Pilot Study of a Transdiagnostic, Emotion-focused Group Intervention for Young Adults With Substance Use Disorders
Phase: NA
Conditions: Substance Use Disorders, Depression, Anxiety, Emotional Disorder, Suicidal Ideation, Suicidal and Self-injurious Behavior
Sponsor: Massachusetts General Hospital

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TITLE: Study of a Transdiagnostic, Emotion-focused Group Intervention for Young Adults 
With Substance Use Disorders 
NCT: NCT03315208 
Document Date: 7.5.2019 
 
 
 
 

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Pilot study of a transdiagnostic, emotion-focused group intervention for young adults with 
substance use disorders 
 
Principal Investigator: Kate Bentley, PhD 
 
DETAILED PROTOCOL 
Version Date: July 5, 2019 
 
I. BACKGROUND AND SIGNIFICANCE 
SUDs among young adults: SUDs, defined as all alcohol and drug use disorders (minus 
nicotine and caffeine), are among the most common and burdensome public health problems in 
the United States. The prevalence of SUD is especially high among young adults.1 Recent 
national surveys indicate that approximately 17% of 18 to 25 year-olds meet SUD criteria, 
compared to about 7% of individuals ages 26 and older and 5% of adolescents.2 Young adults 
also have the highest rates of specific risky (or potentially life-threatening) substance use 
behaviors, including illicit drug use, binge drinking, and heavy drinking.2 Given these statistics, 
it is no surprise that a large proportion of the overall health and economic burden of SUD can be 
attributed to this cohort.3,4,5 
Young adults have been shown to benefit from evidence-based treatments for SUD, such 
as cognitive-behavioral therapy (CBT), certain medications in combination with psychotherapy, 
and mutual-help organizations.6 However, young adults consistently have a less robust response 
than both adolescents and older adults, and tend to be more difficult to retain in SUD treatment.1 
The latter may be at least in part due to lower readiness to stop (or change) substance use.1 Thus, 
there is still room for improvement of outcomes and retention associated with existing SUD 
treatment approaches for this high-need group. 
SUDs and emotional distress: Epidemiological studies have observed high comorbidity 
rates for SUDs and the affective/emotional disorders (i.e., anxiety, depressive, and related 
disorders) across adults and adolescents.7,8,9 The risk of suicidal and nonsuicidal SITBs (e.g., 
suicide ideation and attempts, nonsuicidal self-injury [NSSI]), manifestations of acute emotional 
distress especially prevalent among young adults,10,11 is also elevated among individuals with 
SUD.12,13,14 Unfortunately, the presence of an emotional disorder (especially more severe 
conditions, such as recurrent MDD and bipolar disorder) has a negative impact on SUD 
treatment outcome.15,16 SITBs are high risk, difficult to treat, and can complicate SUD treatment. 
In sum, young adults with SUD and comorbid emotional distress are a sizeable, challenging 
population for whom a novel treatment approach could have a large public health impact. 
Emotion dysregulation as a transdiagnostic treatment target: To this end, we propose to 
target core psychopathological processes related to emotion dysregulation that underlie SITBs 
and commonly co-occurring emotional disorder pathology. One such process is the frequent 
experience of intense negative affect coupled with aversive reactivity to emotional experiences 
when they occur (i.e., neuroticism).17 These aversive reactions result in efforts to avoid, control, 
or suppress emotional experiences, which lead to rebound effects in which emotions return with 
greater frequency and intensity,18 resulting in symptom maintenance/recurrence. This 
temperamental factor has been implicated in the onset and maintenance of anxiety, depressive, 
and other emotional disorders such as OCD and PTSD,17 as well as in SITBs.19 For example, 
neuroticism has been shown to predict suicidal ideation, attempts, and deaths20,21 and leading 

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evidence-based theories point to the role of overwhelming negative affect in contributing to 
suicidal behavior.22,23 It is also well-established that NSSI is most often enacted to relieve acute 
negative affective states.24,25  
Although not necessarily conceptualized as a prototypical emotional disorder, emotion 
regulation difficulties have also been implicated in the development and persistence of SUDs.26 
For example, people with alcohol use disorder (AUD) report elevated emotion dysregulation,27 
neuroticism,28 and negative emotionality.29 Impaired emotion regulation is also associated with 
poorer AUD treatment response.30,31 Emotion dysregulation increases vulnerability to cue-
induced craving and impulsive responding—constructs relevant to all SUDs.32 Alterations in 
emotion regulation neural circuitry (e.g., hypoactivation of the rostral anterior cingulate 
cortex/ventromedial prefrontal cortex) have been observed for example in those with cocaine and 
opiate use disorders.26 Finally, distressing emotional states are precipitants of drug and alcohol 
use,33,34 leading some researchers to conceptualize problematic substance use as a maladaptive 
strategy for down-regulating negative affect,35,36 often colloquially termed “self-medication”. 
 
The Unified Protocol: The Unified Protocol for Transdiagnostic Treatment of Emotional 
Disorders (UP37,38) is an evidence-based psychological intervention designed to be applied across 
anxiety, depressive, and any other disorder in which emotion dysregulation is central. Rather 
than focusing on diagnosis-specific symptoms, the UP seeks to target shared temperamental 
vulnerabilities to emotional disorders (namely, neuroticism) through five emotion-focused CBT 
strategies: increasing mindful emotion awareness, increasing cognitive flexibility, countering 
emotion-driven behaviors, and conducting interoceptive/emotion exposure exercises. Given its 
transdiagnostic format, the UP has the potential to address comorbidity among the emotional 
disorders (and other functionally similar problems such as SUDs) simultaneously and more 
comprehensively than single-diagnosis treatments. This approach also has notable implications 
for dissemination and training, as clinicians could learn only one CBT protocol to flexibly utilize 
across many presentations. 
 
PRELIMINARY STUDIES 
 
The UP has shown efficacy in treating heterogeneous anxiety and comorbid unipolar 
depressive disorders in multiple randomized controlled trials (RCTs), including a recent large-
scale RCT (N=223) in which the UP was shown to be equally efficacious to “gold-standard,” 
single-diagnosis CBT protocols for social anxiety disorder, generalized anxiety disorder, 
obsessive-compulsive disorder, and panic disorder .39,40 Initial findings also support its use for 
primary MDD,41 bipolar disorder,42 PTSD,43 borderline personality disorder,44 and NSSI.45 An 
adapted version of the UP also demonstrated initial feasibility and acceptability for suicidal 
inpatients in a recent pilot study.19  
Regarding applications of the UP to SUD, the one published RCT to date (N=81) found 
the UP to significantly reduce heavy drinking in adults with AUD and anxiety.46 To our 
knowledge, the UP has not yet been evaluated in those with a range of SUDs, though the 
framework is theoretically applicable to any substance use that functions as a maladaptive 
response to negative emotion. In the UP, problematic substance use is conceptualized as an 
avoidant coping response that reciprocally increases the frequency and intensity of negative 
emotions such as anxiety, sadness, anger, etc. Because young adults may be more motivated to 
change emotional disorder symptoms than substance use,1 it is also possible that an integrated, 
emotion-focused treatment like the UP may be associated with less dropout than SUD-specific 
protocols, while still delivering concepts relevant to reducing problematic substance use. 
 

