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

NCT03864653 | Completed Results

• 2 other identifiers: 20182627P30MH058107
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV/AIDS; Methamphetamine Abuse; Depression

Keywords

MSM; PrEP; ART; Sexual Risk Behavior

Outcome Measures

Primary Outcomes (2)

• Depression Symptoms Over Time

  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.

  Last Two Weeks

• HIV-Related Medication Adherence

  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.

  Last 90 Days

Study Arms (1)

MoodGym

OTHER

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

Interventions

MoodGym BEHAVIORAL

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.

MoodGym

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Not currently enrolled within the "Getting Off" program.
• or; more than two weeks post-enrollment in the "Getting Off" program.

Sponsors & Collaborators

• Friends Research Institute, Inc.: lead
• National Institute of Mental Health (NIMH): collaborator
• University of California, Los Angeles: collaborator

Study Sites (1)

Friends Community Center

Los Angeles, California, 90028, United States

Location

Related Links

• MoodGym Intervention
• Getting Off Treatment Manual

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Depression

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Behavioral Symptoms; Behavior

Limitations and Caveats

COVID-19 pandemic travel restrictions reduced ability to conduct timely follow-up in the final months of the study.

Results Point of Contact

• Title: Jesse B. Fletcher, Ph.D. [Research Scientist]
• Organization: Friends Research Institute, Inc.

jfletcher@friendsresearch.org

(323) 463-1601

Study Officials

• Jesse B Fletcher, Ph.D.

  Friends Research Institute, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: March 6, 2019
• Study Start: February 25, 2019
• Primary Completion: March 30, 2020
• Study Completion: May 31, 2020
• Last Updated: September 9, 2020
• Results First Posted: September 9, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)