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Depression Intervention Among Gay and Bisexual Men Receiving Treatment for Methamphetamine Use

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ClinicalTrials.gov Identifier: NCT03864653
Recruitment Status : Recruiting
First Posted : March 6, 2019
Last Update Posted : March 6, 2019
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
University of California, Los Angeles
Information provided by (Responsible Party):
Friends Research Institute, Inc.

Tracking Information
First Submitted Date  ICMJE March 5, 2019
First Posted Date  ICMJE March 6, 2019
Last Update Posted Date March 6, 2019
Actual Study Start Date  ICMJE February 25, 2019
Estimated Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2019)
  • Depression Symptoms [ Time Frame: Last 7 Days ]
    Depression symptoms are measured using the Center for Epidemiologic Studies Depression Scale (Revised; CESD-R) to begin each MoodGym session.
  • HIV-Related Medication Adherence [ Time Frame: Last 30 Days ]
    A participant's self-reported adherence to ART (HIV-positive participants) or PrEP (HIV-negative participants) will be assessed via a short questionnaire.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Depression Intervention Among Gay and Bisexual Men Receiving Treatment for Methamphetamine Use
Official Title  ICMJE Brief Depression Intervention to Optimize Intensive Outpatient Methamphetamine Treatment Among Gay and Bisexual Men Who Have Sex With Men
Brief Summary 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.
Detailed Description

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.

  1. Getting Started

    a. An introduction to MoodGym, including CBT, the different characters and structure of the intervention content, and baseline mental health quizzes (e.g., depression, anxiety) that are scored in real time to help the participant understand their current level of mental health symptoms. This will be done during the first MoodGym session, given its brevity and relationship to the first module.

  2. Feelings Module

    a. Understanding emotions, mood, and physical reactions of depression and anxiety, as well as the impact of your perspective on your personal feelings. Demonstrates links between events, thoughts, feelings, and behaviors.

  3. Thoughts Module

    a. Addresses unwelcome, unhealthy, or intrusive thoughts, and demonstrates how some thoughts can help you overcome mental health symptoms. Discusses how to improve self-esteem by changing thought patterns.

  4. Unwarping Module

    a. Introduces the idea of "warpy" thoughts, including false impressions that one must be perfect, that one can control all things, or that one is worthless if they are criticized.

  5. Destressing Module

    1. Discusses means and strategies to reduce stress, which can have important impacts on depression and anxiety symptoms, and mental health more generally.
  6. Relationships Module

    a. Discusses how relationships can both benefit or worsen one's mental health, and how to monitor and maintain healthy relationships.

  7. Workbook a. Contains all quizzes and tests the participant encounters during each of the above sessions. If a participant would like to retest themselves on some dimension (e.g., depression, anxiety, warpy thoughts), they can revisit the assessment in the Workbook section, and receive an updated score in real time.

Each MoodGym session will last up to one hour and will begin with the brief CESD-R assessment, administered by the Study Counselor via the same computer as the MoodGym intervention, followed by one of the five online modules, which are self-contained and guide the participant through all intervention content. Online modules include quizzes, videos, characters, interactive activities, informational content, personal stories, workbook activities, and content summaries. Sessions can also include interactions with the Study Counselor, as much or as little as the participant chooses to initiate, including supportive feedback, guidance, help, and encouragement on activities.

The SC will monitor participant attendance and conduct a phone call to any participant who does not attend a session for two consecutive weeks.

Participants will be assessed one final time, receiving both the ART and PrEP Uptake and Adherence form and the CESD-R, at 90 days post-enrollment.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Participants who have already enrolled in the methamphetamine outpatient treatment program, and who are still within their first two weeks of treatment, will be offered the chance to co-enroll in a low-intensity depression intervention.
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • HIV/AIDS
  • Methamphetamine Abuse
  • Depression
Intervention  ICMJE Behavioral: MoodGym

MoodGym is a preexisting Internet-based CBT program that uses interactive content and 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. Each MoodGym session takes place entirely on an Internet-connected tablet while in the physical co-presence of a Study Counselor, who can answer questions should they arise. Each session takes approximately one hour to complete.

Study Arms  ICMJE MoodGym
Non-randomized single-arm intervention; eligible persons are newly enrolled methamphetamine use treatment service program (i.e., "Getting Off") participants who will be invited to participate in the study during their enrollment, and can enroll in the study at any time during their first two weeks of program participation. Participants who enroll will take the preexisting, low-intensity MoodGym intervention.
Intervention: Behavioral: MoodGym
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 5, 2019)
42
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Not currently enrolled within the "Getting Off" program.
  • or; more than two weeks post-enrollment in the "Getting Off" program.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jesse B Fletcher, Ph.D. (323) 463-1601 ext 126 jfletcher@friendsresearch.org
Contact: Cathy J Reback, Ph.D. (323) 463-1601 ext 114 reback@friendsresearch.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03864653
Other Study ID Numbers  ICMJE 20182627
P30MH058107 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There is currently no plan to share individual participant data with other researchers.
Responsible Party Friends Research Institute, Inc.
Study Sponsor  ICMJE Friends Research Institute, Inc.
Collaborators  ICMJE
  • National Institute of Mental Health (NIMH)
  • University of California, Los Angeles
Investigators  ICMJE
Principal Investigator: Jesse B Fletcher, Ph.D. Friends Research Institute, Inc.
PRS Account Friends Research Institute, Inc.
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP