Brief Depression Intervention to Optimize Intensive Outpatient Methamphetamine Treatment Among Gay and Bisexual Men Who Have Sex With Men
Phase: NA
Conditions: HIV/AIDS, Methamphetamine Abuse, Depression
Sponsor: Friends Research Institute, Inc.

Page 1 of 14 
 
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20182627
IRB Approved at the 
Protocol Level 
Jun 11, 2019

Page 2 of 14 
 
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A Division of Friends Research Institute, Inc. 
6910 Santa Monica Blvd. 
Los Angeles, CA 90038 
 

Page 4 of 14 
 
 
 
,19(67,*$7255267(5
 
 
Principal Investigator 
Jesse B. Fletcher, Ph.D. 
Research Scientist 
Friends Research Institute, Inc.  
6910 Santa Monica Blvd. 
Los Angeles, CA 90038 
Phone:  (323) 463-1601 x126 
FAX:  (323) 463-0126 
E-Mail:  jfletcher@friendsresearch.org 
  
CHIPTS Mentor 
Cathy J. Reback, Ph.D. 
Senior Research Scientist  
Friends Research Institute, Inc.  
Executive Director, Friends Community Center 
Core Director, Center for HIV Identification, Prevention and Treatment Services 
(CHIPTS) 
6910 Santa Monica Blvd. 
Los Angeles, CA 90038 
Phone:  (323) 463-1601 
FAX:  (323) 463-0126 
E-Mail:  reback@friendsresearch.org 
 

Page 5 of 14 
 
 
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The objective of this study is to evaluate pilot data on the use of an evidence-informed 
depression intervention for optimizing treatment outcomes among gay and bisexual 
men enrolled in the *HWWLQJ2II  outpatient methamphetamine abuse treatment service 
program at Friends Community Center, a division of Friends Research Institute.   
MoodGym  is a five module, once-weekly depression intervention that, like the *HWWLQJ
2II intervention, is based on the principles of Cognitive Behavioral Therapy (CBT). In 
addition to receiving weekly sessions, study participants will be assessed weekly for 
depression symptomology and, if appropriate, quarterly for ART/PrEP uptake and/or 
adherence. This study will examine the feasibility, acceptability, and potential utility of 
augmenting intensive outpatient methamphetamine treatment through the simultaneous 
application of an evidence-based depression intervention.   
 
This study leverages insights on methamphetamine use, depression, and HIV sexual 
risk behavior to enhance a manualized outpatient treatment program for gay and 
bisexual men through the addition of an evidence-based depression intervention. Data 
from this study will clarify both the mediating and moderating influences of depression 
on the use/HIV risk link, may clarify the role of depression on HIV-related (i.e., PrEP or 
ART) medication adherence, and may suggest new avenues of inquiry into the 
behavioral and psychological links between addiction, depression, engagement in HIV 
sexual risk behaviors, and ART/PrEP uptake and adherence. Findings may also inform 
the process of recovery among gay and bisexual methamphetamine users, as evidence 
suggests depressive processes may play an important role.  
 
The specific aims are: 
 
1) 6SHFLILF$LP: Test the feasibility and acceptability of applying among 
participants of the program. 
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behavior outcomes of participants.  
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Page 6 of 14 
 
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Background 
Each year, 70% of new HIV infections in the United States occur with MSM,1 and use is 
identified as a major driving force in the continued HIV/AIDS pandemic affecting MSM 
communities.2 Though studies have consistently demonstrated associations between 
use and HIV transmission among MSM,3,4 recent research has further illustrated that 
depression is likely an under-recognized mechanism in the /HIV link, statistically both 
mediating and moderating the link between use and engagement in sexual risk 
behaviors.5 Further, depression is an obstacle to medication adherence for both HIV-
positive and HIV-negative MSM; depression has been associated with reduced 
adherence to ART medication,6,7 and MSM in the iPrex study with the highest levels of 
depression also demonstrated the lowest levels of PrEP adherence,8 highlighting the 
important effects of depression on biobehavioral efforts to limit HIV transmission among 
MSM. 
 
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This study is a single-arm, non-randomized pilot study.  Eligible participants are newly 
enrolled Getting Off service program 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 (see Figure 1).  
 
 
Study activities will take place contemporaneously with participation in the service 
program (i.e., participants enroll during their first or second week of Getting Off, and 
&RQVHQW	
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Up to 7 Sessions (1x/week) 
Assessed @ Start of Each Weekly Session: 
    - Center for Epidemiologic Studies Depression Scale (Revised) 
Assessed @ Baseline and 3-Month FU Only 
    - ART/PrEP Uptake and Adherence 
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Getting Off 
Pilot Study 

Page 7 of 14 
 
complete the 5 sessions over the remaining 6-7 weeks). If participants complete all five 
MoodGym modules prior to the 8-week endpoint, they will be offered the chance to 
revisit prior module(s); assessments and incentives will continue as scheduled. Getting 
Off program evaluation data from study participants will be matched and compared with 
historical program evaluation data to assess the impact of the MoodGym intervention on 
the Getting Off program outcomes through an observed treatment effects analysis.  

