Inpatient Cognitive-Behavioral Therapy to Reduce Suicide Risk Post-Discharge
Phase: NA
Conditions: Suicide, Attempted
Sponsor: Hartford Hospital

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Study Title: Inpatient Cognitive-Behavioral Therapy to Reduce Suicide Risk Post-Discharge 
 
NCT04168645 
 
Document Date: 6.1.2022 
 

Specific Aims and Hypotheses
Objectives. Although inpatient treatment provides immediate stabilization and crisis management for suicidal 
patients, the risk of suicide post-discharge is substantial, with approximately one third of all suicides by 
individuals with mental disorders occurring in the 90 days following hospitalization.1 These data highlight the 
importance of establishing an empirically-supported inpatient treatment for suicide prevention. Cognitive 
behavioral therapy (CBT) is a strong candidate, given that CBT reduces risk in suicidal outpatients.2-5 In 
addition, our team has completed an open trial, in which we 1) adapted the strongest outpatient CBT protocol6 
for an inpatient setting, 2) demonstrated high levels of feasibility and acceptability, and 3) obtained preliminary 
estimates of efficacy. The objective here, which is the final step before dissemination, is to conduct a large-
scale randomized controlled trial (RCT) comparing CBT (n = 100) to treatment as usual (TAU, n = 100) to 
firmly establish efficacy and collect pilot data on treatment implementation metrics. Our central hypothesis, 
based on strong outpatient data,7  is that inpatient CBT will reduce suicidal behavior, suicidal ideation/intent, 
and inpatient readmission over 6 months post-discharge, compared to TAU. The rationale for the proposed 
study is to inform best practices treatment for hospitalized suicidal patients by establishing for the first time, 
and ultimately disseminating, an empirically-validated inpatient treatment for suicide prevention. Such results 
are expected to have a significant positive impact, because of the high risk of suicidal behavior after discharge 
from inpatient treatment and the substantial public health burden it entails.
We plan to test our central hypotheses and, thereby, accomplish the objective of this application by pursuing 
the following primary specific aims:
Primary Aim 1. Determine the efficacy of inpatient CBT on suicidal behavior over a 6-month follow-up. 
We predict that compared to patients receiving TAU, those receiving CBT will report lower rates of suicidal 
behavior over a 6-month follow-up. . 
Primary Aim 2. Determine the efficacy of inpatient CBT on suicidal ideation/intent at post-treatment and 
over a 6-month follow-up. We predict that compared to patients receiving TAU, those receiving CBT will 
report lower severity of suicidal ideation at post-treatment, and over a 6-month follow-up. 
Primary Aim 3. Determine the efficacy of inpatient CBT on readmission over 6-month follow-up. We 
predict that patients receiving CBT will report fewer inpatient readmissions over the follow-up period.    
In addition to these primary specific aims, the scope of the proposed study will also allow us to pursue several 
secondary aims, as detailed below.
Secondary Aim 1. Determine the efficacy of inpatient CBT on suicide implicit associations at post-
treatment and over a 6-month follow-up. We predict that compared to patients receiving TAU, those 
receiving CBT will report stronger associations between life and self words at post-treatment and over a 6-
month follow-up.
Secondary Aim 2. Determine the extent to which substance use disorders moderate outcome. Given 
that CBT for suicide prevention is a transdiagnostic intervention, we expect that CBT will be efficacious for the 
diverse range of clinical presentations represented in an inpatient sample. However, some research suggests 
that the presence of substance use disorder (SUD) may adversely impact the efficacy of CBT.8,9 Thus, we will 
take care to address comorbid SUD in the current study by utilizing stratified block randomization to ensure 
equal group representation on this variable, and to explore the presence of SUD as a treatment moderator in 
the data analytic plan. 
Secondary Aim 3. Explore additional psychopathological moderators of treatment outcome. Additional 
exploratory analyses will examine the moderating effect of the following psychiatric symptoms, which have 
been found to be associated with increased suicide risk and/or attenuated response to CBT: depression 
severity, impulsivity, hopelessness, distress tolerance, insomnia, and borderline personality traits.   
Exploratory Aim 1. To collect pilot data on implementation metrics. To enhance future 
implementation research we will collect pilot data on implementation metrics such as treatment barriers 
and facilitators.
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IRB APPROVAL DATE: 06/01/2022

Project Description
A. Background and Significance. The proposed research has substantial potential to identify best means to 
prevent suicide in the most highly vulnerable population: inpatients admitted following a suicide attempt.  
Below, we describe the importance of treating this population, the importance of testing CBT in this group, and 
the scientific importance of testing moderators of treatment response.  
A.1. The Significance of Treating Suicidal Behavior in Psychiatric Inpatients.  Suicide is one of the 
top 10 causes of death in the US, accounting for 1.6% of all deaths and 11% of deaths among individuals aged 
25-44.10  Among individuals with depressive disorders, there is an 11% mortality rate from suicide.11  The most 
significant risk factor for suicide is a history of suicide attempts,12 present in 5% of the adult US population.13  
The rate of completed suicide within 1 year is nearly 100 times higher among those who have engaged in 
suicidal behavior than among control subjects.14 Suicidal behavior, therefore, is the most promising target for 
reducing risk of completed suicide.
Most of what is known about the treatment of suicidal behavior comes from clinical trials conducted at the 
outpatient level of care. While these studies (see below) have been highly promising, it is not known whether 
their results extend to the highest-risk group: psychiatric inpatients who are admitted to hospital following a 
suicide attempt. Approximately one third of all suicides by individuals with mental disorders occur in the 90 
days following hospitalization.1  A review of nearly 2 million adult psychiatric inpatients found that the suicide 
rate in the 90 days after discharge for patients diagnosed with depressive disorders was 235.1 per 100,000 
person-years, markedly higher than that in the US general 
population (14.2 per 100,000 person-years).15  A meta-analytic 
review found that the post-discharge rate of suicide was an 
alarming 2078 per 100,000 person-years among patients 
admitted with suicidal ideation or behavior.16 We therefore 
suggest that efforts to reduce rates of suicidal behavior are 
critical for inpatients that have attempted suicide.
