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

NCT01645033 | Completed DMC

• 2 other identifiers: 1111009300P50DA009241-18
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Dependence; Hepatitis; HIV

Keywords

Cognitive Behavioral Therapy; computer

Outcome Measures

Primary Outcomes (2)

• Number of unprotected sexual occurrences, measured by an assessment, the HIV Risk-taking Behavior Scale (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.

  1 month (Number of unprotected sexual occurrences for the 28 days prior to completing an assessment, the HRBS)

• Number of unprotected sexual occurrences, measured by an assessment, the HIV Risk-taking Behavior Scale (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.

  3 months (Number of unprotected sexual occurrences for the 28 days prior to completing an assessment, the HRBS)

Secondary Outcomes (4)

• Knowledge quiz score (measured as percent correct number of items on a knowledge quiz created for this study)

  baseline (measured as percent correct number of items on a knowledge quiz created for this study)

• Knowledge quiz score (measured as percent correct number of items on a knowledge quiz created for this study)

  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 quiz score (measured as percent correct number of items on a knowledge quiz created for this study)

  1 month followup (measured as percent correct number of items on a knowledge quiz created for this study)

• Knowledge quiz score(measured as percent correct number of items on a knowledge quiz created for this study)

  3 month followup (measured as percent correct number of items on a knowledge quiz created for this study)

Study Arms (2)

TAU plus computerized CBT

EXPERIMENTAL

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); Other: Treatment as Usual (TAU)

Treatment as Usual (TAU)

ACTIVE COMPARATOR

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)

Interventions

computerized Cognitive Behavioral Therapy (CBT) OTHER

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.

TAU plus computerized CBT

Treatment as Usual (TAU) OTHER

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

TAU plus computerized CBT; Treatment as Usual (TAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Hartford Dispensary

Hartford, Connecticut, 06120, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Hepatitis

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Liver Diseases; Digestive System Diseases

Study Officials

• Kathleen M Carroll, PhD

  Yale University Department of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2012
• First Posted: July 19, 2012
• Study Start: April 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: September 12, 2014

Record last verified: 2014-09

Locations

US (1)