusion, we have completed two pilot feasibility studies with three waves of participants and examined various elements of feasibility, patient acceptability, and effect size estimates of clinical improvements in PROs that may be achieved with the CBCS-HCV [12].”
From Novel patient-reported outcomes (PROs) used in a pilot and feasibility study of a Cognitive Behavioral Coping Skills (CBCS) group intervention for patients with chronic hepatitis C (2018) · cites this paper as [12]
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Experimental — accuracy not yet measuredIn wave 1 pilot testing, patient acceptability was exceptional, therapist protocol fidelity was high, and participation, retention, and data collection were successful.
“Patient acceptability was exceptional, therapist protocol fidelity was high, and participation, retention, and data collection were successful [12].”
The major challenge in wave 1 was enrollment impediments that prevented block randomization due to providers and patients deferring HCV treatment until newer treatment regimens were available.
“The major challenge was enrollment impediments that prevented block randomization due to providers and patients deferring HCV treatment until newer treatment regimens were available.”
The CBCS-HCV pilot and feasibility study findings extend previous work with the initial wave 1 of study participants.
“The CBCS-HCV pilot and feasibility study findings presented here extend our previous work with the initial wave 1 of study participants [12].”
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Cites
A Global Measure of Perceived Stress
Cohen, S., Kamarck, T., & Mermelstein, R. (1983) · Journal of Health and Social Behavior · doi:10.2307/2136404 · Cited by 32,807 · see citing works
Peginterferon Alfa-2a plus Ribavirin for Chronic Hepatitis C Virus Infection
Fried, M. W., Shiffman, M. L., Reddy, K. R., Smith, C. I., Marinos, G., Gonçales, F. L., Häussinger, D., Moisés Diago, M., Carosi, G., Dhumeaux, D., et al. (2002) · New England Journal of Medicine · doi:10.1056/nejmoa020047 · Cited by 6,386 · see citing works
Self-citationCella, D., Riley, W., Stone, A., Rothrock, N., Reeve, B., Yount, S., Amtmann, D., Bode, R., Buysse, D., Choi, S., et al. (2010) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2010.04.011 · Cited by 5,128 · see citing works
Diagnosis, management, and treatment of hepatitis C: An update # † ‡
Ghany, M. G., Strader, D. B., Thomas, D. L., & Seeff, L. B. (2008) · Hepatology · doi:10.1002/hep.22759 · Cited by 2,971 · see citing works
(2003) · Health and Quality of Life Outcomes · doi:10.1186/1477-7525-1-79 · Cited by 1,506 · see citing works
A stage model of behavioral therapies research: getting started and moving on from stage I.
Rounsaville, B. J., Carroll, K. M., & Onken, L. S. (2001) · Clinical Psychology: Science and Practice · doi:10.1093/clipsy.8.2.133 · Cited by 846 · see citing works
Side effects of therapy of hepatitis C and their management
Fried, M. (2002) · Hepatology · doi:10.1053/jhep.2002.36810 · Cited by 727 · see citing works
Self-citationFoster, G. R., Goldin, R. D., & Thomas, H. C. (1998) · Hepatology · doi:10.1002/hep.510270132 · Cited by 565 · see citing works
Side effects of therapy of hepatitis C and their management
Fried, M. (2002) · Hepatology · doi:10.1002/hep.1840360730 · Cited by 557 · see citing works
Self-citationLawitz, E., Poordad, F. F., Pang, P. S., Hyland, R. H., Ding, X. L., Mo, H., Symonds, W. T., McHutchison, J. G., & Membreno, F. E. (2013) · The Lancet · doi:10.1016/s0140-6736(13)62121-2 · Cited by 547 · see citing works
Zeuzem, S., Ghalib, R. H., Reddy, K. R., Pockros, P. J., Ben‐Ari, Z., Zhao, Y., Brown, D. D., Wan, S. M., DiNubile, M. J., Nguyen, B., et al. (2015) · Annals of Internal Medicine · doi:10.7326/m15-0785 · Cited by 512 · see citing works
Psychological, behavioral, and immune changes after a psychological intervention: a clinical trial
Andersen, B. L., Farrar, W. B., Golden-Kreutz, D. M., Glaser, R., Emery, C. F., Crespin, T. R., Shapiro, C. L., & Carson, W. E. (2004) · Journal of Clinical Oncology · doi:10.1200/jco.2004.06.030 · Cited by 416 · see citing works
Safren, S. A., O’Cleirigh, C. M., Tan, J. Y., Raminani, S. R., Reilly, L. C., Otto, M. W., & Mayer, K. H. (2009) · Health Psychology · doi:10.1037/a0012715 · Cited by 394 · see citing works
How Stress Management Improves Quality of Life After Treatment for Breast Cancer.