A.2. The Significance of Using Cognitive-Behavioral 
Therapy for Suicidal Behavior. Cognitive behavioral therapy 
(CBT) is a brief, collaborative, and skills-based form of 
psychotherapy that is particularly well-suited to the prevention of 
suicide.6 A variety of CBT suicide prevention protocols have 
been tested, yielding a range of efficacy estimates.2-5  The CBT 
protocol used in the proposed study, developed by Rudd and 
colleagues,17 showed the strongest behavioral effect of the 6 
RCTs of CBT that measured suicidal behavior outcomes (see 
Fig. 1).4 Thus, we have selected the CBT protocol with the 
strongest empirical support.  In an RCT of outpatients, this 
protocol resulted in a significant reduction in suicide attempts 
over a 24-month follow-up assessment (hazard ratio = 0.38); 
those receiving CBT were 60% less likely to make a suicide 
attempt than were those receiving TAU (see Fig. 2).7  
The Rudd et al.7 protocol emphasizes teaching skills for 
crisis management (i.e., crisis response plan), maintaining 
safety (e.g., means restriction counseling, survival/hope kit, 
reasons for living list) and emotion regulation (e.g., relaxation, 
mindfulness, sleep hygiene, cognitive therapy). The original 
protocol was designed to be delivered in 12 outpatient 
individual sessions on a weekly or biweekly basis. Prior to pilot 
testing, we recognized that such a protocol would not be 
feasible on an inpatient unit, given the brief length of stay.  We 
will describe in section E our pilot work that involved paring 
down the protocol and switching to a daily, rather than weekly or biweekly, format.  Importantly, the inpatient 
manual included the same conceptual framework and skill content as the outpatient version, but, given 
Fig. 1. Effect sizes for CBT on suicidal behaviors in 
controlled trials (source: Mewton & Andrews, 2016)
Fig. 2. Survival Curves for Time to First Suicide Attempt 
(source: Rudd et al., 2015)
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expected short length of stay, the inpatient manual prioritized (i.e., included in the first three treatment 
sessions) the “core” crisis response plan, as well as skills most directly targeting suicide prevention (means 
restriction counseling, survival/hope kit, reasons for living list, and coping cards). We note that the crisis 
response plan has been independently validated as a stand-alone intervention for suicide prevention across a 
variety of treatment settings, including acute patients seen in the emergency department.18  The crisis 
response plan can be completed in one 30-min session, making it an ideal intervention for settings where time 
spent with the patient is extremely limited (such as the emergency department). Given that inpatient length of 
stay following a suicide attempt will typically be longer than a single day, we chose to investigate a CBT 
protocol which, as noted above, includes several key suicide prevention treatment components in addition to 
the crisis response plan. As the CBT protocol has now been validated in controlled research with outpatients 
and has been deemed feasible in an inpatient setting (See Section E), this proposed RCT will be the final 
empirical support needed before broad dissemination of the protocol within healthcare systems. 
A.3. The Significance of Including and Examining Substance Use Disorder. Substance use disorders 
(SUDs) commonly co-occur with depression,19 and patients with SUDs are at particularly elevated risk for 
suicide attempts20 (across studies, the relative risk ranges from 4.5-16.9).21  However, relatively little is known 
about the effect of CBT for suicidal behavior in patients with SUDs, as such patients are commonly excluded 
from clinical trials. Some evidence points to an attenuated response to CBT and pharmacotherapy for 
depression among substance-using patients.8,9 Of note, the outpatient CBT protocol was validated in a sample 
within which a substantial minority was diagnosed with SUD,7 suggesting that the protocol will be efficacious 
for these patients. However, the moderating effect of SUD on CBT for suicide prevention has not been 
established. To address this research question, we will include inpatients with SUD in the proposed study, and 
will examine whether the presence of a SUD is associated with diminished treatment response. We will use 
stratified block randomization to ensure that SUD is represented equally across the CBT and TAU groups (see 
Section F.5).
A.4. The Significance of Exploring Treatment Moderators. It is critical to identify those patients for 
whom the treatment is most and least effective. Though we predict a high level of success with the CBT 
protocol to be used here, no intervention is effective for all patients.  By identifying those patients who are less 
likely to respond to the intervention, we will be able to better match patients to treatments and will stimulate the 
development of novel future treatments in which the intervention is modified or augmented to meet the needs 
of those groups who receive less benefit. Below, we describe several hypothesized treatment moderators.  
A.4.1.
Depression. Depression is a well-established risk factor for suicidal ideation,22 and higher 
depression severity is associated with greater suicide risk.23 Further, there is some evidence that pre-treatment 
depression severity predicts less depressive symptom reduction in MDD,24 greater risk of relapse25-29 and 
suicidal behavior in SUD,30 and less improvement and lower remission rates in CBT for anxiety disorders.31 We 
will examine whether higher levels of depression are associated with attenuated treatment response for 
suicidal behaviors.
A.4.2.
Impulsivity. There is growing evidence that those who attempt suicide have higher rates of 
impulsive behaviors,32-37 and impulsivity is associated with other known suicide risk factors (e.g., borderline 
personality disorder).38 In outcome studies, greater impulsivity at intake is associated with poorer treatment 
outcomes for SUD,39 eating disorders,40-42 and impulse-control disorders.43 We will attempt to extend previous 
work to examine the role of impulsivity on CBT treatment outcome for suicidal ideation and behavior.
A.4.3.
Hopelessness. Trait hopelessness has been found to predict suicidal thoughts, attempts, and 
completions over periods up to 20 years.44-49 Results for state hopelessness are mixed, with some studies 
finding that state hopelessness is positively correlated with suicidal ideation,50,51 and others finding no 
relationship between state hopelessness and suicidal ideation.52,53 In treatment studies, greater pretreatment 
trait hopelessness was associated with less symptom reduction in inpatient54 and outpatient CBT55 for 
depression. Furthermore, hopelessness that is not responsive early in outpatient cognitive therapy for 
depression predicted worse treatment outcomes, suggesting the potential negative influence of state 
hopelessness.56 We plan to extend previous findings to test whether trait and state hopelessness at pre-
treatment are associated with poorer response to CBT for suicidal behavior.
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A.4.4.
Borderline Personality Disorder. Suicidal behavior is present in 69-80% of patients with 
borderline personality disorder (BPD).32,57-59 The moderating role of BPD in CBT for suicide has not yet been 
tested; however, previous work suggests that the presence of BPD at pre-treatment significantly predicts worse 
outcomes for depression, a known risk factor for suicide,24,50,60,61 and worse outcomes in a partial hospital 
sample.50,62 The current study will examine whether BPD traits moderate treatment outcome for suicidal 
thoughts and behaviors, thus warranting more specific intervention in inpatient settings.
A.4.5.
Number of prior suicide attempts. History of previous suicide attempts has been identified as 
one of the best predictors of future suicide attempts, with two or more attempts conferring elevated risk of 
future suicidal behavior and suicide completion 47,63-66 (e.g., weighted OR = 3.41).44 Those with a history of 
multiple suicide attempts were more likely than single attempters to have higher anxiety, depression, SUD, 
hopelessness, and BPD symptoms, known risk factors for suicide.66,67  Further, data show a negative 
relationship between a history of a suicide attempt and treatment outcome;68  however, the relationship 
between the number of previous suicide attempts and treatment outcome remains understudied. Given the 
high risk of those with a history of multiple attempts, the current study aims to examine if the number of 
previous suicide attempts moderates treatment outcomes. 
A.4.6. Distress Tolerance. Patients with suicidal behavior have been characterized as having low 
distress tolerance.69 Importantly, low distress tolerance may mediate the relationship between negative 
emotion and suicidality.  We will examine the degree to which distress tolerance is associated with suicidality 
at pre-treatment, as well as the relationship between changes in distress tolerance and changes in suicidal 
thinking and behavior.
A.4.7. Insomnia. Insomnia is a well-established risk factor for depressive and anxiety disorders.  
Further, since 2010 alone, over 20 studies have demonstrated that insomnia is also associated with suicide 
risk.70 This relationship could be explained by dysfunctional beliefs about sleep (e.g., hopelessness) as well as 
by the impaired executive function that can result from sleep loss.  We will examine the relationship between 
insomnia and suicidal behavior at pre-treatment, and examine the potential moderating effects of insomnia on 
CBT response.
