Speed et al.

Trials (2022) 23:965

https://doi.org/10.1186/s13063-022-06885-7

RESEARCH Open Access

A comparison of cognitive behavioral

therapy for insomnia to standard of care
in an outpatient substance use disorder clinic
embedded within a therapeutic community:
a RE‑AIM framework evaluation
Traci J. Speed1* , Lisa Hanks1, Gavin Turner2, Evelyn Gurule1, Alexandra Kearson1, Luis Buenaver1,
Michael T. Smith1 and Denis Antoine1

Abstract
Background: Rates of substance use disorders (SUDs) continue to rise in the USA with parallel rises in admissions to
outpatient SUD treatment programs. Insomnia symptoms reduce treatment adherence, trigger relapse, and generally
undermine SUD recovery efforts. Cognitive-behavioral therapy for insomnia (CBT-I) is the first-line treatment recom-
mended for chronic insomnia. No study has examined the effectiveness of CBT-I for individuals who recently entered
an outpatient SUD treatment program embedded within a therapeutic community (i.e., long-term drug-free residen-
tial setting).
Methods: A randomized controlled trial conducted at a SUD program embedded in a therapeutic community aimed
to compare group-based CBT-I (gCBT-I) (N = 10) with the standard of care (SOC) (N = 11) among individuals who have
SUDs and comorbid insomnia. We present a RE-AIM (reach, effectiveness, adoption, implementation, and mainte-
nance) framework evaluation to provide empirical data on gCBT-I feasibility and facilitators and barriers of conducting
an insomnia-focused clinical effectiveness study within a therapeutic community.
Results: Participants in both study arms reported moderately severe insomnia symptoms at admission and reduc-
tions in insomnia symptoms over time. Among participants who completed the Insomnia Severity Index (ISI) beyond
admission, ISI decreased to ≤ 8 (the clinical cutoff for mild insomnia) in 80% of individuals in the gCBT-I group
compared with 25% of individuals in the SOC group. A RE-AIM framework evaluation showed initial success with
Reach and Adoption while Implementation, and Maintenance were limited. Effectiveness was inconclusive because
of challenges with recruitment, intervention integrity, and missing data that precluded meeting the planned recruit-
ment and study aims and led to study termination. Coordination and communication with staff and leadership facili-
tated gCBT-I implementation, yet well-known CBT-I barriers including time- and resource-intensive sleep medicine

*Correspondence: speed@jhmi.edu
1
Department of Psychiatry and Behavioral Sciences, Johns Hopkins University
School of Medicine, 5510 Nathan Shock Drive, Suite 100, Baltimore, MD
21224, USA
Full list of author information is available at the end of the article

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Speed et al. Trials (2022) 23:965 Page 2 of 15

training for interventionalists and maintenance of treatment integrity during an 8-week intervention limited gCBT-I
sustainability.
Conclusions: This analysis supports the feasibility of conducting behavioral sleep medicine research in outpatient
SUD treatment programs embedded within therapeutic communities. Implementation of an insomnia-focused inter-
vention was widely accepted by patients and providers and has potential to address insomnia symptoms in early SUD
recovery. Addressing patient- and organizational-level implementation barriers may enhance the sustainability and
scalability of sleep interventions and provide new hope to effectively treat insomnia among people living with SUDs.
Trial registration: Clini​caltr​ials.​gov: NCT03208855. Registered July 6, 2017https://clinicaltrials.gov/ct2/show/NCT032
08855?term=NCT03208855&draw=2&rank=1
Keywords: Insomnia, Substance use disorder, Cognitive-behavioral therapy, Residential treatment, Recovery

Contributions to the literature insomnia interventions provide a safer alternative in SUD

treatment.
• The RE-AIM implementation framework helped iden- Robust evidence demonstrates that cognitive behav-
tify cognitive-behavioral therapy for insomnia imple- ioral therapy for insomnia (CBT-I) is efficacious and
mentation facilitators and barriers that are unique to safe across myriad psychiatric and medical disorders
residential substance use disorder (SUD) treatment set- [34–40]. CBT-I combines stimulus control theory, sleep
tings. restriction therapy, sleep hygiene, and cognitive thera-
• An insomnia-focused intervention was widely accepted pies [41] to alter maladaptive compensatory behavio-
by both patients and providers and has the potential to ral strategies (e.g., using alcohol or benzodiazepines)
address insomnia symptoms in early SUD recovery. and cognitive processes that maintain disordered sleep.
• Addressing patient- and organizational-level barriers Expert consensus recommends CBT-I as the first line
may enhance the sustainability and scalability of inter- treatment for chronic insomnia [42–44]. The few stud-
ventions targeting insomnia, a robust and potent risk ies that have evaluated CBT-I effectiveness during early
factor for relapse, among people living with SUDs. SUD recovery have only studied individuals with one
SUD, yet substance co-use is common among patients in
SUD treatment [45]. The current evidence demonstrates
Background post-CBT-I improvements in sleep quality and subjective
Rates of substance use disorders (SUDs) continue to insomnia severity among individuals in outpatient SUD
escalate in the USA. Nearly 2 million individuals with treatment for alcohol use disorder (AUD) or on metha-
SUDs seek treatment annually [1]; yet, 40–60% of these done treatment for opioid use disorder (OUD) [46–49].
individuals will relapse within 1 year [2]. Upwards of To our knowledge, no study has evaluated the integra-
70% of individuals seeking SUD treatment report insom- tion of CBT-I in an outpatient SUD program embed-
nia symptoms [3, 4], compared with 30% of the general ded within a therapeutic community (i.e., a long-term
population [5, 6]. Insomnia (i.e., difficulty falling or main- drug-free residential setting that promotes behavioral
taining sleep, or non-restorative sleep despite adequate change and social reintegration) [50–52]. The therapeu-
opportunity) may predate the onset of SUD [7–12], may tic community model has demonstrated significant and
arise from direct effects of drug use [13] or drug with- sustained improvements in SUD and psychosocial out-
drawal, [14] and may persist for months to years after comes; notably longer treatment duration correlates with
abstinence [13, 15–20]. Insomnia symptoms reduce improved outcomes [53]. Addressing insomnia for indi-
treatment adherence, trigger relapse, and generally viduals in therapeutic communities is important because
undermine SUD recovery efforts [21, 22]. Indeed, numer- insomnia is a common, yet modifiable risk factor of sub-
ous studies indicate that subjective and objective meas- stance relapse. Also, promoting good sleep aligns with
ures of insomnia are among the best predictors of relapse the therapeutic community treatment model to assimi-
regardless of the type of substance used [15, 20, 23–31]. late social norms and instill self-reliance [54]. The effec-
While use of sleep aids is associated with greater treat- tiveness of insomnia interventions within therapeutic
ment retention [32], their use in SUD treatment is often communities remains unknown.
inappropriate [33] given their high abuse liability, and To address this crucial gap, we conducted a randomized
risk of falls, cognitive impairment, polypharmacy interac- controlled trial (RCT) evaluating the effectiveness of
tions, and rebound insomnia. Thus, non-pharmacological group-based CBT-I (gCBT-I) compared with the stand-
ard of care (SOC) among individuals with any primary
Speed et al. Trials (2022) 23:965 Page 3 of 15

