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Reducing Depressive Symptoms During HCV Therapy: A Randomized Study

NCT ID: NCT00495768

Last Updated: 2007-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2007-12-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Hepatitis C Depression

Keywords

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Hepatitis C HCV Depression Interferons Ribavirin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Group Training

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Eligibility and interest in treatment for chronic HCV (Hepatitis C).
* Absence of co-infection of HIV or Hepatitis B.
* Age 25-68 years old.
* No treatment with IFN (interferon-alpha) in the past 6 months.
* Residence within a 3-hour drive of the clinic.

Exclusion Criteria

* 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.
* Patients with diabetes mellitus must have good glycemic control. Their Hgb A1 c must be \<8.0%.
* Patients must not have an active malignancy.
* 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.
* Autoimmune disease, such as autoimmune hepatitis, systemic lupus erythematosis, or sarcoidosis, is a contraindication to treatment.
* Active alcohol or intravenous drug use is a contraindication to treatment.
* Patients with a seizure disorder muct be seizure-free for 6 months prior to treatment.
* Patients with a known history of coronary heart disease are excluded.
* 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.
* Patients with severe mental retardation or dementia are excluded because of difficulty in self-administration of medication and in tolerating the side effects.
* 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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

68 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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South Texas Veterans Health Care System

FED

Sponsor Role lead

Responsible Party

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Audie L. Murphy VA Hospital

Principal Investigators

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Stephen L. Stern, M.D.

Role: PRINCIPAL_INVESTIGATOR

South Texas Veterans Hospital, Audie Murphy Division & the University of Texas Health Science Center at San Antonio

Locations

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South Texas Veterans Healthcare System, Audie Murphy Division

San Antonio, Texas, United States

Site Status

Countries

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United States

References

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Akaike H. A new look at the statistical identification model. IEEE, Tranactions Auto Control 1974;19:716-23

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 10451460 (View on PubMed)

American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR), Washington, DC, 2000.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 11927189 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12399946 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11583749 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9416776 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11020090 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10208146 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11495165 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9482539 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12466036 (View on PubMed)

Other Identifiers

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034-0013-391

Identifier Type: -

Identifier Source: org_study_id