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POTENTIAL BENEFITS OF THE PROPOSED RESEARCH 
The greatest potential eventual implication of the proposed research is to improve the 
standard of care for a sizeable population in need of improved treatment approaches: young 
adults with SUD and emotional distress. If the adjunctive UP proves incrementally effective 
when added to TAU, it will contribute to evidence-based treatment guidelines for this 
underserved population. Effectively treating this group would reduce long-term disability and 
costs, improving overall functioning and reducing public health burden. By delivering adaptive 
strategies for emotional responding, this transdiagnostic group intervention offers a low cost, 
easily implemented treatment that may provide greater and more broad-based benefits than 
existing pharmacological and single-diagnosis therapies, and perhaps help prevent future SUD 
relapse. Eventual findings may be used to inform the development of guidelines for treatment of 
young adults (and potentially, other cohorts) with SUD and co-occurring emotional distress. This 
pilot study is the first, necessary step in obtaining preliminary data for future grant applications 
(e.g., K awards) to conduct a larger randomized trial adequately powered to examine short- and 
long-term efficacy, as well as intervention moderators (e.g., SUD type) and mediators. 
 
II. 
SPECIFIC AIMS 
 
We propose to conduct a pilot randomized controlled trial comparing a cognitive-behavioral, 
transdiagnostic, emotion-focused group intervention plus treatment as usual (UP + TAU) to TAU 
alone to within an existing comprehensive outpatient program for young adults with SUD and 
comorbid emotional distress (N=50). Participants will be randomized in a 2:1 ratio to UP + TAU 
or TAU alone conditions. 
 
Specific Aim 1: To evaluate the acceptability and feasibility of adding a transdiagnostic, 
emotion-focused group intervention (16 twice-weekly UP sessions) to TAU in a comprehensive 
outpatient program for young adults with SUDs and elevated emotional distress (N=50).   
Hypothesis 1a. UP participants will report high satisfaction with and acceptability of the 
UP per Client Satisfaction Questionnaire (CSQ-847) and semi-structured clinical 
feedback interview.  
Hypothesis 1b. UP participants will be less likely to drop out from treatment at the 
outpatient program during the study period than those in control condition.  
 
Specific Aim 2: To explore the adjunctive intervention’s acute efficacy in treating emotional 
distress (anxiety, depression, suicidal ideation, NSSI) and indices of SUD (commitment to 
sobriety, craving, quantity and frequency of substance use).  
Hypothesis 2a. UP participants will evidence greater decreases in Overall Anxiety 
Severity and Impairment Scale (OASIS) and Overall Depression Severity and Impairment 
Scale (ODSIS) from pre- to post-treatment than the those in the control condition.  
Hypothesis 2b. UP participants who report past month suicidal thoughts at baseline will 
evidence greater reductions in Beck Scale for Suicidal Ideation (BSI49) scores from pre- 
to post-treatment than those in the control condition.  
Hypothesis 2c. UP participants who report past month NSSI urges or episodes at 
baseline will report a lower frequency of NSSI urges and episodes in a one-month period 
on the Self-Injurious Thoughts and Behaviors Interview-Clinician Rated [SITBI-CR50]- 

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and on the Self-Injurious Thoughts and Behaviors Interview-Self-Rated [SITBI-SR50]at 
post-treatment than the control.  
Hypothesis 2d. UP participants will evidence greater increases in Commitment to 
Sobriety Scale (CSS51) and decreases in Craving Scale52 scores from pre- to post-
treatment than the control.  
Hypothesis 2e. UP participants will report lower quantity and frequency of substance use 
during the study period than those in the control condition. 
 
III. 
SUBJECT SELECTION 
 
We propose to conduct a pilot randomized controlled trial for young adults with SUD and 
comorbid emotional distress who are entering into or currently engaged in treatment within a 
comprehensive outpatient program (ARMS at MGH). We plan to enroll 50 young adults (ages 18 
to 26) with SUD and comorbid emotional distress from ARMS. They will be randomized in a 2:1 
ratio to one of two conditions: 16 twice-weekly sessions of a transdiagnostic, group-based CBT 
intervention (the Unified Protocol [UP]) plus usual services at ARMS (UP + TAU condition) or 
treatment as usual at ARMS (TAU; control condition). All potential subjects must satisfy the 
following inclusion/exclusion criteria upon the study screening visit: 
 
Inclusion criteria: 
1. Young adults ages 18 to 26, inclusive  
2. English language proficiency 
3. Ability to provide written, informed consent 
4. Ability to attend in-person, outpatient sessions 
5. Has provided consent to receive or is currently undergoing treatment at the MGH Addiction 
Recovery Management Service (ARMS) program (i.e., is a new or existing ARMS patient) 
6. Documented DSM-5 SUD diagnosis (limited to alcohol use disorder; cannabis use disorder; 
phencyclidine or other hallucinogen use disorder; inhalant use disorder, opioid use disorder; 
sedative, hypnotic, or anxiolytic use disorder; stimulant use disorder; other (or unknown) 
SUD)  
7. Current elevated emotional distress, as evidenced by ANY ONE of the following: 
a. Score at least in the moderate range on the self-report anxiety questionnaire administered 
by ARMS clinicians during the routine clinical evaluation or by study staff during the 
screening visit 
b. Score at least in the moderate range on the self-report depression questionnaire 
administered by ARMS clinicians during the routine clinical evaluation or by study staff 
during the screening visit 
c. Report of suicidal thoughts in the past week on the SITBI-CR  
d. Report of engagement in NSSI in the past week on the SITBI-CR  
8. Not expected to require inpatient level of care within the next two weeks (as judged 
clinically) 
 
Exclusion criteria: 
1. Documented psychotic disorder (or current, clinically significant psychotic symptoms) that 
render the patient inappropriate for outpatient level of care or participation in group therapy 
(as judged clinically by study staff) 

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2. Current imminent suicide or homicide risk (as judged clinically by study staff) 
3. Unwilling or unable to provide consent for study staff to access subject’s medical records and 
coordinate care and exchange data with ARMS clinical staff 
4. Unwilling or unable to identify an emergency contact 
 
Recruitment: Subjects will be recruited exclusively through the ARMS program at MGH. 
ARMS is an outpatient, dual diagnosis clinic comprising a multidisciplinary team of 
psychiatrists, clinical psychologists, and masters-level social workers who are trained to work 
with adolescents and young adults with substance-related problems. ARMS provides 
comprehensive outpatient individual therapy, group therapy, and outpatient psychiatry 
consultation and follow-up. The investigators have obtained commitment from the Clinical 
Director of ARMS (James McKowen, PhD) to support recruitment of young adult patients at 
ARMS, and to facilitate delivery of the group-based experimental intervention. The ARMS 
program conducts evaluations with approximately 180 new patients per year, the majority of 
whom also present with comorbid depression or anxiety. We will collaborate with the ARMS 
Clinical Director and staff in order to recruit through study flyers and direct referrals from the 
ARMS clinicians (psychiatrists, psychologists, social workers) who conduct routine clinical 
evaluations.  
 
