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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03864653
Recruitment Status : Active, not recruiting
First Posted : March 6, 2019
Last Update Posted : February 6, 2020
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
University of California, Los Angeles
Information provided by (Responsible Party):
Friends Research Institute, Inc.

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.

Condition or disease Intervention/treatment Phase
HIV/AIDS Methamphetamine Abuse Depression Behavioral: MoodGym Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
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
Official Title: Brief Depression Intervention to Optimize Intensive Outpatient Methamphetamine Treatment Among Gay and Bisexual Men Who Have Sex With Men
Actual Study Start Date : February 25, 2019
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.





Primary Outcome Measures :
  1. Depression Symptoms [ Time Frame: 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.

  2. HIV-Related Medication Adherence [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03864653


Locations
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United States, California
Friends Community Center
Los Angeles, California, United States, 90028
Sponsors and Collaborators
Friends Research Institute, Inc.
National Institute of Mental Health (NIMH)
University of California, Los Angeles
Investigators
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Principal Investigator: Jesse B Fletcher, Ph.D. Friends Research Institute, Inc.
Additional Information:
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Responsible Party: Friends Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT03864653    
Other Study ID Numbers: 20182627
P30MH058107 ( U.S. NIH Grant/Contract )
First Posted: March 6, 2019    Key Record Dates
Last Update Posted: February 6, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is currently no plan to share individual participant data with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Friends Research Institute, Inc.:
MSM
PrEP
ART
Sexual Risk Behavior
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders