Hepatitis CNCT00495768
Reducing Depressive Symptoms During HCV Therapy: A Randomized Study
A study testing Group Training in people with Hepatitis C and Depression, run by South Texas Veterans Health Care System at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 68 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C, Depression
- What is being tested?
- Group Training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Dec 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 68 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
South Texas Veterans Healthcare System, Audie Murphy Division
San Antonio, Texas, 78229
About this study
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).
Read the detailed description
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
- Hepatitis C, Depression
- Being tested
- Group Training
- Keywords
- Hepatitis C, HCV, Depression, Interferons, Ribavirin
- Medical subject headings
- Hepatitis C, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group TrainingBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two years
Secondary outcomes (5)
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.
Measured: Two years
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.
Measured: Two years
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.
Measured: Two years
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.
Measured: Two years
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.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2007 (estimated)
- Study startJul 2004
- Study completionDec 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Texas Veterans Health Care System
- Sponsor type
- US federal agency
- Investigators
- Stephen L. Stern, M.D., Principal investigator, South Texas Veterans Hospital, Audie Murphy Division & the University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00495768
- Sponsor's protocol ID
- 034-0013-391
- Status last verified
- Dec 2007
- First submitted
- 2 Jul 2007
- Last updated
- 14 Dec 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Akaike H. A new look at the statistical identification model. IEEE, Tranactions Auto Control 1974;19:716-23
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.
PubMed 10451460American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR), Washington, DC, 2000.
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.
PubMed 11927189Hauser 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.
PubMed 12399946Manns 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.
PubMed 11583749Pruessner 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.
PubMed 9416776Speca 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.
PubMed 11020090Smyth 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.
PubMed 10208146Teasdale 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.
PubMed 11495165Valentine 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.
PubMed 9482539Wichers 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.
PubMed 12466036
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Depressive Symptoms During HCV Therapy: A Randomized Study
- ClinicalTrials.gov ID
- NCT00495768
- Acronym / sponsor ID
- 034-0013-391
- Conditions
- Hepatitis C, Depression
- Keywords
- Hepatitis C, HCV, Depression, Interferons, Ribavirin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- South Texas Veterans Health Care SystemUS federal agency
- Study start
- Jul 2004
- Study completion
- Dec 2007 (estimated)
- First posted
- 3 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 25 to 68 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group TrainingParticipants 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. | Behavioural | – |
Primary outcome
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.
Time frame: Two years
5 secondary outcomes
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.
Time frame: Two years
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.
Time frame: Two years
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.
Time frame: Two years
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.
Time frame: Two years
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.
Time frame: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2007.
- BackgroundAkaike H. A new look at the statistical identification model. IEEE, Tranactions Auto Control 1974;19:716-23
- Background: PubMed 10451460Alter 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.
- BackgroundAmerican Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR), Washington, DC, 2000.
- Background: PubMed 11927189Capuron 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.
- Background: PubMed 12399946Hauser 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.
- Background: PubMed 11583749Manns 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.
- Background: PubMed 9416776Pruessner 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.
- Background: PubMed 11020090Speca 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.
- Background: PubMed 10208146Smyth 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.
- Background: PubMed 11495165Teasdale 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.
- Background: PubMed 9482539Valentine 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.
- Background: PubMed 12466036Wichers 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen L. Stern, M.D. principal investigator
South Texas Veterans Hospital, Audie Murphy Division & the University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Training in people with Hepatitis C and Depression, run by South Texas Veterans Health Care System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00495768, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2007.