Brief Depression Intervention to Optimize Intensive Outpatient Methamphetamine Treatment Among Gay and Bisexual Men Who Have Sex With Men
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- HIV-Related Medication Adherence
研究概览
简要总结
This study is a single-arm, non-randomized pilot study. Eligible participants are newly enrolled participants in an outpatient methamphetamine treatment program, and study activities will take place contemporaneously with participation in the service program. During the first two weeks of the treatment program, participants will be offered the chance to enroll in a low-intensity, internet-based depression intervention called MoodGym. Participants that agree to enroll will be offered the chance to attend up to seven MoodGym sessions at the same time they undergo outpatient methamphetamine treatment. It is hypothesized that sexual risk outcomes, as well as medication adherence (e.g., PrEP/PEP; ART) outcomes will be optimized for participants who enroll to receive the MoodGym intervention content.
详细描述
Participants will be recruited from the Getting Off service program at Friends Community Center. Program participants will be invited to participate in the study at the time that they enroll in the program, and may enroll in the study at any time during their first or second week of program participation. Getting Off program staff will inform new participants about the research study. If the potential participant is interested in learning more about the study he will be directed to meet with the Study Counselor. Both the program staff and the SC will emphasize that participation in this study is voluntary and that participation in the program is not dependent on participation in this study. Interested participants will meet with the in a private room, then read the consent form, have questions answered by the, and sign the consent form if they wish to participate.
All in-person contact (recruitment, screening, consenting, MoodGym sessions, and administration of follow-up interviews) with participants will take place in a private room with a closed door at Friends Community Center. Any telephone calls made to participants during the course of the study will be made from a private office with a closed door, so the phone conversation cannot be heard.
MoodGym is an Internet-based CBT program that uses fun, engaging, interactive content, alongside character-driven narratives, to help alleviate symptoms of depression and comorbid anxiety. The program also aims to improve the individual's functioning by promoting the development of skills and strategies to manage depression.
MoodGym consists of an introduction module, five structured intervention modules, and a workbook of assessments.
- Getting Started
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Currently enrolled within the "Getting Off" (AKA, "Friends Getting Off") outpatient methamphetamine treatment program at Friends Community Center, Los Angeles, CA, USA.
- •and; within two weeks of initial enrollment into the "Getting Off" program.
排除标准
- •Not currently enrolled within the "Getting Off" program.
- •or; more than two weeks post-enrollment in the "Getting Off" program.
结局指标
主要结局
HIV-Related Medication Adherence
时间窗: Last 90 Days
A participant's self-reported adherence to ART (HIV-positive participants) or PrEP (HIV-negative participants) will be assessed via a short questionnaire. HIV-positive participants are asked if they are on an antiretroviral regimen (i.e., ART), and if so, when they began the regimen and their recent adherence patterns. HIV-negative participants are asked if they know what pre-exposure prophylaxis (PrEP) is, whether they are on PrEP, and if so, when they began the regimen.
Depression Symptoms Over Time
时间窗: Last Two Weeks
Depression symptoms are measured using the Center for Epidemiologic Studies Depression Scale (Revised; CESD-R) to begin each MoodGym session. The CESD-R consists of 20 items, each of which is a statement that participants are asked to endorse on a five-point scale from "not at all or less than one day in the last week" to "nearly every day for two weeks." Scores range from 0 thru 80, with higher scores indicating greater depression symptomology. The outcome measure described below indicates the average change in CESD-R scores for each MoodGym session attended.
次要结局
未报告次要终点