Motivational Interviewing to Prevent Suicide in High Risk Veterans
Phase: NA
Conditions: Suicidal Ideation, Treatment Engagement
Sponsor: VA Office of Research and Development

 
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STUDY PROTOCOL AND STATISTICAL ANALYSIS PLAN 
 
 
IRB Protocol Title: Study of a Brief Intervention for Hospitalized Veterans 
 
 
Grant Title: Motivational Interviewing to Prevent Suicide in High Risk Veterans 
 
 
ClinicalTrials.gov Identifier: NCT01544127 
 
 
IRB Approval Date: June 2, 2016 
 
 
 
 

 
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Specific Aims 
 
Psychiatrically hospitalized Veterans are estimated to be at 40-50 times the risk for 
suicide than the general population in the year following discharge. 1, 2 Despite their elevated 
risk, there are no clinical studies testing suicide interventions that are tailored to the population. 
To initiate a program of research that will address this need, we will conduct a randomized 
controlled trial (RCT) to examine the efficacy of Motivational Interviewing to Address Suicidal 
Ideation (MI-SI) plus TAU on suicidal ideation (SI) when compared to TAU alone. The study will 
include 140 high-risk Veterans who are hospitalized on a VA psychiatric inpatient unit. “High-
risk” will be defined as scores over 2 on the Beck Scale for Suicidal Ideation (SSI), which 
prospectively predicts suicide. 3 
 
All participants will receive a baseline assessment of SI, suicidal behavior, and risk 
factors for suicide. Half will be randomized to MI-SI plus TAU and half to TAU alone. 
Participants in the MI-SI group will receive two sessions of MI-SI during their hospitalization plus 
one MI-SI telephone booster session in the month following discharge, in addition to TAU. All 
participants will be asked to complete telephone follow-up assessments at 1, 3 and 6 months 
after discharge. The primary outcome is change in the severity of SI. In exploratory analyses we 
will also examine the impact of MI-SI on treatment engagement, and treatment engagement as 
a mediator of the impact of MI-SI on change in the severity of SI.  
 
The impact of the intervention on suicide risk during hospitalization is also of critical 
importance. In exploratory analyses, we will examine the effect of MI-SI on the severity of SI 
during the inpatient stay. Additionally, MI has been found to impact clients’ in-session talk about 
making changes, which is associated with treatment outcome. In participants who receive MI-SI, 
we will examine the impact of in-session living talk (or talk associated with interest in living) and 
suicide talk (or talk associated with interest in suicide) on the severity of SI during 
hospitalization.    
 
Aim 1: To conduct a randomized controlled trial (RCT) of 140 participants who are at high-risk 
for suicide. Participants will be randomized to receive MI-SI plus TAU, or TAU alone.  
 
Aim 2: To evaluate whether MI-SI plus TAU results in significant reductions in suicidal ideation 
(SI) and increases in treatment engagement when compared to TAU alone. 
 
Primary Hypothesis: Participants who receive MI-SI plus TAU will report greater 
reductions in SI over follow-up, than participants who receive TAU alone. 
 
Exploratory Hypothesis 1: Participants who receive MI-SI plus TAU will engage in more 
treatment over follow-up than participants who receive TAU alone. 
 
Exploratory Hypothesis 2: Treatment engagement over follow-up will partially mediate 
the impact of MI-SI on SI. 
 
Aim 3: To evaluate improvements during hospitalization.   
 
Exploratory Hypothesis 3: Participants who receive MI-SI plus TAU will report greater 
reductions in SI during hospitalization, than participants who receive TAU alone. 
 
Exploratory Hypothesis 4: In participants who receive MI-SI plus TAU, in-session living 
talk will be positively associated with reductions in SI during hospitalization. 

 
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Exploratory Hypothesis 5: In participants who receive MI-SI plus TAU, in-session suicide 
talk will be negatively associated with reductions in SI during hospitalization. 
 
Findings from this RCT will set the stage for an RCT to test the efficacy of MI-SI on risk 
for suicidal behavior in high-risk Veterans, and future studies exploring the mechanisms by 
which MI-SI may work. Findings will also contribute to the development and implementation of 
other suicide interventions that target the needs of high-risk Veterans and the implementation of 
efficacious suicide interventions across VA. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Background and Significance 
 
Psychiatrically Hospitalized Veterans are at High-risk for Suicide. Psychiatric disorders are 
known to increase risk for suicide in the general population, 4-7 as well as in Veterans. In a study 
integrating VA medical records with National Death Index (NDI) data, depression, substance 
use disorders, post-traumatic stress disorder, other anxiety disorders, bi-polar disorder and 
schizophrenia were shown to increase risk for suicide in Veterans. 8 General population studies 
indicate that the months following discharge from psychiatric hospitalization are particularly 
high-risk periods for individuals with psychiatric disorders, 9-12 and these findings have been 
replicated with Veterans. In a prospective study of psychiatric inpatients from 128 VAMCs, the 
suicide rate in the year following discharge was 445/100,000, 1 over 40 times the rate in the 
general population (11/100,000). 13 Nearly half (46%) died within 3 months of discharge 
underscoring that the initial months are a period of great risk for Veterans. Factors associated 
with suicide included major depression, substance abuse, and post-discharge treatment 
engagement. 1 In a study of depressed Veterans who received treatment from VA, 2 the suicide 
rate in the 12 weeks following hospitalization was 568/100,000, almost five times the rate of 
Veterans who received outpatient treatment for depression (114/100,000), 2 and 50 times the 
rate in the general population (11/100,000), confirming the need for preventive interventions for 
this population.  
 
Existing Interventions Are Inadequate for this Purpose. Existing interventions may not meet 
the immediate needs of psychiatrically hospitalized Veterans. Most Cognitive Behavioral 
Therapy (CBT) interventions that have been tested fall into the categories of Cognitive Therapy 
(CT), Dialectical Behavioral Therapy (DBT), and Problem-Solving Therapy (PST).  14 In general, 
suicidal behavior is conceptualized as a maladaptive coping strategy and patients are taught 
problem-solving and coping skills. CT for suicide prevention plus intensive case management 
plus treatment as usual (TAU) has been shown to reduce suicide attempts when compared to 
intensive case management plus TAU. 15 DBT has also been found to reduce suicide attempts 
in comparison to TAU and therapy by experts. 16-18 Although PST has been shown to reduce 
depressive symptoms, 19 it was not found to reduce suicidal behavior in a meta-analysis. 20 In 
their current form, CT for suicide prevention and DBT are too intensive to deliver during acute 
inpatient hospitalization. The average stay on the acute inpatient unit at the Syracuse VAMC is 
approximately 9 days; CT for suicide prevention lasts ten sessions, and DBT consists of two 
sessions a week for a year. Thus, research examining the efficacy and effectiveness of brief 
interventions for psychiatrically hospitalized Veterans at high-risk for suicide is needed.  
 
Motivational Interviewing to Address Suicidal Ideation (MI-SI) is Promising. Motivational 
Interviewing (MI) is a clinical approach that was originally developed to help motivate patients to 
change hazardous drinking behavior. It is defined as a “a client-centered, directive method for 
enhancing intrinsic motivation to change by exploring and resolving ambivalence,” 
21 
Hypothesized to work through interpersonal and behavioral pathways, 22 MI provides patients 
with an empathic relationship that helps them feel understood and supported. However, it is also 
directive in that clinicians actively elicit and reinforce change talk, or talk indicating that the 
patient is thinking about making changes, and commitment talk, or talk indicating that the patient 
is committed to making changes, which are predictive of reduced post-treatment substance use. 
23, 24 MI can also be used to target ambivalence about living and dying that is often observed in 
individuals who are thinking about suicide 25. It provides an empathic relationship that increases 
patients’ willingness to openly discuss their thoughts about living and dying, and also provides 
techniques that can be used to elicit and reinforce living talk (talk indicating that the client is 
thinking about living), and commitment talk (talk indicating that the client is committed to living or 

 
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trying to make life worth living), thereby reinforcing patients’ wish to live and engage in life 
sustaining and enhancing behavior. 
 
Resolving ambivalence about living and dying may be critical to reducing risk for suicidal 
behavior. In their conceptualization of SI, Kovacs and Beck wrote that the “overt suicidal act is 
viewed as the outcome of the internal subjective struggle between the wish to live and the wish 
to die, rather than the consequence of a single unidirectional motivation. 26 Research testing this 
hypothesis has used an index of the ratio of the wish to die to the wish to live that was created 
with items from Beck’s Scale for Suicidal Ideation (SSI). 27 Outpatients whose wish to die 
outweighed their wish to live made more severe attempts 26 and were more likely to die by 
suicide. 28 Conversely, individuals whose wish to live outweighs their wish to die may be less 
likely to think about suicide, and subsequently engage in suicidal behavior. 25 They may also be 
more likely to engage in life sustaining and enhancing behavior such as mental health and 
substance abuse treatment. 29  
 
 
MI-SI’s focus on resolving current SI makes it a promising addition to the VA suicide 
prevention strategy. In general, the VA strategy is based on using a suicide risk assessment to 
identify high-risk Veterans, mandating the use of a Safety Plan to identify warning signs and 
coping skills that can be used to reduce risk, and using Suicide Prevention Coordinators to 
oversee the care of high-risk Veterans. However, the VA does not have a treatment component 
that directly targets the resolution of current SI, which may impact the effectiveness of the 
services being offered. Veterans whose wish to die is stronger than their wish to live may not be 
willing to engage in treatments or services that can reduce their risk for suicidal behavior. For 
example, the Safety Plan is used to help individuals identify warning signs that indicate 
increased risk (e.g. physical pain or loneliness) and coping skills (e.g., taking a walk or calling 
someone) that can be used to reduce their risk. Veterans who want to die more than they want 
to live may not be willing to develop a Safety Plan or use it to address their warning signs. 
However, Veterans who want to live more than they want to die may be willing to engage in 
such activities. MI-SI can be used to explore Veterans’ ambivalence about living and dying, and 
enhance their wish to live and engage in life sustaining and enhancing behavior. Theoretically, 
MI-SI should therefore complement the Safety Plan and the other components of the VA suicide 
prevention strategy.  
 
 
Over 200 RCTs have been conducted using MI, 22 and findings from these studies 
support its potential as a brief intervention for Veterans at high-risk for suicide. In the most 
recent comprehensive meta-analysis, an average of two MI sessions was found to have a 
medium-to-large effect size in the first 3 months after treatment (Cohen’s d = 0.77), 30 a period 
of great risk in psychiatrically hospitalized Veterans. A brief course of MI can be as efficacious 
as more intensive treatments. In Project MATCH, four sessions of MI yielded outcomes that did 
not differ from those following twelve sessions of CBT and Twelve Step Facilitation (TSF). 31, 32 
MI has been shown to reduce self-injury. In individuals hospitalized for alcohol-related injuries, 
one session of MI reduced alcohol-related re-injury by almost 50% over 3 years. 33 When added 
to another treatment, MI has been shown to promote treatment engagement and improve 
treatment outcome. 30, 34 MI may also be uniquely suited for use with Veterans as it has been 
found to reduce hazardous drinking in Veterans. 35 It has also been shown to be more 
efficacious with angry patients than alternative treatments, 31, 32 and anger may interfere with the 
efficacy of clinical interventions with Veterans. 36 MI-based interventions may also translate to 
practice within VA as non-research clinicians can be trained to use it effectively. 34  
 
 
 

 
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Study of Speech 
MI theory posits that speech is one pathway through which MI increases clients’ 
motivation to change hazardous behavior. 22 Accordingly, much MI process outcome research 
examines the impact of clinician and client verbalizations on the outcome of treatment. In 
studies across problems (e.g., alcohol use, gambling), populations (e.g., adolescents, adults), 
and treatments (e.g., MI, CBT) change talk (that concerns changing) predicted commitment 
strength 37 and positive treatment outcomes, 23, 38, commitment strength also predicted 
treatment outcome. 37, 39, 40 However, counter-change talk (that concerns not changing) 
predicted negative treatment outcome. 38 Client speech during MI-SI sessions may therefore 
represent a wealth of information regarding patient risk and degree of improvement. Living talk 
(that concerns living) and suicide talk (that concerns suicide) that occurs during MI-SI sessions, 
for example, may be important predictors of treatment outcome. Additionally, the researchers at 
the CoE are keenly interested in conducting future methodological research on speech and 
suicide risk and may ultimately examine other aspects of speech (i.e., acoustical). 
 