SUD and comorbid insomnia at an outpatient SUD pro- The Cornerstone Clinic (CC) is a Johns Hopkins Uni-
gram embedded within a therapeutic community. We versity School of Medicine operated state-licensed
implemented a group-based intervention as commonly behavioral health program accredited by the Commis-
used in intensive outpatient, inpatient, stepped-care, sion on the Accreditation of Rehabilitation Facilities
and residential SUD recovery programs because group (CARF) that provides on-site SUD treatment to resi-
treatment is more cost- and time-efficient and promotes dents of HUM since 2012. CC is not a level III facility
social reinforcement of target behaviors [55, 56]; gCBT-I for substance withdrawal (residents who require medi-
is equally efficacious as individual treatment [57]. cal management for acute withdrawal are transferred to
Following early termination of the RCT for reasons dis- the nearest emergency department) and at the time of
cussed below we conducted an implementation science this study provision of medications for OUD (mOUD)
evaluation of the gCBT-I intervention. Implementation was unavailable due to standard HUM therapeutic com-
science framework evaluation can help examine facilita- munity principles. CC provides conventional outpatient
tors and barriers of real-world implementation and sus- behavioral health care where the intensity of treatment
tainability and standardize reporting outcomes [58, 59]. is based on American Society of Addiction Medicine
Reach, Effectiveness, Adoption, Implementation, and (ASAM) criteria [66]. Aligning with standard HUM
Maintenance (RE-AIM) is a well-established framework therapeutic community principles, CC clients are not
used effectively in substance use services research [60– able to take benzodiazepine or benzodiazepine-like sleep
62]. While the application of implementation science aids and certain psychotropic medications are restricted
frameworks to evaluate health behavior interventions is due to their abuse liability (e.g., quetiapine). CC’s prac-
common [58, 61, 63], their use to evaluate the dissemi- tice guidelines are grounded within an evidenced-based
nation of sleep interventions in clinical settings is limited model of reinforcement-based treatment (RBT), which
[64]. We present an implementation science evaluation employs a client-centered approach to treatment. RBT
utilizing the RE-AIM framework to provide empirical begins with a comprehensive functional analysis of drug
data on gCBT-I feasibility and to evaluate facilitators and use behavior and is accompanied by goal setting and pos-
barriers of gCBT-I implementation to promote dissemi- itive reinforcement for treatment engagement. The RBT
nation and sustainability of sleep interventions as a com- modality has been studied across different SUD treat-
ponent of early SUD recovery. ment populations with good efficacy [67, 68]. HUM has
recognized CC as an essential component of the treat-
Methods ment plan for its residents. All HUM clients are eligible
Setting for CC, and they are prioritized by key markers that are
The Helping Up Mission (HUM) is a faith-based residen- indicative of higher SUD acuity (i.e., HIV status, intra-
tial therapeutic community [52, 54, 65] established in venous drug use, recent discharge from a rehabilita-
1885 that provides holistic and comprehensive treatment tion program, hospital, or penal facility). Most clients
services with a focus on blending spirituality with medi- (~98%) admitted to CC meet criteria for intensive outpa-
cine. HUM provides housing, access to health care (i.e., tient treatment (IOP) (ASAM II.1). These clients report
medical, mental health, and dental), and rehabilitative to CC for a total of at least 9 hours of group and indi-
services to men from the greater Baltimore area. There is vidual SUD treatment dispersed over 4 days per week.
a steady state census of over 525 men residing at HUM; Within approximately 12 weeks once ASAM criteria for
residents can live there for 1 year while in HUM’s Spirit- IOP level are no longer applicable, clients step down to
ual Recovery Program. HUM established a pilot women’s ASAM level 1 outpatient treatment, which consists of 3
program in late 2019 and expanded its women’s services hours total per week of group and individual treatment.
in 2021. Throughout the program, residents participate in On average, clients receive IOP and outpatient treatment
the faith-based classes and contribute to different aspects for a total of 4 months. Clients who are administratively
of HUM’s daily operations (i.e., cook, janitor, security) discharged from HUM (i.e., if they relapse) are simulta-
and in the latter portion of the first year, residents can neously discharged from CC.
engage in a job training program and obtain internships. CC clients provide randomized urine samples for
Given that HUM residents have unstable housing, low toxicology testing in conjunction with their standard
socio-economic backgrounds, and severe SUDs, hous- clinic treatment. At the time of this report, clients sub-
ing for the entire year provides an opportunity for res- mitted weekly randomized tests, but the clinic has since
toration beyond only SUD treatment. HUM’s proximity adopted a smart testing system recommended by the
to The Johns Hopkins Health System has helped foster a American Society of Addiction Medicine [69]. Urine
community-academic partnership. samples are collected on-site and sent to an outside
laboratory for testing. Results are returned through the
Speed et al. Trials (2022) 23:965 Page 4 of 15