A.5. The Significance of Exploring Implicit Associations as an Outcome. Advances in the 
measurement of implicit cognition provide an opportunity to test whether automatic associations of self with 
death can provide a behavioral marker for suicide risk. Nock et al.71 measured implicit associations—the 
strength of a person's automatic association between mental representations of objects (concepts) in 
memory—about death/suicide in psychiatric ED patients.  The Implicit Association Test (IAT, described in 
section F.2.6) is a brief computer-administered test that uses patients’ reaction times when classifying 
semantic stimuli to assess automatic mental associations about life and death.  Preliminary results from the 
IAT are impressive.  Cross-sectionally, patients who had attempted suicide showed a significantly stronger 
implicit association between death and self than did patients who had not attempted suicide. Moreover, the 
implicit association of death with self was associated with an approximately 6-fold increase in the odds of 
making a suicide attempt in the next 6 months, exceeding the predictive validity of known risk factors (e.g., 
depression, suicide attempt history) and both patients’ and clinicians’ predictions.71  
B. The Innovation of the Proposed Study. Our application of a well-validated treatment protocol to an acute 
inpatient population is innovative because of the unique characteristics of inpatients including short length of 
stay, severe levels of psychiatric distress, and very high risk of subsequent suicide attempts.  Our 
modifications, which have proven effective in our pilot research (see section E), required us (with substantial 
consultation from Dr. Rudd) to focus the CBT protocol to those elements deemed most critical for acute care.  
Our exploration of multiple moderating factors will allow us to determine those patients for whom CBT is most 
effective. In addition, inclusion of the IAT as an outcome measure is innovative, as it moves the inquiry beyond 
traditional clinical variables and assessment methods. 
C. Qualifications, Experience, and Productivity of the Applicant.  The applicant, David Tolin, Ph.D., is an 
accomplished treatment outcome researcher with particular expertise in clinical trials of CBT. Dr. Tolin is the 
founder and director of the Anxiety Disorders Center/Center for Cognitive Behavioral Therapy at the Institute of 
Living, and an Adjunct Professor of Psychiatry at Yale University School of Medicine. Dr. Tolin has obtained 
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over $5M of funding to support his research from organizations including the National Institute of Mental Health 
and the Donaghue Medical Research Foundation. He has amassed a publication record which includes over 
180 peer-reviewed journal articles. As outlined in section E, Dr. Tolin was PI on a pilot open trial, conducted in 
support of the present proposal, investigating CBT for suicide prevention in adults who had made a suicide 
attempt. 
Dr. Tolin’s effort on the current proposal will be further supported by a strong investigative team 
including co-investigator Gretchen Diefenbach, Ph.D., and consultants M. David Rudd, Ph.D. and Ralitza 
Gueorguieva, Ph.D. Dr. Diefenbach has collaborated with Dr. Tolin for the past 17 years. She has extensive 
experience with CBT treatment manual development and took the lead role in revising the manual for use in 
the pilot study (see section E). Dr. Rudd is an expert in CBT for suicide prevention and was a co-author of the 
original CBT manual.6 He trained staff at the IOL in the treatment and provided ongoing consultations into the 
clinical application of the manual as well as study methodology. He will continue to play a similar consulting 
role during the proposed RCT. Dr. Gueorguieva has collaborated with Dr. Tolin on multiple clinical trials. Her 
expertise is in data analytic strategies for repeated measures designs. Dr. Gueorguieva will consult on data 
analytic strategies (e.g., power estimates) as well as conduct multi-level modeling statistical analyses.    
 
D. Research Facilities.  This study will be conducted at the Institute of Living (IOL). The IOL is one of the 
oldest psychiatric hospitals in the nation and is currently the largest psychiatric hospital in Hartford HealthCare 
(HHC), the largest health care system in Connecticut. HHC is a fully integrated health system which includes a 
tertiary-care teaching hospital, an acute-care community teaching hospital, an acute-care hospital and trauma 
center, three community hospitals, a large multispecialty physician group, a regional home care system, an 
array of senior care services, a large physical therapy and rehabilitation network, and the state’s most 
extensive behavioral health network, comprised of three psychiatric and substance abuse treatment facilities, 
including the IOL. The IOL offers both inpatient and ambulatory services, thus providing continuity across 
levels of care. The IOL offers a large inpatient division, including child/adolescent, adult, and geriatric services, 
and hosts approximately 3,800 admissions annually. The adult inpatient division specifically is comprised of 
two 24-bed units. Further, the IOL is committed to the Zero Suicide Academy Initiative, which was developed 
by the Suicide Prevention Resource Center and the National Action Alliance for Suicide Prevention to improve 
the assessment and treatment of suicide. The Zero Suicide Academy Team meets monthly with staff across 
clinical areas and disciplines at the IOL. The IOL has implemented training in the Chronological Assessment of 
Suicide Events (C.A.S.E.), C-SSRS, and mental health first aid. The Zero Suicide Initiative is now being 
adapted across the behavioral health network of HHC. 
E. Prior Related Work. In this section, we describe our pilot study, conducted this year at the IOL.  The aims 
of this study were to refine the CBT manual6 for an inpatient setting, to pilot our assessment and treatment 
strategy, and to collect preliminary data on the feasibility, acceptability, and clinical efficacy of the protocol.
E.1. Participants. Six participants were enrolled in the study. Participants were all women, with a mean 
age of 34 (SD = 15.36, range = 18-58). A third of the sample self-identified as a member of a racial/ethnic 
minority group. Inclusion criteria were adults (age 18-65 inclusive) who made a suicide attempt within one 
week of hospital admission. Admission was defined as admission to either the medical floor (in cases where 
medical stabilization was required) or to the psychiatric inpatient unit (in cases where medical stabilization was 
not required). Suicide attempt was defined as self-directed behavior that deliberately resulted in injury or the 
potential for injury for which there was evidence, whether explicit or implicit, of intent to die. Participants were 
excluded if they were not fluent in English, when the inpatient treatment plan included electroconvulsive 
therapy, current SUD, or active mania; history of schizophrenia spectrum disorder, mental retardation, or 
organic brain illness; or any other psychiatric or medical condition that in the investigator’s opinion would 
preclude informed consent or participation in the trial. We note that although we excluded participants with 
SUD in the pilot study, these patients will be included in the proposed RCT (see Section A.3 for rationale).  
E.2. Measures. Study measures were administered by an independent evaluator (IE) who was not 
involved in the patients’ treatment. Diagnostic status was assessed using the Diagnostic Interview for Anxiety, 
Mood, and Obsessive-Compulsive and Related Disorders (DIAMOND).72 Suicidal ideation and behavior was 
assessed using the Columbia Suicide Severity Rating Scale (C-SSRS).73 Depressive symptoms were 
measured using the Structured Interview Guide for the Hamilton Rating Scale for Depression (SIGH-D).74  
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Acceptability of treatment was assessed using the Client Satisfaction Questionnaire (CSQ).75 Implicit 
associations were measured using the suicide IAT. For additional information about the measures, please see 
section F.2
 
E.3. Treatment. We adapted the treatment manual from Bryan and Rudd6 to align with the acute care and 
short lengths of stay of inpatient settings. As noted in Section A.2, the inpatient manual included the same 
conceptual framework and skill content as the outpatient version. However, to maximize efficiency we 
structured the treatment into two phases - Phase I Crisis Management and Phase II Emotion Regulation Skills 
Training. Phase I was comprised of three sessions which entailed psychoeducation about the CBT treatment 
model; developing an individualized case conceptualization, crisis response plan, survival kit, and coping 
cards; identifying reasons for living; and conducting means restriction counseling. Phase II was comprised of 
seven sessions of emotion regulation skills training which included sleep hygiene, relaxation, mindfulness, 
cognitive therapy, and activity planning. Given that discharge timelines were variable and many patients were 
discharged with little forewarning, relapse prevention was incorporated in whichever session was final and 
involved a review of the material covered to date. The treatment manual allowed for up to 10 sessions 
(depending on length of stay) to be administered once daily in a fixed session order. 