Antoni, M. H., Lechner, S. C., Kazi, A., Wimberly, S. R., Sifre, T., Urcuyo, K. R., Phillips, K. K., Glück, S., & Carver, C. S. (2006) · Journal of Consulting and Clinical Psychology · doi:10.1037/0022-006x.74.6.1152 · Cited by 350 · see citing works
Behavioral Insomnia Therapy for Fibromyalgia Patients: A Randomized Clinical Trial
Edinger, J. D., Wohlgemuth, W. K., Krystal, A. D., & Rice, J. R. (2005) · Archives of Internal Medicine · doi:10.1001/archinte.165.21.2527 · Cited by 330 · see citing works
Cella, D. F., & Nowinski, C. J. (2002) · Archives of Physical Medicine and Rehabilitation · doi:10.1053/apmr.2002.36959 · Cited by 273 · see citing works
Edinger, J. D., Olsen, M. K., Stechuchak, K. M., Means, M. K., Lineberger, M. D., Kirby, A. C., & Carney, C. E. (2009) · SLEEP · doi:10.1093/sleep/32.4.499 · Cited by 259 · see citing works
“They treated me like a leper”
Zickmund, S. L., Ho, E. Y., Masuda, M., Ippolito, L., & LaBrecque, D. R. (2003) · Journal of General Internal Medicine · doi:10.1046/j.1525-1497.2003.20826.x · Cited by 215 · see citing works
Recommendations for the management of hepatitis C virus infection among people who inject drugs
Grebely, J., Robaeys, G., Bruggmann, P., Aghemo, A., Backmund, M., Bruneau, J., Byrne, J., Dalgård, O., Feld, J. J., Hellard, M. E., et al. (2015) · International Journal of Drug Policy · doi:10.1016/j.drugpo.2015.07.005 · Cited by 194 · see citing works
Fatigue and Health-Related Quality of Life (HRQL) in Chronic Hepatitis C Virus Infection
Kallman, J., O’Neil, M. M., Larive, B., Boparai, N., Calabrese, L., & Younossi, Z. M. (2007) · Digestive Diseases and Sciences · doi:10.1007/s10620-006-9708-x · Cited by 181 · see citing works
Effect of a cognitive behavioral intervention on reducing symptom severity during chemotherapy
Given, C., Given, B., Rahbar, M., Jeon, S., McCorkle, R., Cimprich, B., Galecki, A., Kozachik, S., Brady, A., Fisher-Malloy, M. J., et al. (2004) · Journal of Clinical Oncology · doi:10.1200/jco.2004.01.241 · Cited by 180 · see citing works
The effects of HCV infection and management on health-related quality of life
Younossi, Z. M., Kallman, J. B., & Kincaid, J. (2007) · Hepatology · doi:10.1002/hep.21565 · Cited by 173 · see citing works
Golin, C. E., Earp, J. A., Tien, H. C., Stewart, P. W., Porter, C. Q., & Howie, L. J. (2006) · JAIDS Journal of Acquired Immune Deficiency Syndromes · doi:10.1097/01.qai.0000219771.97303.0a · Cited by 144 · see citing works
Self-citationDepression, anemia and health-related quality of life in chronic hepatitis C
Dan, A. A., Martin, L. M., Crone, C., Ong, J. P., Farmer, D. W., Wise, T. N., Robbins, S., & Younossi, Z. M. (2005) · Journal of Hepatology · doi:10.1016/j.jhep.2005.11.046 · Cited by 141 · see citing works
Everson, G. T., Towner, W. J., Davis, M. N., Wyles, D. L., Nahass, R., Thuluvath, P. J., Etzkorn, K., Hinestrosa, F., Tong, M. J., Rabinovitz, M., et al. (2015) · Annals of Internal Medicine · doi:10.7326/m15-1000 · Cited by 111 · see citing works
Boceprevir and Telaprevir in the Management of Hepatitis C Virus-Infected Patients
Butt, A. A., & Kanwal, F. (2011) · Clinical Infectious Diseases · doi:10.1093/cid/cir774 · Cited by 104 · see citing works
Younossi, Z., Stepanova, M., Zeuzem, S., Dusheiko, G., Esteban, R., Hézode, C., Reesink, H., Weiland, O., Nader, F., & Hunt, S. (2014) · Journal of Hepatology · doi:10.1016/j.jhep.2014.04.003 · Cited by 103 · see citing works