patient’s electronic medical record which only CC staff Data collection and outcome measures
reviews. The following substances are part of the stand- Sleep measures
ard qualitative panel for the clinic: opioids (including The Structured Interview for Sleep Disorders (SIS-D)
fentanyl), methadone, marijuana, alcohol (ETs and ETg), [70] was adapted to DSM-5 criteria and implemented
cocaine, amphetamines, and benzodiazepines (300 ng/ to diagnose and classify insomnia and identify poten-
ML). LCMS confirmatory testing are available as needed. tial intrinsic sleep disorders, including sleep apnea.
Results remain confidential among CC providers in Subjects who screened positive for sleep apnea were
accordance with the Code of Federal Regulations 42, part informed and referred to a primary care physician for
2 (42CFR). clinical evaluation. If they did not have a primary care
To address client scheduling and attendance problems, physician, CC staff helped establish care. Individuals
CC began compiling weekly statistics on attendance and who screened positive for apnea were eligible to partic-
intake data that were distributed to HUM staff as a foun- ipate in the study to mirror real world clinical settings.
dation for a collaborative, weekly face-to-face staff meet-
ing. This ongoing academic-community partnership has
yielded operational strategies that improved the mean Insomnia
IOP attendance rate from 49% in FY14 to 80% in FY18. The Insomnia Severity Index (ISI) is a validated insom-
This attendance rate has allowed for enhancement and nia screening instrument with good psychometric
broadening of services (e.g., gCBT-I) to address critical properties [71] previously used in studies of SUD [72–
gaps in treatment. One such gap was highlighted when 74]. The ISI has well established cut-off criteria demar-
preliminary data revealed that 34% of HUM clients met cating clinical insomnia [75, 76]; a total score of 8–14
criteria for clinical insomnia at intake. Given the poten- suggests subthreshold insomnia, 15–21 suggests mod-
tial for insomnia to trigger relapse, this trial aimed to erately severe clinical insomnia, and 22–28 suggests
evaluate the effectiveness of embedding this efficacious severe clinical insomnia.
insomnia-focused behavioral health intervention into the
program.
Sleep diary
Participants Diary measures of sleep have become standard meth-
The study was conducted by CC staff at HUM. CC has ods for assessing outcomes in insomnia clinical trial lit-
an average census of 50-60 clients, or approximately 33% erature [77, 78]. Prospective daily monitoring has been
of the HUM residents in the Spiritual Recovery Program. shown to minimize memory biases that threaten the
Participants were enrolled between August 28, 2017, and validity of global retrospective ratings. Diary informa-
October 5, 2019. Treatments and follow-up were com- tion was collected with paper diaries which are widely
pleted by April 13, 2020. HUM residents aged 18–65 used in sleep/insomnia research and have demon-
years old are referred to CC within 2 weeks of HUM strated sound psychometric properties [78, 79]. While
admission. CC clients who signed a HIPAA-compliant studies in individuals with primary insomnia have been
permission form to be screened for research studies shown to overestimate SOL and WASO, diaries provide
complete patient-reported outcome measures (PROMs) a valid, relative index of sleep continuity disturbance
within 1 week of CC admission. that is sensitive to change because overestimation
CC clients were eligible for the RCT based on the fol- remains consistent over time [34, 80–82]. Comparable
lowing inclusion criteria: (1) enrolled in CC for less than to most outpatient and/or residential SUD treatment
3 weeks; (2) resident at HUM; (3) has a SUD; (4) ≥ 18 programs, HUM residents are beholden to a black out
years old; (5) Insomnia Severity Index (ISI) ≥ 8 at CC period in which they do not have access to personal
admission; (6) self-report of sleep onset latency (SOL) > phones or computers for the first 45 days of treatment.
30 min, wake after sleep onset (WASO) > 30 min, or a Use of paper diaries allowed participants to maintain
combination of SOL and WASO > 30 min; and (7) self- daily sleep diaries independent of access to mobile
report insomnia symptom frequency > 3 nights/week technology. Diary questions included bedtime, time
for > 1 month. Exclusion criteria included the following: of final awakening, time out of bed, estimated SOL,
(1) history of bipolar disorder; (2) history of seizure dis- WASO, and visual analog scale (VAS) ratings of subjec-
order; (3) suicidal ideation; (4) acute alcohol withdrawal tive sleep quality and fatigue. The subjective measures
requiring medical attention; (5) medical, psychiatric, of sleep (e.g., SOL, WASO, sleep efficiency [SE], and
or concomitant condition interfering with treatment total sleep time [TST]) were averaged across a one-
or requiring hospitalization; and (6) inability to provide week monitoring period to provide a weekly estimate
informed consent. used for statistical computations.
Speed et al. Trials (2022) 23:965 Page 5 of 15

