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Computer-based Cognitive Behavioral Therapy for Risky Behaviors in Opioid Dependent Patients

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01645033
First received: July 17, 2012
Last updated: September 11, 2014
Last verified: September 2014
  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

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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:

  • Teaching about the treatment program
  • Teaching important ideas about sexual behaviors risks
  • Increasing knowledge about specific sexually transmitted diseases
  • Discussions of ways to reduce or minimize spread of diseases related to drug use [for example, Hepatitis and Human Immunodeficiency virus (HIV, the virus responsible for causing AIDS)]
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:

  • Teaching about the treatment program
  • Teaching important ideas about sexual behaviors risks
  • Increasing knowledge about specific sexually transmitted diseases
  • Discussions of ways to reduce or minimize spread of diseases related to drug use [for example, Hepatitis and Human Immunodeficiency virus (HIV, the virus responsible for causing AIDS)]
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:

  • Teaching about the treatment program
  • Teaching important ideas about sexual behaviors risks
  • Increasing knowledge about specific sexually transmitted diseases
  • Discussions of ways to reduce or minimize spread of diseases related to drug use [for example, Hepatitis and Human Immunodeficiency virus (HIV, the virus responsible for causing AIDS)]

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01645033

Locations
United States, Connecticut
Hartford Dispensary
Hartford, Connecticut, United States, 06120
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Kathleen M Carroll, PhD Yale University Department of Psychiatry
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01645033     History of Changes
Other Study ID Numbers: 1111009300, P50DA009241-18
Study First Received: July 17, 2012
Last Updated: September 11, 2014
Health Authority: United States: Federal Government

Keywords provided by Yale University:
Cognitive Behavioral Therapy
computer

ClinicalTrials.gov processed this record on November 24, 2014