0RRG*\P 
MoodGym is a seven module computer-optimized, evidenced-based intervention for 
adults with depression and/or anxiety symptoms. Though MoodGym modules can be 
taken by participants without assistance, evidence suggests results may be improved by 
applying in a more structured setting. In this pilot study, MoodGym will be delivered with 
support and guidance from a trained Study Counselor. Each week participants will be 
asked to attend one one-hour individual appointment with the Study Counselor to 
complete a MoodGym module, for up to seven weeks. 
 
Phone Call After One Missed Session of MoodGym 
The SC will monitor participant attendance and conduct a phone call to any participant 
who does not attend a scheduled session, to reschedule.  
 
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Inclusion Criteria  
• A participant enrolled in the Getting Off service program at Friends Community 
Center; and, 
• Within his first or second week in the program 
 
Exclusion Criteria  
• Not a participant in his first or second week of the Getting Off service program at 
Friends Community Center 
 
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Recruitment and Enrollment 
Participants will be recruited from the Getting Off service program at Friends 
Community Center. Program participants will be invited to participate in the study at the 
time that they enroll in the program, and may enroll in the study at any time during their 
first or second week of program participation. Getting Off program staff will inform new 
participants about the research study. If the potential participant is interested in learning 
more about the study he will be directed to meet with the Study Counselor. Both the 
program staff and the SC will emphasize that participation in this study is voluntary and 
that participation in the program is not dependent on participation in this study. 
Interested participants will meet with the in a private room, then read the consent form, 
have questions answered by the, and sign the consent form if they wish to participate.  
 
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 

Page 8 of 14 
 
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. 
 
0RRG*\P Intervention 
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 
a. 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.  
 

Page 9 of 14 
 
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.  
 
Incentive Schedule 
All incentives will be paid in gift cards, no cash will be given. The total amount a 
participant can earn for participating in the study is $70. Participants can earn $10 for 
each session they attend, up to seven session, at the conclusion of each session. After 
each gift card is dispensed, participants will be asked to sign a sheet, specific only to 
them, indicating they have received the incentive payout. 
 
Timeline 
 
Table 1. Proposed Timeline 
of Study Activities 
Year 1 
Q1
 Q2
 Q3
  Q4
 
Month 1  2  3  4  5  6  7  8  9  10  11  12 
Study Activities 
Obta
in IRB Approva
l 
X X X 
      
 
 
 
H
ire/Tra
in Study Counse
lor 
X  X             
  
  
  
Enro
l
l 42 MA-Us
ing MSM (6/mo) 
       X  X  X  X  X  X  X 
  
  
MoodGym Imp
lementat
ion 
       X  X  X  X  X  X  X  
X  
X 
Data C
lean
ing & Ana
lys
is 
                  
  
   
X 
Beg
in Pub
l
icat
ion & D
issem
inat
ion                   
  
   
X 
 
 
STATISTICAL CONSIDERATIONS 
Assessments 
1. Center for Epidemiologic Studies Depression Scale (Revised). The Center for 
Epidemiologic Studies Depression Scale (Revised) [CESD-R]9 is a widely used 
depression assessment which consistently shows strong psychometric properties and 
concurrent validity with clinical diagnostic instruments.
10 The CESD-R will be 
administered at the start of each session.  
 
2. ART and PrEP Uptake and Adherence. Administered at baseline enrollment in the 
pilot study and 3-month follow-up only. The ART and PrEP Uptake and Adherence form 
briefly queries HIV-positive and HIV-negative participants as to whether they have 
begun and/or adhered to a prescribed ART or PrEP regimen in the past 3 months. 
 
