Ignite Creation Date:
2025-12-24 @ 5:52 PM
Ignite Modification Date:
2026-02-26 @ 3:52 PM
Study NCT ID:
NCT00495768
Status:
UNKNOWN
Last Update Posted:
2007-12-14
First Post:
2007-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reducing Depressive Symptoms During HCV Therapy: A Randomized Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012681', 'term': 'Sensitivity Training Groups'}], 'ancestors': [{'id': 'D011615', 'term': 'Psychotherapy, Group'}, {'id': 'D012960', 'term': 'Socioenvironmental Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2004-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2007-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2007-12-13', 'studyFirstSubmitDate': '2007-07-02', 'studyFirstSubmitQcDate': '2007-07-02', 'lastUpdatePostDateStruct': {'date': '2007-12-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patients in the experimental group will have less of an increase in their HAM-D score over the first 6 months of treatment; score on a depression rating scale at study visits 1-5.', 'timeFrame': 'Two years'}], 'secondaryOutcomes': [{'measure': 'Patients in the experimental group will have less of an increase in their PHQ-9 score over the first 6 months of treatment; score on a rating scale at study visits 1-5.', 'timeFrame': 'Two years'}, {'measure': 'Patients in the experimental group will have less of an increase in their BDI score over the first 6 months of treatment; score on a rating scale at study visits 1-5.', 'timeFrame': 'Two years'}, {'measure': 'Fewer patients in the experimental group will have developed a major depressive episode over the first 6 months of treatment; score on MDD module (MINI)at study visits 1-5.', 'timeFrame': 'Two years'}, {'measure': 'Patients in the experimental group will have less of a decline in their self-rated general health (item #1 of the SF-36) over the first 6 months of treatment.', 'timeFrame': 'Two years'}, {'measure': 'Patients in the experimental group will have less of an increase in self-rated irritability (item #6 of the BSI ) over the first 6 months of treatment.', 'timeFrame': 'Two years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hepatitis C', 'HCV', 'Depression', 'Interferons', 'Ribavirin'], 'conditions': ['Hepatitis C', 'Depression']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Akaike H. A new look at the statistical identification model. IEEE, Tranactions Auto Control 1974;19:716-23'}, {'pmid': '10451460', 'type': 'BACKGROUND', 'citation': 'Alter MJ, Kruszon-Moran D, Nainan OV, McQuillan GM, Gao F, Moyer LA, Kaslow RA, Margolis HS. The prevalence of hepatitis C virus infection in the United States, 1988 through 1994. N Engl J Med. 1999 Aug 19;341(8):556-62. doi: 10.1056/NEJM199908193410802.'}, {'type': 'BACKGROUND', 'citation': 'American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR), Washington, DC, 2000.'}, {'pmid': '11927189', 'type': 'BACKGROUND', 'citation': 'Capuron L, Gumnick JF, Musselman DL, Lawson DH, Reemsnyder A, Nemeroff CB, Miller AH. Neurobehavioral effects of interferon-alpha in cancer patients: phenomenology and paroxetine responsiveness of symptom dimensions. Neuropsychopharmacology. 2002 May;26(5):643-52. doi: 10.1016/S0893-133X(01)00407-9.'}, {'pmid': '12399946', 'type': 'BACKGROUND', 'citation': 'Hauser P, Khosla J, Aurora H, Laurin J, Kling MA, Hill J, Gulati M, Thornton AJ, Schultz RL, Valentine AD, Meyers CA, Howell CD. A prospective study of the incidence and open-label treatment of interferon-induced major depressive disorder in patients with hepatitis C. Mol Psychiatry. 2002;7(9):942-7. doi: 10.1038/sj.mp.4001119.'}, {'pmid': '11583749', 'type': 'BACKGROUND', 'citation': 'Manns MP, McHutchison JG, Gordon SC, Rustgi VK, Shiffman M, Reindollar R, Goodman ZD, Koury K, Ling M, Albrecht JK. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet. 2001 Sep 22;358(9286):958-65. doi: 10.1016/s0140-6736(01)06102-5.'}, {'pmid': '9416776', 'type': 'BACKGROUND', 'citation': 'Pruessner JC, Wolf OT, Hellhammer DH, Buske-Kirschbaum A, von Auer K, Jobst S, Kaspers F, Kirschbaum C. Free cortisol levels after awakening: a reliable biological marker for the assessment of adrenocortical activity. Life Sci. 1997;61(26):2539-49. doi: 10.1016/s0024-3205(97)01008-4.'}, {'pmid': '11020090', 'type': 'BACKGROUND', 'citation': 'Speca M, Carlson LE, Goodey E, Angen M. A randomized, wait-list controlled clinical trial: the effect of a mindfulness meditation-based stress reduction program on mood and symptoms of stress in cancer outpatients. Psychosom Med. 2000 Sep-Oct;62(5):613-22. doi: 10.1097/00006842-200009000-00004.'}, {'pmid': '10208146', 'type': 'BACKGROUND', 'citation': 'Smyth JM, Stone AA, Hurewitz A, Kaell A. Effects of writing about stressful experiences on symptom reduction in patients with asthma or rheumatoid arthritis: a randomized trial. JAMA. 1999 Apr 14;281(14):1304-9. doi: 10.1001/jama.281.14.1304.'}, {'pmid': '11495165', 'type': 'BACKGROUND', 'citation': 'Teasdale JD, Scott J, Moore RG, Hayhurst H, Pope M, Paykel ES. How does cognitive therapy prevent relapse in residual depression? Evidence from a controlled trial. J Consult Clin Psychol. 2001 Jun;69(3):347-57. doi: 10.1037//0022-006x.69.3.347.'}, {'pmid': '9482539', 'type': 'BACKGROUND', 'citation': 'Valentine AD, Meyers CA, Kling MA, Richelson E, Hauser P. Mood and cognitive side effects of interferon-alpha therapy. Semin Oncol. 