E.4. Results
E.4.1. Treatment Acceptability. A high degree of treatment acceptability was evident as all patients 
who were identified as study eligible (n = 8) agreed to participate. Two participants were subsequently 
excluded after a current SUD was diagnosed. All patients who started treatment (n = 6) continued treatment 
until discharge and on average reported a high degree of satisfaction with the study intervention (Client 
Satisfaction Questionnaire [CSQ] total score M = 3.49, SD = 0.73). All but one participant completed the follow-
up assessments.  
E.4.2. Treatment Outcome. Participants completed 4 treatment sessions on average (SD = 2.73, 
range = 3-8). There was a large pre- to post-treatment treatment effect size (Cohen’s d' = 0.98) for 
improvement in suicidal ideation (C-SSRS intensity subscale t5 = 2.40, p = .06). Patients also reported a large 
(d' = 1.33) and statistically significant (t5 = 3.26, p = .023) improvement in depression from pre-to-post 
treatment as assessed by the SIGH-D. Results from the IAT also indicated stronger associations between self 
and life words at post-treatment, compared to pre-treatment (d' = 1.28). There were no reported suicide 
attempts of any kind (i.e., aborted, interrupted, actual), no reported preparatory acts or behaviors, and no 
reported non-suicidal self-injury over follow-up. Two participants reported suicidal ideation over the follow-up 
period. One reported experiencing wishes to be dead (without actual thoughts of killing self) at the 3-month 
follow-up, and the other reported active suicidal ideation without intent to act at the 1-month follow-up and 
wishes to be dead (without actual thoughts of killing self) at the 2-month follow-up. When present, the intensity 
of suicidal ideation ranged from 10-13 on the C-SSRS during follow-up.   
F. Methods for the Proposed Study
F.1. Participants. We will recruit 200 consecutive adult inpatients at the IOL. We will enroll participants 
with a recent (i.e., within one week of hospitalization) suicide attempt or who endorse current (i.e., listed as a 
reason for admission) suicidal ideation with plan (with or without details worked out and with or without intent) 
in addition to a history of at least one suicide attempt within the past 2 years. Other inclusion/exclusion criteria 
will be identical to those in our pilot study (see section E.1), with the exception that we will now include patients 
with a diagnosis of a SUD and schizophenia spectrum disorders other than schizophrenia or schizoaffective 
disorder.  In addition, in order to allow sufficient time for study completion, we will exclude participants if the 
attending anticipates discharging the patient within 4 business days of consult. In order to increase safety 
during the COVID-19 pandemic, participants will be excluded if they test positive for COVID-19. In addition, 
participants will be excluded if they are unwilling to wear a mask during in-person research procedures. We will 
systematically assess sexual orientation and gender identity. 
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Fig. 3. Current patient flow (4 months) applying 
proposed RCT criteria.
Admissions
N =302
Eligible
N = 47
No suicide attempt (N = 233)
History of schizophrenia, MR, or 
organic brain illness (N = 10)
Discharged before screen 
completed (N = 9)
Not fluent in English (N = 1)
ECT (N = 1)
Excluded by attending (n = 1)
F.1.1. Feasibility of Recruitment. During our pilot work, we conducted a search of electronic medical 
records for IOL inpatients admitted 3/16/18-7/10/18 and documented reasons for study exclusion.  As shown in 
Fig. 3, the primary reason for exclusion was an absence of a 
clear suicide attempt.  Other patients were excluded due to 
history of schizophrenia spectrum disorder, mental retardation, 
or organic brain illness, or early discharge before screening 
could be completed. Over this 4-month period, 47 patients 
appeared to meet the inclusion criteria for the proposed study 
(approximately 12 admissions per month). With this patient flow 
we will be able to reach our enrollment target even if we 
experience a more conservative eligible participant flow and/or 
acceptance rate than we had in our pilot study (we need an 
average of 9.52 participants per month to meet the proposed 
enrollment target). 
F.2. Measures
F.2.1. Diagnostic Measure.  Diagnostic status will be 
assessed at pre-treatment using the Diagnostic Interview for 
Anxiety, Mood, and Obsessive-Compulsive and Related 
Disorders (DIAMOND),72 a semi-structured interview for DSM-5 
psychiatric disorders. The DIAMOND assesses for a wide range 
of DSM-5 disorders which will allow for determining diagnostic 
inclusion/exclusion criteria as well as characterization of the study sample. In addition to anxiety, mood, and 
obsessive-compulsive and related disorder, the DIAMOND assesses for substance use disorders, trauma- and 
stressor-related disorders, schizophrenia spectrum and other psychotic disorders, feeding and eating 
disorders, somatic symptom and related disorders, and a subset of neurodevelopmental disorders (tic 
disorders and attention deficit hyperactivity disorders). The DIAMOND shows very good to excellent ( = 0.68) 
inter-rater reliability for depressive disorders, and very good ( = 0.65) inter-rater reliability for SUDs.  Similarly, 
test-retest reliability for the depressive disorders and SUDs is very good (both  = 0.76). 
 
F.2.2. Demographic Questionnaire. Demographic information including age, biological sex, race and 
ethnicity will be obtained from the medical record for all consented participants. Patients who are enrolled in 
the study will complete an expanded demographic questionnaire which will include questions about gender 
identity and sexual orientation. 
F.2.3. Health Form. Diagnoses will be obtained from the medical record for all consented participants. 
In addition, patients who are enrolled in the study will complete a self-report indicating the presence of chronic 
medical conditions. 