Alcohol and drug use Maintenance is reported as the implementation facili-

Clients are diagnosed with primary and secondary SUDs tators and barriers for sustainability and scalability.
based on clinical assessment using DSM-5 criteria [83].
Study procedures
Screening
RE‑AIM outcome measures The Johns Hopkins Institutional Review Board approved
While we initially intended to enroll 80 participants and the study protocol. All participants provided written
have 40 completers, we identified challenges that led us informed consent. CC clients who had ISI ≥ 8 on admis-
to end the study early and conduct an implementation sion were approached by research staff to determine their
framework analysis. The RE-AIM framework (Table 1) interest in the research study. CC clients who expressed
guides the presentation of our results. interest were scheduled for one screening visit to estab-
Reach was measured by two metrics. At the individ- lish eligibility for participation. Screening occurred
ual level, we measured the percent of CC clients who outside of weekly scheduled CC individual and group
consented to the study with the numerator defined as therapy, so it did not interfere with IOP treatment and
the number of eligible CC clients who consented to the included research diagnostic interviews with an adapted
RCT study. The denominator included eligible CC clients SIS-D [70]. Participants completed 5 multiple-choice
who were scheduled for RCT screening visit based on a questions about the study to assess their understanding
CC admission ISI score ≥ 8 and eligible medical history of the information provided prior to enrollment.
and declined participation. At the organizational level,
we measured the percent of enrolled participants who Randomization
attended gCBT-I session 1. We considered this an organi- The allocation sequence was generated using Research
zational outcome measure given the nuances of care Randomizer [84], which provides a 1:1 computer-gen-
coordination involved in scheduling participants for the erated allocation of random numbers. No factors were
gCBT-I session. used for stratification or planned blocking. The allocation
Effectiveness was measured as our a priori RCT pri- sequence was maintained on a password protected, insti-
mary outcomes: ISI and subjective sleep parameters (i.e., tution-encrypted, HIPAA-compliant cloud-based server.
SOL, WASO, SE, TST) at post-intervention. After participants provided their consent, research staff
Adoption was measured at the provider level. The per- randomized participants to gCBT-I or SOC based on the
cent of eligible providers who conducted gCBT-I was cal- next available arm on the sequentially numbered list.
culated as the number of CC providers who completed
behavioral sleep medicine training to become gCBT-I Interventionists
interventionists. SOC was provided by CC behavioral health providers
Implementation has two metrics. Adherence to sleep including psychiatrists or licensed masters-level mental
diary completion was defined as the percent of partici- health counselors (e.g., LCPC) who have experience in
pants who completed weekly sleep diaries during the general behavioral medicine interventions and substance
8-week gCBT-I intervention or 8-week SOC period, and use. Two interventionists with specialized sleep medicine
gCBT-I completion was defined as the percent of those training led each gCBT-I session. gCBT-I interventional-
enrolled in the intervention arm who attended all 8 ists were either CC counselors (1 woman, 1 man), Johns
gCBT-I sessions. Hopkins psychiatrists (2 women, 1 man), or an advanced

Table 1 RE-AIM outcome measures

I P O

Reach x % eligible CC clients who consented to study

x % enrolled participants who attended 1st gCBT-I session
Effectiveness x ISI at post-intervention and 3-month follow-up
x Subjective sleep parameters at post-intervention
Adoption x % eligible providers who led gCBT-I
Implementation x Adherence to sleep diary completion
x % gCBT-I participants who attended 8 sessions
Maintenance x x x gCBT-I implementation facilitators and barriers
I individual, P provider, O organizational, CC Cornerstone Clinic, gCBT-I group cognitive behavioral therapy for insomnia, ISI Insomnia Severity Index
Speed et al. Trials (2022) 23:965 Page 6 of 15

psychology doctoral candidate (1 woman). Interven- SOC

tionists received training in behavioral sleep medicine As previously mentioned SOC included 9 total hours of
through a 3-day CBT-I workshop (University of Penn- weekly services comprised of group and/or individual
sylvania) and/or an extensive 3-month training period behavioral health sessions. Participants randomized to
that included formal didactic lectures on sleep, assigned SOC were instructed how to complete daily sleep dia-
readings on sleep medicine, hands-on training, review ries and where to handoff diaries each week and receive
of treatment manuals, and observations of CBT-I. A CC a new paper diary.
provider was present for each gCBT-I session.
Statistical analysis
Baseline participant sociodemographic and clinical char-
Treatment protocols acteristics were summarized and stratified by gCBT-I and
gCBT‑I SOC groups. Continuous variables were summarized as
We administered three separate closed-group (4–5 par- mean and SD and analyzed using a t-test for approxi-
ticipants/group) standardized 8-session (60 min/session) mately normally distributed variables. Categorical varia-
multicomponent interventions based on our published bles were summarized as number (%) and analyzed using
treatment manual [85] adapted for group-based treat- a χ2 test. Statistical significance was assessed at the 0.05
ment. Groups were conducted between November 1, level, and all tests were two-sided. All analyses were con-
2017–January 4, 2018, March 7, 2018–April 25, 2018, and ducted using SPSS (IBM statistics, Version 24).
October 9, 2019–November 27, 2019. Major intervention
components included sleep restriction therapy, stimulus Results
control therapy, cognitive therapy for insomnia, and sleep Reach
hygiene education. Sessions included reviewing each Of the 29 participants who attended the screening ses-
individual’s paper diary data, charting progress, setting sion, 28 (96.5%) provided informed consent, and of
measurable goals, discussing adherence, and reinforcing those, 21 (75%) were eligible for enrollment. The con-
learned skills. Each gCBT-I session counted towards one sort diagram (Fig. 1) shows participant enrollment and
weekly group therapy session. allocation. Table 2 shows the baseline demographic