Summary. Veterans who are hospitalized on Acute Psychiatric Inpatient units are at high-risk 
for suicide, particularly in the months following hospitalization. MI-SI is a promising intervention 
to accomplish this because it can be used to resolve ambivalence about living and dying by 
reinforcing the wish to live, thereby reducing SI and increasing treatment engagement. 
Moreover, the existing VA suicide prevention strategy does not directly target the resolution of 
current SI. The proposed study will examine the efficacy of MI-SI on change in SI. It will also 
explore the impact of MI-SI on treatment engagement and the impact of treatment engagement 
on change in SI. The study will also provide data for future studies to explore the mediating 
effects of in-session suicide and living talk, the mechanisms by which MI-SI is hypothesized to 
work.  
 
Work Accomplished 
Pilot Study #1 (MIRB# 00475). We 
conducted a pilot study to: 1) establish 
the feasibility of conducting a RCT on 
the 16-bed acute inpatient unit at the 
Syracuse 
VAMC; 
2) 
test 
the 
acceptability of MI-SI; and 3) explore 
the impact of MI-SI on SI and 
treatment engagement. The study 
utilized a pre-post design and was 
approved by the Syracuse VA IRB. 
Researchers recruited two days a 
week. Patients who met eligibility 
criteria 
(e.g., 
were 
permitted 
to 
participate by clinicians, from the 
catchment area, and not psychotic, 
manic, 
or 
demented) 
were 
approached. Those who consented 
completed a screening assessment 
(e.g., psychosis and mania modules of 
the Mini International Neuropsychiatric 
Interview [MINI], 41 Mini Mental Status 
Exam [MMSE], 42, 43 SSI) 44 to ensure 
that they were at high-risk for suicide 
and could engage with therapists in 
30 (83%) 
Consented/ 
Screened 
Figure 2: Study Flow Diagram 
36 
Approached 
6 (17%) Refused  
16 (53%)  
Eligible 
14 (47%) Excluded 
12 Did not meet criteria 
1 Discharged 
1 Refused  
3 (19%) Discharged 
13 (81%) 
Received 
 MI-SI 
11(85%) 
Completed 
Follow-up 
2 (15%) Lost to Follow-up 
1 Inpatient 
1 Refused 
 
  

 
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MI-SI. High-risk was defined as scores over 2 on the Beck Scale for Suicidal Ideation (SSI), 
which prospectively predicts suicide. 3 Eligible participants received a baseline assessment, 
were schedule to complete two MI-SI sessions over three days, a post-treatment assessment, 
and a 60-day follow-up assessment. 
 
Findings indicated that an RCT is feasible. Recruitment spanned 24 weeks (2/16/2010 to 
8/11/2010 with 2 weeks of no-recruiting).  Two hundred and eighteen patients were admitted to 
the unit, 130 (60%) did not meet eligibility criteria, and 52 (24%) were unavailable to 
researchers as they were scheduled for discharge within 48 hours of identification by study staff. 
Of the 36 who were approached, 30 (83%) consented, 16 of 30 (36%) had SSI scores over 2, 
and 3 of 16 (19%) were discharged before receiving the first MI-SI session. Thirteen received 
MI-SI, for a recruitment mean of 0.54 participants per week. Nine of 13 (70%) completed two 
MI-SI sessions. Follow-up data was collected for 11 of 13 (85%). One was admitted to an 
inpatient PTSD unit and was unable to return to Syracuse to complete follow-up. The second 
withdrew from participating. 
 
All 13 participants were male, average age was 46.77 (10.49), 9 (69.2%) were non-
Hispanic white, 7 (53.8%) had seen combat, 8 (61.5%) had a previous suicide attempt, and 5 
(38.5%) had more than one. Chart reviews indicated that 11 of 13 (85%) had mood disorders, 
10 (77%) anxiety disorders, 7 (54%) substance use disorders, and 2 (15%) attention deficit 
disorders. All 13 had been engaged in mental health or substance use treatment in the year 
prior to admission. Findings showed that MI-SI was acceptable to participants. The mean (SD) 
CSQ-8 score was 3.58 (.40), indicating that they were “3 = mostly” to “4 = very satisfied”. 
 
Findings suggested that MI-SI has promise and is worthy of continued study. Pre-post 
effect sizes were computed using the formula: ES = (Mpre – Mpost)/SDpre (Tables 1 and 2). 45 A 
standard version (last week) of the SSI was used at baseline and follow-up, and a modified 
version (past 48 hours) was used at post-treatment.  Participants who received MI-SI 
experienced reductions in the severity of SI, with an effect size of 3.39 from baseline to post-
treatment indicating an immediate reduction in SI. The effect size from baseline to follow-up was 
1.95, indicating continued reduction. These effect sizes are recognized as clinically significant, 
46 and compare favorably to TAU data collected by consultant Dr. Comtois. In a study of 15 
participants recruited primarily from inpatient units, with additional patients from the Emergency 
Department, Consult-Liaison, and Crisis Intervention services from an urban medical center, 
SSI scores fell 9 points from baseline to 60-day assessment. The reduction was almost half the 
17.9-point reduction observed in this study. The percentage of participants whose SSI scores 
fell below the high risk threshold (< 3) was used to confirm clinical significance. Thirty-three 
percent of scores from baseline to post-treatment fell below the threshold (< 3), as did 64% of 
scores from baseline to follow-up. All participants attended one mental health or substance 
abuse treatment session after discharge. Of the 11 participants with follow-up data, 7 (64%) 
completed 4 or more sessions, which compares favorably to previously reported rates. 1 
 
 
 
 
 
 
 
 
 

 
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Table 1. Post-treatment Outcomes for MI-SI Pilot Study (N = 9) 
Measure  
Baseline 
Mean (SD) 
Post-Treatment 
Mean (SD) 
Effect 
Size 
% Below 
Cutoff 
SSI  
27.56 (4.88) 
11 (10.44) 
3.39 
33.33 < 3 
 
Table 2. Follow-up Outcomes for MI-SI Pilot Study (N = 11) 
Measure 
Baseline 
Mean (SD) 
Follow-up 
Mean (SD) 
Effect 
Size 
% Below 
Cutoff 
SSI  
23.45 (9.19) 
5.55 (9.32) 
1.95 
63.64 < 3 
 
Pilot Study #2 (MIRB# 00512). Experience conducting the pilot study led to protocol changes 
that were piloted in a second study. The design of study #2 was identical to study #1 with the 
following exceptions: the unit was staffed five days a week to reduce the number of patients 
who were unavailable or scheduled for discharge within 48 hours of identification by study staff, 
the two MI-SI sessions were completed over two rather than three days to increase the 
percentage of participants that completed both sessions, and 60-day follow-up assessments 
were not conducted. Participants were recruited for four weeks from 1/3/2011 to 1/28/2011. 
Thirty-six patients were admitted to the unit, 22 (61%) were ineligible, and 6 (17%) were 
unavailable or discharged within 48 hours of identification. These six patients were discharged 
because they requested release, were transferred for detoxification, or were released because 
they disrupted the milieu. Of the patients who were admitted to the unit, 8 (22%) were 
approached and consented, and 2 (6%) met eligibility criteria and completed both MI-SI 
sessions. Recruiting 5 days a week reduced the number of patients who were unavailable or 
discharged within 48 hours of identification, and conducted MI-SI sessions on consecutive days 
increased the percentage of participants who completed both sessions. 
 
Restatement of Aims 
 
Aim 1: To conduct a randomized controlled trial (RCT) of 140 participants who are at high-risk 
for suicide. Participants will be randomized to receive MI-SI plus TAU, or TAU alone.  
 
Aim 2: To evaluate whether MI-SI plus TAU results in significant reductions in suicidal ideation 
(SI) and increases in treatment engagement when compared to TAU alone. 
 
Primary Hypothesis: Participants who receive MI-SI plus TAU will report greater 
reductions in SI over follow-up, than participants who receive TAU alone. 
 
Exploratory Hypothesis 1: Participants who receive MI-SI plus TAU will engage in more 
treatment over follow-up than participants who receive TAU alone. 
 
Exploratory Hypothesis 2: Treatment engagement over follow-up will partially mediate 
the impact of MI-SI on SI. 
 
Aim 3: To evaluate improvements during hospitalization.   
 
Exploratory Hypothesis 3: Participants who receive MI-SI plus TAU will report greater 
reductions in SI during hospitalization, than participants who receive TAU alone. 
 
Exploratory Hypothesis 4: In participants who receive MI-SI plus TAU, in-session living 
talk will be positively associated with reductions in SI during hospitalization. 

 
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Exploratory Hypothesis 5: In participants who receive MI-SI plus TAU, in-session suicide 
talk will be negatively associated with reductions in SI during hospitalization. 
 
Methods 
 
 
Treatment Setting 
The study will take place on the 18-bed 
Acute Psychiatric Inpatient unit at the Syracuse 
VAMC. In 2009, the previous 16-bed unit treated 
498 Veterans, approximately 41 a month, and the 
average length of stay was 9 days. 
 
Participants 
Participants will include 140 Veterans 
recruited from the Acute Psychiatric Inpatient Unit. 
Pilot data suggests that we will screen 320 
patients to identify 140 participants. A sample size 
of 140 would provide up to 28 participants for 
training and piloting, and 112 participants for the 
RCT. The sample will be predominantly male and 
white non-Hispanic, though females and minorities 
will be eligible. 47  
 
Inclusion criteria. 1) Veteran status, 2) admitted 
to the unit, 3) age 18 and over, 4) English 
speaking, 5) able to understand the study and 
provide informed consent, 6) clinically cleared to 
participate (e.g., not violent), 7) receiving (or will 
receive) health care from a VA facility in upstate 
NY and 8) at increased risk for suicide (SSI > 2)  
 
Exclusion criteria. 1) current psychosis, 2) 
current mania, 3) dementia, 4) prisoner status, and 5) being inaccessible and discharged from 
the unit less than 48 hours after being identified by study staff.  
 
Estimated Flow. Pilot data suggests that we can recruit approximately 0.54 participants per 
week. At this rate, we will recruit an estimated 112 participants in 4 years (208 weeks). 
Retention at 2 months using face-to-face assessments was 85%. The face-to-face assessment 
was changed to a telephone assessment to expand the catchment area to improve recruitment 
and increase retention. Assuming 80% retention at 6-month follow-up, we will have data from 90 
Veterans.  
 
General Procedures 
 
Recruitment. Potentially eligible patients will be identified during daily staff meetings. Clinic 
staff will determine if patients are stable enough to participate and will ask if they are interested 
in learning about the study. Staff will introduce interested patients to a trained researcher 
(bachelor’s, master’s, or doctorate level) who will review the consent form, describe the study in 
detail, and answer any questions the patient may have in a private setting.  
Baseline Assessment 
 
Phase 
1 
2 MI-SI 
Sessions  
Consent and Screening 
3 Month Follow-up  
Randomization 
Phase 
2 
 
TAU 
 
1 Month Follow-up  
1 MI-SI 
Booster 
Session  
 
 
TAU 
 
Figure 3: Study Design 
6 Month Follow-up  
 
 
 
 
 
 
 
Phase 
3 
 

 
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Maintaining Recruitment Log. Researchers will attend morning staff meetings and maintain a 
log of all participants who are admitted to the unit during recruitment for three reasons: a) to 
identify potential participants, b) to keep track of who is potentially eligible and has been 
approached so as not to approach someone who has already refused, and c) to describe 
participants who are potentially eligible but were discharged before researchers could approach 
them for consent. The log will be completed during staffing each morning and stored on the 
unit. A digital log will also be maintained on the T-drive to describe potentially eligible 
participants who were discharged before they could be approached. The trial will span over 4 
years, a paper log will be overly bulky and a digital log will enable us to search for duplicates. 
The log will be completed during staffing each morning and researchers will not access medical 
records until informed consent is provided. Only data that is absolutely necessary will be 
collected in the log, which will never leave the unit. Categories were taken from the 2010 
CONSORT Statement 48, and Explanation and Elaboration 49. The log will include last name 
and first initial (to ensure that patients are not approached more than once), date of admission, 
voluntary status, reported SI, whether the individual was approached, why patients were 
ineligible (e.g., psychotic, manic, cognitive deficits, active duty, outside catchment area, 
discharged within 48 hours, other), other reasons they were excluded, and whether they were 
enrolled.  
 
CPRS Notes. After the informed consent process is completed, researchers will enter a Study 
Initiation Note into the participants’ digital medical record. To ensure that mental health staff is 
aware of patients’ participation, the attending psychiatrist and nurse manager of the unit will be 
added as a signees. They will also be added to MI-SI session noted which will document 
whether the individual exhibited suicidal ideation, plan, or intent during the session.   
 