Clinicians who conduct the routine clinical evaluation for treatment at ARMS will identify 
potentially eligible participants based on information obtained during the routine evaluation, 
which includes assessment of DSM-5 criteria for SUD. If a patient has already voluntarily 
provided written consent to be contacted about research opportunities during the ARMS intake 
process, study staff may contact them via phone call to provide more information about the study 
and, if interested, schedule a screening visit. Alternatively, during either the routine ARMS 
evaluation feedback session or the routine ARMS treatment recommendations session, which 
occur either in the same visit or over the course of two visits, potentially eligible participants 
may be presented with information about the study (including a study flyer) by an ARMS 
clinician. Additionally, existing ARMS patients may also be presented with information about 
the study by their ARMS clinician. Potentially eligible subjects who express interest in 
participating in the study will then be approached by a study clinician at the end of a routine 
ARMS clinical session to conduct a brief (under one hour) in-person study screening visit, which 
may take place at ARMS, the MGH Depression Clinical and Research Program (DCRP), or the 
MGH Center for Addiction Medicine (CAM). Study staff may walk participants between ARMS 
and the DCRP or CAM as needed. If a study clinician is unavailable or the participant cannot 
stay to complete the study screening visit after a routine ARMS visit, the participant will be 
contacted to schedule a separate in-person study screening visit. When presenting the study to 
interested participants, ARMS clinicians will ask for their preferred method(s) of communication 
(phone call, email, and/or text message), which study staff will then use to contact participants to 
schedule the screening/baseline visit. Up to five consecutive (unanswered) contact attempts will 
be made to interested participants to schedule the screening/baseline visit. 
 
IV. 
SUBJECT ENROLLMENT 
 
A total of 50 subjects who have a documented current DSM-5 diagnosis of SUD and elevated 
emotional distress (operationalized as: score in at least the moderate range on self-report 

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measures of anxiety or depression used for clinical purposes at ARMS, and/or report of suicidal 
thoughts or NSSI in the past week) will be enrolled in the study. An ARMS clinician will 
determine possible subject eligibility based on information obtained during the routine clinical 
evaluation for ARMS treatment. Those who are deemed potentially eligible and express interest 
in the study will then undergo a brief in-person screening visit with a study clinician. The 
screening visit, which will take about 60 minutes, will consist of a meeting with a study clinician 
to provide informed consent and confirm study eligibility (via review of information obtained 
during routine ARMS clinical care and completion of the SITBI-CR). For participants who 
report suicidal thoughts in the past week or having made a suicide plan or suicide attempt in the 
past year on the SITBI-CR, a clinical risk assessment (including severity of ideation and 
presence of plan, intent, and access to means) will be conducted during the visit in order to 
ensure participant safety and eligibility for the study (i.e., no imminent suicide risk). The study 
clinician conducting the screening visit will consult the ARMS Clinical Director (or, if Dr. 
McKowen is unavailable, another licensed clinician on-site) immediately regarding risk in any 
questionable cases to determine the appropriate action, per usual ARMS clinical procedures. 
Eligible participants will then complete the Timeline Follow Back (TLFB53,54) as an interview, in 
which participants recall the quantity and frequency of substance use during a specified time 
window (e.g., past month) using a calendar, and several self-report questionnaires, including the 
BSI, CCS, and Craving Scale (see Table 1). The study clinician will also fill out a concomitant 
treatment log to identify the participant’s overall treatment plan, including medication and 
therapy. Data obtained at this screening visit will be considered the “pre-treatment” assessment. 
After eligibility criteria are determined and participants have completed the screening/baseline 
assessment, participants will be randomly assigned to UP+TAU or TAU only conditions using a 
permuted block randomization procedure. The permuted block randomization schedules will be 
generated by an independent biostatistician from the MGH Biostatistics Center prior to enrolling 
the first subject into the study. Groups, or “blocks,” of 5 individuals will be randomized at a time 
to one of the two treatment conditions (UP+TAU or TAU alone) using a 2:1 randomization 
scheme, defined as 2 blocks randomized to UP + TAU for every 1 block randomized to TAU 
alone. Randomizations will be conducted using a web-based randomization program developed 
by the MGH Biostatistics Center. The randomization code will be generated within the web-
based program by study staff only when the randomization occurs, i.e. once the last participant of 
each group has completed baseline. Participants will then be contacted by study staff via their 
preferred method of communication to notify them of their study condition. 
Study staff will be masters and doctoral-level staff members from ARMS and/or the MGH 
Depression Clinical and Research Program (DCRP) who donate time to conduct assessments 
and/or deliver treatment for research studies. Masters-level advanced practicum students at 
ARMS or DCRP may also contribute to the study as part of their training. ARMS and DCRP 
clinicians (psychologists, psychiatrists, licensed clinical social workers, research/clinical fellows, 
advanced practicum students) will be included as study staff and able to conduct assessments 
and, as long as they have also received training in the protocol, deliver the UP treatment (see 
Study Intervention). All study procedures will be conducted with a licensed clinician on-site at 
ARMS, the DCRP, or CAM who can conduct additional risk assessment and/or help facilitate 
transfer to the Acute Psychiatry Service in the MGH emergency room if needed. 

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Procedures for obtaining informed consent:  
Informed consent will be obtained at the time of the screening visit, prior to the collection of any 
data for the study. Before or upon meeting with the study clinician, subjects will receive a 
written copy of the consent form that includes an easy-to-read description of the protocol, risks 
and benefits, privacy concerns, and provisions for subjects who decide to discontinue the study. 
Subjects will be informed that they may voluntarily discontinue participation in the study at any 
time. A study clinician then review the consent form with the participant and provide the 
opportunity for the subject to ask questions. Participation in this study is voluntary and subjects 
may withdraw from the study at any time. The IRB-approved informed consent document will be 
signed and dated by the subject and the clinician obtaining consent. 
 
In addition to consent for study participation, subjects will be asked to provide consent to 
coordinate care and share clinical data with/from the ARMS program, including review of 
medical records (e.g., routine ARMS clinical evaluation) to confirm inclusion/exclusion criteria,  
extract relevant clinical data obtained during the routine ARMS clinical evaluation from the 
medical record (e.g. diagnoses, treatment history, family history of substance use), track 
treatment engagement at ARMS, and facilitate good clinical care during the study. Subjects who 
are unable or unwilling to provide such consent will not be eligible for further participation. 
Subjects will also be asked to provide consent for audio-recording of group treatment sessions. 
The purpose of audio-recording, measuring therapist adherence to the treatment protocol, will be 
explained. Subjects who decline consent to audio-record their sessions will not be enrolled in the 
study. On the consent form, subjects will also be asked to list their preferred methods of 
communication between sessions (regarding scheduling and other logistical issues) and will be 
presented with pertinent information about the risks of the various methods of communication. 
Participants will be asked to provide consent to be contacted via e-mail and/or text messaging 
over the course of the study for scheduling purposes and appointment reminders.  
 
