Psychoeducation Reaches HCV-infected Methadone/Buprenorphine Substituted Patients in Standard Antiviral Treatment (Permit)
Study objective: Feasibility and efficacy of a standardised psychosocial intervention (psychoeducation) in substituted opioid dependent patients
Intravenous Drug Abuse
Chronic Hepatitis C
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Psychoeducation Reaches HCV-infected Methadone/Buprenorphine Substituted Patients in Standard Antiviral Treatment|
- Retention in antiviral treatment (feasibility) [ Time Frame: within the first 24/48 weeks ] [ Designated as safety issue: No ]
- Psychological health [ Time Frame: within the first 24/48 weeks ] [ Designated as safety issue: Yes ]
- Medical process on the basis of retention in substitution treatment [ Time Frame: within the first 24/48 weeks ] [ Designated as safety issue: Yes ]
- Permanent virus suppression [ Time Frame: within the first 24/48 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2005|
|Study Completion Date:||November 2009|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
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:
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.
No Intervention: Treatment as usual
Control group did not received no intervention.
- Retention in antiviral treatment (feasibility)
- Mental Health Mental health is monitored by means of the Symptom Checklist 90-R (SCL-90-R). Its sum score, the Global Severity Index (GSI), serves as indicator. Mental health will be regarded as stable in case of a change of less than 6 GSI-points, otherwise mental health will be regarded as improved (GSI - 6 points) or decreased (GSI + 6 points).
- Course of Addiction Course of addiction under antiviral treatment will be monitored according to retention in substitution treatment, compliance with scheduled visits, and co-consumption of illicit drugs (patients record, urinalysis).
- Sustained viral response (SVR) SVR as measured by polymerase chain reaction 6 months after per protocol antiviral treatment (ITT-analysis).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00844272
|Principal Investigator:||Jörg Gölz, MD||Praxiszentrum Kaiserdamm|