Fig. 1 CONSORT flow diagram

Speed et al. Trials (2022) 23:965 Page 7 of 15

Table 2 Demographic and clinical factors

Total SOC gCBT-I p-value
N = 21 N = 11 N = 10

Age in years (SD) 40.6 (13.2) 45.6 (14.1) 35.1 (10.0) .07
Gender (%)
Male 21 (100) 11 (100) 10 (100) NA
Race (%) .29
American Indian 1 (4.8) 0 (0) 1 (10)
> One race 1 (4.8) 0 (0) 1 (10)
Black/African American 8 (38.1) 5 (45.5) 3 (30)
White/Caucasian 11 (52.4) 6 (54.5) 5 (50)
Ethnicity (%)
Not Hispanic or Latino 0 (0) 0 (0) 0 (0) NA
Employment in past 90 days (%) .14
Full-, part-time, or student 9 (42.9) 6 (54.6) 3 (30)
Retired 1 (4.8) 1 (9.1) 0 (0)
Unemployed/disability 11 (52.4) 4 (36.4) 7 (70)
Income (%) .36
$0–$15,000 11 (52.4) 4 (36.4) 7 (70)
$15,001–$30,000 2 (9.5) 2 (18.2) 0 (0)
$30,001–$45,000 2 (9.5) 1 (9.1) 1 (10)
$>45,000 1 (4.8) 1 (9.1) 0 (0)
Missing 5 (23.8) 3 (27.3) 2 (20)
Relationship status (%) .12
Never married 13 (61.9) 6 (54.5) 7 (70)
Married 2 (9.5) 0 (0) 2 (20)
Divorced/separated 5 (23.8) 4 (26.4) 1 (10)
Widowed 1 (4.8) 1 (9.1) 0 (0)
Smoking tobacco
No 2 (9.5) 2 (18.2) 0 (0)
Yes 19 (90.5) 9 (81.8) 10 (100) .17
Number cigarettes smoked (%)
0 2 (9.5) 2 (18.2) 0 (0) .08
1–10 11 (52.4) 3 (27.3) 8 (80)
11–20 7 (33.3) 5 (45.5) 2 (20)
> 20 1 (4.8) 1 (9.1) 0 (0)
Primary SUD .19
Alcohol 4 (19) 2 (18.2) 2 (20)
Opiates 14 (66.7) 6 (54.5) 8 (80)
Marijuana 1 (4.8) 1 (9.1) 0 (0)
Cocaine 2 (9.5) 2 (18.2) 0 (0)
Days since last drug use (SD) 27.2 (5.1) 27.1 (5.9) 27.3 (4.3) .99
Prior detox or rehab admissions (SD) 4.0 (3.0) 4.2 (3.6) 3.8 (2.4) .73
ISI 17.0 (5.4) 17.3 (5.9) 16.7 (5.3) .82
SOC standard of care, gCBT-I group cognitive behavioral therapy for insomnia, SUD substance use disorder, ISI Insomnia Severity Index, *p < 0.05

and clinical characteristics of the randomized partici- (80%) attended the first gCBT-I session. One partici-
pants. There were no statistically significant differ- pant did not attend the first gCBT-I session and was
ences between groups including baseline ISI. Of the ineligible to continue in the study. One participant
participants enrolled in the gCBT-I treatment arm, 8 was discharged from HUM prior to his first gCBT-I
session.
Speed et al. Trials (2022) 23:965 Page 8 of 15

Effectiveness treatment for 171 ± 25 days. gCBT-I showed pre-post

Study participants self-reported moderately severe improvements in subjective sleep outcomes including
insomnia symptoms at admission (Table 1). Figure 2 SOL, WASO, and SE (Fig. 3). Additionally, TST improved
shows trends in ISI across participant’s treatment dura- from 5 h at pre-intervention to 6 h at post-gCBT-I; TIB
tion. Most participants reported reductions in insomnia appropriately decreased from 7 h at pre-intervention to
symptoms while in CC treatment. Among participants 6.6 h at post-gCBT-I. Sleep diary data was not collected
with ISI scores beyond admission, insomnia severity beyond gCBT-I sessions.
decreased below or at the clinical cutoff for mild insom- For this RE-AIM analysis, we limited effectiveness to
nia (ISI ≤ 8) in 4 out of 5 individuals in the gCBT-I post-intervention sleep outcomes, yet it is important
group, compared with one out of 4 individuals in the to note that in planning the clinical effectiveness study
SOC group. The participants who graduated from CC (3 in 2017, our a priori primary outcomes included sleep
gCBT-I and 2 SOC participants) remained in outpatient outcomes through 6-month post-intervention, and our

Fig. 2 Insomnia Severity Index over time comparing gCBT-I versus SOC

Fig. 3 Pre-to-post-intervention diary-derived sleep parameters of gCBT-I participants