V. 
STUDY PROCEDURES 
 
TAU condition: After randomization, participants randomized to the TAU condition will 
undergo usual care at ARMS for the next 8-10 weeks. Usual care at ARMS typically consists of 
a combination of up to 3 group therapy sessions per week, individual weekly therapy, and/or 
psychopharmacology appointments as needed. Some ARMS patients are offered and choose to 
engage in all three treatment modalities (group therapy, individual therapy, and 
psychopharmacology), whereas others only engage in one treatment modality. No requirements 
will be placed on TAU participants with regard to TAU dosage and TAU will be consistent with 
each participant’s clinical treatment plan at ARMS; however, TAU attendance (e.g., number of 
appointments) for all participants will be tracked by study staff. Four to 6 weeks after 
randomization, TAU participants will complete a mid-treatment assessment, during which they 
will complete the same self-report questionnaires (plus TLFB and concomitant treatment log 
with a study clinician) administered at the screening/baseline visit (see Measures). Eight to 10 
weeks after randomization, they will repeat the same measures for the in-person “post-treatment” 
assessment. During both the mid- and post-treatment assessments, should a participant report 
suicidal thoughts in the past week on the SITBI-SR or clinically significant increases in NSSI, a 
clinical risk assessment (including severity of ideation and presence of plan, intent, and access to 
means) will be conducted by a study clinician in order to ensure participant safety and that the 

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participant remains stable to be treated in an outpatient setting. After completing the post-
treatment assessment, their study participation will be complete. 
UP + TAU condition: After randomization, participants randomized to the UP + TAU condition 
will undergo TAU at ARMS and be offered 16 additional, twice-weekly group UP sessions, also 
at ARMS (see Intervention). Participants in the UP + TAU condition will undergo the same mid- 
and post-treatment assessments as the TAU condition, plus the CSQ-8 and a semi-structured 
interview to collect feedback about the intervention (see Measures). The mid-treatment 
assessment will occur after each participant’s 8th UP session OR between 4-6 weeks after 
randomization, and the post-treatment assessment will occur within two weeks after each 
participant’s 16th UP session. The same risk assessment procedures for mid- and post-treatment 
assessments used in the TAU condition will also apply to the UP + TAU condition. Should a UP 
+ TAU participant condition have two consecutive unplanned absences from a UP group session, 
up to three attempts to contact will be made regarding their absence. There will not be a 
maximum number of missed UP sessions warranting a participant to step out of the 16-session 
group protocol. After completing the post-treatment assessment, their participation in the study 
will be complete. 
Group UP sessions will take place at the ARMS program at MGH. Study assessment visits 
(screening/baseline, mid-treatment, and post-treatment) may take place at the ARMS program, 
the Depression Clinical and Research Program (DCRP), or the Center for Addiction Medicine 
(CAM) at MGH. Study staff may walk participants between ARMS and the DCRP or CAM as 
needed. 
In sum, the proposed study involves the following points of contact: (1) obtaining informed 
consent and screening/baseline assessment, (2) mid-treatment assessment involving self-report 
questionnaires and TLFB, (3) post-treatment assessment involving self-report questionnaires and 
TLFB (primary endpoint), and (4) 16 twice-weekly group UP sessions for those randomized to 
the UP + TAU condition.  
If participants are unable to complete the clinician-rated measures in-person at their mid- or post-
treatment assessments, they will be given the option to complete this portion of the visit via 
phone call with a study clinician. Should any risk issues arise, the clinician will complete a risk 
assessment while on the phone with the participant. A licensed clinician will always be on-site 
for consultation as needed during assessments conducted over the phone. 
If participants are unable to complete the self-reported measures in-person at their 
screening/baseline, mid-treatment, or post-treatment assessments, they will be e-mailed a link to 
the self-report battery in Redcap to complete remotely. Study staff will review the completed 
SRQ assessment in Redcap within 24 (business) hours of submission for report of suicidal 
thoughts, and within one week to assure their completeness. Should a participant report suicidal 
thoughts in the past week on the SITBI-SR, a clinical risk assessment (including severity of 
ideation and presence of plan, intent, and access to means) will be conducted over the phone by a 
study clinician to ensure participant safety and that the participant remains stable to be treated in 
an outpatient setting. Additionally, a clinical risk assessment will be conducted over the phone 
by a study clinician in response to reports of increased NSSI that are deemed clinically 

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significant. Up to three attempts to contact will be made for this risk assessment before calling a 
participant’s designated emergency contact. 
Participants may receive recruitment and scheduling messages, as well as appointment reminders 
via e-mail or text message over the course of the study, depending on their preferred method of 
communication. Up to three consecutive (unanswered) contact attempts to the participant will be 
made for participants in both conditions to schedule mid- and post-treatment assessments. If a 
participant misses the mid-treatment assessment, but is still responsive to contact attempts, they 
will still be able to complete the post-treatment assessment. If a participant in either condition is 
unresponsive to three consecutive unanswered contact attempts within a three-week period at any 
point within the 10-week study, they will be considered dropped out from the study and no 
further follow-up will be made; the ARMS clinical team will also be notified.  
 
Participants will make $100 for completion of the three assessments ($25 for the pre- and mid-
treatment assessments, and $50 for the post-treatment assessment) and up to an additional $80 
for session attendance. Session attendance will be compensated as follows: participants will 
receive $5 per session attended (up to 16 UP sessions in the UP+TAU group and up to 16 TAU 
sessions in the TAU along group). This amount represents approximate cost of travel to/from up 
to two sessions per week. In the TAU group, the number of possible sessions a patient can attend 
a week varies depending on the patient’s individualized (clinical) treatment plan at ARMS; thus, 
receiving $5 per session attended (for up to 2 weekly sessions) is appropriate given individual 
patients’ variable session time commitment as part of TAU. Payment for study assessments will 
take place in the form of a check, which can take between 4 to 8 weeks to process. Payment for 
UP group and TAU session attendance will be in the form of $5 gift cards to stores that do not 
sell alcohol or contain a pharmacy (e.g., Dunkin Donuts), which will be provided on an ongoing 
basis throughout the study. 
 
The following list includes descriptions of each measure being used in the proposed study. 
 
Client Satisfaction Questionnaire (CSQ-847). This 8-item self-report questionnaire will be given 
to participants in the UP + TAU condition only at the post-treatment assessment to acceptability 
of and satisfaction with the UP group treatment. 
 
Demographics Questionnaire. This measure assesses age, sex, gender, ethnicity, education, and 
employment, and will be administered at the screening/baseline visit only.  
 
Beck Scale for Suicide Ideation (BSI49). This 19-item self-report measure will be used to measure 
intensity of attitudes, behaviors, and plans to die by suicide over the past week at pre-, mid-, and 
post-treatment assessments.  
 