Participant Procedures. The study will consist of three phases. Phase 1, the assessment 
phase (15 min.), will be conducted on day 2 or 3 of hospitalization to confirm eligibility. Eligible 
participants will immediately complete the baseline assessment of risk factors and outcome 
variables (50 min.). Phase 2, the treatment phase, will occur between day 2 or 3 and discharge. 
Participants will be randomized to MI-SI plus TAU or to TAU alone. The MI-SI plus TAU 
condition will include one or two sessions of MI-SI (50 mins. each) in addition to TAU. Sessions 
will be held on consecutive days and recorded using a digital audio recorder, which will be 
coded for clinician fidelity. Phase 3, the follow-up phase, will take place after discharge. 
Participants in the MI-SI plus TAU condition will complete 1 booster MI-SI telephone session 
within 1 month of discharge (30-50 min.). All participants will be contacted by telephone to 
complete follow-up assessments (50 min.) at 1, 3, and 6 months to measure outcome variables 
and risk factors. Research assistants who are blind to condition will complete follow-up 
assessments. 

 
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Table 3: Complete List of Measures 
 
 
Domain 
 
 
Measure 
 
 
Purpose 
 
Time of Assessment 
 
Screen 
 
Baseline 
 
*Follow-ups 
in hospital 
**Follow-
ups  after 
discharge 
Demographics 
UAB 
Screen 
√ 
 
 
 
Veteran Status 
UAB 
Screen 
√ 
 
 
 
Psychotic Disorders 
MINI 
Screen 
√ 
 
 
 
Manic Episode 
MINI 
Screen 
√ 
 
 
 
Cognitive Deficits 
MMSE 
Screen 
√ 
 
 
 
TBI 
TBI-ID 
Screen 
√ 
 
 
 
Suicidal Ideation (SI) 
SSI 
Outcome 
√ 
 
√ 
√ 
Depression 
PHQ-9 
Risk Factor 
 
√ 
 
√ 
PTSD 
PCL-C 
Risk Factor 
 
√ 
 
√ 
Anxiety 
BAI 
Risk Factor 
 
√ 
 
√ 
Alcohol Use 
AUDIT 
Risk Factor 
 
√ 
 
√ 
Drug Use 
DAST-10 
Risk Factor 
 
√ 
 
√ 
Substance Use 
Frequency 
SUF 
Risk Factor 
 
√ 
 
√ 
Substance Problems 
InDUC 
Risk Factor 
 
√ 
 
√ 
Insomnia 
ISI 
Risk Factor 
 
√ 
 
√ 
Anger 
LHA 
Risk Factor 
 
√ 
 
 
Suicidal Behavior 
C-CSSRS 
Risk Factor 
 
√ 
 
√ 
Contemplation Ladders 
CL 
Risk Factor 
 
√ 
√ 
√ 
Treatment Engagement 
TSR 
Outcome 
 
√ 
 
√ 
Health Care Climate 
HCCQ 
Outcome 
 
√ 
√ 
 
Self-Regulation 
SRQ 
Outcome 
 
√ 
√ 
 
Competence 
PCQ 
Outcome 
 
√ 
√ 
 
Participatory Decision 
Making  
PDM 
Outcome 
 
√ 
√ 
√ 
   *In hospital follow-ups occur 2-3 days and 3-5 days after baseline assessment.   
   **Post-discharge, follow-ups occur at approximately 1, 3, and 6 months.   
 
Screening Assessment. The screening assessment will be used to confirm eligibility. Current 
psychosis and mania were identified as exclusionary criteria because they may interfere with 
the ability of patients to engage in MI-SI. Dementia and TBI-related dementia were included 
because they also may interfere with the ability to engage in MI-SI. Measures are highly 
structured and can be administered by a trained research assistant. A study therapist will review 
all screening assessments and follow up with individuals who do not have a clear presentation 
to ensure that they are eligible. Measures will include (Table 3): 
 
1. Standard Demographics (9 items): A standard socio-demographic form will be used.  
 
2. Veterans Status (8 items): Items that are used by Center for Integrated Healthcare at 
the Syracuse VAMC will be used to assess Veteran experiences.  
 
3. Current Psychosis (14 items): Patients identified as currently having psychotic 
experiences by clinical staff will be excluded from participating. Patients who consent will be 

 
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screened for current psychosis using a two-step process. At step 1, the psychotic disorders 
section of the Mini International Neuropsychiatric Interview (MINI) 41 will be used to assess for 
current psychosis. At step 2, research assistants will consult with clinical staff to confirm current 
psychosis, because the MINI current psychosis scale has been shown to be overly sensitive. 
4. Current Mania (7 items): Patients identified as currently manic by clinical staff will also 
be excluded from participating. The manic episode section of the MINI will be used to assess for 
current mania. The current mania scale has also been found to be overly sensitive, so the same 
two-step process proposed used to confirm current psychosis will be used to confirm current 
mania.   
 
5. Dementia (22 items): The Mini Mental Status Examination (MMSE) 42, 43 is a reliable, 
valid, and widely used screen for dementia. Dementia will be identified by a score of 23 or 
lower. 
 
6. TBI (7 items): The Ohio State TBI-ID short form is a valid and reliable screen for TBI. 
50 TBI-related dementia will be identified by positive screen for moderate to severe TBI and a 
score of 26 or lower on the MMSE, the conservative cutoff point for the MMSE. 51 
 
7. Suicidal Ideation (SI): SI will be measured with the Scale for Suicidal Ideation (SSI) 27. 
The SSI is an interview that measures the “intensity of the patient’s specific attitudes, behaviors, 
and plans to commit suicide” (p. 4). 44 Participants will be asked about “current” suicidal ideation 
defined as occurring during the past week (SSI-C),suicidal ideation at its “worst point” in the 
patient’s life (SSI-W) at baseline, and “acute” suicidal ideation in the last 48 hours. The SSI is 
considered the gold standard measure for SI, has been found to have good internal consistency 
(α = 0.84), construct validity, 52 and predictive validity as scores over 2 are predictive of suicide, 
3 and has been used with Veterans. 53 The SSI-C will be used to measure SI the week prior to 
admission to obtain an accurate measure of SI during the period of acute risk that preceded 
hospitalization, and to avoid underestimating the severity of SI due to the benefits of 
hospitalization. The SSI-C is sensitive to change over time in adult clinical samples and will also 
be used to assess the severity of SI at follow-up assessments. 3 
 
Baseline Assessment. To describe the sample, all participants will complete the baseline 
assessment that will include measures of depression, substance use disorders, PTSD, and trait 
anxiety as they have been found to increase risk for suicide in Veterans, 8 treatment 
engagement which is associated with suicide after discharge from psychiatric hospitalization, 1 
insomnia which may be associated with suicide risk in Veterans, 54 anger is associated with 
increased suicide risk and may impact the effectiveness of MI based interventions for Veterans, 
31, 32, 36, 55 and previous suicidal behavior which is a robust predictor of suicide. 5 Although there 
are no measures of motivation to live, we are also interested in piloting a motivation to live 
measure as a potential risk factor. We are also adding three measures that assess mechanisms 
through which MI-SI may work and therefore serve as short-term outcomes. They will be used 
to describe the sample and may be controlled for in the analyses if there are differences 
between conditions.  
 
1. Depression (9 items): The Physicians Health Questionnaire (PHQ-9) 56 is a reliable 
and valid self-report assessment of depressive symptoms that is used by VA. 57  
 
2. PTSD (17 items): The PTSD Checklist Civilian Version (PCL-C) 58 is a reliable and 
valid self-report assessment of PTSD symptoms 59 that is used with Veterans. 60  

 
Britton-13
3. Anxiety (21 items): The Beck Anxiety Inventory (BAI) 61 is a reliable and valid self-
report measure of anxiety.  
 
4. Alcohol Use Disorders (10 items): Alcohol Use Disorders Identification Test (AUDIT) 62 
is a self-report measure designed to assess hazardous alcohol use that is reliable and valid in 
Veterans. 63 
 
5. Drug Abuse (10 items): A reliable and valid 10-item short-form of the Drug Abuse 
Screening Test (DAST) 64 will be used to assess non-prescription drug abuse, not including 
alcohol abuse. The DAST has been used with Veterans. 65 
 
6. Substance Use Frequency past 90 days / Drug of Choice (12 items): The Substance 
Use Frequency Form (SUFF) is a measure that was developed by Dr. Conner to assess 
substance use frequency and drug of choice. It is based on questions commonly used in the 
substance abuse literature. 66   
 
7. Drug Use Consequences (15 items): The Inventory of Drug Use Consequences 
(INDUC) 67 is the gold-standard self-report assessment of substance-related consequences in 
the past 90 days. It has been used with Veterans. 68  
 
 
8. Insomnia (7 items): The Insomnia Severity Index (ISI) is a widely used, reliable and 
valid self-report instrument of sleep difficulty. 69 
 
9. Anger (5 items): The Lifetime History of Aggression Questionnaire (LHAQ) is a brief, 
valid, and reliable measure of aggression 70.   
 
10. Treatment Engagement (26 items): Treatment engagement will be measured using 
the Alcohol and Drug Services, Medication, Medical Services, and Psychological Services 
sections of the Treatment Services Review (TSR-6) which have been shown to be both reliable 
and valid. 71 The TSR-6 will be used at baseline and the 1, 3 and 6 month follow-ups to inquire 
about use of these services. The baseline assessment will be used to compare engagement in 
psychological and alcohol and drug service use between groups to assess whether it needs to 
be accounted for in the analyses. Engagement in psychological and alcohol and drug services 
will also be assessed at each follow-up assessment and used as an exploratory outcome. 
Treatment engagement will be treated as a dichotomous outcome, and will be defined according 
to the Substance Abuse and Mental Health Services Administration (SAHMSA) Washington’s 
Circle standards, 72 which have been adopted by VA. 73 For residential patients and inpatients, 
treatment engagement is defined as attending two outpatient visits in the 30-days after 
discharge. In Veterans with substance use disorders, this measure of treatment engagement 
has been found to be associated with treatment outcome 74 and hospitalization in those with a 
suicide attempt history. 75 In Veterans discharged from psychiatric hospitalization, completing 
two outpatient sessions in at least two of the six months after discharge has also been found to 
be associated with suicide. 1 
 
11. Suicidal Behavior (18 items): The Colombia Suicide Severity Rating Scale (C-SSRS) 
76 will be used to assess history of suicidal behavior at baseline and at follow-up assessment. It 
has been mandated for use in medication trials by the FDA. 77 
 
12. Contemplation Ladders (2 items): There are no motivation to live measures in the 
suicide literature. However, the substance abuse literature has found that contemplation ladders 
provide valid and reliable measure of motivation to change substance use behaviors 78, 79 We 

 
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have created a contemplation ladder that measures the transition from thinking about suicide to 
thinking about living, and a second that measures the transition from thinking about suicide to 
engaging in behavior that makes life worth living. 
 
13. Health Care Climate (6 items): The Health Care Climate Questionnaire (HCCQ) is 
the short form of a measure that assesses patients’ perceptions of their healthcare providers, 
which is based on a longer measure that has been validated in healthcare environments. 105 
 
14. Treatment Self-Regulation (17 items): The Treatment Self-Regulation Questionnaire 
(TSRQ) is a measure that assesses patients’ sense of autonomy or self-regulation in deciding if 
they want to live. It is based on a measure that is validated for other weight loss. 105 
 
15. Perceived Competence (4 items): The Perceived Competence Questionnaire (PCQ) 
assesses patients’ confidence that they can make healthy changes. It is based on a measure 
that has been used with a number of populations including diabetics. 106 
 
16. Participatory Decision Making (PDM) (3 items): The Participatory Decision Making 
(PDM) is a measure of participant decision making. 107-117 
 
Maintaining Blind Outcome Assessments. In-hospital and post-discharge follow-up 
assessments will be conducted by research assistants who are blind to condition. The blind will 
be maintained by having research assistants who are not involved in the baseline and treatment 
phases of the study conduct the assessment by telephone from the CoE. After each outcome 
assessment, research assistants will be asked if they thought the participant was assigned to 
the experimental condition (MI-SI plus TAU), control condition (TAU alone), or don’t know which 
condition the participant was assigned to. They will also be asked how they decided the 
condition to ensure that the blind was indeed broken and the determination was not due to 
extraneous information such as positive outcome, which would presumably lead a research 
assistant to guess the MI-SI plus TAU over TAU alone. If blinding was successful, research 
assistants will not be able to determine assignment at a better than chance rate. 80  
 
Randomization. Prior to randomization, participants will be stratified by SSI scores to increase 
the probability of balanced assignment, which may decrease the probability of a Type 1 error 
and increase power. 81 Stratification will be based on a median split using data from pilot study 
#1. Participants who score below 24 will be in the lower SSI group, and those who score 24 and 
above will be in the higher SSI group. A blocked randomization procedure using block sizes of 4 
and 6 participants will also be used to assure no significant imbalance between the numbers of 
participants in each condition at any time, and to protect against guessing condition assignment. 
82 Randomization will occur prior to the start of the trial and the results will be recorded in sealed 
envelopes. After the baseline assessment, the researcher will choose the next envelope (within 
the strata and block) to determine the participant’s assignment. The researcher will then inform 
the study therapist that a participant has been randomized to receive MI-SI.  
 
