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

NCT01645033 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2014-09-12

No results posted yet for this study

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.

Conditions

  • Opioid Dependence
  • Hepatitis
  • HIV

Interventions

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 \[for example, Hepatitis and Human Immunodeficiency virus (HIV, the virus responsible for causing AIDS)\]

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH
  • Yale University

    lead OTHER

Principal Investigators

  • Kathleen M Carroll, PhD · Yale University Department of Psychiatry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01645033 on ClinicalTrials.gov