Commitment to Sobriety Scale (CSS51). This 5-item, psychometrically valid self-report measure 
will be used to assess participants’ commitment to sobriety at pre-, mid-, and post-treatment time 
points.  
 
Craving Scale52. This self-report measure, which is made up of three items rated on a visual 
analogue scale from 0-10 and has been validated for use across multiple substances, will be used 
to assess craving at pre-, mid-, and post-treatment time points.  

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Emotion Regulation Questionnaire (ERQ55). The ERQ is a 10-item self-report measure assessing 
two emotion regulation strategies—cognitive reappraisal and expressive suppression. It will be 
used at the three assessment points to capture changes in emotion regulation during the study.  
 
Brief Experiential Avoidance Questionnaire (BEAQ56): The 15-item BEAQ is a modified, briefer 
version of the original 62-item Multidimensional Experiential Avoidance Questionnaire 
(MEAQ), self-report measure of six experiential avoidance domains: behavioral avoidance, 
distress aversion, procrastination, distraction/suppression, repression/denial, and distress 
endurance. It will be used at the three assessment time points to capture changes in experiential 
avoidance. 
 
Overall Anxiety Severity and Impairment Scale (OASIS57). This is a 5-item, self-report measure 
assessing the anxiety-related severity and impairment in the past week. It will be administered at 
each of the three assessment points to participants in both conditions. Participants in the UP + 
TAU condition will also complete it at the start of each UP session, per the treatment protocol37.  
 
Overall Depression Severity and Impairment Scale (ODSIS58). This 5-item, self-report measure 
captures severity and impairment of depression in the past week. It will be administered at each 
of the three assessment points to participants in both conditions. Participants in the UP + TAU 
condition will also complete it at the start of each UP session, per the treatment protocol37. 
 
Self-Injurious Thoughts and Behaviors Interview-Clinician-Rated Version (SITBI-CR50). This 
clinician-rated measure will be used to capture suicidal thoughts and behaviors and NSSI over 
lifetime, past year, past month, and past week at the screening/baseline visit. 
 
Self-Injurious Thoughts and Behaviors Interview-Self-Report Version (SITBI-SR50). This self-
report measure will be used to capture suicidal thoughts and behaviors and NSSI in the past 
month at the mid-treatment and post-treatment assessments. 
 
Timeline Follow Back (TLFB53,54). The TLFB will be administered as an interview at all three 
time points in order to determine frequency and quantity of substance use, as well as percent 
days abstinent, since the last assessment (or at pre-treatment, over the past month). For the 
TLFB, participants mark the days on which they used a substance and indicate which 
substance(s) (and how much) they used.  
 
Patient Health Questionnaire (PHQ-963): A nine-item measure of depressive symptoms. It will 
be administered at each of the three assessment points to participants in both conditions. 
 
Generalized Anxiety Disorder Assessment (GAD-764): A 7-item measure of generalized anxiety 
symptoms. It will be administered at each of the three assessment points to participants in both 
conditions. 
 
Short Version of the UPPS-P Impulsive Behavioral Scale (SUPPS-P65): A 20-item version of the 
original UPPS-P Impulsive Behavior Scale that assess five distinct facets of impulsivity: 
negative urgency, sensation seeking, lack of premeditation, lack of perseverance, and positive 

12 
 
urgency. It will be administered at each of the three assessment points to participants in both 
conditions. 
 
Emotion Reactivity Scale (ERS66): A 21-item self-report measure of emotion sensitivity, 
intensity, and persistence. It will be administered at each of the three assessment points to 
participants in both conditions. 
 
Drug Use Motives Questionnaire (DUMQ67, 68): An adapted version of the original Drug Use 
Motives Questionnaire; a 17-item measure to assess reasons or motives for using substances. 
It will be administered at the screening/baseline visit only. 
 
Concomitant Treatment Log: A log that captures overall treatment plan, including therapy and 
medication, as well as the corresponding start and stop dates for each treatment. A study 
clinician will complete the log at the screening/baseline visit, and update the log at the mid- and 
post-treatment assessment visits. 
 
Study clinicians and subjects will complete all measures on paper copies. Data collected will 
then be entered directly into REDCap by study staff.  
 
Table 1 (below) outlines the schedule of assessments for the study. 

13 
 
Table 1. Schedule of Assessments  
Assessment 
Screen 
/Baseli
ne  
Week 1 
Week 2 
Week 3 
Week 4 / 
Mid-
treatment 
Week 5 
Week 6 
Week 7 
Week 8 / 
Post-
treatment 
Informed Consent 
Form 
X 
 
 
 
 
 
 
 
 
Demographics/ 
Contact Info 
X 
 
 
 
 
 
 
 
 
Inclusion/ 
Exclusion 
X 
 
 
 
 
 
 
 
 
Adverse Events 
Tracking Form 
 
 
 
 
X 
 
 
 
X 
Concomitant 
Treatment Log 
X 
 
 
 
X 
 
 
 
X 
PHQ-9 
X 
 
 
 
X 
 
 
 
X 
GAD-7 
X 
 
 
 
X 
 
 
 
X 
SUPPS-P 
X 
 
 
 
X 
 
 
 
X 
ERS 
X 
 
 
 
X 
 
 
 
X 
DUMQ 
X 
 
 
 
 
 
 
 
 
SITBI-CR 
X 
 
 
 
 
 
 
 
 
SITBI-SR 
 
 
 
 
X 
 
 
 
X 
BSI  
X 
 
 
 
X 
 
 
 
X 
CSS 
X 
 
 
 
X 
 
 
 
X 
Craving Scale 
X 
 
 
 
X 
 
 
 
X 
TLFB 
X 
 
 
 
X 
 
 
 
X 
ERQ 
X 
 
 
 
X 
 
 
 
X 
BEAQ 
X 
 
 
 
X 
 
 
 
X 
OASIS 
X 
X (UP + 
TAU only) 
X (UP + 
TAU only) 
X (UP + 
TAU only) 
X 
X (UP + 
TAU only) 
X (UP + 
TAU only) 
X (UP + 
TAU only) 
X 
ODSIS 
X 
X (UP + 
TAU only) 
X (UP + 
TAU only) 
X (UP + 
TAU only) 
X 
X (UP + 
TAU only) 
X (UP + 
TAU only) 
X (UP + 
TAU only) 
X 
CSQ-8 and 
Feedback Interview 
 
 
 
 
 
 
 
 
X (UP + 
TAU only) 
 
 
 
 
 
 
 
 
 
 
Approximate Time 
Estimate 
 < 60 
min 
< 5 min 
< 5 min 
< 5 min 
45 to min  
< 5 min 
< 5 min 
< 5 min 
45 (TAU) 
to 60 min 
(UP+TAU) 

14 
 
 
Study Intervention 
 
Study Therapists and Training: Masters- or doctoral-level clinicians at ARMS and/or the 
DCRP will deliver the UP treatment. One to two therapists will (co-)lead each group session. All 
study therapists will be trained in the protocol by Kate Bentley (co-investigator), who has been 
extensively trained and certified in delivering the UP by a treatment developer. Study therapists 
will meet weekly with Dr. McKowen (ARMS Clinical Director) for clinical supervision, or more 
frequently as needed. A licensed clinician will be on-site at ARMS and available for consultation 
and risk management as needed whenever a UP group is conducted. Consistent with routine 
clinical practice at ARMS, should a participant present with clear alcohol or drug intoxication or 
spontaneously disclose suicidal or homicidal ideation during a UP group session, a study 
clinician will meet individually with the participant for a clinical risk assessment. If needed, a 
transfer to the MGH emergency room will be facilitated immediately. 
 