Speed et al. Trials (2022) 23:965 Page 9 of 15

a priori secondary outcomes included (1) attrition rates their completed paper sleep diaries to the sessions. None
in SUD treatment at 3- and 6-month follow-up and (2) of the participants in the SOC group returned his sleep
depressive symptoms, pain, and pain catastrophizing at diaries.
3- and 6-month follow-up. While we also intended to
measure SUD relapse rates through 3-month follow-up Maintenance
(unpublished trial protocol), we did not report this out- During weekly research meetings with CC mental health
come measure on clini​caltr​ials.​gov. In 2019, after com- providers and monthly meetings with HUM leadership,
pleting 2 rounds of unblinded gCBT-I interventions, we we discussed strategies to improve study workflow. We
recognized gaps in our study design that limited gCBT-I identified gCBT-I implementation facilitators at the
treatment integrity (see Implementation), thus limiting patient, provider, and organizational level (Table 3). At
inferences of our secondary outcomes. We subsequently the patient level, (1) patients expressed interest in learn-
removed depression and pain as outcomes on clini​caltr​ ing about and treating their insomnia as evidenced by
ial.​gov. SUD outcomes are not reported for similar nearly ubiquitous enrollment and adherence to CBT-I
reasons. treatment recommendations. At the provider level, (1)
behavioral health therapists, psychiatry residents, and
advanced postdoctoral candidates demonstrated will-
Adoption
ingness to learn CBT-I and serve as interventionists.
CC employed 4 behavioral health counselors across
We consistently had two interventionists attend each
the study duration. One counselor completed behav-
gCBT-I session. At the organizational level, (1) we had a
ioral sleep medicine training prior to study onset and
well-established clinical research infrastructure to iden-
one counselor had completed behavioral sleep medicine
tify eligible CC clients; (2) we planned and coordinated
training prior to CC employment. The 2 other counselors
gCBT-I sessions to avoid scheduling conflicts with CC
did not complete behavioral sleep medicine training due
and HUM activities; and (3) we maintained consistent
to financial and time constraints.
communication between HUM and CC leadership. Spe-
cifically, clients who provided informed consent upon
Implementation entering CC completed a battery of PROMs assessing
Three participants (30%) randomized to gCBT-I com- psychosocial factors within 1 week of CC admission.
pleted all 8 sessions within 8–9 weeks (56–63 days). Based on an ISI ≥ 8, CC staff scheduled eligible clients
One participant (10%) was discharged before the inter- for a screening/informed consent session in evenings or
vention began. Six participants (60%) were discharged on weekends. Research staff sent the list of consented
from HUM before completing the intervention; one of participants via a HIPAA-compliant correspondence to
those six participants was discharged between weeks 7 CC staff who scheduled the clients for gCBT-I. gCBT-I
and 8 of CBT-I. gCBT-I participants completed an aver- sessions were included on CC clients’ weekly schedules
age of 5 sessions and remained at HUM for an average to promote treatment adherence. Similar to the screening
of 37 days after the first gCBT-I session. Following the appointment, gCBT-I sessions were scheduled at a pre-
first gCBT-I session, 100% of gCBT-I attendants brought determined time that did not coincide with scheduled

Table 3 Facilitators and barriers of conducting an insomnia intervention within a therapeutic community
Level Facilitators Barriers

Patient Patient interest in learning about sleep and treating insomnia Maintenance of treatment integrity because participants missed
gCBT-I sessions
Provider Staff and students willing to complete sleep medicine training Efforts to minimize workload for staff that limited opportunity to
and conduct gCBT-I sessions recruit gCBT-I participants
Staff and volunteer turnover that delayed recruitment
Sleep medicine training that was time- and resource-intensive
Organizational Well-established clinical research infrastructure within the Limited opportunities to collect weekly paper sleep diaries as part
behavioral health program of standard clinical practice
gCBT-I sessions that did not conflict with scheduled SUD treat- Time gap from behavioral health program enrollment to 1st gCBT-
ment I session
Consistent communication with staff and leadership in the
behavioral health program and therapeutic community
RCT​randomized controlled trial, gCBT-I group cognitive behavioral therapy for insomnia
Speed et al. Trials (2022) 23:965 Page 10 of 15

CC or HUM activities. Additionally, CC staff educated 101 ± 76 days of treatment and we were missing a critical
HUM staff on the potential clinical utility of CBT-I and window to intervene in acute SUD recovery. Additionally,
reviewed initial challenges and successes with the inter- days until gCBT-I completion (51 days to first gCBT-I
vention. Thus, HUM was amenable to modifying curfew session plus 57 days of the 8-week intervention) equaled
rules and adapting space for participants to use before days in CC treatment and precluded our ability to meas-
their designated (i.e., delayed) bedtimes. HUM com- ure 3- and 6-month follow-up of sleep and SUD-related
municated these adaptations with nighttime security so outcomes.
that participants had adequate opportunity to comply In summary, while we had sufficient recruitment
with the CBT-I protocol. No study harms or unintended pool to enroll 80 participants in a 2-year period, we
effects were reported by participants from either group, only accrued 25% of our targeted sample in that period.
staff, or leadership. Implementation barriers led to gaps in (1) recruitment;
In this context, we also identified gCBT-I implementa- (2) data collection (e.g., missing sleep diaries from the
tion barriers. At the patient level, (1) we found that it was SOC group, no long-term follow-up outcomes); and (3)
impractical to exclude participants for missing one ses- intervention integrity (e.g., delayed time to gCBT-I, poor
sion, despite our concerns with maintaining treatment treatment adherence). We recognized that optimizing
integrity. Yet, it was also impractical to lead a group- recruitment, gCBT-I treatment integrity, and data col-
based cognitive session if participants had not adequately lection for the successful completion of an effectiveness
learned sleep-focused behavioral therapy. At the provider trial were not possible without substantial changes to our
level, (1) conducting screening/consent during non- protocol and additional funding to hire research coordi-
workday hours limited recruitment opportunities; (2) nators. Hence, we terminated the study with the intent of
the onboarding of new research staff and volunteers to using this implementation framework to inform future
conduct screens led to recruitment delays; and (3) sleep studies.
medicine training was time- and resource-intensive (e.g.,
3-day seminar and 3-month training curriculum). Specif- Discussion
ically, we mostly relied on research volunteers to conduct Insomnia is common in SUD and a robust predictor of
the consent/screening process in evenings and on week- relapse. CBT-I is recommended as first-line treatment for
ends. Volunteer turnover led to frequent onboarding and chronic insomnia in adults, yet it is not widely dissemi-
delays in screening. The lack of volunteers to conduct nated in real-world clinical settings, including behavioral
screening during non-work hours was a primary reason health programs [86]. Our implementation science evalu-
for the 2- and 6-month-long gaps between the 3 gCBT-I ation of a RCT that compared gCBT-I with SOC in an
treatments. While our interventionists had ample access outpatient SUD program embedded within a therapeutic
to sleep medicine training, many behavioral health clin- community showed initial success with Reach (96.5% of
ics are not associated with an academic medical center, screened clients provided informed consent to partici-
thus limiting scalability. At the organizational level, (1) pate in the research study; 80% attended the first gCBT-
we did not implement a sufficient method to collect I session) and Adoption (50% of counselors completed
paper sleep diaries from the SOC group and (2) rand- sleep medicine training). Effectiveness was inconclusive.
omizing 4-5 participants to gCBT-I or SOC took several Due to our small sample size, missing data, and study
weeks and delayed treatment. Regarding paper diaries, termination inferences about effectiveness were not pos-
we considered having CC therapists collect weekly sleep sible. We did not observe between group differences in
diaries, yet suspected this could interfere with the SOC insomnia severity at post-treatment. We observed pre-
treatment arm (i.e., therapists could inadvertently pro- post improvements in the secondary outcomes of sleep
vide sleep education while discussing the paper diary parameters in the gCBT-I intervention arm, although we
with their clients). Remuneration proved an insufficient did not sufficiently collect comparator data. Poor treat-
reward, but care was taken to not offer an amount that ment integrity precluded analysis of a priori secondary
that could be viewed as coercive in relation to other outcomes: attrition, SUD relapse rates. Implementation
contingency rewards available in the clinic at the time. at the individual and organization level was also limited;
Regarding the time gap from admission to intervention, only 30% of participants in the gCBT-I intervention com-
it took an average of 25 ± 10 days from initial CC visit pleted the 8-week intervention. Regarding Maintenance,
to enroll participants in the study; accumulating a cohort we faced well-known CBT-I implementation barriers,
of 4–5 individuals for the gCBT-I intervention arm took including limited time and resources for intervention-
an average of 51 ± 23 days from initial CC visit to the ists to complete sleep medicine training and a nearly
first gCBT-I session. Thus, CC clients started the inter- 2-month delay from CC entry to gCBT-I onset, that limit
vention approximately half-way through an average of sustainability and dissemination of an 8-session gCBT-I
Speed et al. Trials (2022) 23:965 Page 11 of 15