F.2.4. Suicidal Behavior. Suicidal behavior will be assessed using the Columbia Suicide Severity 
Rating Scale (C-SSRS), a widely used suicide assessment measure.73 Several suicidal behaviors are 
assessed on the C-SSRS including the presence or absence of each of the following: suicide attempt, 
interrupted attempt, aborted attempt, and preparatory acts or behaviors. When an attempt is present, actual 
lethality is assessed on 6-point scale (0 = “no physical or very minor physical damage” to 5 = “death”). When 
actual lethality is rated as 0 then potential lethality is assessed on a 3-point scale (0 = “behavior not likely to 
result in injury” to 2 = “behavior likely to result in death despite medical care”). Presence or absence of non-
suicidal self-injury is also assessed as these behaviors are associated with future suicide attempts.76  The 
lifetime version of the C-SSRS will be administered at pre-treatment to assess both the total number of 
behaviors ever present as well as the number of behaviors present in ”the past month.” At subsequent 
assessments the “since last visit” version will be administered with the timeframe for “since admission” at 
posttreatment, and “past month” at follow-up assessments. The behavior scales of the C-SSRS have 
demonstrated sensitivity to change across treatment, sensitivity and specificity in identifying lifetime actual and 
interrupted attempts73, and predictive validity for identifying future suicidal behaviors and rehospitalization.77,78  
Further, the C-SSRS behavior scales show moderate agreement with other measures of suicide risk.73,79,80 The 
C-SSRS has shown good inter-rater reliability for rating the number of lifetime attempts , interrupted attempts, 
aborted attempts, preparatory behaviors, and non-suicidal self-injury ( = 0.54 - 0.81).81,82 
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F.2.5. Suicidal Ideation/Intent. Suicidal ideation and intent will also be assessed using the same C-
SSRS versions and timeframes as described above (Section F.2.2).73 Two subscales as described by Posner 
and colleagues 73 will be extracted: severity and intensity. The severity subscale is a single item describing the 
nature of suicidal thoughts: 1 = “wish to be dead,” 2 = “nonspecific active suicidal thoughts,” 3 = “suicidal 
thoughts with methods,” 4 = “suicidal intent,” and 5 = “suicidal intent with plan.” The C-SSRS severity subscale 
does not include a category for patients endorsing suicidal thoughts, with a specific plan, but without intent. For 
the purposes of this study participants meeting those criteria will be scored a “5”, as this is the only item that 
includes a specific plan (i.e., a plan with details fully or partially worked out) in the description. The intensity 
subscale is comprised of five items assessing the characteristics of suicidal ideation (frequency, duration, 
controllability, deterrents to intent and/or attempt, and reason for the ideation). The C-SSRS severity and 
intensity scales show moderate agreement with other measures of suicidal ideation.73 The C-SSRS intensity 
scale has demonstrated adequate internal consistency (α = .73)73 and both suicidal ideation scales have 
shown moderate agreement with other measures of suicidal ideation.73,79,80 Further, the suicidal ideation scales 
have demonstrated predictive validity to detect future suicidal behaviors and rehospitalization. 77-79,83 The C-
SSRS shows good inter-rater reliability and multi-method agreement.80,81,84 Suicidal ideation will also be 
assessed using the Adult Suicidal Ideation Questionnaire (ASIQ)85, a 25-item self-report scale designed to 
assess the frequency and severity of suicidal ideation. The ASIQ has demonstrated moderate positive 
correlations with depression, hopelessness, and past suicide attempts, good internal reliability, and good test-
retest reliability.85 Suicidal ideation/intent will also be assessed through self-reported intensity of Wish to Live 
and Wish to Die (0 = “Not at all” to 8 = “Very Much”) and listing and rank ordering by importance up to five 
reasons for living and reasons for dying.86 To reduce participant burden the reasons for living/dying listing task 
will be completed only at the posttreatment assessment. 
F.2.6. Implicit Association Test. As described in section 
A.5, the IAT71 is a brief computer-administered test that uses 
patient’s reaction times when classifying semantic stimuli to 
measure the automatic mental associations they hold about life and 
death. The IAT (see Fig. 4) is a computerized test that requires 
participants to classify stimuli representing the constructs of “death” 
(i.e., die, dead, deceased, lifeless, and suicide) and “life” (i.e., alive, 
survive, live, thrive, and breathing) and the attributes of “me” (i.e., I, 
myself, my, mine, and self) and “not me” (i.e., they, them, their, 
theirs, and other). Response latencies for all trials are recorded. 
The relative strength of each participant’s association between 
“death” and “me” is indexed by calculating a D score for each 
participant; positive D scores represent a stronger association between death and self (i.e., faster responding 
on the “death”/“me” blocks relative to the “life”/“me” blocks), and negative scores represent a stronger 
association between life and self. Participants will complete a web-based version of the IAT, which will allow for 
assessment both during treatment and during follow-up. The web-based version of the IAT is hosted by 
Millisecond using HIPAA-compliant software. IAT reaction time data are stored on a Millisecond server for 
download by ADC study staff. No PHI will be stored on the server. However, data on the server are labeled 
with a code provided by ADC study staff for future linking with other participant data by ADC study staff. Only 
ADC study staff will have access to the list linking the IAT codes with other participant identifiers. Storage of 
coded IAT reaction time data on the Millisecond server is described in the study consent form.   
F.2.7. Service Utilization. Prescribed medication will be determined at intake and discharge through 
the electronic medical record. Interviews with the participant at each follow-up assessment will track changes 
in medication. Service utilization will also be assessed at each follow-up assessment through interview with the 
participant using a modified version of the Cornell Service Index Short Form and using a query of the HHC 
electronic medical record to determine changes in prescribed medications, as well as the number of 
encounters recorded for ER visits, outpatient behavioral health, and inpatient behavioral health (including 
length of stay). 
F.2.8. Implementation Metrics. Implementation data will be collected from patients and the system. 
Patients. Acceptability will be assessed in part through refusal and discontinuation rates. To obtain additional 
information about potential barriers and facilitators to implementation, patients who refuse study participation 
Fig. 4. Screen shot from the suicide Implicit 
Association Test (IAT).
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and/or discontinue study participation will be asked 1) the reason for refusal/discontinuation and 2) if there are 
any changes that could be make that would make BCBT a more acceptable treatment option. Patients in the 
experimental condition will also complete the Client Satisfaction Questionnaire CSQ, 75 at discharge 
assessment. The CSQ is an 8-item self-report assessing perceived quality and effectiveness of services, 
satisfaction with services, whether participants would return for similar treatment, and whether they would 
recommend this treatment to others. There is also a space for “comments” where the participant can write 
additional qualitative feedback. Each quantitative item is rated from 1 to 4 with higher numbers indicating 
higher satisfaction. The CSQ demonstrates good internal consistency and correlates with alternative 
satisfaction measures 87. Patients will also complete the Utility of Techniques questionnaire at each monthly 
follow-up assessment. The Utility of Techniques questionnaire asks whether or not the patient learned the skill 
during inpatient stay, and for those skills endorsed “yes”, participants rate the frequency of use and helpfulness 
(if skill was used) of the five strategies taught during BCBT: Crisis Response Plan, Survival Kit, Reasons for 
Living List, Coping Cards, and Means Restriction. The questionnaire contains 5 to 10 items, as the helpfulness 
item for each skill is only prompted if some use is indicated. All patients will complete a modified version of the 
Views on Inpatient Care (VOICE) questionnaire at baseline and posttreatment assessments. The original 
VOICE questionnaire has 7 sections, and it has been modified by only utilizing 2 sections. The modified 
version is a 7-item self-report assessing perceived quality of care on the inpatient unit, with an emphasis on 
adequacy of staff, therapy, and activities. Each quantitative item is rated from 1 to 6, with higher numbers 
indicating higher satisfaction and there are two spaces for comments for qualitative feedback. The VOICE 
measure has good validity and internal and test-retest reliability. System. All study staff will track barriers 
encountered during study implementation via the Implementation Barriers Log. In addition, qualitative feedback 
regarding staff’s views on barriers and facilitators to BCBT implementation will be collected via an anonymous 
survey at the end of study enrollment. Costs will be estimated via tracking of time for implementation of 
treatment and related documentation procedures.
F.2.9. Adverse Event Assessment. Adverse events will be assessed at every study visit using the 
questions “Have there been any changes to your physical health since the last time we met?” and “Have there 
been any changes to your mental health since the last time we met?” worded for the appropriate timeframe of 
each assessment timepoint. Adverse events will be tracked and reported according to policy 910. 
