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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03864653|
Recruitment Status : Recruiting
First Posted : March 6, 2019
Last Update Posted : March 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|HIV/AIDS Methamphetamine Abuse Depression||Behavioral: MoodGym||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 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|
|Estimated Primary Completion Date :||September 30, 2019|
|Estimated Study Completion Date :||December 31, 2019|
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 [ 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.
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
|Contact: Jesse B Fletcher, Ph.D.||(323) 463-1601 ext firstname.lastname@example.org|
|Contact: Cathy J Reback, Ph.D.||(323) 463-1601 ext email@example.com|
|United States, California|
|Friends Community Center||Recruiting|
|Los Angeles, California, United States, 90028|
|Contact: Jesse B Fletcher, Ph.D. 323-463-1601 ext 126 firstname.lastname@example.org|
|Contact: Cathy J Reback, Ph.D. 13234631601 ext 114 email@example.com|
|Principal Investigator: Jesse B Fletcher, Ph.D.|
|Principal Investigator:||Jesse B Fletcher, Ph.D.||Friends Research Institute, Inc.|