Treatment Conditions. Participants will be randomized to MI-SI plus TAU or TAU alone. 
 
MI-SI. Participants who are randomized to the experimental treatment will receive one or 
two sessions of MI-SI on the unit (see manual in Appendix). The overarching goal of MI-SI is to 
shift motivation away from suicide and towards living and recovery. MI-SI consists of three 
phases: 1) exploring the presenting problem, 2) building the motivation to live, and 3) 
strengthening the commitment to living. In phase 1, clinicians and patients explore patients’ 
presenting problem and their thoughts about suicide, which amplifies their reasons for living. In 

 
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phase 2, clinicians help patients explore their reasons for living including a detailed exploration 
of their beliefs and values to enhance their motivation to live. In phase 3, clinicians instill hope 
and strengthen patients’ confidence that they can establish a life that is worth living by helping 
them develop a concrete plan. The plan is written out on a worksheet that is provided to the 
patient at the end of the session. Transitioning between phases is dependent on the willingness 
of participants to follow the clinicians’ direction, as requiring participants to transition through the 
phases before they are ready to do so may reduce the impact of MI-SI. For example, requiring 
patients who are not ready to develop concrete plans to do so has been found to undermine 
their commitment to follow-through with their plans. 22 
 
In session 1, clinicians will attempt to proceed through all three phases. In session 2, 
clinicians will summarize session one and use patients’ response to the summary to decide 
which phase to return to. If patients are in phase 3, clinicians’ will help them refine and reinforce 
their plan. If they are undecided about mental health or substance abuse treatment, clinicians 
will return to phases 1 or 2 and explore reasons against engaging in treatment, build the 
motivation to engage in it, and strengthen their commitment to do so. Veterans in the MI-SI 
condition will also complete one telephone booster MI-SI session (30-50 mins.) within one-
month (weeks 3-6) after discharge. Telephone contact within one month after discharge is a 
component of treatments that have been found to reduce risk for suicidal behavior and will be 
used to increase the dosage of MI-SI. 83, 84 Participants will be provided a handout with the 
scheduled telephone follow-up and therapist contact information. Telephone sessions will 
consist of an abbreviated MI-SI interview following the strategy of session 2. For telephone 
sessions, phase 3 will include a review of their mental health and substance abuse treatment 
and explore alternative or additional treatments if they are called for. All MI-SI sessions will also 
be recorded for coding.  
 
 
TAU. All patients that are admitted to the acute psychiatric unit receive standard 
inpatient treatment that includes medication management, case management, meals and a bed, 
and milieu therapy consisting of creative and social activities (e.g., crafts, video games, 
karaoke). Families of Veterans may also receive education concerning the Veteran’s problems 
to create a supportive home environment. Suicidal patients receive additional services. VA 
mental health clinicians are required to complete a Safety Plan with all suicidal Veterans, and 
each VAMC has hired a Suicide Prevention Coordinator (SPC) to oversee the care of high-risk 
patients. The Syracuse VAMC also hired Case Managers to help meet essential living needs of 
suicidal Veterans. SPCs and Case Managers work collaboratively to help suicidal patients 
transition from inpatient to outpatient treatment. Chart reviews will provide a detailed description 
of the components of TAU that each participant receives so that suicide-specific TAU can be 
described in detail. Suicide-related TAU will be controlled for in analyses if differences are 
observed between conditions.  
 
In-Hospital Follow-ups. These assessments will be conducted 2-3 days and 3-5 days after the 
baseline assessment, during the course of hospitalization. If patients are discharged during this 
time, only the first follow-up will be obtained.  Participants will be asked to complete a “modified” 
SI that assesses suicidal ideation over the past 48 hours to assess recent change 85, 86, 
Contemplation Ladders and the PDM. When it is time to conduct the in-hospital follow-up 
assessment, a researcher on the unit will call a researcher at the CoE who will conduct the 
assessment by telephone. This will ensure that outcome assessments are conducted by 
researchers who are blind to condition.  
 
Post-Discharge Follow-ups. Follow-up assessments will be conducted at 1, 3, and 6 months 
via telephone. A telephone follow-up will enable us to expand the catchment area and assess 

 
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participants who are hospitalized or in residential treatment and unable to return to the medical 
center. Procedures will include mailing participants the assessment measures to ease 
administration. There is precedence for this strategy, as the telephone administered SSI was 
the primary outcome for the PROSPECT trial, supporting use of the method. 87, 88 In addition to 
the SSI, we will also use all risk-factors measures that are used at baseline including the PHQ-
9, PCL-C, BAI, AUDIT, DAST-10, SUF, InDUC, ISI, C-SSRS, Contemplation Ladders, HCCQ, 
TSRQ, PCQ, PDM as well as the exploratory outcome measure the TSR-6 (Table 3).  The 
window for each assessment will open at the midpoint between the previous assessment and 
the current assessment, and close at the midpoint between the current assessment and the 
following assessment (e.g., open two weeks before month 1 and close at the end of month 2, 
the midpoint between 1 and 3 month assessments), and close 3 months after the 6-month 
follow-up. 
 
Comprehensive tracking procedures will be implemented to follow-up with participants. 
Because we found no methodological papers on following-up with Veterans our follow-up 
procedures were informed by the substance abuse research methodology literature as 
individuals with substance use disorders are notoriously difficult to follow. 89-91 Procedures were 
revised after the pilot study. Tracking procedures will include: 1) careful hiring, training, and 
supervision of study personnel; 2) establishing rapport and clarifying procedures with 
participants; 3) obtaining detailed identifying information and locator data; 4) obtaining contact 
information for friends and family members who may assist in locating the participant; 5) 
remunerating participants for their time and effort; 6) making it easy for participants to contact 
staff personnel and leave messages; 7) providing assistance to participants when they request 
it; 8) maintaining flexibility and ease in scheduling and keeping appointments; 9) designing a 
follow-up assessment battery that is not burdensome; 10) providing a handout with scheduled 
follow-up assessments and researchers contact information; 11) contacting participants in 
advance of appointments; 12) making repeated and varied contact attempts; 13) updating 
contact information regularly using contacts and medical records; 14) and asking for consent to 
contact VA and non-VA treatment facilities that they may receive care from. The follow-up 
assessment will be used to measure outcomes and risk factors for suicidal behavior.  
 
At each follow-up we will also inquire about use of the Safety Plan that was completed 
on the inpatient unit. We will ask 1) if participants remembered doing the Safety Plan, 2) where 
they keep their Safety Plan, 3) if they used it while having suicidal thoughts, and 4) how they 
used it. 
 
Chart Reviews. Research assistants will review participants’ charts at two points during the 
study. The baseline chart review will take place after the baseline interview. Research 
assistants will cull treatment data from VA medical records using a protocol that we have used 
in a previous study. Center staff has received 8 hours of training in the protocol and achieved 
inter-rater reliability as part of the previous study. The protocol emphasizes suicidality, service 
engagement in the past year, services received during the visit prior to hospitalization, and risk 
factors for suicide such as depression and substance use disorders. Follow-up chart reviews will 
occur in concordance with the 6-month follow-up assessment. The protocol will be an 
abbreviated version of baseline protocol, with the time period limited to the 6 months following 
discharge. The chart review will also be used to assess use of VA suicide prevention services 
including the Safety Plan, SPCs, High-risk List, and case managers so that we can describe 
TAU components that participants receive. Center research assistants already trained in the 
chart review protocol that will be used. If additional assistants need training, we will use the 
existing training protocol, which consists of 8 hours of training in the protocol and reviewing 
practice charts. 

 
Britton-17
 
Research Assistant Training and Supervision. Research assistants will conduct all 
assessments and receive detailed training and supervision to ensure standardization. 
 
Initial Training. The PI will provide initial training in the detailed interview-based 
measures. In this initial training, all staff will also receive training in the safety procedures 
(described in the patient safety section). The interviews contain three measures that require 
extensive training and supervision to achieve consistency of administration and scoring: SSI, 
TSR, and C-SSRS. Training for these measures will make use of lectures to learn about the 
measures and role-plays to reach proficiency. The PI will observe research assistants’ first two 
research interviews to ensure that they are using the instruments appropriately and provide 
corrective feedback. If indicated, interviews will be observed until proficiency is reached. 
Training and supervision for each measure are included below. All administrations will be 
recorded and random samples will be independently coded for reliability. Researchers will use 
digital recorders on the unit, and earbuds that plug into the recorders for telephone 
assessments.  
 
SSI training: Dr. Conner has received training from the developers of the SSI, used it 
extensively, and trained the PI in its administration and scoring. The PI will provide two 
hours of training for the research assistants.  
 
TSR training: The PI has used the TSR in both pilot studies that were conducted with 
high-risk Veterans. Research assistants will receive two hours of training for the 
measure.  
 
C-SSRS training: The PI has received training in the administration and scoring of the C-
SSRS from Dr. Posner, the developer of the measure. He will provide two hours of 
training in the C-SSRS for the research assistants.  
 
Weekly Supervision. The PI will provide weekly supervision for the research assistants 
and lead a monthly half-day meeting in Canandaigua. The agenda will include a review of 
participant flow including recruitment, scheduling, and retention of subjects; issues pertaining to 
administration, scoring, entering, and storing interview protocols; subject safety issues; 
consensus meetings for SSI ratings; consensus meetings for chart reviews; discussion of 
adverse events; and on a quarterly basis, reviewing the quality of data gathered. Research 
assistants will also review one another’s interview packets for completeness and errors at these 
meetings.  
 
MI-SI Training and Supervision. MI-SI will be delivered by masters and doctorate-level 
research clinicians who will have received specialized training and supervision. 
 
 
MI-SI Training. Training will consist of sixteen hours. It will consist of 8 hours of training 
in general MI followed by eight hours of MI-SI training. Training modalities include listening to 
power-point presentations, selected readings from the MI text 21 and the MI-SI manual (included 
in Appendix), MI exercises, and listening to and discussing recorded examples of MI-SI. The PI 
will observe the first two interviews to ensure that therapists meet MITI fidelity criteria and 
provide corrective feedback. Additional training activities will be scheduled as necessary. 
 
MI-SI Supervision. An RCT evaluating methods for training MI clinicians found that 
ongoing coaching and/or feedback is needed to maintain proficiency in MI. 92 The PI will provide 
weekly supervision for MI-SI clinicians, focusing on promoting the fidelity of MI-SI by discussing 

 
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difficult cases, listening to and discussing recorded MI-SI interviews, and reviewing MI materials 
and publications.   
 
Interview Coding and Training. MI-SI sessions will be recorded and coded for fidelity using 
the MITI, 93 which requires specialized training. 
 
MITI Coding and Training. The MITI is a behavioral coding system that is used to code 
20-minute samples of tape for adherence to MI principles (e.g. empathy, autonomy support) and 
use of specific MI techniques (e.g. reflections, open questions). Summary values from coded 
interviews will be used to assess fidelity, 94 and provide material for supervisory sessions. A 
random selection of interviews will be double-coded and inter-rater reliability will be computed 
using inter-class correlation coefficients. 95  
 
The PI will provide MITI training to the research assistants who are coding the MI-SI 
therapy sessions. The protocol that will be used is identical the one use by Kurt Derman, Ph.D., 
an MI Training expert who trained coders for Project MATCH, 31, 32 and trained the PI. Training 
will consist of eight hours and include reviewing the MITI coding scale, coding MI interviews and 
comparing the codes to “gold standard” codes available on the MI website, 96 and coding 
recordings of MI-SI interviews. Coders will be considered reliable when they achieve reliabilities 
of good or better (ICC > .60) on 80% of MITI codes. 97 
 
MI-SCOPE Coding and Training. The Sequential Code for Observing Process 
Exchanges (SCOPE), 98 will be adapted for use with suicidal clients. SCOPE is a coding 
scheme developed to examine sequential therapeutic interactions between clinicians and clients 
to study the psychotherapy process and its relation to treatment outcome. 24 It includes the 
codes used for the MITI, and additional codes for clinicians (e.g., confrontation, emphasize 
control, feedback), and clients (e.g., follow, ask, commitment). We will adapt the MI-SCOPE by 
adding codes for living and suicide talk, and other suicide-related statements. Interviews are 
transcribed, and both transcripts and audio recordings are used for coding. A random selection 
of interviews will be double-coded and inter-rater reliability will be computed using inter-class 
correlation coefficients. 95  
The PI will also provide MI-SCOPE training to the research assistants who are coding 
the therapy sessions. The MI-SCOPE protocol is identical to that used by the developers of MI-
SCOPE. 24 Because the MI-SCOPE is more intensive, training will consist of sixteen hours and 
include reviewing the MI-SCOPE coding scale, coding MI-SI interviews and comparing the 
codes to “gold standard” codes that the PI derives. Coders will be considered reliable when they 
achieve reliabilities of good or better (ICC > .60) on 80% of MITI codes. 97 
 
Analytical Plan 
 
Data Preparation. All data will be screened for missing data, outliers, non-normality, non-
linearity, and non-homoscedasticity. A combination of statistics and graphic representations will 
be used to complete these screens. Specifically, missing values analyses, descriptive analyses, 
frequencies, scatter plots and histograms will be used. The assumptions underlying the 
proposed statistical analyses will also be tested, which may lead to data transformations or the 
use of more appropriate statistics. Additionally, imbalances in important covariates between 
randomized groups will be tested at baseline, which may lead to the identification of covariates 
to be included in the analyses. Findings will be used to fine-tune the analytical plan if statistical 
assumptions are unmet or model fit is poor. All analyses will be based on an intent-to-treat 
approach, analyzed as randomized, include all available data, use multiple imputation for 
missing data if appropriate, and use one-tailed tests with p < .05 as the cutoff for statistical 
significance. The study is not powered to test exploratory hypotheses, and we therefore do not 

 
Britton-19
expect to detect significant differences between groups. If the analyses are reported as part of 
the primary RCT, we will use a p-value of .01 to define statistical significance. 
 
