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

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ClinicalTrials.gov Identifier: NCT01645033
Recruitment Status : Completed
First Posted : July 19, 2012
Last Update Posted : September 12, 2014
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Yale University

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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 or disease Intervention/treatment Phase
Opioid Dependence Hepatitis HIV Other: computerized Cognitive Behavioral Therapy (CBT) Other: Treatment as Usual (TAU) Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Computer-based Cognitive Behavioral Therapy for Risky Behaviors in Opioid Dependent Patients
Study Start Date : April 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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)]


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01645033


Locations
United States, Connecticut
Hartford Dispensary
Hartford, Connecticut, United States, 06120
Sponsors and Collaborators
Yale University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Kathleen M Carroll, PhD Yale University Department of Psychiatry
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01645033     History of Changes
Other Study ID Numbers: 1111009300
P50DA009241-18 ( U.S. NIH Grant/Contract )
First Posted: July 19, 2012    Key Record Dates
Last Update Posted: September 12, 2014
Last Verified: September 2014

Keywords provided by Yale University:
Cognitive Behavioral Therapy
computer