Statistical Analyses 

Page 10 of 14 
 
Specific statistical analyses will be chosen based on the distributional properties of the 
variables being analyzed; sociodemographics or other variables found to significantly 
influence primary outcomes may be tested for inclusion as statistical controls and/or 
bases for contingency analyses. The outcome of primary analytical interest, i.e., 
engagement in HIV sexual risk behaviors, is most amenable to analyses employing the 
negative binomial or logistic link functions, for count and dichotomous 
operationalizations, respectively. Descriptive statistics will be provided for all variables, 
and inferential models related to Specific Aim 2 will assume three complementary but 
parallel analytical approaches. First (H2a), an observed treatment effects dosage 
response analysis will test for observed associations between attendance to the weekly 
sessions and reductions in both the magnitude (negative binomial) and/or likelihood 
(logistic) of engagement in HIV sexual risk behaviors [note: sexual risk behavior data is 
gathered during standard *HWWLQJ2II procedures]; analyses will be double-robustly 
estimated to ensure proper model specification.11 Second (H2b), the same model will be 
estimated, but will further include participants’ CESD-R depression scores both as a 
main effect, as well as in a statistical interaction term with the number of sessions 
attended. Planning such a nested analysis allows for full specification of the effects of 
depression, both directly and in response to the intervention. Third (H2c), participants’ 
HIV sexual risk behavior outcomes will be statistically contrasted against those same 
outcomes from a group of historical matched controls sampled from the  program (2009-
2017) and matched using either caliper or nearest neighbor algorithm (based on method 
of best fit)12 using participant age, race/ethnicity, HIV status, and the severity of their  
use. The proposed Secondary Aim will be tested using the Bernoulli family and logistic 
link function, where uptake or satisfactory (i.e.,  85%) adherence to ART/PrEP during 
the course of the intervention will be coded a “1”, “0” otherwise, and regressed on 
intervention exposure and/or CESD-R depression scores. 
 
Missing Data 
General Estimation Equation (GEE) analyses will test patterns of missing data in the 
follow-up assessments. Follow-up assessment data will be coded trichotomously (i.e., 
observed, intermittent missing, missing due to dropout) and regressed on arm 
assignment and relevant covariates (e.g., racial/ethnic identity, age) to ensure 
appropriate application of inferential logic. If a non-ignorable pattern of missing data is 
discovered (note: confirmed by Little’s test of non-random missingness), sensitivity 
analyses will be conducted to ascertain which missing data management strategy (e.g., 
multiple partial imputation) should be applied.    
 
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0RRG*\P Online Modules 
The online modules do not report any sensitive data related to participants’ mental 
health. All usage measures will be based on the recording of the modules completed by 
each participant during weekly sessions, and depression symptoms and trends are 
assessed via the weekly CESD-R assessments.  
 
Study Counselor-Administered Assessments 
The will briefly assess participants’ depression symptoms (via the CESD-R) at the 

Page 11 of 14 
 
beginning of each weekly session, and HIV-related medication uptake/adherence (via 
the ART and PrEP Uptake and Adherence form) at baseline and 3 month follow-up. In 
both cases, assessments will be administered via an online data entry form 
administered from the same computer the sessions are accessed. The online data entry 
form and short-term data hosting will be contracted using Qualtrics, a global data entry 
firm Friends Research Institute has ongoing multi-year contracts providing access to 
online survey creation and implementation software. The Qualtrics’ system is HIPAA 
compliant and conforms to industry standard (e.g., ISO 27001 and FEDRAMP 
compliant) encryption and data security. Study data will be hosted on the Qualtrics 
cloud for the duration of the study, and will be removed at the completion of the data 
collection phase.  
 
021,725,1*$1'$'9(56((9(175(3257,1*
Adverse event reporting will follow the WIRB policies.  Serious adverse events (SAEs) 
include any of the following outcomes for the participant: 1) death; 2) acute life-
threatening incidents; 3) hospitalization or the prolongation of a hospitalization; or 4) 
persistent or significant disability. SAEs events may be communicated to the principal 
investigator by participants or staff, or may be observed directly by the principal 
investigator. SAEs will be reported regardless of whether they are considered study-
related.  
 
Distress Policy 
In the instance of: 
 
 
1) a participant presenting with a gun or other weapon, and/or threatening physical 
violence against staff, himself, or an identified other person;  
 
2) a family member or friend of a participant informing a staff member that a 
participant is threatening to harm staff, himself, or an identified other person; 
 
the Friends Community Center 'LVWUHVV3URWRFROIRU3DUWLFLSDQWVDW)ULHQGV&RPPXQLW\
&HQWHU is automatically triggered. Staff immediately contact a trained counselor or 
clinician to assess the situation and advise management. Staff are provided with a 
phone tree providing the names and contact information (including mobile phones and 
pagers) for six trained counselors/clinicians familiar with, and who have agreed to carry 
out, the Friends Community Center 'LVWUHVV3URWRFRO. In the case of extreme immediate 
threat, staff are trained to remove themselves, immediately dial 911, and to ensure the 
safety of themselves, other staff, and participants above all else.  
 
Regulatory Updates 
The principal investigator will report any information related to unanticipated risks or 
new information that may change the risk-benefit ratio to the WIRB IRB. This 
information may come from the current study or findings from other studies. Any 
changes in the protocol or consent as a result of this information will be promptly 
reported to the WIRB and CHIPTS. The Principal Investigator will also report any 
irregularities in the conduct of the study such as: participant enrollment; obtaining 
informed consent; and, data collection and processing. 