Aim 2: To evaluate whether MI-SI plus TAU results in significant reductions in suicidal ideation 
(SI) and increases in treatment engagement when compared to TAU alone. 
 
Primary Hypothesis: Participants who receive MI-SI plus TAU will report greater 
reductions in SI over follow-up than participants who receive TAU alone. 
 
Primary Analysis 1: An over-dispersion Poisson generalized linear mixed model (GLMM) 
with maximum likelihood estimation will be used to examine the effect of MI-SI on the severity of 
SI at 1, 3, and 6 months follow-up. GLMM was chosen because random effects are added to the 
model to account for repeated measures within subjects. An over-dispersion Poisson GLMM will 
be used because the SSI is bounded at zero and had a standard deviation larger than the mean 
at follow-up in our pilot data, indicating over-dispersion. If data do not meet the assumptions of a 
Poisson distribution, we will use a negative binomial or zero-inflated negative binomial. The 
benefit of using maximum likelihood estimation is that it yields unbiased estimates in the 
presence of missing data, if data are missing at random. Because participants may receive one 
or two sessions of MI-SI, and the change pattern may not be linear over time, we will test 
sessions of MI-SI, time of assessment, and their interaction in follow-up analyses. As an added 
measure of clinical significance, we will report the number of participants in each group who fall 
below the two-point cut-off. 
 
Because the presence of any suicidal behavior (i.e., attempted suicide, interrupted 
attempts, preparatory behavior) is an important outcome, we will use a mixed effects general 
logistic model to examine the effect size of MI-SI on the incidence of suicidal behavior as 
measured by the C-SSRS over follow-up assessments. 
 
Exploratory Hypothesis 1: Participants who receive MI-SI plus TAU will engage in more 
treatment over follow-up than participants who receive TAU alone. 
 
Exploratory Analysis 1: Multivariable logistic regression will be used to examine the 
effect of MI-SI on treatment engagement. The Hosmer-Lemeshow statistic will be used to 
evaluate model fit, and odds ratios with 95% confidence intervals will be derived using the 
method of maximum likelihood. 99 Because participants may receive one or two sessions of MI-
SI, we will conduct a sensitivity analysis examining the number of MI-SI sessions as a predictor 
of treatment engagement. Because this is an underpowered exploratory analysis, we will also 
conduct secondary analyses using other definitions of treatment engagement such as number 
of sessions attended.  
 
We will also examine the impact of the intervention on use of the Safety Plan coping 
strategies. To test treatment differences, we will use a multivariable logistic regression. 
 
Exploratory Hypothesis 2: Treatment engagement over follow-up will partially mediate 
the impact of MI-SI on SI. 
 
Exploratory Analysis 2:  Analyses will examine treatment engagement as a mediator of 
the impact of MI-SI plus TAU on SI. Treatment engagement is expected to partially mediate the 
relationship between randomization to the MI-SI group and SI over follow-up, such that the 
relationship is smaller but the effect size is still significant. Structural equation modeling (SEM) 
will be used to examine this potential mediation relationship. SEM is a method for creating latent 

 
Britton-20
variables and identifying and describing causal relationships between the latent variables. We 
decided to use SEM because it simultaneously tests independent and conjoint relationships and 
uses latent variables, which minimizes measurement error. The model will consist of both latent 
and observed variables. Latent variables will be used for variables such as SI (via the SSI) to fit 
the data for this population. Observed variables will be used for variables such as randomization 
to MI-SI and treatment engagement (via the TSR). Because these analyses will be 
underpowered, this exploration will be based on effect sizes rather than statistical significance. 
Furthermore, we will also conduct more basic mediation regression models as secondary 
analyses. 
 
Aim 3: To evaluate improvements during hospitalization.   
 
Exploratory Hypothesis 3: Participants who receive MI-SI plus TAU will report greater 
reductions in SI during hospitalization, than participants who receive TAU alone. 
 
Exploratory Hypothesis 4: In participants who receive MI-SI plus TAU, in-session living 
talk will be positively associated with reductions in SI during hospitalization. 
 
Exploratory Hypothesis 5: In participants who receive MI-SI plus TAU, in-session suicide 
talk will be negatively associated with reductions in SI during hospitalization. 
 
 
Exploratory Analyses 3-5: Data will be analyzed using GLMM to account for repeated 
measures within subjects 100 with a focus on within subject decreases in SI (assessed with SSI 
scores). A minimum of two GLMMs will be used to examine the effect of MI-SI on the severity of 
SI at 2-3 and 3-5 days after the baseline assessment, the strength of in-session living and 
suicide talk and the severity of SI at 2-3 and 3-5 days after the baseline assessment. We will 
also examine the associations between in-session living and suicide talk on the severity of SI 
over 1, 3, and 6 months follow-up.  
 
Power Analysis: Recruitment will provide data on 112 participants. Assuming a retention rate 
of 80%, data on 90 participants will be available at the 6 month follow-up. To estimate the 
statistical power afforded by 90 participants for the severity of SSI, power analyses were 
conducted using STATA 11 101 “sampsi2” package, which uses calculations based on Frison 
and Pocock model. 
102 Specifying method of analysis (change), number of baseline 
assessments (1), number of post assessments (3), correlation between baseline and follow-up 
scores (r = .50), correlation between follow-up scores (r = .70), and standard deviation (sd = 
8.4) for the outcome variable using Frison and Pocock’s recommendations and our pilot data, 
we would have .94 power to identify a 5-point difference in mean SSI scores between treatment 
arms, .81 power to identify a 4-point difference, and .60 power to identify a 3-point difference. 
The study would therefore be adequately powered to find an effect size of .5 for the primary 
outcome. If there is concern that the experimental intervention caused harm and the trial is not 
stopped, we will conduct two-sided analyses instead of the one-sided analyses we proposed. 
Power analyses suggest we will have .88 power to identify a 5-point difference, .71 power for a 
4-point difference, and .47 power for a 3-point difference with the proposed 90 participants (45 
in each group), indicating that the trial will still be fairly well powered. 
 
Data Management, Entry, and Storage 
 
Overview. All data will be collected during in-person interviews in private offices at the 
Acute Psychiatric Inpatient Unit at the Syracuse VAMC, by phone in a private office at 
Canandaigua VAMC, or chart reviews that take place in either the Syracuse or Canandaigua 

 
Britton-21
VAMC. The Research Compliance Officer for Canandaigua VAMC will be called when patients 
are consented and given participants’ last name and last four digits of their social security 
number. Other copies of the consent will be delivered in person or through secure VA mail to 
the Syracuse Institutional Review Board and Syracuse VAMC Medical Records. Only research 
staff associated with the study will handle or have access to any of the research data collected 
for this study. Individuals with access to the data will be persons listed on the IRB-approved 
study protocol. Once paper consent, interview forms, and electronic digital recordings (digital 
recording machine) are completed, they will be stored in locked file cabinets in a study-
dedicated office maintained by the Center for Integrated Healthcare (CIH) located in the D-wing 
of the Syracuse VAMC, or by the CoE located at the Canandaigua VAMC. All consent forms will 
be signed by the PI, or co-investigators Dr. Conner or Dr. Pigeon.  
 
Data from interviews, audio recordings, and chart reviews will be entered into electronic 
databases from designated offices located at the CIH at the Syracuse VAMC, and the CoE at 
the Canandaigua VAMC. The study-related research staff or assistants will enter data into a 
database located in a secure folder on the VISN 2 remote/disconnected “T” drive maintained by 
the Canandaigua VAMC for use by CoE staff to store all research data.  Access to the folder in 
which the database is located will be restricted to those individuals listed on the IRB-approved 
study protocol as being associated with this project. Data will be analyzed on the “T” drive as 
well 
as 
the 
Veteran’s 
Informatics 
and 
Computing 
Infrastructure 
(VINCI, 
see 
http://www.hsrd.research.va.gov/for_researchers/vinci/), a secure workspace for accessing, 
storing, and analyzing VA data located on VA secure servers behind VA firewalls will be used to 
analyze the data. VINCI is funded by HSR&D and is a collaboration between the VA Office of 
Information Technology (OI&T) and the Veterans Health Administration’s Office of Research 
and Development (VHA ORD). VINCI workspaces are supported by server level redundant 
backup systems and secured behind extensive VA cyber security systems including VPN 
secured access, VA authentication systems, encryption and firewall. During the analysis phase 
data will temporarily be copied to secure storage on the VINCI workspace through a secure file 
copy. VINCI offers a suite of analytical tools including that will be used to produce the analysis. 
When the analysis is complete, data stored on the VINCI secure workspace will be returned to 
the “T” drive. When all data are entered, processed, and analyzed, the paper forms and digital 
recordings will be maintained and/or destroyed in whatever manner is recommended by the 
Information Security Officer. De-identified data will be stored indefinitely so it can be used in 
future publications. 
 
Data Collected During the Screening, Baseline, and Follow-up Assessments. To explain 
in detail, for each participant, there will be three paper packets, a consent file that contains the 
patient’s name, unique participant ID#, other identifying information, and a copy of the consent 
form, a data file that contains the measures with the unique participant ID# written at the top of 
each page but no other identifying information that is stored at the Syracuse VAMC, and a 
second data file from telephone assessments that is stored at the CoE.  In this way, sensitive 
information from the interviews contained in the measures cannot be linked with identifying 
information unless one has the consent and a data packet.   
 
Data Collected from Audio Recordings. At the beginning of all audio recordings, the 
investigator will speak the participant’s unique ID#, type of session (e.g., MI-SI session #1, one-
month follow-up assessment), and the date of the interview. The recording device will be locked 
in the file cabinet with the paper packets. The recorded information will be copied to a secure 
server on a password and firewall protected computer and then the data on the recorder will be 
erased. The recorded data will remain on the server until it is coded and will be erased 

 
Britton-22
according to VA guidelines. Data from coded MI-SI sessions will also be recorded on paper 
score sheets that will be stored in the participant’s packet with the other measures.  
 
Access to Data. Only the research staff collecting data at Syracuse (not staff or patients 
at the Syracuse VAMC), research staff responsible for coding, entering and analyzing data, 
along with Dr. Britton will have access to the keys to the cabinets and the password protected 
computer where data are stored.  We will not transmit or share data outside of the VA. 
 
Data Management. Interviewers will visually review all forms for completeness while the 
participant is in the interview. He or she will discuss any incomplete sections with the participant 
and encourage completion of the form. Specific forms corresponding to each of the assessment 
areas (aggression, etc.) will be developed and each page will contain the participant’s unique 
ID# in case pages become detached.  A check sheet detailing what needs to be collected during 
each interview will be kept to ensure data quality. Also, a master check sheet will be developed 
with a form for each participant to ensure that all procedural requirements (e.g., Consent signed 
by PI, IRB and Research Compliance Officer notified of new participant, CPRS note entered) 
are accomplished for each participant.   
 
Data Entry. Once all forms are complete, the interviewer will have his/her packet edited 
by another member of the study team, and will then enter the data. The system will have 
appropriate logical and data entry checks built into it to reduce the most common types of data 
entry errors.  The study database will be held on a password protected hard drive that will be 
backed up weekly. Dr. Britton will define the requirements of the system and maintain or refine 
the system as needed. Once all information is entered and verified, then the original paper 
records will be returned to their locked cabinets.  Dr. Britton will review the data each month in 
order to identify any logical inconsistencies or omissions that may have occurred.  Any problems 
will be brought to the attention of the programmer for remediation. All identifying information will 
be destroyed in consultation with the Information Security Officer (ISO) in agreement with VA 
policy. 
 
