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

Conditions

Hepatitis | HIV | Opioid Dependence

Trial Phase

N/A

Trial Purpose and Description

Trial 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.


Trial Description


We plan to conduct a randomized pilot trial evaluating the feasibility and promise of
computerized CBT as a single module targeting risky sexual behavior in a HIV/Hepatitis C
virus(HCV) high risk population. In the context of a drug treatment program, we will
randomize 60 methadone maintenance patients to either standard treatment as usual at the
program (TAU) or TAU plus the HIV/HCV/STD risk reduction module of CBT4CBT("Stay Safe").
Participants will be assessed at baseline, one month and three month time points. The
primary outcome measures will be knowledge regarding risk of infection and transmission of
HIV/HCV/STD,self report assessment of risky sexual practices, retention in the study and
client satisfaction with the module. Our specific aims are as follows:

1. To determine the feasibility of integrating CBT4CBT/"Stay Safe" into this setting.
Feasibility will be determined by completion of assessments at 1 and 3 month time
points (retention) and satisfaction ratings by participants randomized to the computer
module.

2. Compare knowledge of HIV/HCV/STD transmission and its prevention before and after
intervention. This will be assessed by percent correct answers on a quiz administered
at each assessment.

3. To evaluate changes in drug and sex risk behaviors by treatment. The primary outcome
measure will be number of unprotected sexual encounters on self-assessment instruments
for risky sexual behaviors.

We hypothesize that the single session of computer-based CBT will result in reduced risky
sexual behaviors and increased knowledge of HIV/HCV/STD transmission with differences in
retention by intervention. A successful outcome for this pilot project would result in an
effect size of 0.30 or more on outcomes of risk behavior. This intervention will be
compared to treatment as usual at the participating site, which currently consists of two
group educational sessions on safety regarding risks of HIV/AIDS and hepatitis.

Preliminary Data- The case for computer-based behavioral treatments Computer-assisted
therapies offer a relatively novel approach to the dissemination of Evidence Based Therapies
(EBT) for behavioral interventions. Existing evidence points to their efficacy and
cost-effectiveness. Computer-based interventions offer a number of attractive
characteristics for use in primary care and substance treatment settings. Their low cost
coupled with high consistency, accessibility and standardization are some associated
advantages. Ease of implementation will be critical to reaching patients in remote and
rural areas or in small medical offices as primary care providers become a mainstay of
substance abuse treatment. Risky sexual behaviors can be targeted without the potential
negative associations of face to face behavioral interventions for this highly sensitive
domain and thus may be ideally modulated with computer-based therapies. Equivalency to
counselor-based education for learning new health behaviors, cost-effectiveness, patient
satisfaction and accessibility for illiterate patients are other advantages shown with
computer-based therapy.

Computer-based CBT: Carroll et al. at Yale have developed an effective computer-based
version of CBT, called "CBT4CBT" and have demonstrated its efficacy in reducing drug use and
building coping skills.(38) The program makes extensive use of 'movies' as teaching tools:
In each module, the user watches an individual confront a difficult situation relevant to
that module's topic; after teaching the key skill through a variety of strategies, the
'movie' repeats but has a different ending because the characters implement the targeted
coping skills. In developing CBT4CBT, we sought to develop an engaging version of CBT that
could take advantage of the capacity of computer-based learning to convey information via a
wide range of media (e.g., text, video, graphics, audio instruction, interactive exercises).
The CBT4CBT program is highly user-friendly, requiring no previous experience with
computers and minimal use of text-based material (i.e., minimal reading is required), and is
highly interactive. In particular, we capitalize on the use of videotaped examples to allow
users to actually see examples of individuals utilizing skills and strategies in a range of
realistic situations. Viewers are able to watch real-life challenges acted out and safe
behaviors modeled, while addressing negative or detrimental thought processes that
predispose to unhealthy or risky behavior choices (e.g. making a decision to have sex
without a condom). Viewer knowledge base is targeted by didactic portions and role playing
is modeled by the actors. The module includes the opportunity for the client to print out
and perform 'homework' worksheets, shown to be predictive for successful outcomes in CBT.
The module allows for considerable control by the viewer, who can choose the speed of
progression through the screens and has the capability to go back to previous screens for
reviewing.

Single CBT module application: Our original feasibility, efficacy, durability and
cost-effectiveness studies for addictions treatment employed the full version of CBT4CBT,
comprised of 7 modules. One independent module focuses entirely on targeting risky sexual
and drug use practices (titled "Stay Safe"), but has not been evaluated as an independent
module for effects on risk reduction. The "Stay Safe" module was developed by Dr. Kathleen
Carroll and her team at Yale in consultation with the Connecticut AIDS Education and
Training Center director (Karina Danvers) and others. Its development involved the input
of the CBT experts (Dr. Carroll, Dr. Michael Copenhaver), infectious disease specialists and
substance abuse treatment patients who volunteered to review the module. Like the substance
abuse targeted sections, the script was written to be easily recognizable across many
socioeconomic and cultural groups. Professional actors were hired to play the parts of
substance users in two separate high risk situations, one sexual and one Intravenous drug
use (IDU). Skills are taught with multimedia presentation allowing the user to direct the
pace of the module, as well as to view the consequences of various choices during the risky
situation. The intervention for the proposed pilot study is this single targeted module,
"Stay Safe". The module can be completed on virtually any computer, and thus is ideal for
implementation in this, and a wide range of settings. Its expense for clinical use will
also be reduced as a result of its brevity. These characteristics will make it easily
disseminated, with "real world" applications for settings of substance use treatment and
primary care medicine.

Overview: In order to maximize scientific yield from this project, we intentionally
designed the study to parallel the landmark Calsyn(5) and Tross(6) randomized trials
evaluating effects of the 5-session group CDC behavioral approach for risky sex practices
reduction in substance abuse treatment programs. We seek to compare as closely as possible
the variable of therapy type (computerized CBT in our study versus group therapy for safer
sex skills building in theirs), so we sought to minimize the differences between outcome
measures and methods. Use of parallels in design and outcome measures will allow us to
'benchmark' outcomes to reported changes in those studies.

Study Population and Sample: Hartford Dispensary (Hartford, CT) will serve as the site.
Drug treatment and medical services are offered on an outpatient basis there. This study
will enroll clients undergoing IDU treatment with methadone at the site. These clients come
in regularly for scheduled maintenance medication and clinical monitoring as well as
standard counseling. Many (roughly 55%) of these patients are already HCV and/or HIV
positive and therefore pose a significant risk for the transmission of the virus through
routes other than IDU.

Recruitment: Clients will be identified through self-presentation response to
advertisements and fliers in the clinic. Drug counseling providers may also ask clients if
they are interested in participating in the study. A sample size of 60 (30 patients per
group) is feasible and would be sufficient to detect a large effect size on risky sexual
behavior of [Cohen's d= 0.3, (alpha.05, power0.8)]. This effect size is smaller than that
reported for behavioral studies in the literature, but should be sufficient to evaluate
feasibility and promise of the proposed intervention in this pilot.

Participation Guidelines

Age:
18 Years and older
Gender:
Both

Eligibility 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)
Sponsor:
National Institute on Drug Abuse (NIDA)
Yale University
Dates:
April 2012
Last Updated:
January 10, 2014
Study HIC#:
1111009300

Clinicaltrials.gov ID: NCT01645033