intervention in real-world residential therapeutic com- Expanding the treatment to all HUM residents could
munities. Conversely, communication between HUM address the previously mentioned barrier of insufficient
and CC was optimal for study implementation, which study participants for a RCT yet would require more
will aid future iterations of the study. resources and an improved triaging system.
The RE-AIM framework addresses the external validity This study also quashed our initial postulates about the
of clinical research as a method to facilitate translation feasibility of protocol implementation. Specifically, we
of research into clinical practice [87, 88]. A significant expected that an inhospitable sleeping environment (e.g.,
chasm exists between the robust efficacy of CBT-I in roommates snoring, lack of white noise, inability to regu-
clinical trials and its dissemination into clinical practice late room temperature or light) within a residential set-
[86]. This work uniquely contributes to the literature by ting would uniquely impede participants’ willingness and
identifying common and unique CBT-I implementation ability to adhere to the CBT-I protocol [42, 89]. Partici-
facilitators and barriers in the context of an academic- pants did not substantiate this concern suggesting that
community partnership and therapeutic community set- communal sleeping environments may not be a barrier
ting. Implementation facilitators included a pre-existing to conducting further insomnia interventions within resi-
behavioral health research program, adequate synergy dential therapeutic communities. Evidence of pre-post
between the research program and the various commu- improvements in sleep parameters provides additional
nity stakeholders (e.g., clients, staff, volunteers, provid- support that CBT-I treatment adherence is potentially
ers, and leadership) to initiate an insomnia intervention, feasible in residential settings.
a standardized screening protocol within the behavioral Given that chronic insomnia is a well-established
health program to access the target population, and fre- predictor of SUD relapse, several RCTs have been con-
quent communication between various stakeholders. ducted in outpatient settings among community-dwell-
In addition to previously discussed common barriers, ing individuals and Veterans living with a SUD with the
the RE-AIM framework shed light on critically important hope that CBT-I positively influences SUD recovery. To
barriers specific to conducting an RCT within a behavio- date, the extant literature has examined CBT-I in alco-
ral health program. First, participants did not have suffi- hol-dependent adults in early recovery [46–48], young
cient access to the intervention despite their interest. One adults who are actively drinking [90], and patients on
client was discharged from care before initiating gCBT-I methadone treatment for OUD [49]. Collectively, these
and six clients were discharged from HUM before com- studies found that CBT-I improved subjective insomnia
pleting the intervention. Inadvertently, our strategy to symptoms relative to control but did not modify SUD
use a group-based intervention delayed treatment onset outcomes. Similarly, we found that individuals who
because it took several weeks to randomize 4–5 partici- received the gCBT-I intervention reported pre-to-post
pants per group. Additionally, we experienced gaps in improvements in subjective sleep including sleep conti-
recruitment due to volunteer turnover. Thus, future stud- nuity, sleep efficiency, and total sleep time. Contrary to
ies may need to consider alternative research designs to the literature, we did not find between-groups differ-
avoid delays in intervention onset and gaps in recruit- ences in self-reported insomnia severity, and the present
ment. Second, requiring attendance at every gCBT-I study did not analyze SUD outcomes. A consistently
session increased treatment attrition. Recognizing that reported limitation across the extant literature is that
clients may miss a session due to conflicting medical or studies have been underpowered to detect changes in
psychosocial appointments that are critical to their stabi- substance use [46–49, 90]. We speculate that additional
lization early in treatment, we modified this requirement nuanced barriers may limit CBT-I’s effectiveness at
to allow participants to miss up to 4 out of 8 sessions. An reducing SUD severity. For instance, except for Arnedt
unresolved barrier remains, how to balance treatment and colleague’s [46] CBT-I adaption to include educa-
integrity with leniency for missing groups. Third, par- tion about alcohol’s effects on sleep, to the best of our
ticipant remuneration for return of weekly paper sleep knowledge, none of the studies adapted CBT-I to focus
diaries did not suffice in the SOC group; hence, we had on SUD; although participants may have received con-
inadequate comparator data to evaluate our secondary current SUD treatment [48]. RE-AIM or other imple-
outcomes. Finally, our study targeted CC clients who mentation science frameworks may be useful planning
reported mild-to-severe insomnia at CC admission. We tools to guide iterative changes to CBT-I to more effec-
excluded HUM residents who did not attend CC and CC tively address the relationship between insomnia and
clients who may have experienced new onset insomnia substance use among SUDs populations.
beyond admission. Thus, we potentially missed a large Our study is the first to evaluate CBT-I among indi-
cohort of residents in the therapeutic community pro- viduals with multiple types of primary SUDs, and
gram who could benefit from an insomnia intervention. often co-occurring SUDs (CODs), and to offer CBT-I
Speed et al. Trials (2022) 23:965 Page 12 of 15

