Recruiting
Phase 1

Behavioral Activation

Sponsor:

Massachusetts General Hospital

Code:

NCT01255280

Conditions

Crystal Methamphetamine Abuse

Crystal Methamphetamine Dependence

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Behavioral Activation Therapy and Risk Reduction Counseling (BAT-RR)

Information, Motivation, Behavioral skills change approach to sexual risk reduction

Study Details

Brief summary:

The purpose of this study is to research a new behavioral treatment to reduce sexual risk-taking in men who have sex with men (MSM) who abuse crystal methamphetamine (crystal meth), and are at risk for HIV acquisition. This study proposes using a treatment based on our original pilot study that incorporates risk reduction and behavioral activation therapy. In order to help learn what types of treatment programs best help individuals who abuse crystal meth and engage in sexual risk-taking, we will compare our treatment to a control group. The treatment group will receive therapy incorporating behavioral risk reduction counseling with behavioral activation therapy to treat depression, helping individuals reengage in their life. The control group will receive the risk reduction counseling without the behavioral activation therapy. The current study hopes to explore the efficacy of this previous developed treatment in a two-arm pilot randomized controlled trial.

Conditions

Crystal Methamphetamine Abuse

Crystal Methamphetamine Dependence

Study ID

NCT01255280

Start date

Jan, 2011

Status verified date

May, 2012

Completion date

Dec, 2013

Anticipated

Primary completion date

Dec, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age: 18 years or older
  • Self-reports as a man who has sex with men
  • HIV-uninfected and verifies serostatus at baseline (HIV antibody testing and positive tests will be confirmed by Western Blots; see Human Subjects for operational aspects)
  • Meets DSM-IV diagnostic criteria for crystal meth abuse/dependence
  • Self reported unprotected anal intercourse-receptive or insertive-with a non-monogamous male sexual partner, while concurrently using crystal meth (use of meth must be a few hours prior to, or during, sex) in the prior three months

Exclusion Criteria:

  • Unable to provide informed consent due to severe mental or physical illness, or substance intoxication at the time of interview
  • Has lived in the greater Boston area for three months or less (as a means to enhance participant retention)
  • Discovery of active suicidal ideation at the time of interview (these patients will be referred immediately for treatment, but may join the study when this is resolved)

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Information, Motivation, Behavioral skills

The comparison condition will only receive the two IMB risk reduction sessions. The intervention will begin with modules that focus directly with sexual risk reduction practices. It will begin with a discussion of one's sexual history, sexual risk limits, and barriers (e.g., motivation or skills) to staying in their sexual risk limits. This session will also involve a Q\&A discussion and the use of a fact sheet regarding HIV acquisition risk behaviors (information). The next session will involve motivational interviewing and the formulation of an individualized behavioral skills plan as needed.

experimental: Behavioral Activation Therapy and Risk Reduction Counseling

This intervention is given to patients in the experimental condition only and is comprised of 10 sessions-1 baseline session focused on orienting and rationale, 2 focused on risk reduction (consistent with the IMB model: information, motivation, and behavioral skills), 6 incorporating behavioral activation therapy/risk reduction counseling, and 1 final session on relapse prevention. Each session will last approximately fifty minutes in length; and will also involve a review of the previous materials,and hence the behavioral activation approach will be woven back into the risk reduction content.

Interventions

Behavioral Activation Therapy and Risk Reduction Counseling (BAT-RR)

This intervention is given to patients in the experimental condition only and is comprised of 10 sessions.

Information, Motivation, Behavioral skills change approach to sexual risk reduction

The comparison condition will only receive the two IMB risk reduction sessions.

Primary outcome measure

  • Change in sexual risk [ Time Frame: Baseline and three months post-treatment; baseline and six months post-treatment ]

Central Contacts and Locations

Central contacts

Matthew Mimiaga, ScD, MPH

617-927-6084MMimiaga@fenwayhealth.org

Janna Gordon

617-643-1168jrgordon@partners.org

Locations

Fenway Community Health

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Jaclyn White, MPH

617-927-6101jwhite@fenwayhealth.org

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jun 1, 2012

Last verified

May, 2012

Keywords

  • Crystal methamphetamine abuse
  • Crystal methamphetamine dependence
  • Sexual risk behavior
  • Men who have sex with men (MSM)
  • Behavioral activation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2012-06-01.