F.2.10. Moderators. Substance Use.  Substance use disorder diagnoses will be obtained using the 
DIAMOND as described in section F.2.1. Severity of alcohol use will be assessed using the Alcohol Use 
Disorders Identification Test (AUDIT),88 a 10-item self-report measure of problematic alcohol use. The AUDIT 
has demonstrated strong internal consistency, test-retest reliability, and sensitivity and specificity compared to 
other measures of alcohol use.89 Severity of drug use over the past year will be assessed using the Drug 
Abuse Screening Test (DAST),90 a 20-item self-report measure.  The DAST has demonstrated excellent 
internal consistency, and adequate convergent and divergent validity.90-92  Depression.  Depression symptoms 
will be assessed using the depression subscale of the 21-item Depression Anxiety Stress Scales-21 (DASS-
21).93 The DASS-21 has demonstrated good internal consistency across scales, and good convergent validity 
with other measures.93 Impulsivity. Impulsivity will be measured using the impulsivity scale of the Difficulties in 
Emotion Regulation Scale (DERS).94 The DERS has demonstrated high internal consistency, good test-retest 
reliability, and adequate construct and predictive validity.94 Hopelessness. Hopelessness will be assessed  
using the State-Trait Hopelessness Scale (STHS).95 The STHS is a 23-item self-report scale that consists of 
the 10-item State Hopelessness Subscale (SHS) and the 13-item Trait Hopelessness Subscale (THS), both of 
which assess negative attitudes about the future. Both subscales have demonstrated internal reliability and 
moderate correlations with the Beck Hopelessness Scale and Patient Health Questionnaire.95 Trait 
hopelessness will also be assessed using a brief version of the Suicide Cognitions Scale (SCS).96 The SCS 
includes 18-items assessing beliefs about burdensomeness, unlovability, and intolerance of distress, which 
confer vulnerability to suicidal thoughts and behaviors independent of the individual’s current state. The SCS 
has demonstrated good predictive validity for suicidal ideation and future suicide, and adequately discriminates 
between those with and without a history of suicide attempts.96 The Brief SCS is a 9-item self-report including 
the same three subscales as the original scale97 Borderline Personality Disorder. Symptoms of borderline 
personality disorder will be assessed using the McLean Screening Instrument for Borderline Personality 
Disorder (MSI-BPD).98 The MSI-BPD is a 10-item self-report measure that has demonstrated good sensitivity 
and specificity in detecting symptoms of borderline personality disorder compared to the Diagnostic Interview 
for DSM-IV Personality Disorders (DIPD-IV),99 good test-retest reliability, and acceptable internal 
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consistency.98  History of Suicidal Behavior. As noted above (See Section F.2.2), history of suicidal behavior 
(number of prior suicide attempts) will be assessed using the lifetime version of the C-SSRS.  Distress 
Tolerance. Distress Tolerance will be assessed using the Distress Tolerance Scale (DTS).100 The DTS is a 15-
item self-report measure assessing the degree to which individuals experience negative emotions as 
intolerable (e.g., “When I feel distressed or upset, all I can think about is how bad I feel”). The DTS has 
evidenced good reliability and internal consistency in clinical samples.101 Insomnia. The Insomnia Severity 
Index (ISI) is a 7-item self-report of sleep problems (onset, maintenance), dissatisfaction, interference, and 
distress with good psychometric properties.102  Schizophrenia Spectrum Disorder. If n = 1 participant is 
enrolled with this diagnosis we will analyze the data with and without including this participant. If 5 or more 
participants with schizophrenia spectrum disorder are enrolled we will explore this diagnosis as a moderator. 
F.3. Brief CBT. As described in section E.3, we had previously adapted Bryan and Rudd’s6 treatment 
manual for an inpatient setting. This protocol included up to 10 sessions (depending on length of stay). 
However, our pilot data suggested that this protocol was too lengthy, as no patients received the full protocol. 
As noted above the average number of sessions attended was 4. In addition, feedback from the study clinician 
and supervising psychologists (including one psychologist who listened to audiotapes of all pilot treatment 
sessions) suggested that introducing a variety of CBT skills in rapid succession (i.e., with one new skill 
introduced each day) as was done in Phase II of the pilot treatment manual may not have provided adequate 
time for practice and consolidation of the “core” crisis management skills introduced in Phase I. Thus, in the 
RCT we will only include the Phase 1 Crisis Management sessions (sessions 1-3) delivered daily (excluding 
weekends and legal holidays), plus a relapse prevention session (session 4) delivered as close to discharge as 
possible. In cases where the patient is discharged earlier than the expected four business days from attending 
consult, two sessions may be completed in the same day and/or the all skills review may be incorporated into 
whatever session is final in order to cover as much treatment material as possible prior to discharge.  
Delivering a 4-session, behavioral skill-based protocol in the RCT is consistent with the typical experience of 
patients in our pilot study (M sessions = 4) and is supported by meta-analytic research indicating that the most 
efficacious CBT suicide prevention protocols are those that focus on treating suicidal behaviors directly (rather 
than targeting comorbid psychiatric distress).4 This protocol will also be a more feasible, focused, and 
standardized product for the next step of dissemination. Details of the 4-session protocol are outlined below. In 
cases where the session material is not completed in one meeting, additional meetings will be scheduled in 
order to cover all session material. 
Session 1. Session 1 begins with an introduction to the structure and content of CBT and specification 
of preventing suicide attempts as the treatment goal. Informed consent is confirmed following reminders about 
the voluntary nature of the treatment and limitations of confidentiality. Next, the therapist completes 
psychoeducation about the “suicide mode,”6 the CBT case conceptualization model for suicidal behavior. The 
suicide mode includes baseline risk factors (i.e., factors which predispose or make one vulnerable to suicide) 
interacting with triggering events leading to acute risk factors (i.e., temporary exacerbations in emotions, 
thoughts, physiology, and behaviors associated with suicide). The therapist further describes how CBT targets 
modifiable aspects of the suicide mode in order to enhance safety. Next, the therapist conducts a narrative 
assessment asking patients to tell their “story” of the index suicide attempt (i.e., the attempt which preceded 
current admission) and constructs an individualized suicide mode case conceptualization. At the end of the 
session, a crisis response plan is developed, which involves identifying warning signs, self-management 
strategies, supportive friends or family members, and professional resources which could be accessed if 
needed in a crisis. Session 1 lasts for 90 minutes and patients are provided with pocket-sized composition 
notebooks in which they record key concepts from the session such as the suicide mode, crisis response plan, 
and main takeaways or “lessons learned.” The treatment log is used to promote between-session practice as 
well as improve accessibility of the session content in the future. Following CBT the treatment log serves as a 
written relapse prevention tool. 
Session 2. The primary goal of Session 2 is to increase cognitive flexibility and ambivalence toward 
suicide by focusing attention on positive aspects of living. Two interventions are introduced. First, the therapist 
introduces reasons for living by asking patients to describe reasons why they do not want to die and what 
prevents them from making another suicide attempt. For example, responsibility to children or pets, to enjoy 
pleasures such as certain foods or experiences, or to be alive during important future events are common 
reasons for living. The reason for living is reinforced through a visualization exercise focusing on vivid and 
specific details to increase emotional salience and improve access from memory. The second intervention is 
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creating a survival kit (sometimes also called a hope box). The therapist provides the patient with a white 
cardboard container and asks the patient to identify items that could be placed in the box that would serve as 
concrete visual reminders of positive experiences. Common items included in the survival kit include pictures 
of loved ones, inspirational quotes, or mementos from positive life events. The rationale for choosing each item 
is reviewed by the therapist in order to discourage inclusion of any potentially iatrogenic items. 
Session 3. In Session 3 the therapist completes counseling on reducing access to lethal means. This is 
an essential component to preventing death by suicide. Because activations of the suicide mode are 
temporary, creating barriers to lethal means can create a window of opportunity for suicide distress to subside 
and/or for the patient to enact a crisis response plan. Even if the patient makes a suicide attempt, doing so with 
a less lethal form of means still reduces the likelihood of injury and improves the patient’s chances of surviving. 