Page 12 of 14 
 
 
+80$13$57,&,3$176
Institutional Review Board (IRB) Review and Informed Consent 
This protocol, the informed consent document and any subsequent modifications will be 
reviewed and approved by WIRB, which is responsible for oversight of the study. A 
signed consent form will be obtained from each study participant. The consent form will 
describe the purpose of the study, the procedures to be followed, and the risks and 
benefits of participation. A copy of the consent form will be given to the participant, and 
this fact will be documented in the participant’s record. 
 
&5,7(5,$)2535(0$785(678'<',6&217,18$7,21
The study may be discontinued at any time by CHIPTS, or other government agencies 
as part of their duties to ensure that research participants are protected.    
 
 

Page 13 of 14 
 

5()(5(1&(6
 
1. Centers for Disease Control and Prevention. +,96XUYHLOODQFH5HSRUW, 2015; vol. 27. 
http://www.cdc.gov/hiv/library/reports/hiv-surveillance.html. Published November 2016. 
Accessed 03/16/2018. 
 
2.  Centers of Disease Control and Prevention (2016). *D\DQG%LVH[XDO0HQ
V+HDOWK. 
Atlanta, GA: National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention. 
https://www.cdc.gov/msmhealth/substance-abuse.htm. Accessed 03/16/2018. 
 
3.  Halkitis, P. N., Levy, M. D., & Solomon, T. M. (2016). Temporal relations between 
methamphetamine use and HIV seroconversion in gay, bisexual, and other men who 
have sex with men. -RXUQDORIKHDOWKSV\FKRORJ\, 21(1), 93-99. 
 
4. Hoenigl, M., Chaillon, A., Moore, D. J., Morris, S. R., Smith, D. M., & Little, S. J. 
(2016). Clear links between starting methamphetamine and increasing sexual risk 
behavior: a cohort study among men who have sex with men. -RXUQDORIDFTXLUHG
LPPXQHGHILFLHQF\V\QGURPHV (1999), 71(5), 551. 
 
5.  Fletcher, J. B., & Reback, C. J. (2015). Depression mediates and moderates effects 
of methamphetamine use on sexual risk taking among treatment-seeking gay and 
bisexual men. +HDOWKSV\FKRORJ\, 34(8), 865. 
 
6.  Grenard, J. L., Munjas, B. A., Adams, J. L., Suttorp, M., Maglione, M., McGlynn, E. 
A., & Gellad, W. F. (2011). Depression and medication adherence in the treatment of 
chronic diseases in the United States: a meta-analysis. -RXUQDORIJHQHUDOLQWHUQDO
PHGLFLQH, 26(10), 1175-1182. 
 
7.  Yoo-Jeong, M., Waldrop-Valverde, D., McCoy, K., & Ownby, R. L. (2016). A 
Structural Equation Model of HIV-related Symptoms, Depressive Symptoms, and 
Medication Adherence. -RXUQDORI+,9DQG$,'6, 2(3). 
 
8.  Mehrotra, M. L., Glidden, D. V., McMahan, V., Amico, K. R., Hosek, S., Defechereux, 
P., ... & Schechter, M. (2016). The effect of depressive symptoms on adherence to daily 
oral PrEP in men who have sex with men and transgender women: a marginal structural 
model analysis of the iPrEx OLE study. $,'6DQG%HKDYLRU, 20(7), 1527-1534. 
 
9.  Eaton, W. W., Smith, C., Ybarra, M., Muntaner, C., & Tien, A. (2004). Center for 
Epidemiologic Studies Depression Scale: Review and Revision (CESD and CESD-R). 
In M. E. Maruish (Ed.), 7KHXVHRISV\FKRORJLFDOWHVWLQJIRUWUHDWPHQWSODQQLQJDQG
RXWFRPHVDVVHVVPHQW,QVWUXPHQWVIRUDGXOWV (pp. 363-377). Mahwah, NJ, US: 
Lawrence Erlbaum Associates Publishers. 
 

Page 14 of 14 
 
10.  Van Dam, N. T., & Earleywine, M. (2011). Validation of the Center for 
Epidemiologic Studies Depression Scale—Revised (CESD-R): Pragmatic depression 
assessment in the general population. 3V\FKLDWU\UHVHDUFK, 186(1), 128-132. 
 
11.  Drukker, D. (2014). Double-Robust Treatment Effects. 6WDWD1HZV, 29(1), 3-5. 
 
12.  Austin, P. C. (2014). A comparison of 12 algorithms for matching on the propensity 
score. 6WDWLVWLFVLQPHGLFLQH, 33(6), 1057-1069.