Trial Outcomes & Findings for Depression Intervention Among Gay and Bisexual Men Receiving Treatment for Methamphetamine Use (NCT NCT03864653)

Last Updated: 2020-09-09

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

39 participants

Primary outcome timeframe

Last Two Weeks

Results posted on

2020-09-09

Participant Flow

Participant milestones

Participant milestones
Measure	MoodGym Non-randomized single-arm intervention; eligible persons are newly enrolled methamphetamine use treatment service program (i.e., "Getting Off") participants who will 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 answe
Overall Study STARTED	39
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	MoodGym Non-randomized single-arm intervention; eligible persons are newly enrolled methamphetamine use treatment service program (i.e., "Getting Off") participants who will 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 answe
Overall Study Withdrawal by Subject	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MoodGym n=38 Participants Non-randomized single-arm intervention; eligible persons are newly enrolled methamphetamine use treatment service program (i.e., "Getting Off") participants who will 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 answe
Age, Continuous	44.87 years STANDARD_DEVIATION 10.27 • n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	38 Participants n=93 Participants
Race/Ethnicity, Customized White	12 Participants n=93 Participants
Race/Ethnicity, Customized Black	4 Participants n=93 Participants
Race/Ethnicity, Customized Latinx	19 Participants n=93 Participants
Race/Ethnicity, Customized Multiracial/Multiethnic/Other	3 Participants n=93 Participants
Region of Enrollment United States	38 participants n=93 Participants
Tenure of Heavy Methamphetamine Use	5.11 years STANDARD_DEVIATION 5.41 • n=93 Participants
Methamphetamine Use	8.11 days STANDARD_DEVIATION 9.23 • n=93 Participants

PRIMARY outcome

Timeframe: Last Two Weeks

Outcome measures

Outcome measures
Measure	MoodGym n=38 Participants Non-randomized single-arm intervention; eligible persons are newly enrolled methamphetamine use treatment service program (i.e., "Getting Off") participants who will 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 answe
Depression Symptoms Over Time	-0.062 Units on a Scale Interval -0.095 to -0.03

PRIMARY outcome

Timeframe: Last 90 Days

Population: HIV-Positive Study Participants who reported on their ART medication adherence at 90-day follow-up (zero HIV-negative participants enrolled who reported being on PrEP).

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.

Outcome measures

Outcome measures
Measure	MoodGym n=9 Participants Non-randomized single-arm intervention; eligible persons are newly enrolled methamphetamine use treatment service program (i.e., "Getting Off") participants who will 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 answe
HIV-Related Medication Adherence	4.78 doses missed Standard Deviation 3.87

Adverse Events

MoodGym

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MoodGym n=39 participants at risk Non-randomized single-arm intervention; eligible persons are newly enrolled methamphetamine use treatment service program (i.e., "Getting Off") participants who will 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 answe
Blood and lymphatic system disorders Blood Clot	2.6% 1/39 • Number of events 1 • 90 days
Skin and subcutaneous tissue disorders Cellulitis	2.6% 1/39 • Number of events 1 • 90 days

Other adverse events

Adverse event data not reported

Additional Information

Jesse B. Fletcher, Ph.D. [Research Scientist]

Friends Research Institute, Inc.

Phone: (323) 463-1601

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place