During session 3 the therapist assesses for access to means, including access to firearms, and then 
collaboratively develops a plan to restrict means. Common examples of means restriction are to remove 
firearms from the home or to have a family member lock up and dispense medications. The means restriction 
plan is shared with the unit clinician to review during family meetings. In session 3 the therapist also introduces 
coping cards to modify cognitive factors of the suicide mode. The suicide mode thoughts are written on one 
side of the card and alternative responses are written on the other side of the card. The coping cards provided 
a concrete memory aid 
for alternative thoughts 
when the patient’s 
negative thoughts are 
activated in the suicide 
mode.  
Session 4. In the 
final session, the 
therapist reviews all 
previous CBT skills and 
reinforces the treatment 
log as a reference to use 
after discharge. Two 
relapse prevention tasks 
are completed as well. 
The participant is 
directed to imagine the 
index suicide episode as 
well as a hypothetical 
future suicide episode. 
For each, the therapist 
assists guides the 
participant to imagine 
him- or herself utilizing 
one or more skills 
learned in BCBT to 
effectively manage the 
situation. In addition, 
anticipated high risk 
situations are identified 
and any necessary changes to the crisis response plan are made. This plan is also shared with the patient’s 
unit clinician. The therapist discusses the upcoming discharge and reviews specific ways that CBT skills can 
be integrated into daily life. 
F.4. Treatment as Usual. TAU includes 24-hour care through a multidisciplinary team providing treatment 
on the basis of a short-term stabilization model. While each patient receives an individualized treatment plan, 
programming may include pharmacotherapy, group psychotherapy, case management/individual therapy, 
rehabilitation therapy, recreation therapy, vocational counseling, family therapy, and collaboration with outside 
Table 1. Measurement Schedule.
Intake
Discharge
Follow-Up
1-
Mo
2-
Mo
3-
Mo
4-
Mo
5-
Mo
6-
Mo
DIAMOND
X
Demographic Form
X
Health Form
X
C-SSRS
X
X
X
X
X
X
X
X
IAT
X
X
X
X
X
X
X
X
ASIQ
X
X
X
X
X
X
X
X
DASS-21
X
X
X
X
X
X
X
X
STHS-State
X
X
X
X
X
X
X
X
STHS-Trait
X
AUDIT
X
DAST
X
DERS-Impulsivity
X
SCS
X
X
X
X
X
X
X
X
MSI-BPD
X
VOICE modified
X
X
Utility of Techniques
X
X
X
X
X
X
Client Satisfaction
X
Service Utilization/CSI mod. 
X
X
X
X
X
X
AE Assessment
X
X
X
X
X
X
X
X
Implementation Barriers Log
X
X
X
X
X
X
X
X
DTS
X
X
X
X
X
X
X
X
ISI
X
Wish to Live\Wish to Die
X
X
X
X
X
X
X
X
Reasons for Living\Dying
X
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providers. As part of the Zero Suicide Initiative, telephone calls are made after discharge to all patients 
admitted following a suicide attempt to ensure that patients are following their discharge plans, including 
connecting with referrals to outpatient services. By the initiation of this study, all patients admitted following a 
suicide attempt will also be discharged with a personal safety plan.103 
F.5. Procedure. Eligible participants will be identified through the same multi-step screening process 
utilized in our pilot study, starting with a review of admission logs and followed by consultation with the 
participant’s attending psychiatrist to confirm eligibility criteria. Participants passing both of these screens will 
be recruited either in person or by phone/videoconference by a member of the research staff. Interested 
participants will provide written informed consent prior to any study procedures. For patients who are admitted 
to the hospital involuntarily, documentation of competency to provide consent will be completed by the 
attending physician as well. The third step of the screening process will be a baseline clinical interview 
including the DIAMOND and C-SSRS. Given that randomization does not occur until after the baseline 
interview, this interview may be conducted by any Ph.D.-level clinical study personnel who has completed 
training certification in the administration of these measures. In situations where the intake is completed by a 
post-doctoral fellow, the fellow will be supervised by study personnel who is a licensed psychologist. The 
baseline assessment will also include the  IAT and the following self-report measures: Demographic Form, 
ASIQ, AUDIT, DAST, DASS, STHS, DERS Impulsivity subscale, SCS, MSI-BPD, ISI, DTS, Wish to Live\Die, 
and VOICE modified (a full schedule of events is outlined in Table 1). 
Participants meeting all inclusion and none of the exclusion criteria will be randomly assigned (using a 
computer-generated randomization schedule) to either CBT or TAU using stratified block randomization on 
SUD. We expect, based on pilot data analyses, that approximately two-thirds of patients in each group will be 
diagnosed with SUD. Patients assigned to CBT will participate in all aspects of their prescribed treatment plan 
(i.e., TAU) and in addition will receive up to 4 sessions of CBT (depending on length of stay), lasting 1.5 hours 
for the first session and 1 hour for the remaining sessions, following the manualized protocol described above. 
Treatment will be conducted by a doctoral-level clinician trained in the manualized procedures. Training will 
involve reading the manual, reviewing videos from the training conducted by Dr. Rudd’s previously at the IOL, 
reviewing sessions of pilot study participant treatments, participating in mock treatment role-plays, and 
completing treatment of at least 2 participants under close supervision (i.e., with all sessions reviewed by the 
supervising psychologist). Audiotapes will be made of each session and transcriptions will be made from a 
subsample of participants who consented for transcription of their sessions. A psychologist trained in the CBT 
protocol will review audiotapes of 10% of sessions and will rate treatment fidelity according to a checklist 
developed in collaboration with Dr. Rudd and utilized in our pilot study (> 90% treatment fidelity was rated for 
all pilot participants). Transcriptions may also undergo qualitative coding for content analysis of case 
conceptualizations and treatment content (e.g., suicide mode features such as the role of substance use in 
suicide attempts). As preliminary analyses have found over 10% of the study sample identifies as transgender 
this study provides a unique opportunity to develop understanding of how minority stress relates to suicide risk 
for transgender patients as well as explore the experience of transgender patients engaged in suicide 
prevention therapy. We will code themes related to transgender minority stress in suicide attempt narratives 
and BCBT treatment (e.g., environmental and external events such as discrimination or harassment; social 
connectedness; psychological vigilance; anticipation of negative events related to gender identity; internalized 
transphobia, resilience, gender-affirming care, and transitioning). We have obtained funding from the Hartford 
Hospital Medical Staff to support the additional time required to complete these transcriptions and content 
analyses (“Reducing Disparities in Suicide Prevention Treatment for Transgender People”, Diefenbach, PI).   
Participants assigned to TAU will engage in usual care. For the post-treatment assessment, participants will 
meet with an independent evaluator (IE; a clinician who is not the patient’s treatment provider and is blind to 
study group assignment) either in person or by phone/videoconference to complete the C-SSRS. The 
participant will also complete the IAT and self-report measures (ASIQ, DASS, STHS-State, SCS, DTS, Wish to 
Live\Die, Reasons for Living\Dying, Client Satisfaction) as close to discharge as possible. In the event that 
patients are discharged prior to completing this assessment, the assessment will be completed by phone and 
remote data collection as will typically be done for follow-up assessments. After discharge, participants will 
have a telephone interview each month for 6 months of follow-up. The IE will administer the C-SSRS, IE 
Medications Interview, and CSI modified interview. In addition, participants will complete the IAT remotely, and 
the ASIQ, DASS,  STHS-State, SCS, DTS, Wish to Live\Die, and Utility of Techniques through REDCap,104 a 
secure data management website. When patients are readmitted to one of the study units during the follow-up 
assessment time period, the follow-up assessment may be conducted on the unit with study staff providing 
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computer and phone access in order to complete data collection. Participants will be reimbursed $50 for each 
post-treatment/follow-up assessment. IE meetings will also be audiotaped to facilitate monthly IE calibration 
meetings to prevent against rater drift. Transcriptions will be made from a subsample of participants who 
consented for transcription of their study meetings. After each interaction between IE and the participant, the IE 
will complete an IE Assessment of the Blind which tracks if and how IEs became unblinded to condition as well 
as requires IEs to guess the condition of the participant and rate their confidence.
