Computer-based Cognitive Behavioral Therapy for Risky Behaviors in Opioid Dependent Patients
This study is currently recruiting participants.
Verified July 2012 by Yale University
Sponsor:
Yale University
Collaborator:
Information provided by (Responsible Party):
Kathleen M. Carroll, Yale University
ClinicalTrials.gov Identifier:
NCT01645033
First received: July 17, 2012
Last updated: July 18, 2012
Last verified: July 2012
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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) |
| 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:
- Unprotected sexual occurrences [ Time Frame: baseline ] [ 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.
- Unprotected sexual occurrences [ Time Frame: 1 month ] [ 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.
- Unprotected sexual occurrences [ Time Frame: 3 months ] [ 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 [ Time Frame: baseline ] [ 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 [ Time Frame: immediately after CBT ] [ 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 [ Time Frame: 1 month followup ] [ 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 [ Time Frame: 3 month followup ] [ 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
| Estimated Enrollment: | 60 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: TAU plus CBT
Standard treatment (TAU) plus a short session using a computer program 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.
|
|
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: 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.
|
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 IDU 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01645033
Contacts
| Contact: Elizabeth Ferris, B.A. | 860 305-7011 | elizabeth.ferris@yale.edu |
| Contact: Dianne Duffey, M.D. | 203 932-5711 ext 7489 | dianne.duffey@yale.edu |
Locations
| United States, Connecticut | |
| Hartford Dispensary | Recruiting |
| Hartford, Connecticut, United States, 06120 | |
| Sub-Investigator: Paul McLaughlin, BA | |
Sponsors and Collaborators
Yale University
Investigators
| Principal Investigator: | Kathleen M Carroll, PhD | Yale University Department of Psychiatry |
More Information
No publications provided
| Responsible Party: | Kathleen M. Carroll, Professor, Department of Psychiatry, Yale University |
| ClinicalTrials.gov Identifier: | NCT01645033 History of Changes |
| Other Study ID Numbers: | 1111009300, P50DA009241-18 |
| Study First Received: | July 17, 2012 |
| Last Updated: | July 18, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Yale University:
|
CBT computer |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Opioid-Related Disorders Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Substance-Related Disorders |
Mental Disorders Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants |
ClinicalTrials.gov processed this record on May 19, 2013