Compensation 
Research staff will collect participant’s names, social security numbers, and the 
addresses they wish their reimbursement check be sent to. The information will be shared with 
CoE support staff, who will instruct accounting to issue a check in the patient’s name to be sent 
to the desired address.  Checks will be issued after the patients are discharged from the unit, 
and after follow-up assessment. Participants who complete the screen will be compensated with 
a $10 personal check that will be sent to the address of their choice. Patients who meet 
eligibility criteria and continue through phase 2 and 3 will receive an $80 check for completing 
each follow-up assessment. Participants who are discharged prior to completing both MI-SI 
sessions will still be eligible for the follow-up appointment. An $80 remuneration for the follow-up 
is required to compensate subjects for any expense they have to make the interview, time for 
the assessment, and as encouragement to maintain contact with the researchers. This level of 
remuneration is consistent with the minimum recommended amount for retaining subjects in 
substance abuse treatment research, does not promote substance abuse and is not perceived 
as coercive by participants 103, 104. By completing the screen ($10), and the 3 follow-up 
assessments ($240), participants can earn $250. 
 
 
 
 
 

 
Britton-23
Human Subjects 
 
Risk to Subjects 
 
Human Participants Involvement and Characteristics. All participants will be at high risk for 
emerging suicidality, suicidal behavior, and other negative outcomes. Suicidal behavior is also 
an outcome and is therefore expected to occur. Safeguards will be built into the study to prevent 
suicidal behavior before it occurs, and to ensure an appropriate response. 
 
Potential Risks. There are no physical risks in this study.  Psychological risks are 1) 
emerging suicidality, 2) distress caused by the personal nature of the interview, recalling 
distressing events and life problems, and discussing suicide-related issues, and 3) potential 
need to break confidentiality in the event of suicide risk or violence risk or child abuse.  
Protection from Risk 
 
Suicidality. Participation in the study will provide patients who are at elevated risk for emerging 
suicidality, suicidal behavior, and other negative outcomes with a formal assessment of suicide 
risk on the unit and a re-assessment of risk one, three and six months after discharge. 
Participating in the study will provide more information on patients’ suicide risk than would 
otherwise be available. If the interviewer becomes aware that a participant might be thinking 
about or planning to make an attempt, the interviewer will ask the following questions: 1) Do you 
have a desire to kill yourself that you think you might act on?  2) Do you have a plan for killing 
yourself?, and 3) Do you intend to carry the plan out? After the interviewer has noted any 
suicide desire, plans, or intent, the interviewer will review available assessment measures that 
may help evaluate the severity of the participant’s risk. If the interviewer determines the 
participant is at imminent risk, the appropriate safety plan will be initiated. 
 
Inpatient Safety Plan. Baseline and MI-SI interviews will take place while participants are 
on the unit, ensuring 24-hour availability of hospital staff and emergency services. If patients are 
determined to be at imminent risk for suicide, the interviewer will inform clinical staff of the 
participant’s risk so that staff can attend to their needs. All participants will be informed that 
interviewers will need to disclose participants’ risk level to clinical staff during the informed 
consent process. To aid in the protection and treatment of participants, interviewers will always 
inform participants of their desire to inform clinical staff. If a decision is made to notify staff, the 
interviewer will speak with a member of the treatment staff responsible for clinical care by phone 
or in person. The persons to contact will be clarified with program administrators prior to 
implementing the study, and information that bears directly on risk (e.g., level of depression, 
suicide plan, access to a weapon, prior attempts, etc.) will be disclosed. If clinical staff desires, 
interviewers will serve as a resource to treatment staff, providing guidance and consultation in 
developing a safety plan. All clinical decisions will be made by the Syracuse VA clinical staff, 
and interviewers will in no way usurp their authority.  
To protect participants who are involuntarily hospitalized to ensure that they realize that 
their participation in the study is voluntary, researchers will have a staff member witness the 
informed consent process (please note that there is a witness signature line on the consent 
form).  
 
Telephone Safety Plan. Participants who are randomized to the Motivational Interviewing 
to Address Suicidal Ideation (MI-SI) condition will receive one telephone MI-SI session after 
discharge and all follow-up assessments will be conducted by telephone. Emergency 
procedures will be initiated if patients are determined to be at imminent risk for suicide using the 
risk assessment described above. Participants determined to be at risk will be asked if they are 

 
Britton-24
willing to be transferred to the Veteran Crisis Line. Veteran Crisis Line responders are well 
trained in emergency procedures and have working protocols for locating callers and initiating 
rescues. All telephone sessions will be conducted at the Center of Excellence (CoE) to ensure 
that the clinicians’ telephone is set up for transfers to the Crisis Line. Calls can be transferred 
with a four step process. 
 
 
 
 
 
 
 
 
 
 
It is possible that participants may refuse to be transferred to the Crisis Line or hang up. 
As a result, research clinicians will ask participants to use a landline for MI-SI telephone 
sessions so that the number can be tracked to an address if emergency services are needed. 
For participants who only have a cell phone, interviewers will begin each session by asking the 
participant for the address from which they are calling so that the clinician can send help if it is 
needed. Because participants may give a false address, clinicians will consult with Crisis Line 
responders who have a protocol for emergency responses for cell phone callers.  
 
Adverse Events (AE). All suicide attempts and episodes of imminent risk that require 
intervention will be considered adverse events and will be addressed according to IRB 
regulations. The determination of an AE will be made by an investigator other than the PI (i.e., 
Dr. Conner or Dr. Pigeon), to reduce the possibility of bias. Syracuse VA IRB also requires that 
serious adverse events, any event leading to a deviation from the protocol such as emergency 
hospitalization (e.g., to address acute suicidality) or death, be reported to the principal 
investigator within 24 hours, who is required to report them to the IRB within 48 hours. Adverse 
events that are minor such as temporary distress will be recorded by interviewers and reported 
to the IRB annually. All adverse events will be reported to the principal investigator within 24 
hours to establish the level of significance and determine the appropriate procedure. 
 
Distress. If, during any interview, participants appear to be disturbed by the content of the 
interview, the interviewer will stop asking questions and provide support, and if distress persists, 
suspend the interview. If distress is experienced by participants on the unit, interviewers will 
disclose the participants’ distress to treatment providers so that staff may follow up with the 
participant therapeutically and monitor their condition, with the participants’ permission. In the 
rare event that distress is severe such that there is immediate danger to the participant or to 
others, staff will be informed immediately. Participants, however, will be informed of the 
interviewer’s decision. Discomfort may also arise later that day. Participants will be informed this 
may occur and will be encouraged to speak with a staff member, the interviewer, or another 
investigator involved in the study. If participants become distressed during the follow-up 
interview, interviewers will discuss scheduling an appointment at a local facility during the 
follow-up assessment session to increase the chance that the participant will engage in 
treatment, and provide the phone number of the National Veterans Crisis Line (1-800-273-
TALK). 
 
Confidentiality. During the informed consent process, participants will be informed of the limits 
of confidentiality which include the need to break confidentiality if the participant is determined 
to be a threat to self or others and if a child is exposed to abuse or neglect. The assessment 
battery does not contain questions about planned acts of violence or questions about abuse or 
Warm Transfer Process 
1. Press the conference button. 
2. Dial 1-800-273-8255 press option 1 and a Crisis Line responder will answer. 
3. Describe the participants risk and provide name and telephone number.  
4. Pressing the conference button and participants will be linked with Crisis Line counselors.  

 
Britton-25
neglect of children, other than the suicide risk assessments.  If participants spontaneously 
report plans or intent to carry out an act of violence, or spontaneously disclose child 
maltreatment, the interviewer will contact the primary investigator to make a plan that may 
include, depending on the nature of the information, a disclosure to treatment staff and making a 
child abuse report. 
 
To add a further layer of protection for our participants we will apply for a Certificate of 
Confidentiality from the National Institute of Mental Health (NIMH).  Confidentiality Certificates 
are issued by the National Institutes of Health (NIH) pursuant to Section 301 (d) of the Public 
Health Services Act (42 U.S.C. Section 241(d)) to afford special privacy protection to research 
participants. A Certificate helps the researcher avoid compelled “involuntary disclosure” (e.g. 
subpoenas) of identifying information about a research participant.  It does not prevent voluntary 
disclosures such as disclosure to protect the subject or others from serious harm, as in cases of 
child abuse.  Also, a researcher may not rely on a Certificate to withhold data if the participant 
consents to the disclosure. NIMH requires a letter of approval from the IRB prior to awarding a 
Certificate of Confidentiality to an investigator. Certificates of Confidentiality were successfully 
obtained for the two pilot studies we conducted on the Acute Inpatient Unit at the Syracuse 
VAMC. 
 
Data Monitoring Committee  
The Centralized CSR&D Data Monitoring Committee (DMC) will be providing additional 
oversight for the project and function as a Data Safety Monitoring Board (DSMB).  The DMC is 
charged with guiding the safe scientific and ethical conduct of projects. At least once a year, the 
PI will send information to the DMC on recruitment progress, participant retention, and progress 
of data management and analyses. Serious adverse events and unanticipated problems are 
reported to the DMC as they occur.  DMC recommendations on study performance, continuation 
or alteration of a protocol, and participant safety strategies or concerns are formulated after 
each data reassessment and forwarded to the PI and ACOS/R of each site. The DMC may 
consider study performance to be sufficiently poor that the project should be placed on 
probation, and specific conditions associated with continuation. The DMC may recommend 
study termination in some circumstances. Local institutional rules for conducting research and 
reporting issues to the facility R&D Committee and/or IRB are not changed by being monitored 
simultaneously by a centralized DMC. Upon receipt of the report, the PI will be responsible for 
transmitting a copy of the report to the IRB. 
 
Potential Benefit of the Proposed Research to the Subject and Others 
There may or may not be direct benefits to participants. However, participants at 
elevated risk for suicide will be identified so that the issue can be addressed during treatment 
and at follow-up. Knowledge resulting from the research may also contribute to the prevention of 
Veteran suicides. 
 

 
Britton-26
References 
 
1. Desai RA, Dausey DJ, Rosenheck RA. Mental health service delivery and suicide risk: The 
role of individual patient and facility factors. Am J Psychiatry. 2005;162(2):311-318. Ameran 
Psyhatr Assn. Available from: Desai, Rani A.: rani.desai@yale.edu. 
2. Valenstein M, Kim HM, Ganoczy D, et al. Higher-risk periods for suicide among VA patients 
receiving depression treatment: Prioritizing suicide prevention efforts. J Affect Disord. 
2009;112(1-3):50-58. 
3. Brown GK, Beck AT, Steer RA, Grisham JR. Risk factors for suicide in psychiatric 
outpatients: A 20-year prospective study. J Consult Clin Psychol. 2000;68(3):371-377. Ameran 
Psyhooga Assn. 
4. Cavanagh JTO, Carson AJ, Sharpe M, Lawrie SM. Psychological autopsy studies of suicide: 
A systematic review. Psychol Med. 2003;33(3):395-405. 
5. Harris EC, Barraclough B. Suicide as an outcome for mental disorders: A meta-analysis. 
British Journal of Psychiatry. 1997;170(3):205-228. 
6. Nock MK, Borges G, Bromet EJ, Cha CB, Kessler RC, Lee S. Suicide and suicidal behavior. 
Epidemiol Rev. 2008;30:133-154. 
7. Yoshimasu K, Kiyohara C, Kazuhisa M. Suicidal risk factors and completed suicide: Meta 
analyses based on psychological autopsy studies. Environmental Health and Preventive 
Medicine. 2008;13(5):243-256. 
8. Ilgen MA, Bohnert AS, Ignacio RV, et al. Psychiatric diagnoses and risk of suicide in 
veterans. Arch Gen Psychiatry. 2010;67(11):1152-1158. 
9. Appleby L, Shaw J, Amos T, et al. Suicide within 12 months of contact with mental health 
services: National clinical survey. BMJ. 1999;318(7193):1235-1239. 
10. Goldacre M, Seagroatt V, Hawton K. Suicide after discharge from psychiatric inpatient care. 
Lancet. 1993;342(8866):283-286. 
11. Meehan J, Kapur N, Hunt IM, et al. Suicide in mental health in-patients and within 3 months 
of discharge. national clinical survey. British Journal of Psychiatry. 2006;188:129-134. 
12. Qin P, Nordentoft M. Suicide risk in relation to psychiatric hospitalization: Evidence based 
on longitudinal registers. Arch Gen Psychiatry. 2005;62(4):427-432. 
13. Centers for Disease Control and Prevention. Wisqars injury mortality reports 1999-2007. 
http://www.cdc.gov.ezpminer.urmc.rochester.edu/ncipc/wisqars/. Accessed 5/20, 2011. 
14. Tarrier N, Taylor K, Gooding P. Cognitive-behavioral interventions to reduce suicide 
behavior: A systematic review and meta-analysis. Behav Modif. 2008;32(1):77-108. Available 
from: Tarrier, Nicholas: nicholas.tarrier@manchester.ac.uk. 
15. Brown GK, Have TT, Henriques GR, Xie SX, Hollander JE, Beck AT. Cognitive therapy for 
the prevention of suicide attempts: A randomized controlled trial. JAMA: Journal of the American 
Medical Association. 2005;294(5):563-570. Available from: Brown, Gregory K.: 
gregbrow@mail.med.upenn.edu. 
16. Linehan MM, Comtois KA, Murray AM, et al. Two-year randomized controlled trial and 
follow-up of dialectical behavior therapy vs therapy by experts for suicidal behaviors and 
borderline personality disorder. Arch Gen Psychiatry. 2006;63(7):757-766. Available from: 
Linehan, Marsha M.: linehan@u.washington.edu. 
17. van den Bosch LMC, Koeter MWJ, Stijnen T, Verheul R, van den Brink W. Sustained 
efficacy of dialectical behaviour therapy for borderline personality disorder. Behav Res Ther. 
2005;43(9):1231-1241. Available from: van den Bosch, Louisa M.C.: wiesvdbosch@planet.nl. 
18. Verheul R, van den Bosch LMC, Koeter MWJ, de Ridder MAJ, Stijnen T, van den Brink W. 
Dialectical behaviour therapy for women with borderline personality disorder: 12-month, 
randomised clinical trial in the netherlands. British Journal of Psychiatry. 2003;182(2):135-140. 
Available from: Verheul, Roel: roel.verheul@deviersprong.net. 