Treatment Fidelity: Recommendations suggested by the NIH Behavior Change Consortium 
workgroup on treatment fidelity will be implemented. Therapists will be trained on the UP 
treatment, and adherence to the manual will be monitored. Group sessions will be audio-recorded 
in order to facilitate supervision and manual adherence. A random selection of audiotapes will be 
rated for adherence using scales adapted from a previous, large-scale grant-funded UP trial40. 
Study therapists will meet at least monthly to discuss adherence to the protocol, or more 
frequently as needed.  
 
Description of the UP Treatment 
 
The UP was originally designed as a time-limited, CBT protocol to be delivered in 12 to 16 
individual outpatient therapy sessions37. Previous studies have demonstrated that the original UP 
can be successfully modified for administration in other formats (e.g., 12 2-hour weekly 
outpatient group sessions60, 5 one-hour individual inpatient sessions19). For this study, the UP 
will be delivered over the course of 16, 1-hour twice-weekly sessions, delivered over an 8-week 
period, in order to be consistent with the length of existing group treatment session (1 hour) and 
average group treatment engagement (8 weeks) at ARMS.  
 
Each of the original 8 UP modules (motivation enhancement, functional assessment of emotions, 
mindful emotion awareness, cognitive flexibility, countering emotion-driven behaviors, 
interoceptive exposure, emotion exposure, relapse prevention37) will be delivered to a small 
group of up to 10 participants. See Table 2 for weekly session content. One UP group will be 
running at any point in time within ARMS, Admission will be partially rolling, such that new 
study participants can enter the group intervention at any point through UP Week 5 (and then, for 
example, would attend UP Weeks 1-4 after UP Week 8). If a participant beginning the group 
treatment during UP Week 5 misses one of the two UP Week 5 sessions, they will undergo an 
individual “catch-up” session before UP Week 6 in order to ensure that they have received all the 
UP Week 5 material before proceeding to UP Week 6. Participants will not be permitted to begin 
the group during UP Weeks 6-8 as these sessions (interoceptive and emotion exposure exercises) 
are contingent upon learning the emotion management skills presented during UP Weeks 1-5. 
Should a group of five participants be randomized to the UP + TAU condition during UP Weeks 
6-8, they will wait up to attend their first UP group session until UP Week 1 begins again (up to 

15 
 
4 weeks). During this waiting period, they will still be encouraged to engage with usual ARMS 
services. It is also possible that, if there are not currently enough other people enrolled in the 
study to form a group, participants may be asked to wait to attend the group.  In this case, 
participants may be given the opportunity (but will not be required) to have brief individual 
meetings with a study clinician until enough participants are enrolled to form a group. When a 
participant attends their first UP group session, the first few minutes of the session will be spend 
orienting the new participant to the structure and logistics of the group, as well as delivering a 
brief introduction to the overall goal of the UP treatment (i.e., modify emotion regulation 
strategies as a way to help decrease the intensity and frequency of maladaptive emotional 
experiences with the goal of improving functioning). Homework will be assigned at each 
session, including worksheets and handouts adapted from the UP client workbook.38  
 
 
See Table 2 below for weekly session content of the UP group. 
 
 

16 
 
 
Table 2. UP Session Content 
UP Week # 
UP Session # 
Point of entry to 
group? 
Session Content 
Week 1 
Session 1 
Yes 
Motivation enhancement (UP Module 1): 
-Discuss importance and fluctuation of motivation 
during treatment 
-Conduct decisional balance exercise (i.e., identify pros 
and cons of change, address ambivalence) 
-Identify goals for treatment in goal-setting exercise 
Week 1 
Session 2 
Yes 
Functional assessment of emotion (UP Module 2): 
-Discuss nature and function of emotions 
-Introduce three-component model of emotion 
(thoughts, physical sensations, behaviors/ behavioral 
urges) 
-Introduce ARC of emotion (antecedents, responses, 
consequences) 
Week 2 
Session 3 
Yes 
Mindful emotion awareness (UP Module 3): 
-Discuss utility of present-focused, nonjudgmental 
awareness of emotions 
-Introduce and practice mindful emotion awareness 
through experiential exercises 
Week 2 
Session 4 
Yes 
Cognitive flexibility (UP Module 4): 
-Discuss interactive relationship of thoughts and 
emotions 
-Introduce negative automatic thoughts 
-Practice using cognitive challenging strategies to 
generate more flexible, balanced interpretations 
Week 3 
Session 5 
Yes 
Countering emotion-driven behaviors (UP Module 5): 
-Discuss short-term and long-term consequences of 
emotion-driven behaviors (EDBs) 
-Identify common maladaptive EDBs 
-Present rationale for countering EDBs with alternative 
actions 
-Generate examples of adaptive alternative actions 
Week 3 
Session 6  
 
(Repeat 
Session 3) 
Yes 
Mindful emotion awareness (UP Module 3): 
-Discuss utility of present-focused, nonjudgmental 
awareness of emotions 
-Introduce and practice mindful emotion awareness 
through experiential exercises 
Week 4 
Session 7 
 
(Repeat 
Session 4) 
Yes 
Cognitive flexibility (UP Module 4): 
-Discuss interactive relationship of thoughts and 
emotions 
-Introduce negative automatic thoughts 
-Practice using cognitive challenging strategies to 
generate more flexible, balanced interpretations 
Week 4 
Session 8 
 
(Repeat 
Session 5) 
Yes 
Countering emotion-driven behaviors (UP Module 5): 
-Discuss short-term and long-term consequences of 
emotion-driven behaviors (EDBs) 
-Identify common maladaptive EDBs 
-Present rationale for countering EDBs with alternative 
actions 
-Generate examples of adaptive alternative actions 
Week 5 
Session 9 
Yes 
Review of UP Modules 2 and 3: 
-Re-introduce concept of functional nature of emotions 
and three-component model  
-Re-introduce and practice mindful emotion awareness  