1998 Feb;25(1 Suppl 1):39-47.'}, {'pmid': '12466036', 'type': 'BACKGROUND', 'citation': 'Wichers M, Maes M. The psychoneuroimmuno-pathophysiology of cytokine-induced depression in humans. Int J Neuropsychopharmacol. 2002 Dec;5(4):375-88. doi: 10.1017/S1461145702003103.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to conduct a randomized controlled trial of an 8-visit non-pharmacologic group intervention in reducing the severity of depressive symptoms in veterans who receive IFN and ribavirin for the treatment of Hepatitis C. We hypothesize that over the first 6 months of treatment with IFN and ribavirin for the 45 patients who receive the 8-visit intervention early in the course of treatment in addition to usual care (experimental group) will have lower scores on the CES-D, a standard depression rating scale, than the 45 patients who receive only usual care (control group).', 'detailedDescription': 'In this study, subjects will be randomly assigned (by chance, like the flipping of a coin) to one of two study groups. Half the subjects will be assigned to a training program, which will consist of 8 sessions over a period of 8 weeks in which they will be instructed in cognitive therapy ( a method of identifying and "talk back" to one\'s negative thoughts) and a variety of other stress-reducing techniques. The other half will be assigned to a control groups, which will no receive instruction in cognitive therapy or the other stress-reducing techniques. All subjects, both those in the training program and in the control group, will receive the usual care for hepatitis C that all patients in the Hepatology Clinic receive. All subjects will also be asked to participate in 6 testing visits over the course of the study. The first testing visit will last about 3 hours, which the others will last between 1 1/2 and 2 hours. Subjects will alo be interviewed by telephone about their personal and family medical and psychiatric history. This will take about an hour.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '68 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligibility and interest in treatment for chronic HCV (Hepatitis C).\n* Absence of co-infection of HIV or Hepatitis B.\n* Age 25-68 years old.\n* No treatment with IFN (interferon-alpha) in the past 6 months.\n* Residence within a 3-hour drive of the clinic.\n\nExclusion Criteria:\n\n* Patients must be willing to undergo treatment with PEG-interferon and ribavirin. They must be aware of the side effects of treatment and be motivated to self-administer the medications and come to regularly scheduled appointments.\n* Patients with diabetes mellitus must have good glycemic control. Their Hgb A1 c must be \\<8.0%.\n* Patients must not have an active malignancy.\n* If patients have a history of severe psychiatric illness or are found to have one by screening with the CES-D, a psychiatrist must approve treatment. If the psychiatric problem is minor, it can be managed by the primary care physician or hepatitis C provider.\n* Autoimmune disease, such as autoimmune hepatitis, systemic lupus erythematosis, or sarcoidosis, is a contraindication to treatment.\n* Active alcohol or intravenous drug use is a contraindication to treatment.\n* Patients with a seizure disorder muct be seizure-free for 6 months prior to treatment.\n* Patients with a known history of coronary heart disease are excluded.\n* Patients with complications of cirrhosis may not be treatment candidates. Those who have a platelet count of \\<50,000, large esophageal varices (grade 3-4), uncontrolled ascites, or uncontrolled encephalopathy are excluded.\n* Patients with severe mental retardation or dementia are excluded because of difficulty in self-administration of medication and in tolerating the side effects.\n* The patient and partner much agree to observe strict contraception to avoid pregnancy, since the medication is fetotoxic up to 6 months after treatment completion.'}, 'identificationModule': {'nctId': 'NCT00495768', 'briefTitle': 'Reducing Depressive Symptoms During HCV Therapy: A Randomized Study', 'organization': {'class': 'FED', 'fullName': 'South Texas Veterans Health Care System'}, 'officialTitle': 'Reducing Depressive Symptoms During HCV Therapy: A Randomized Study', 'orgStudyIdInfo': {'id': '034-0013-391'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Group Training', 'type': 'BEHAVIORAL', 'description': 'Participants will be trained in techniques that are useful to cope with possible side effects of treatment, such as: keeping a journal (expressive writing), breathing exercises, cognitive behavioral therapy, mindfulness meditation, and exercise.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'South Texas Veterans Healthcare System, Audie Murphy Division', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Stephen L. Stern, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'South Texas Veterans Hospital, Audie Murphy Division & the University of Texas Health Science Center at San Antonio'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'South Texas Veterans Health Care System', 'class': 'FED'}, 'responsibleParty': {'oldNameTitle': 'Dr, Stephen L. Stern', 'oldOrganization': 'Audie L. Murphy VA Hospital'}}}}