Symptom Prevalence and Clustering of Symptoms in People Living with Chronic Hepatitis C Infection
Lang, C. A., Conrad, S., Garrett, L., Battistutta, D., Cooksley, W. G. E., Dunne, M. P., & Macdonald, G. A. (2006) · Journal of Pain and Symptom Management · doi:10.1016/j.jpainsymman.2005.08.016 · Cited by 99 · see citing works
COGNITIVE BEHAVIORAL CONTROL OF ARTHRITIS PAIN
Keefe, F. J., & Caldwell, D. S. (1997) · Medical Clinics of North America · doi:10.1016/s0025-7125(05)70515-0 · Cited by 90 · see citing works
Early increase in vegetative symptoms predicts IFN-α-induced cognitive-depressive changes
Wichers, M., Koek, G. H., Robaeys, G., Praamstra, A. J., & Maes, M. H. J. (2004) · Psychological Medicine · doi:10.1017/s0033291704003526 · Cited by 84 · see citing works
Treloar, C., Rance, J., Bath, N., Everingham, H., Micallef, M. A., Day, C., Hazelwood, S., Grebely, J., & Dore, G. J. (2015) · International Journal of Drug Policy · doi:10.1016/j.drugpo.2015.01.005 · Cited by 80 · see citing works
Cognitive function in hepatitis C patients with advanced fibrosis enrolled in the HALT-C trial
Fontana, R. J., Bieliauskas, L. A., Back‐Madruga, C., Lindsay, K. L., Kronfol, Z., Lok, A. S.-F., Padmanabhan, L., & the HALT-C Trial Group (2005) · Journal of Hepatology · doi:10.1016/j.jhep.2005.04.006 · Cited by 78 · see citing works
Lopez, C., Antoni, M., Penedo, F., Weiss, D., Cruess, S., Segotas, M.-C., Helder, L., Siegel, S., Klimas, N., & Fletcher, M. A. (2011) · Journal of Psychosomatic Research · doi:10.1016/j.jpsychores.2010.11.010 · Cited by 71 · see citing works
Comorbidities associated with the increasing burden of hepatitis C infection
Basseri, B., Yamini, D., Chee, G. M., Enayati, P. D. P., Tran, T. T., & Poordad, F. F. (2010) · Liver International · doi:10.1111/j.1478-3231.2010.02235.x · Cited by 61 · see citing works
Lechner, S. C., Whitehead, N. E., Vargas, S. E., Annane, D. W., Robertson, B., Carver, C. S., Kobetz, E. K., & Antoni, M. H. (2014) · JNCI Monographs · doi:10.1093/jncimonographs/lgu032 · Cited by 51 · see citing works
E-Health Program for Patients with Chronic Disease
Marziali, E. (2009) · Telemedicine and e-Health · doi:10.1089/tmj.2008.0082 · Cited by 50 · see citing works
A Review of Sleep Disturbance in Hepatitis C
Sockalingam, S., Abbey, S. E., Alosaimi, F. D., & Novák, M. (2009) · Journal of Clinical Gastroenterology · doi:10.1097/mcg.0b013e3181b314ea · Cited by 41 · see citing works
Role of Sleep Disturbance in Chronic Hepatitis C Infection
Carlson, M. D., Hilsabeck, R. C., Barakat, F., & Perry, W. (2010) · Current Hepatitis Reports · doi:10.1007/s11901-010-0030-x · Cited by 38 · see citing works
Adherence During Antiviral Treatment Regimens for Chronic Hepatitis C
Evon, D. M., Golin, C. E., Bonner, J. E., Grodensky, C. A., & Velloza, J. (2014) · Journal of Clinical Gastroenterology · doi:10.1097/mcg.0000000000000151 · Cited by 38 · see citing works
Self-citationPrevalence of Fibromyalgia Among Patients With Chronic Hepatitis C Infection
Mohammad, A. F., CAREY, J. J., Storan, E. R., Scarry, M., Coughlan, R. J., & Lee, J. M. (2012) · Journal of Clinical Gastroenterology · doi:10.1097/mcg.0b013e3182485528 · Cited by 37 · see citing works
Palyo, S. A., Schopmeyer, K. A., & McQuaid, J. R. (2012) · Psychological Services · doi:10.1037/a0025987 · Cited by 37 · see citing works
Chronic hepatitis C and antiviral treatment regimens: Where can psychology contribute?