17 
 
Week 5 
Session 10 
Yes 
Review of UP Modules 4 and 5: 
-Re-introduce negative automatic thoughts and 
generating flexible, balanced interpretations 
-Re-introduce countering EDBs with adaptive 
alternative actions 
Week 6 
Session 11 
No 
Interoceptive exposure (UP Module 6): 
-Discuss the important role of physical sensations in 
emotional experience 
-Present the rationale of improving objective awareness 
and tolerance of distressing physical sensations 
-Conduct in-session interoceptive exposure exercises 
Week 6 
Session 12 
No 
Emotion exposure (UP Module 7): 
-Present the rationale for conducting emotion exposure 
exercises (including the natural course of emotion) 
-Conduct emotion exposure exercise as a group (e.g., 
imagining an emotional situation, listening to emotion-
provoking music, or watching an emotional video 
while practicing new emotion management skills) 
Week 7 
Session 13 
 
(Repeat 
Session 11) 
No 
 
Interoceptive exposure (UP Module 6): 
-Discuss the important role of physical sensations in 
emotional experience 
-Present the rationale of improving objective awareness 
and tolerance of distressing physical sensations 
-Conduct interoceptive exposure exercise(s) as a group 
Week 7 
Session 14 
 
(Repeat 
Session 12) 
No 
Emotion exposure (UP Module 7): 
-Present the rationale for conducting emotion exposure 
exercises (including the natural course of emotion) 
-Conduct emotion exposure exercise as a group (e.g., 
imagining an emotional situation, listening to emotion-
provoking music, or watching an emotional video 
while practicing new emotion management skills) 
Week 8 
Session 15 
No 
Relapse prevention (UP Module 8): 
-Review key treatment concepts and emotion 
management skills 
-Identify ongoing opportunities for skills practice 
-Identify long-term goals 
Week 8 
Session 16 
No 
Relapse prevention (UP Module 8): 
-Review key treatment concepts and emotion 
management skills 
-Identify ongoing opportunities for skills practice 
-Identify long-term goals 
 
VI. 
BIOSTATISTICAL ANALYSIS 
 
Power: The proposed pilot study is the first, necessary step in obtaining preliminary data to 
justify future larger, randomized trials. Although we will test for statistical significance, the 
primary aim is to obtain usable feasibility and acceptability data, as well as to estimate the 
adjunctive intervention’s effect size in order to conduct more adequately powered studies in the 
future. As such, a formal power analysis was not conducted a priori; however, the proposed N 
(50 subjects) is in line with other recent pilot RCTs examining the feasibility and preliminary 
efficacy of cognitive-behavioral group interventions for young adults61 and teens62 with SUD.  
 
Preliminary analyses will describe the participants’ demographic and clinical characteristics. 
Comparisons will be made using Mann-Whitney or chi-square tests to determine if the 

18 
 
randomization provided a balanced sample and if participants who dropped out differ from those 
who did not. All analyses will be conducted using the SPSS and/or Stata statistical packages. 
 
Specific Aim 1: We will use descriptive statistics to report satisfaction ratings with the UP 
intervention (total CSQ-8 score; Hypothesis 1a) and number of UP sessions attended. We will 
use chi-square tests to evaluate differences in the proportion of participants in each condition 
who drop out of treatment at the ARMS program during the study period (Hypothesis 1b).  
 
Specific Aim 2: Analyses will be intention-to-treat, such that participants will be analyzed as part 
of their allocated group irrespective how much treatment was received. Continuous variables 
(OASIS, ODSIS, BSI, CSS, and Craving Scale scores, frequency of NSSI urges and episodes 
captured by the SITBI, quantity and frequency of substance use, percent days abstinence [PDA]) 
will be analyzed with generalized mixed effect modeling, which imputes missing values based 
on maximum likelihood estimates of missing parameters (Hypotheses 2a, 2b, 2c, 2d, 2e). Time-
by-condition interactions will be analyzed to test the efficacy of the adjunctive intervention. 
Known confounding variables (e.g., age, gender) will be included as covariates in these analyses. 
Effect sizes between the two conditions will also be reported. Although we will test for statistical 
significance, as previously noted, the primary aim of this pilot study is to estimate the 
intervention’s effect size before conducting larger, more adequately powered future studies. 
 
VII. 
RISKS AND DISCOMFORTS 
 
There are some potential risks and burdens to participating in the study. Risks and discomforts 
associated with receiving psychotherapy are generally considered modest, but can include a 
worsening of psychiatric symptoms as well as psychological discomfort associated with 
discussion of one’s difficulties and potentially emotionally-provoking experiential exercises. For 
group psychotherapy specifically, participants may also feel uncomfortable sharing personal 
information in front of others and experience a triggering of distressing thoughts and feelings 
while listening to others discuss sensitive issues related to substances use and emotional health. 
Participants will be given telephone numbers of the clinicians involved in the study if they would 
like to talk about any discomforts and will be able to stop the study intervention at any time 
without penalty. All group leaders are also skilled in delivering group therapy and navigating 
group discussion of sensitive topics. Second, answering detailed questionnaires and undergoing 
clinician interviews regarding substance use and psychological problems may create a mild 
degree of discomfort. For the possibility of subjective discomfort from answering questions, 
distress will be minimized by assurance that participants can refuse to answer any question that 
they do not feel comfortable addressing and may withdraw from the study at any time without 
penalty. Further, study clinicians are skilled in talking about sensitive information with subjects, 
and subjects may decide to end an interview at any time. Third, coming in for UP group sessions 
and/or assessments may be seen as time-consuming and inconvenient. For study visits involving 
assessments and not treatment, we have provided compensation for subjects’ time, 
commensurate with hourly compensation for non-treatment studies being conducted at MGH. 
We have also provided compensation for up to two weekly treatment sessions, commensurate 
with the approximate costs of travel. 
 

19 
 
Breach of confidentiality is possible, though highly unlikely because all information will be 
identified with a numeric code only and stored in a locked file cabinet or on encrypted 
computerized databases. An enrollment database linking names and study identification numbers 
will be kept in a secure folder separate from other subject data sources. Only study staff will 
have access to this database. All staff are or will be fully trained in relevant ethical principles and 
procedures, including confidentiality. All assessment and treatment procedures will be 
supervised by the PI. Audiotapes will be erased upon completion of data analysis. We will ask all 
UP group participants to keep the information that others share during the groups confidential.  
 
Subjects will be informed of all of the aforementioned risks during the consent process. 
 
VIII. POTENTIAL BENEFITS 
 
It is possible that the participants may not receive any direct benefit from participation in the 
study. However, it is hoped that the experimental intervention could provide relief from 
substance use related problems, emotional disturbances, and improve the level of functioning 
exhibited in young adults with SUD and co-occurring emotional distress.  
 
Subjects participating in this study may experience individual benefits from receiving the 
adjunctive group intervention. The intervention, which will be conducted by a master’s or 
doctoral-level clinician, will be provided to the participants at no charge. Participants will make 
$100 for completion of the three assessments and up to an additional $80 for session attendance. 
If patients do not complete the full screening visit due to ineligibility, compensation will not be 
provided as it is anticipated that inclusion/exclusion criteria will be determined within the first 15 
minutes of the visit; in addition, every effort will be made to conduct the screening visit 
immediately following the subject’s routine ARMS evaluation feedback or treatment 
recommendations sessions so that the subject need not travel back to MGH for a separate 
screening visit. Participants will not be compensated for treatment sessions.  
 