We recognize that obtaining follow-up data is critical. Therefore, we will take several steps to optimize our 
ability to collect such data. During the informed consent process, participants will be asked to provide multiple 
forms of contact including a direct telephone contact and e-mail as well as  the back-up numbers of at least two 
family members or friends in case study staff are unable to reach the participant at the direct number. If study 
staff is unable to reach the participant for follow-up at all contact numbers provided following no less than three 
call attempts, then a letter will be sent to the participant requesting that they contact the study staff. If no reply 
is received from 1 week of mailing the first letter, than a second letter will be sent requesting that the 
participant contact the study staff and also indicating a date by which study staff will no longer contact them to 
schedule follow-up calls. If no reply is received by the indicated date, then the participant will be considered 
lost to follow-up. In an effort to assess suicide attempts and other important outcome variables (e.g., 
readmission) over the follow-up period, medical records and publicly available death records will continue to be 
reviewed.   
F.6. Data Analytic Plan
F.6.1. Power Analysis. We predict, based on remarkably consistent results from longitudinal studies 
of inpatients post-discharge,105-107 that the rate of suicidal behavior during the follow-up period for TAU patients 
will be approximately 37%.  We further predict, based on Rudd et al.’s7 outpatient study that that CBT will 
reduce the incidence of suicidal behavior by approximately 73% over the 6-month follow-up period (i.e., the 
rate of suicidal behavior for CBT patients will be approximately 10%).  To err on the conservative side, we will 
power for a 50% decrease in rate of suicidal behavior (i.e., 37% vs. 18.5%).  To detect a difference of this 
magnitude with 80% power (alpha = 0.05, two-tailed), we would need 90 individuals per group.  To ensure 
robustness of results, we propose to recruit 100 patients per group.  For the continuous outcome variables, 
assuming up to 20% dropout, this N will provide us with more than 80% power to detect a medium effect size 
(d=0.50, f=0.25 for the comparison of interest (i.e. between-group differences post-baseline) to address the 
primary aims at 0.025 significance level (adjusted for two outcome variables for aim 2).  
F.6.2. Assumptions. Data distributions of continuous variables will be checked for normality using 
normal probability plots prior to statistical analysis. Transformations will be applied if necessary. Descriptive 
statistics will be calculated using all available data at each time point. The analyses will be performed on the 
modified intent-to-treat sample (i.e., all randomized individuals that complete at least one CBT session). 
F.6.3. Primary Hypotheses. We will test the primary aim hypotheses using mixed effects models 
(linear mixed effects models for continuous outcomes and generalized linear mixed models for categorical 
outcomes), a statistical approach that uses all available data on individuals and provides flexibility in modeling 
the correlational structure of the data, and results in unbiased and maximally efficient estimates under missing 
at random assumptions. Group, Time and the interaction of Group x Time will be fixed predictors. We will use 
all available data on individuals completing at least one CBT session and will include the stratification factor 
(SUD) as another factor in the models. The best-fitting variance-covariance structure (e.g., compound 
symmetry, autoregressive, etc.) for continuous outcomes will be selected using Schwartz’s Bayesian 
Information Criterion (BIC). We expect a statistically significant interaction of Group (CBT versus TAU) x Time 
(pre-treatment, post-treatment, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month follow-up) for the 
dependent variables of interest: suicidal behavior, suicidal ideation/intent, and rehospitalization with significant 
between-group differences at the post-baseline time points. Power is calculated based on the average of the 
post-baseline time-points but we will also have the ability to estimate effect sizes between groups by time point 
with associated confidence intervals Analyses of suicide behavior will also be used to estimate absolute risk 
reduction between the treatment and control group and to derive estimates of numbers needed to treat to 
prevent one more suicide attempt.
F.6.4. Exploratory Moderator Analyses. We will explore the moderating effect of suicide risk 
variables (i.e., depression severity, impulsivity, hopelessness, BPD, DTS, ISI, number of previous attempts) on 
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CBT effects by repeating the analyses described above with moderator variables and its interactions with the 
other factors in the model (group, time) added as categorical predictors. Significant interactive effects of the 
moderator variable with treatment condition (TAU versus CBT) will be interpreted to meet this exploratory aim. 
For all potential moderators we will estimate treatment effect sizes with confidence intervals within level of the 
moderator (e.g. among individuals with SUD, among individuals without SUD) in order to inform future studies.
F.6.5. Exploratory Implementation Data Analyses. Exploratory implementation metrics will be 
summarized using descriptive statistics. 
G. Strengths and Weaknesses
G.1. Strengths of the Proposed Study. The primary strength of this study is its high-impact focus, in 
which we aim to prevent suicide in the most highly vulnerable (yet understudied) population: inpatients 
admitted following a suicide attempt.  Relatedly, a major strength is our use of an empirically-supported 
intervention for suicidal behavior that is ready for broad dissemination within this population following a 
successful RCT. The outpatient protocol has been tested in a RCT,7 and demonstrates the strongest effect of 
any cognitive-behavioral intervention on suicidal behavior.4 Our sample size ensures adequate power to test 
the study hypotheses. Our multimodal assessment, including implicit associations, will yield a rich database 
that allows us to test multiple hypotheses about treatment outcomes as well as moderating factors.  Finally, the 
research environment is a significant strength. As part of a large, statewide healthcare system, we are poised, 
when the aims of the proposed study are met, to disseminate this treatment across hospitals.
G.2. Weaknesses of the Proposed Study. Because of the time-limited nature of inpatient hospitalization, 
it is noted that not all of the original outpatient treatment protocol6 will be used.  Rather, this treatment is 
focused more on the acute issues of crisis stabilization and establishing reasons for living, with decreased 
(though not absent) emphasis on elements such as emotion regulation skill building.  A similar truncated 
protocol has been found to be efficacious in controlled research in emergency departments18 and shows good 
feasibility and initial efficacy in our pilot work (see section E).  We also note that because of varying lengths of 
stay, all patients may not receive the same “dose” of treatment.  We considered standardizing length of stay, 
but opted against this for ethical reasons of providing least restrictive treatment.  Our sample size and data 
analytic strategy will allow us to examine the relationship between number of sessions and treatment outcome.
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H. Literature Cited
1.
Huisman A, Kerkhof AJ, Robben PB. Suicides in users of mental health care services: treatment 
characteristics and hindsight reflections. Suicide Life Threat Behav. 2011;41(1):41-49.
2.
Tarrier N, Taylor K, Gooding P. Cognitive-behavioral interventions to reduce suicide behavior: A 
systematic review and meta-analysis. Behavior Modification. 2008;32(1):77-108.
3.
Mann JJ, Apter A, Bertolote J, et al. Suicide prevention strategies: a systematic review. JAMA. 
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