 
Britton-27
19. Bell AC, D'Zurilla TJ. Problem-solving therapy for depression: A meta-analysis. Clin Psychol 
Rev. 2009;29(4):348-353. 
20. Hawton K, Townsend E, Arensman E, et al. Psychosocial versus pharmacological 
treatments for deliberate self harm. Cochrane Database of Systematic Reviews. 
2000(2):001764. 
21. Miller WR, Rollnick S. Motivational Interviewing: Preparing People for Change (2nd Ed.). 
New York, NY: Guilford Press; 2002. 
22. Miller WR, Rose GS. Toward a theory of motivational interviewing. Am Psychol. 
2009;64(6):527-537. 
23. Moyers TB, Martin T, Christopher PJ, Houck JM, Tonigan JS, Amrhein PC. Client language 
as a mediator of motivational interviewing efficacy: Where is the evidence? Alcoholism: Clinical 
and Experimental Research. 2007;31(Suppl 3):40S-47S. 
24. Moyers TB, Martin T, Houck JM, Christopher PJ, Tonigan JS. From in-session behaviors to 
drinking outcomes: A causal chain for motivational interviewing. Journal of Consulting & Clinical 
Psychology. 2009;77(6):1113-1124. 
25. Britton PC, Williams GC, Conner KR. Self-determination theory, motivational interviewing, 
and the treatment of clients with acute suicidal ideation. J Clin Psychol. 2008;64(1):52-66. 
26. Kovacs M, Beck AT. The wish to die and the wish to live in attempted suicides. J Clin 
Psychol. 1977;33(2):361-365. 
27. Beck AT, Kovacs M, Weissman A. Assessment of suicidal intention: The scale for suicide 
ideation. J Consult Clin Psychol. 1979;47(2):343-352. 
28. Brown GK, Steer RA, Henriques GR, Beck AT. The internal struggle between the wish to die 
and the wish to live: A risk factor for suicide. Am J Psychiatry. 2005;162(10):1977-1979. 
29. Britton PC, Patrick H, Williams GC. Motivational interviewing, self-determination theory, and 
cognitive behavioral therapy to prevent suicidal behavior. Journal of Cognitive Behavioral 
Practice. 2011;18(1):16-27. 
30. Hettema J, Steele J, Miller WR. Motivational interviewing. Annual Review of Clinical 
Psychology. 2005;1(1):91-111. Available from: Hettema, Jennifer: jhettema@unm.edu;Steele, 
Julie: jmsteele@unm.edu;Miller, William R.: wrmiller@unm.edu. 
31. Project MATCH Research Group. Matching alcoholism treatments to client heterogeneity: 
Project MATCH posttreatment drinking outcomes. J Stud Alcohol. 1997;58(1):7-29. 
32. Project MATCH Research Group. Matching alcoholism treatments to client heterogeneity: 
Project MATCH three-year drinking outcomes. Alcoholism: Clinical and Experimental Research. 
1998;22(6):1300-1311. 
33. Gentilello LM, Rivara FP, Donovan DM, et al. Alcohol interventions in a trauma center as a 
means of reducing the risk of injury recurrence. Ann Surg. 1999;230(4):473-80; discussion 480-
3. 
34. Carroll KM, Ball SA, Nich C, et al. Motivational interviewing to improve treatment 
engagement and outcome in individuals seeking treatment for substance abuse: A multisite 
effectiveness study. Drug & Alcohol Dependence. 2006;81(3):301-312. 
35. Bien TH, Miller WR, Boroughs JM. Motivational interviewing with alcohol outpatients. 
Behavioural and Cognitive Psychotherapy. 1993;21(4):347-356. 
36. Forbes D, Creamer M, Hawthorne G, Allen N, McHugh T. Comorbidity as a predictor of 
symptom change after treatment in combat-related posttraumatic stress disorder. Journal of 
Nervous & Mental Disease. 2003;191(2):93-99. 
37. Hodgins DC, Ching LE, McEwen J. Strength of commitment language in motivational 
interviewing and gambling outcomes. Psychology of Addictive Behaviors. 2009;23(1):122-130. 
38. Baer JS, Beadnell B, Garrett SB, Hartzler B, Wells EA, Peterson PL. Adolescent change 
language within a brief motivational intervention and substance use outcomes. Psychology of 
Addictive Behaviors. 2008;22(4):570-575. 

 
Britton-28
39. Amrhein PC, Miller WR, Yahne CE, Palmer M, Fulcher L. Client commitment language 
during motivational interviewing predicts drug use outcomes. J Consult Clin Psychol. 
2003;71(5):862-878. Available from: Amrhein, Paul C.: amrhein@unm.edu. 
40. Aharonovich E, Amrhein PC, Bisaga A, Nunes EV, Hasin DS. Cognition, commitment 
language, and behavioral change among cocaine-dependent patients. Psychology of Addictive 
Behaviors. 2008;22(4):557-562. 
41. Sheehan DV, Lecrubier Y, Sheehan KH, et al. The mini-international neuropsychiatric 
interview (M.I.N.I.): The development and validation of a structured diagnostic psychiatric 
interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59(Suppl 20):22-33;quz. 
42. Crum RM, Anthony JC, Bassett SS, Folstein MF. Population-based norms for the mini-
mental state examination by age and educational level. JAMA. 1993;269(18):2386-2391. 
43. Folstein MF, Folstein SE, McHugh PR. Mini-mental state. Journal of Psychiatric Research. 
1975;12:189-198. 
44. Beck AT, Brown GK, Steer RA, Dahlsgaard KK, Grisham JR. Suicide ideation at its worst 
point: A predictor of eventual suicide in psychiatric outpatients. Suicide and Life-Threatening 
Behavior. 1999;29(1):1-9. 
45. Feske U, Chambless DL. Cognitive behavioral versus exposure only treatment for social 
phobia: A meta-analysis. Behavior Therapy. 1995;26(4):695-720. 
46. Cohen J. Statistical Power Analysis for the Behavioral Sciences. 2nd ed. Hilsdale, NJ: 
Erlbaum; 1988. 
47. Yano EM, Hayes P, Wright S, et al. Integration of women veterans into VA quality 
improvement research efforts: What researchers need to know. Journal of General Internal 
Medicine. 2010;25(Suppl 1):56-61. 
48. Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: Updated guidelines for 
reporting parallel group randomised trials. J Cin Epi. 2010. 
49. Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 explanation and elaboration: 
Updated guidelines for reporting parallel group randomised trial. J Clin Epi. 2010. 
50. Corrigan JD, Bogner J. Initial validity and reliability of the ohio state university TBI 
identification method. Journal of Head Trauma Rehabilitation. 2007;22(6):318-329. 
51. O'Bryant SE, Humphreys JD, Smith GE, et al. Detecting dementia with the mini-mental state 
examination in highly educated individuals. Arch Neurol. 2008;65(7):963-967. Available from: 
http://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=medl&AN=186
25866; http://openurl.lib.rochester.edu/find?url_ver=Z39.88-
2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rfr_id=info:sid/Ovid:medl&rft.genre=article&rft_id=
info:doi/&rft_id=info:pmid/18625866&rft.issn=0003-
9942&rft.volume=65&rft.issue=7&rft.spage=963&rft.pages=963-
7&rft.date=2008&rft.jtitle=Archives+of+Neurology&rft.atitle=Detecting+dementia+with+the+mini-
mental+state+examination+in+highly+educated+individuals.&rft.aulast=O%27Bryant. 
52. Beck AT, Brown GK, Steer RA. Psychometric characteristics of the scale for suicide ideation 
with psychiatric outpatients. Behav Res Ther. 1997;35(11):1039-1046. 
53. Bell JB, Nye EC. Specific symptoms predict suicidal ideation in vietnam combat veterans 
with chronic post-traumatic stress disorder. Mil Med. 2007;172(11):1144-1147. 
54. Pigeon W, Britton PC, Ilgen MA, Conner KR. Sleep disturbance preceding suicide among 
veterans. Am J Public Health. in press. 
55. Giegling I, Olgiati P, Hartmann AM, et al. Personality and attempted suicide. analysis of 
anger, aggression and impulsivity. J Psychiatr Res. 2009;43(16):1262-1271. 
56. Spitzer RL, Kroenke K, Williams JBW, Patient Health Questionnaire Primary Care Study 
Group, US. Validation and utility of a self-report version of PRIME-MD: The PHQ primary care 
study. JAMA: Journal of the American Medical Association. 1999;282(18):1737-1744. 

 
Britton-29
57. Corson K, Gerrity MS, Dobscha SK. Screening for depression and suicidality in a VA 
primary care setting: 2 items are better than 1 item. Am J Manag Care. 2004;10(11 Pt 2):839-
845. 
58. Weathers FW, Ruscio AM, Keane TM. Psychometric properties of nine scoring rules for the 
clinician-administered posttraumatic stress disorder scale. Psychol Assess. 1999;11(2):124-133. 
59. Keen SM, Kutter CJ, Niles BL, Krinsley KE. Psychometric properties of PTSD checklist in 
sample of male veterans. Journal of Rehabilitation Research & Development. 2008;45(3):465-
474. 
60. Hankin CS, Spiro A,3rd, Miller DR, Kazis L. Mental disorders and mental health treatment 
among U.S. department of veterans affairs outpatients: The veterans health study. Am J 
Psychiatry. 1999;156(12):1924-1930. 
61. Beck AT, Epstein N, Brown G, Steer R. An inventory for measuring clinical anxiety: 
Psychometric properties. Journal of Consulting & Clinical Psychology. 1988;56(6):893-897. 
62. Saunders JB, Aasland OG, Babor TF, de la Fuente JR, Grant M. Development of the 
alcohol use disorders identification test (AUDIT): WHO collaborative project on early detection 
of persons with harmful alcohol consumption--II. Addiction. 1993;88(6):791-804. 
63. Bradley KA, McDonell MB, Bush K, Kivlahan DR, Diehr P, Fihn SD. The AUDIT alcohol 
consumption questions: Reliability, validity, and responsiveness to change in older male primary 
care patients. Alcoholism: Clinical & Experimental Research. 1998;22(8):1842-1849. 
64. Skinner HA. The drug abuse screening test. Addict Behav. 1982;7(4):363-371. 
65. Justice AC, McGinnis KA, Atkinson JH, et al. Psychiatric and neurocognitive disorders 
among HIV-positive and negative veterans in care: Veterans aging cohort five-site study. AIDS. 
2004;18(Suppl 1):S49-59. 
66. Gmel G, Graham K, Kuendig H, Kuntsche S. Measuring alcohol consumption--should the 
'graduated frequency' approach become the norm in survey research? Addiction. 
2006;101(1):16-30. Available from: Gmel, Gerhard: ggmel@sfa-ispa.ch. 
67. Tonigan JS, Miller WR. The inventory of drug use consequences (InDUC): Test-retest 
stability and sensitivity to detect change. Psychology of Addictive Behaviors. 2002;16(2):165-
168. Available from: Tonigan, J. Scott: jtonigan@unm.edu. 
68. McKay JR, Lynch KG, Shepard DS, Pettinati HM. The effectiveness of telephone-based 
continuing care for alcohol and cocaine dependence: 24-month outcomes. Arch Gen Psychiatry. 
2005;62(2):199-207. 
69. Bastien CH, Vallieres A, Morin CM. Validation of the insomnia severity index as an outcome 
measure for insomnia research. Sleep Med. 2001;2(4):297-307. 
70. Coccaro EF, Berman ME, Kavoussi RJ. Assessment of life history of aggression: 
Development and psychometric characteristics. Psychiatry Res. 1997;73(3):147-157. 
71. Cacciola JS, Alterman AI, Lynch KG, Martin JM, Beauchamp ML, McLellan AT. Initial 
reliability and validity studies of the revised treatment services review (TSR-6). Drug & Alcohol 
Dependence. 2008;92(1-3):37-47. 
72. Garnick DW, Lee MT, Chalk M, et al. Establishing the feasibility of performance measures 
for alcohol and other drugs. Journal of Substance Abuse Treatment. 2002;23(4):375-385. 
73. VA Office of Quality and Performance. Continuity of care VHA performance measure. 
Washington, DC: VA Office of Quality and Performance; 2005. 
74. Harris AHS, Humphreys K, Bowe T, Tiet Q, Finney JW. Does meeting the HEDIS substance 
abuse treatment engagement criterion predict patient outcomes? The Journal of Behavioral 
Health Services & Research. 2008;37(1):25-39. 
75. Glass JE, Ilgen MA, Winters JJ, Murray RL, Perron BE, Chermack ST. Inpatient 
hospitalization in addiction treatment for patients with a history of suicidal attempt: A case of 
support for treatment performance measures. Journal of Psychoactive Drugs. 2010;42(3):315-
325. 