for individuals living in a residential therapeutic com- regarding sleep and SUD outcomes were not possible.
munity. Sleep disturbances are highly prevalent among Third, the study was conducted over a 2-year period
individuals in residential therapeutic communities. and only in men (HUM was a men’s therapeutic com-
Wilkerson and colleagues recently showed that most cli- munity through 2019). Although, there were no signifi-
ents who entered a community IOP for SUD treatment cant changes among infrastructure, clinical staff, and
had significant sleep disturbances, regardless of primary leadership at CC or HUM during the 2-year period, it
SUD or COD, and that insomnia severity, but not sleep is possible that internal or external variations across
quality or sleepiness, predicted IOP treatment comple- the long study duration impacted results between
tion [45, 91]. This is important because it suggests that groups. Also, women could experience different out-
insomnia-focused interventions such as CBT-I may comes. Fourth, to protect client confidentiality and to
widely benefit individuals in intensive levels of SUD maintain clients’ satisfaction levels, we did not audio-
care regardless of type of primary SUD or CODs and record gCBT-I sessions to evaluate treatment fidelity,
buttresses support for further CBT-I implementation instead we had one CC counselor attend most ses-
science studies within IOPs, residential facilities, and sions. Fifth, this study did not collect placebo or sham
therapeutic communities. control group data on sleep parameters. Due to this
Future directions to enhance CBT-I implementation lack of data and the small sample size, our findings do
and sustainability in real world SUD clinics may focus not inform power analysis for future RCTs. Sixth, we
on expanding reach, identifying target populations, did not plan the RCT using the RE-AIM framework.
decreasing burdens of time and access to services, and Thus, we did not establish a priori decision points to
incorporating the intervention into existing clinical align the process with RE-AIM indicators in our clini-
workflow while reducing demand on clinical resources cal trial evaluation. Seventh, we are missing data on a
and staff. Using the RE-AIM framework, we have iden- portion of clients who attended the first screening ses-
tified potential adaptations for future clinical studies at sion only. Next, at the time of this study, mOUD was
our current study site. These include (1) engaging clients inaccessible for HUM residents due to standard ther-
and other stakeholders in intervention planning, (2) apeutic community principles. The unabated rise in
transitioning to a brief behavioral treatment for insom- drug fatalities and urgent need for access to evidence-
nia (BBTI) that would remove the barrier of specialty based SUD treatments has led to a paradigm shift in
sleep medicine training and time constraints [92, 93], the role of mOUD in SUD recovery among therapeutic
(3) incorporating a sleep assessment during the behav- communities, including HUM. Future studies are war-
ioral health intake as a billable service, (4) expanding ranted to further our understanding of the effective-
eligibility criteria to include all therapeutic community ness of behavioral sleep interventions for individuals
residents regardless of insomnia scores at admission, on mOUD. Finally, while we consider it advantageous
(5) offering an introductory insomnia educational ses- to conduct clinical research among patients within a
sion early in SUD treatment to increase client interest population the Health Resources and Services Admin-
in insomnia therapy, and (6) integrating the electronic istration defines as underserved [94], some may con-
health record with HIPAA and 42CFR-compliant web sider the present study population too complex and
applications (i.e., REDCap) to more efficiently collect heterogeneous for analyses. Despite these limitations,
data on insomnia and substance use related outcomes. we believe that this paper presents a transparent and
Additionally, mixed-methods analyses that collect and pragmatic subjective evaluation of our clinical trial
triangulate quantitative and qualitative data from cli- that offers novel insights into behavioral management
ents and other stakeholders will be essential to inform of comorbid insomnia and SUDs and supports the
future implementation and adaptations of insomnia design and implementation of future randomized trials
interventions. that would benefit from recruitment across additional
Our results must be considered in the context of or larger settings.
study limitations which can be accounted for in future
studies. First, it does not meet the CONSORT exten- Conclusion
sion guidelines for randomized pilot and feasibility tri- This is the first study to apply the RE-AIM framework
als as feasibility was not an a priori primary outcome. to the evaluation of a RCT of an insomnia intervention
Second, the limited number of participants accrued conducted among a therapeutic community. These find-
due to study termination precludes any relevant group ings emphasize the importance of engaging multiple
comparisons; thus, the completed study diverged from stakeholders in the adaptation of insomnia interventions
the planned RCT regarding recruitment and study among SUD treatment programs. Improved treatment
aims as inferences about intervention effectiveness of insomnia as part of comprehensive evidence-based
Speed et al. Trials (2022) 23:965 Page 13 of 15

outpatient SUD treatment programs may provide an References

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1 patients with chronic opioid abuse: a polysomnographic evaluation in
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School of Medicine, 5510 Nathan Shock Drive, Suite 100, Baltimore, MD
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