Evon, D. M., Golin, C. E., Fried, M. W., & Keefe, F. J. (2013) · Journal of Consulting and Clinical Psychology · doi:10.1037/a0029030 · Cited by 32 · see citing works
Self-citationSelf-Efficacy and Adherence to Antiviral Treatment for Chronic Hepatitis C
Bonner, J. E., Esserman, D. A., Golin, C. E., & Evon, D. M. (2013) · Journal of Clinical Gastroenterology · doi:10.1097/mcg.0000000000000055 · Cited by 28 · see citing works
Self-citationEvon, D. M., Esserman, D. A., Bonner, J. E., Rao, T., Fried, M. W., & Golin, C. E. (2013) · Journal of Viral Hepatitis · doi:10.1111/jvh.12079 · Cited by 28 · see citing works
Self-citationRamsey, S. E., Engler, P. A., Stein, M. D., Brown, R. A., & Cioe, P. A. (2011) · Journal of Addiction Research & Therapy · doi:10.4172/2155-6105.1000109 · Cited by 21 · see citing works
Robaeys, G. (2007) · World Journal of Gastroenterology · doi:10.3748/wjg.v13.i43.5736 · Cited by 19 · see citing works
The Hepatitis C Self-Management Program
Groessl, E. J., Ho, S. B., Asch, S. M., Stepnowsky, C. J., Laurent, D. D., & Gifford, A. L. (2013) · Health Education & Behavior · doi:10.1177/1090198113477112 · Cited by 18 · see citing works
A telehealth intervention for veterans on antiviral treatment for the hepatitis C virus.
Silberbogen, A. K., Ulloa, E. W., Mori, D. L., & Brown, K. (2012) · Psychological Services · doi:10.1037/a0026821 · Cited by 13 · see citing works
Spiegel, B. M. R., Younossi, Z. M., Hays, R. D., Revicki, D., Robbins, S., & Kanwal, F. (2005) · Hepatology · doi:10.1002/hep.20659 · Cited by 7 · see citing works
Flagged first, then by citations
1 of the 51 references couldn’t be matched to a known paper.
Research works printed but not linked: 3
- [35]Antoni M. Ironson G. Schneiderman N. Cognitive-behavioral Stress Management 2007 Oxford University Press New York
- [36]Evon D.M. Golin C.E. Fried M.W. Keefe F.J. Chronic hepatitis C and antiviral treatment regimens: where can psychology contribute? J. Consult. Clin. Psychol. 81 2 2013 361 374 22730952 PMC3504622
- [38]Linehan M.M. Skills Training Manual for Treatment of Borderline Personality Disorder 1993 Guilford Press New York, NY
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Evon, D. M., Golin, C. E., Ruffin, R., Ayres, S., & Fried, M. W. (2018) · Pilot and Feasibility Studies · doi:10.1186/s40814-018-0285-5 · Cited by 8 · see citing works
Self-citationSohail, M. M., Ahmad, S., & Maqsood, F. (2019) · Journal of Religion and Health · doi:10.1007/s10943-019-00761-6 · Cited by 8 · see citing works
Evon, D. M., Liu, C., Rollason, C., Lechner, S. C., Brown, A. R., Harrison, D. S., Stewart, P. W., Bailey, D. E., Morland, L. A., & Barritt, A. S. (2025) · Hepatology Communications · doi:10.1097/hc9.0000000000000849 · Cited by 1 · see citing works
Self-citationErkrankungen von Leber und Pankreas
Kapfhammer, H. (2022) · Springer eBooks · doi:10.1007/978-3-662-65873-4_7
Deutsch‐Link, S., Hurr, S., Gallagher, H., Green, E. W., Hendershot, C. S., Lynch, M.-J., Velez, D., & Shroff, H. (2026) · Clinical Transplantation · doi:10.1111/ctr.70667
- Authors
- Evon, D. M., Golin, C. E., Ruffin, R., & Fried, M. W.
- Affiliations
- University of North Carolina at Chapel Hill (US)
- Durham VA Medical Center (US)
- Corresponding author
- Evon, Donna M.
- Venue
- Contemporary Clinical Trials Communications
- Publisher
- Elsevier BV
- Published
- 2017-06
- Volume
- 6
- Pages
- 85-96
- ISSN
- 2451-8654 (ISSN-L)
- PMC
- PMC5654628
- OpenAlex
- W2601896856
- Cited by
- 5
- References
- 51
- Citations by year
- 2026: 1 · 2025: 1 · 2022: 1 · 2019: 1 · 2018: 1
- FWCI
- 0.34
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Contemporary Clinical Trials Communications (publishedVersion, cc-by-nc-nd)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- University of Miami
- National Institute of Allergy and Infectious Diseases (P30AI050410)
- National Institute of Diabetes and Digestive and Kidney Diseases (K24DK066144, K23DK089004)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (K24HD069204)
- Topics
- Health Sciences › Medicine › Hepatology › Hepatitis C virus research
- Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
- Social Sciences › Psychology › Clinical Psychology › Psychotherapy Techniques and Applications
- Keywords
- chronic hepatitis C, cognitive behavioral therapy, coping strategies, group intervention, psychosocial interventions, intervention development, feasibility testing, patient acceptability, participant retention, therapist fidelity
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