Depression Intervention Among Gay and Bisexual Men Receiving Treatment for Methamphetamine Use
NCT ID: NCT03864653
Last Updated: 2020-09-09
Study Results
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View full resultsBasic Information
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COMPLETED
NA
39 participants
INTERVENTIONAL
2019-02-25
2020-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* and; within two weeks of initial enrollment into the "Getting Off" program.
Exclusion Criteria
* or; more than two weeks post-enrollment in the "Getting Off" program.
MALE
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
University of California, Los Angeles
OTHER
Friends Research Institute, Inc.
OTHER
Responsible Party
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Principal Investigators
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Jesse B Fletcher, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Friends Research Institute, Inc.
Locations
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Friends Community Center
Los Angeles, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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MoodGym Intervention
Other Identifiers
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20182627
Identifier Type: -
Identifier Source: org_study_id
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