Depression Intervention Among Gay and Bisexual Men Receiving Treatment for Methamphetamine Use
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|ClinicalTrials.gov Identifier: NCT03864653|
Recruitment Status : Completed
First Posted : March 6, 2019
Results First Posted : September 9, 2020
Last Update Posted : September 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|HIV/AIDS Methamphetamine Abuse Depression||Behavioral: MoodGym||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|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)|
|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|
|Actual Primary Completion Date :||March 30, 2020|
|Actual Study Completion Date :||May 31, 2020|
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.
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.
- Depression Symptoms Over Time [ 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. The outcome measure described below indicates the average change in CESD-R scores for each MoodGym session attended.
- 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.
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
|United States, California|
|Friends Community Center|
|Los Angeles, California, United States, 90028|
|Principal Investigator:||Jesse B Fletcher, Ph.D.||Friends Research Institute, Inc.|