NCT00844272|CompletedPhase 4DMC
Psychoeducation Reaches HCV-infected Methadone/Buprenorphine Substituted Patients in Standard Antiviral Treatment
Permit
Loading search results
Sponsor study identifier
interventional
189
0 countries
N/A
Study Start
May 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2008
Actual (reported)Study Completion
November 2009
Actual (reported)Study objective: Feasibility and efficacy of a standardised psychosocial intervention (psychoeducation) in substituted opioid dependent patients
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2005
Date type not reportedThis date has not been verified as actual or estimated.
November 2008
Actual (reported)February 12, 2009
Actual (reported)February 16, 2009
Actual (reported)November 2009
Actual (reported)Retention in antiviral treatment (feasibility)
within the first 24/48 weeks
Psychological health
within the first 24/48 weeks
Medical process on the basis of retention in substitution treatment
within the first 24/48 weeks
Permanent virus suppression
within the first 24/48 weeks
PE group sessions lasted 60 minutes and were carried out under continuous supervision. The manualised program was especially tailored to (former) IDUs in HCV treatment, containing the following aspects: * Module 1: HCV infection and symptoms, course of illness, interaction with opioid dependence, further problems and risk factors * Module 2: HCV treatment, side effects, psychiatric and somatic comorbidities, reinfection and drug use, risk behaviour * Module 3: Coping strategies, resources and self-help, effective use of health-care support, the role of social environment, healthy living \& nutrition
Control group did not received no intervention.
Group-therapeutic intervention with 12 sessions plus 5 update sessions with 24-week therapy duration and/or 12 sessions plus 10 update sessions with 48-week therapy duration Module I: Create understanding, resources, problems and solutions Module II: Information on hepatitis C infection Module III: Information on treatment Module IV: Specific information on depression and withdrawal symptoms under interferon The meetings take a minimum of 60 min. time, should be once weekly. The group size should lie between 6 and 12 participants. The group leaders are trained in performance of the psycho-education.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Reimer J, Schmidt CS, Schulte B, Gansefort D, Golz J, Gerken G, Scherbaum N, Verthein U, Backmund M. Psychoeducation improves hepatitis C virus treatment during opioid substitution therapy: a controlled, prospective multicenter trial. Clin Infect Dis. 2013 Aug;57 Suppl 2:S97-104. doi: 10.1093/cid/cit307.
Jörg Gölz, MD
Praxiszentrum Kaiserdamm
189 participants (actual enrollment reported by the registry).
First Submitted
February 12, 2009
First Posted
February 16, 2009
Study Start
May 2005
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
November 2008
Actual (reported)Study Completion
November 2009
Actual (reported)Last Updated
May 28, 2015
Record last verified: 2015-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: