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Computer-based Cognitive Behavioral Therapy for Risky Behaviors in Opioid Dependent Patients
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Purpose
The purpose of this study is to determine if a computerized version of Cognitive Behavioral Therapy (CBT) can improve high-risk sexual behaviors in patients attending an outpatient methadone treatment clinic. This population is at high risk for contracting and spreading hepatitis and HIV. When added to their treatment as usual (TAU), the CBT session will increase the total exposure of clients to education about how to reduce risky sexual and needle use behaviors and provides real world examples. This study seeks to determine if the use of this CBT program is easily added into the clinical program and if patients are satisfied with its use.
The main hypothesis is that the use of computerized CBT in addition to treatment as usual will improve knowledge and reduce occurrences of unprotected sexual activity. The study will also look at patient and clinic costs related to the CBT intervention, drug use and retention/adherence.
| Condition | Intervention |
|---|---|
| Opioid Dependence Hepatitis HIV | Other: computerized Cognitive Behavioral Therapy (CBT) Other: Treatment as Usual (TAU) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Computer-based Cognitive Behavioral Therapy for Risky Behaviors in Opioid Dependent Patients |
- Number of unprotected sexual occurrences, measured by an assessment, the HIV Risk-taking Behavior Scale (HRBS) [ Time Frame: 1 month (Number of unprotected sexual occurrences for the 28 days prior to completing an assessment, the HRBS) ]Self-report of unprotected sexual occurrences for the previous 28 days will be recorded; measurements are obtained at baseline, 1 month and 3 months following randomization.
- Number of unprotected sexual occurrences, measured by an assessment, the HIV Risk-taking Behavior Scale (HRBS) [ Time Frame: 3 months (Number of unprotected sexual occurrences for the 28 days prior to completing an assessment, the HRBS) ]Self-report of unprotected sexual occurrences for the previous 28 days will be recorded; measurements are obtained at baseline, 1 month and 3 months following randomization.
- Knowledge quiz score (measured as percent correct number of items on a knowledge quiz created for this study) [ Time Frame: baseline (measured as percent correct number of items on a knowledge quiz created for this study) ]Knowledge on a quiz designed for this study. Answers will be true/false and % correct will be used as the outcome measure. Questions will pertain to sexual activity practices (e.g. the use of condoms), as they relate to the transmission of HCV, HIV and STD's
- Knowledge quiz score (measured as percent correct number of items on a knowledge quiz created for this study) [ Time Frame: immediately after CBT (quiz administered up to two hours following intervention), measured as percent correct number of items on a knowledge quiz created for this study ]Knowledge on a quiz designed for this study. Answers will be true/false and % correct will be used as the outcome measure. Questions will pertain to sexual activity practices (e.g. the use of condoms), as they relate to the transmission of HCV, HIV and STD's
- Knowledge quiz score (measured as percent correct number of items on a knowledge quiz created for this study) [ Time Frame: 1 month followup (measured as percent correct number of items on a knowledge quiz created for this study) ]Knowledge on a quiz designed for this study. Answers will be true/false and % correct will be used as the outcome measure. Questions will pertain to sexual activity practices (e.g. the use of condoms), as they relate to the transmission of HCV, HIV and STD's
- Knowledge quiz score(measured as percent correct number of items on a knowledge quiz created for this study) [ Time Frame: 3 month followup (measured as percent correct number of items on a knowledge quiz created for this study) ]Knowledge on a quiz designed for this study. Answers will be true/false and % correct will be used as the outcome measure. Questions will pertain to sexual activity practices (e.g. the use of condoms), as they relate to the transmission of HCV, HIV and STD's
| Enrollment: | 63 |
| Study Start Date: | April 2012 |
| Study Completion Date: | December 2013 |
| Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: TAU plus computerized CBT
Standard treatment (TAU) plus a short session using a computer program containing computerized CBT to understand risks related to sexual and other behaviors and how those risks relate to spread of infections.
|
Other: computerized Cognitive Behavioral Therapy (CBT)
Standard treatment (as described in TAU) plus a short session using a computer program containing CBT to understand risks related to sexual and other behaviors and how those risks relate to spread of infections.
Other: Treatment as Usual (TAU)
This is the infectious disease orientation that would normally be received at this clinic to address risky behavior. This orientation generally includes individual and group therapy sessions that discuss behaviors and the resulting risk of sexually or drug-related infections (for example: use of a condom). Sessions will generally include items such as:
|
|
Active Comparator: Treatment as Usual (TAU)
This is the infectious disease orientation that would normally be received at this clinic to address risky behavior. This orientation generally includes individual and group therapy sessions that discuss behaviors and the resulting risk of sexually or drug-related infections (for example: use of a condom). Sessions will generally include items such as:
|
Other: Treatment as Usual (TAU)
This is the infectious disease orientation that would normally be received at this clinic to address risky behavior. This orientation generally includes individual and group therapy sessions that discuss behaviors and the resulting risk of sexually or drug-related infections (for example: use of a condom). Sessions will generally include items such as:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- mental capability to complete the study (as determined by MMSE, Mini Mental Status Exam score >25),
- age 18 or older,
- able to speak, read and understand English,
- actively enrolled in methadone maintenance for intravenous drug use for 30 days or longer;
- had unprotected vaginal or anal intercourse or oral sex within the past 6 months;
- not pregnant or trying to become pregnant.
Exclusion Criteria:
- have an untreated bipolar or schizophrenic disorder
- are pregnant (by self-report) or trying to become pregnant (these may unduly influence behaviors of sexual activity)
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01645033
| United States, Connecticut | |
| Hartford Dispensary | |
| Hartford, Connecticut, United States, 06120 | |
| Principal Investigator: | Kathleen M Carroll, PhD | Yale University Department of Psychiatry |
More Information
| Responsible Party: | Yale University |
| ClinicalTrials.gov Identifier: | NCT01645033 History of Changes |
| Other Study ID Numbers: |
1111009300 P50DA009241-18 ( US NIH Grant/Contract Award Number ) |
| Study First Received: | July 17, 2012 |
| Last Updated: | September 11, 2014 |
Keywords provided by Yale University:
|
Cognitive Behavioral Therapy computer |
ClinicalTrials.gov processed this record on June 23, 2017