Benefits to future patients, researchers and clinicians could include the development of more 
effective and efficient treatment for substance use-related problems and emotional distress 
experienced by young adults.  
 
IX. 
MONITORING AND QUALITY ASSURANCE 
 
Safety Monitoring: Participants’ suicidality and homicidality will be assessed by a study 
clinician for degree of immediate risk (plan of harm, intent to harm, means to harm) at each 
assessment visit. If a participant is determined to be at imminent risk of harm, a transfer to the 
MGH emergency room will be facilitated immediately for further evaluation. If additional 
treatment is warranted (e.g., inpatient hospitalization), the PI will assess the appropriateness of 
the participant’s continuation in the study based on the exclusion criteria and clinical well-being 
of the individual. The PI will continue to monitor the mental status of participants and/or 
discontinue participation in the study if appropriate. Participants will be dropped from the study 
for unstable mental health rendering them inappropriate to be treated in an outpatient setting 
(e.g., new onset SI/HI with intent and/or plan) and/or severe noncompliance with study 
procedures.   

20 
 
 
Continued drug use and alcohol consumption is to be expected to some degree with outpatient 
treatment, including at ARMS specifically. This will be monitored throughout the treatment 
period. If a participant presents with acute alcohol or drug intoxication to a study assessment 
visit or UP group session and is determined (by a study clinician) to require emergency services, 
a transfer to the MGH emergency room will be facilitated immediately. Participants’ 
involvement in the study will not be disclosed to emergency services.  
 
General safeguards consistent with good clinical practice will be in place for all subjects enrolled 
in the study. As part of routine clinical care at ARMS, all subjects will have an ARMS clinician 
contact who they can access by pager 24 hours a day, 7 days per week for emergencies. During 
the informed consent process and as needed throughout the study, subjects will be encouraged to 
page their ARMS clinician contact in the event of a crisis. As part of the MGH, all research 
subjects can access the Acute Psychiatry Service in the emergency room at any time of the day 
or night. The PI will be responsible for monitoring the safety of the study and complying with 
the reporting requirements. Continuous, close monitoring of participant safety will include 
prompt and frequent reporting of safety data (i.e., adverse/serious adverse events) to the MGH 
IRB and/or appropriate study staff with oversight responsibility. Serious adverse events (SAEs) 
will be reported to the Data Safety and Monitoring Board (DSMB) members. SAEs will also be 
reviewed by the PI every 6 months during progress reports as well as during the written report 
required by the IRB as part of the annual IRB renewal process.   
Data Safety and Monitoring Board (DSMB): A DSMB will be assembled prior to the start of 
the study. This will consist of three independent staff-level investigators; one will have expertise 
in clinical interventions with individuals with SUD; the second will have expertise in clinical 
trial design; the third will have expertise in biostatistical analysis. The DSMB will meet every six 
months during the study to review progress, address any difficulties with recruitment, and 
address any safety related matters that may arise. The DSMB will be provided with unblinded 
data from the study so as to determine whether that risk to subjects outweighs the potential 
benefits. If at any time during the course of the study, the DSMB judges that risk to subjects 
outweighs the potential benefits, the DSMB shall have the discretion and responsibility to 
recommend that the study be terminated. In addition to the IRB, all DSMB members will be 
informed of any serious adverse events occurring during the study.   
 
Adverse Event Reporting: Consistent with good clinical practice, safety will be closely 
monitored by study staff. The PI will oversee all study activities including self-report and 
clinician ratings. All procedures have been designed to minimize subject discomfort, and no 
subject will be asked to engage in research procedures not outlined in the consent form. Subjects 
will be monitored for adverse events at each assessment visit by a study clinician. All adverse 
events (including unexpected and serious AEs) will be recorded and reported in accordance with 
Partners HealthCare guidelines. A subject may be dropped from the study at any time due to 
adverse events.  We will follow and adhere to all guidelines as defined and outlined on the 
Partners Human Research Committee web site: 
http://healthcare.partners.org/phsirb/adverse.htm.The PI will be responsible for ensuring that 
adverse events are reported to the local IRB in compliance with local and federal requirements. 
Any changes to the protocol will be made in accordance with MGH IRB policies. 
 

21 
 
Data Monitoring: The PI will be responsible for ongoing quality control, including data 
integrity and protocol compliance. All clinician-rated data will be collected on paper and entered 
into Redcap. All self-report data that is collected on paper will be entered into Redcap. If a 
participant is unable to complete self-report measures in person, the data will be entered directly 
into Redcap remotely by the participant. To ensure usability of self-report data, a member of 
study staff (whoever is conducting the assessment) will review all self-report measures within 
one week of submission to insure their completeness. All self-report assessment forms and 
clinician-administered instruments will be reviewed by study staff within one week of their 
completion to assure that they are being completed correctly. Any errors in completion will be 
reviewed to determine if directions or procedures for the assessments need to be altered. In this 
case, permission from the IRB will be requested to change any procedure. The group sessions 
will also be audiotaped (with subjects’ permission) and a random selection will be rated for 
competence and adherence to the protocol. This will also ensure the usability of the data. 
 
Confidentiality:  
Sources of materials. Research material will be obtained from living human subjects. Data will 
be collected directly from participants using self-report questionnaires and clinician interviews 
measuring demographic variables, psychiatric symptoms, and history and current pattern of 
alcohol and other drug use. Diagnostic status and other information on mental and physical 
health conditions will be obtained from the routine ARMS clinical evaluation for the purpose of 
confirming inclusion/exclusion criteria. As noted in the study exclusion criteria, participants will 
also be required to provide consent for study staff to access the participant’s medical records and 
exchange data with ARMS staff in order to track treatment engagement at ARMS and facilitate 
good clinical care. 
 
Linkages and access to identifying information. All research-related records initiated as a result 
of a subject’s participation in this study that reveal the subject’s identity, will remain confidential 
except as may be required by law. Participant names and contact information will be maintained 
in a recruitment/enrollment database during the course of the study. Once individuals enroll in 
the study, names will be linked to study ID number in this database, which will be kept in a 
restricted access folder on a secure server. Signed consent forms will be kept in a locked file 
cabinet, separate from any other study data. Once data collection is completed, the corresponding 
recruitment/enrollment database will be deleted as it will then be unnecessary to maintain the 
link between participant identity and study data. Subjects will only be contacted regarding future 
studies if they indicate that they are interested in being contacted by initialing in the specific 
section of the consent form. 
 
De-identified data. Research data collected from this study will not identify the subjects 
individually, and will be linked to an ID number. Data obtained from our studies may be 
published, but published data will not identify individual participants. Original research-related 
records may be reviewed by the Partners Human Research Committee, and regulatory authorities 
for the purpose of verifying clinical trial procedures and/or data. De-identified study data will be 
kept either in a restricted access folder on a secure server or in a locked file cabinet. All 
information collected as part of this study will be accessible only to research staff who have 
completed mandatory training in the protection of human subjects. 

22 
 
 
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