 
Britton-30
76. Posner K, Oquendo MA, Gould M, Stanley B, Davies M. Columbia classification algorithm of 
suicide assessment (C-CASA): Classification of suicidal events in the FDA's pediatric suicidal 
risk analysis of antidepressants. Am J Psychiatry. 2007;164(7):1035-1043. Available from: 
Posner, Kelly: posnerk@childpsych.columbia.edu. 
77. Meyer RE, Salzman C, Youngstrom EA, et al. Suicidality and risk of suicide- definition, drug 
safety concerns, and a necessary target for drug development: A consensus statement. J Clin 
Psychiatry. 2010;71(8):e1-e21. 
78. Biener L, Abrams DB. The contemplation ladder: Validation of a measure of readiness to 
consider smoking cessation. Health Psychology. 1991;10(5):360-365. Available from: 
http://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=med3&AN=19
35872; http://openurl.lib.rochester.edu/find?url_ver=Z39.88-
2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rfr_id=info:sid/Ovid:med3&rft.genre=article&rft_id
=info:doi/&rft_id=info:pmid/1935872&rft.issn=0278-
6133&rft.volume=10&rft.issue=5&rft.spage=360&rft.pages=360-
5&rft.date=1991&rft.jtitle=Health+Psychology&rft.atitle=The+Contemplation+Ladder%3A+validat
ion+of+a+measure+of+readiness+to+consider+smoking+cessation.&rft.aulast=Biener. 
79. Hogue A, Dauber S, Morgenstern J. Validation of a contemplation ladder in an adult 
substance use disorder sample. Psychology of Addictive Behaviors. 2010;24(1):137-144. 
Available from: 
http://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=medl&AN=203
07121; http://openurl.lib.rochester.edu/find?url_ver=Z39.88-
2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rfr_id=info:sid/Ovid:medl&rft.genre=article&rft_id=
info:doi/&rft_id=info:pmid/20307121&rft.issn=0893-
164X&rft.volume=24&rft.issue=1&rft.spage=137&rft.pages=137-
44&rft.date=2010&rft.jtitle=Psychology+of+Addictive+Behaviors&rft.atitle=Validation+of+a+cont
emplation+ladder+in+an+adult+substance+use+disorder+sample.&rft.aulast=Hogue. 
80. Schulz KF, Grimes DA. Blinding in randomized trials: Hiding who got what. The Lancet. 
2002;359(9307):696-700. 
81. Kernan WN, Viscoli CM, Makuch RW, Brass LM, Horwitz RI. Stratified randomization for 
clinical trials. J Clin Epidemiol. 1999;52(1):19-26. Available from: 
http://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=med4&AN=99
73070; http://openurl.lib.rochester.edu/find?url_ver=Z39.88-
2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rfr_id=info:sid/Ovid:med4&rft.genre=article&rft_id
=info:doi/&rft_id=info:pmid/9973070&rft.issn=0895-
4356&rft.volume=52&rft.issue=1&rft.spage=19&rft.pages=19-
26&rft.date=1999&rft.jtitle=Journal+of+Clinical+Epidemiology&rft.atitle=Stratified+randomization
+for+clinical+trials.&rft.aulast=Kernan. 
82. Schulz KF, Grimes DA. Unequal group sizes in randomized trials: Guarding against 
guessing. Lancet. 2002;359(9310):966-970. 
83. Fleischmann A, Bertolote JM, Wasserman D, et al. Effectiveness of brief intervention and 
contact for suicide attempters: A randomized controlled trial in five countries. Bulletin of the 
World Health Organization. 2008;86(9):703-709. 
84. Vaiva G, Vaiva G, Ducrocq F, et al. Effect of telephone contact on further suicide attempts in 
patients discharged from an emergency department: Randomised controlled study. BMJ. 
2006;332(7552):1241-1245. 
85. Miller IW, Norman WH, Bishop SB, Dow MG. The modified scale for suicidal ideation: 
Reliability and validity. Journal of Consulting & Clinical Psychology. 1986;54(5):724-725. 
86. Russ MJ, Kashdan T, Pollack S, Bajmakovic-Kacila S. Assessment of suicide risk 24 hours 
after psychiatric hospital admission. Psychiatric Services. 1999;50(11):1491-1493. 

 
Britton-31
87. Alexopoulos GS, Reynolds CF,3rd, Bruce ML, et al. Reducing suicidal ideation and 
depression in older primary care patients: 24-month outcomes of the PROSPECT study. Am J 
Psychiatry. 2009;166(8):882-890. 
88. Bruce ML, Ten Have TR, Reynolds CF3, et al. Reducing suicidal ideation and depressive 
symptoms in depressed older primary care patients: A randomized controlled trial. JAMA. 
2004;291(1):1081-1091. 
89. BootsMiller BJ, Ribisl KM, Mowbray CT, Davidson WS, Walton MA, Herman SE. Methods of 
ensuring high follow-up rates: Lessons from a longitudinal study of dual diagnosed participants. 
Subst Use Misuse. 1998;33(13):2665-2685. 
90. Desmond DP, Maddux JF, Johnson TH, Confer BA. Obtaining follow-up interviews for 
treatment evaluation. J Subst Abuse Treat. 1995;12(2):95-102. 
91. Twitchell GR, Hertzog CA, Klein JL, Schuckit MA. The anatomy of a follow-up. Br J Addict. 
1992;87(9):1327-1333. 
92. Miller WR, Yahne CE, Moyers TB, Martinez J, Pirritano M. A randomized trial of methods to 
help clinicians learn motivational interviewing. J Consult Clin Psychol. 2004;72(6):1050-1062. 
Available from: Miller, William R.: wrmiller@unm.edu. 
93. Moyers TB, Martin T, Manuel JK, Hendrickson SML, Miller WR. Assessing competence in 
the use of motivational interviewing. J Subst Abuse Treat. 2005;28(1):19-26. Available from: 
Moyers, Theresa B.: tmoyers@unm.edu. 
94. Miller WR, Mount KA. A small study of training in motivational interviewing: Does one 
workshop change clinician and client behavior? Behavioural and Cognitive Psychotherapy. 
2001;29(4):457-471. 
95. Shrout PE, Fleiss JL. Intraclass correlations: Uses in assessing rater reliability. 
Psychological Bulletin. 1979;2:420-428. 
96. Motivational Interviewing Network of Trainers (MINT). Training. 
http://motivationalinterview.org/training/index.html. Accessed 2/28, 2011. 
97. Cicchetti DV. Guidelines, criteria, and rules of thumb for evaluating normed and 
standardized assessment instruments in psychology. Psychol Assess. 1994;6(4):284-290. 
98. Martin T, Moyers TB, Houck JM, Christopher PJ, Miller WR. Motivational interviewing 
sequential code for observing process exchanges (MI-SCOPE) coder's manual. 
http://casaa.unm.edu/download/scope.pdf. Accessed May/20, 2010. 
99. Hosmer DW, Lemeshow S. Applied Logistic Regression. New York: Wiley; 1989. 
100. Dobson AJ, Barnet AG. Introduction to Generalized Linear Models. 3rd ed. Boca Raton, 
FL: Chapman and Hall/CRC; 2008. 
101. STATA Corporation. STATA statistical software. College Station, TX:2008;10. 
102. Frison L, Pocock SJ. Repeated measures in clinical trials: Analysis using mean summary 
statistics and its implication for design. Statistics in Medicine. 1992;11(13):1685-1704. 
103. Festinger DS, Marlowe DB, Croft JR, et al. Do research payments precipitate drug use or 
coerce participation?. Drug & Alcohol Dependence. 2005;78(3):275-281. 
104. Festinger DS, Marlowe DB, Dugosh KL, Croft JR, Arabia PL. Higher magnitude cash 
payments improve research follow-up rates without increasing drug use or perceived coercion. 
Drug & Alcohol Dependence. 2008;96(1-2):128-135. 
105. Williams GC, Grow VM, Freedman ZR, Ryan RM, Deci EL. Motivational predictors of 
weight loss and weight-loss maintenance. J Pers Soc Psychol. 1996;70(1):115-126. 
106. Williams GC, Freedman ZR, Deci EL. Supporting autonomy to motivate patients with 
diabetes for glucose control. Diabetes Care. 1998;21(10):1644-1651. 
107. Hong J1, Reed C, Novick D, Haro JM, Aguado J.  Clinical and economic consequences of 
medication non-adherence in the treatment of patients with a manic/mixed episode of bipolar 
disorder: results from the European Mania in Bipolar Longitudinal Evaluation of Medication 
(EMBLEM) study.  Psychiatry Res. 2011 Nov 30;190(1):110-4. 

 
Britton-32
108. Novick D1, Haro JM, Suarez D, Perez V, Dittmann RW, Haddad PM.  Predictors and 
clinical consequences of non-adherence with antipsychotic medication in the outpatient treatment 
of schizophrenia.  Psychiatry Res. 2010 Apr 30;176(2-3):109-13. 
109. J Scott, M Pope.  Self-reported adherence to treatment with mood stabilizers, plasma levels, 
and psychiatric hospitalization.  Am J Psychiatry.  2002;159(11): 1927-1929. 
110. ML Parchman, JE Zeber, Palmer RF.  Participatory decision making, patient activation, 
medication adherence, and intermediate clinical outcomes in type 2 diabetes: a STARNet study.  
2010.  Ann Fam Med. 2010.  8(5): 410-417. 
111. M Heisler, RR Bouknight, RA Hayward, et al.  The Relative Importance of Physician 
Communication, Participatory Decision Making, and Patient Understanding in Diabetes 
Self‐Management.  J General Internal Med.  2002; 17(4):  243–252. 
112. J Schneider, SH Kaplan, S Greenfield, Li W, Wilson IB. Better Physician-Patient 
Relationships Are Associated with Higher Reported Adherence to Antiretroviral Therapy in 
Patients with HIV Infection. J Gen Intern Med.  2004;19(11): 1096–1103. 
113. Haskard Zolnierek KB,  DiMatteo RM.  Physician Communication and Patient Adherence 
to Treatment: A Meta-analysis.  Med Care.  2009 Aug; 47(8): 826–834.  
114. Zygmunt A, Olfson M, Boyer CA, et al.  Interventions to improve medication adherence in 
schizophrenia.  Journal of Psychiatry.  2002;159(10): 1653-1664. Psychiatry Res. 2011 Nov 
30;190(1):110-4. doi: 10.1016/j.psychres.2011.04.016. Epub 2011 May 14. 
115. Kaplan SH, Gandek B, Greenfield S, Rogers WH, Ware JE.  Patient and Visit 
Characteristics Related to Physicians' Participatory Decision-Making Style: Results from the 
Medical Outcomes Study.  Medical Care.  Vol. 33, No. 12 (Dec., 1995), pp. 1176-1187 
116. Kaplan SH, Greenfield S, Gandek B, Rogers WH, Ware JE.  Characteristics of Physicians 
with Participatory Decision-Making Styles. Ann Intern Med. 1996;124(5):497-504. 
117. J Hamann, R Mendel, R Cohen, S Heres. Psychiatrists' use of shared decision making in the 
treatment of schizophrenia: patient characteristics and decision topics.  Psychiatric Services.  
2009;60:1107–1112.