Social Connections and Late Life Suicide
Phase: NA
Conditions: Depression, Suicidal Ideation
Sponsor: University of Rochester

Cover Page for Study Protocol
Social Connections and Late-Life Suicide
NCT02188485   Unique Protocol ID: K23MH096936
Kim Van Orden, PI
Document Date: September 19, 2016

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AGING WELL & SOCIAL CONNECTIONS:  
Study Protocol for K23MH096936 
Principal Investigator: Kim Van Orden, PhD 
Co-Investigators: Yeates Conwell, MD 
Sub-investigators: Laurel Prothero, BS; Caroline Silva, PhD 
I. RATIONALE FOR THE STUDY AND SPECIFIC AIMS
Purpose: With the long-term goal of improving interventions for late-life suicide, the purpose of this study is to 
examine whether a mechanism by which behavioral interventions reduce risk for suicide is by increasing social 
connectedness. 
Background: Suicide in late-life is a significant public health problem. Older adults have higher rates of suicide 
than younger individuals in most countries worldwide1 2 and the size of the older adult population will soon rise 
dramatically in the U.S.3 4 We can, therefore, anticipate a very large rise in the number of older adults who die 
by suicide in coming decades.5 However, current approaches to late-life suicide prevention are severely 
limited. It is not known how to prevent suicide among older adults.  It is known, however, that primary care is a 
key site for prevention: two-thirds or more of older adults who die by suicide are seen by primary care 
physicians within a month of their deaths, and up to half within a week.6 7 Further, depression is a strong risk 
factor, but the vast majority of depressed older adults do not die by suicide.8 Social disconnectedness—the 
degree to which older adults feel connected to, and as if they contribute to, valued relationships—is associated 
with depression,9 suicide ideation10 11 suicide attempts,12 and suicide deaths13 14 in later life. There are three 
intervention studies that have yielded promising outcomes regarding suicide deaths in later life15-17 and the 
common element across the studies is the promotion of social connectedness through connections to 
providers or peers.18 Thus, among depressed older adult primary care patients, social disconnectedness is 
both a risk factor for late-life suicide and a potential intervention target.18 However, despite strong evidence 
that social disconnectedness increases risk for suicide (and other negative health outcomes) in later life,13 19-26 
scant data are available indicating that any intervention is effective in increasing social connectedness among 
older adults.24 27 Despite the likelihood of this association, the question has simply not been comprehensively 
addressed. Therefore, this study examines whether a manualized (thus replicable) behavioral intervention 
does, in fact, increase connectedness. To do so requires establishing that ‘connectedness effects’ are not fully 
accounted for by changes in depression (a strong risk factor for late-life suicide)18 or cognitive functioning (a 
correlate of late-life depression that impacts capability to engage in interventions).18  
Overview of the Design: We propose to examine whether a manualized intervention that targets 
connectedness—ENGAGE—increases connectedness in older adults who report clinically significant social 
disconnectedness—operationalized as feeling lonely and/or like a burden on others. We propose a randomized 
controlled trial comparing ENGAGE with care-as-usual (CAU), using n=100 primary care patients aged ≥ 60 
years who report social disconnectedness (i.e., loneliness or burdensomeness). At baseline, 3-week, 6-week 
and 10-week assessments, subjects will report on social connectedness, depression, and suicide risk.  
Specific Aims & Hypotheses:  
Aim 1: To examine whether a manualized intervention can increase connectedness among older adults: 
H1a: ENGAGE will produce greater increases in connectedness—measured as greater belongingness and 
lower burdensomeness—compared to CAU, while adjusting for depression and cognitive functioning. 
H1b: ENGAGE will produce comparable increases in connectedness for men and women. Examining this 
hypothesis will provide effect size estimates, which can be used to guide power analysis for a subsequent R01. 
This finding will have important implications for prevention, given high suicide rates among elderly men.  
Aim 2: To examine whether an intervention targeting social functioning also reduces late-life suicide risk: 
H2a: ENGAGE will produce greater decreases in depression symptom severity compared to CAU. 
H2b: ENGAGE subjects will report lower levels of desire for death (i.e., death ideation) post-treatment than 
CAU. 
Aim 3: To examine increases in connectedness as a mechanism whereby ENGAGE decreases depression: 

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H3a/b: Growth in connectedness over 3 and 6 weeks will be associated with decrements in depressive 
symptoms over 10 weeks (a), while accounting for baseline influences of cognition (b).  
H3c: Connectedness during treatment (i.e., 3 and 6 weeks), will predict depression level post-treatment (i.e., 
10 weeks). 
H3d: The association in H3c, between connectedness and subsequent depression, will be strongest for those 
in the intervention condition. 
 
II. CHARACTERISTICS OF THE RESEARCH POPULATION 
 
a) Number of Subjects: The study will recruit and enroll 300 subjects into the study using the procedures 
described below. The target number of randomized subjects is n=50 in each group; in our experience 
recruiting thus far, 30% of those enrolled are eligible and willing to be randomized, thus we must enroll 
up to 300 subjects to reach our target number of randomized subjects. After providing informed consent 
and completing a baseline assessment, subjects will be randomized to receive either the intervention, 
ENGAGE (n=approximately 50), or care as usual (CAU; n= approximately 50.) Because we are 
interested in whether men and women respond to the intervention differently, we will stratify the 
randomization by gender.. We will also stratify on antidepressant medication usage at baseline (i.e., 
those being prescribed antidepressant medications) in order to ensure that outcomes are due to 
ENGAGE not medications. Subjects will be primary care patients from practices enrolled in the Greater 
Rochester Practice-Based Research Network (GR-PBRN).  
 
b) Gender, Age, Racial, and Ethnic Origin of Subjects: The GR-PBRN serves approximately 30% of 
adults in Monroe County and is generally representative of the population of Monroe County. Although 
we propose to recruit subjects from within the Greater Rochester Practice-Based Research Network (as 
well as outside sources if needed), we anticipate that our study will include subjects representative of 
the current Greater Rochester Practice-Based Research Network (GR-PBRN) client mix. That 
distribution is provided in the Targeted/Planned Enrollment Table below. We intend to purposefully 
select practices, rather than approach them in a random order, so that we can assure the sample is 
generally representative of the race/ethnicity of the entire network (i.e., 78% White, 14% African 
American, 3% Hispanic). We plan to enroll an equal number of men and women. All subjects will be 60 
years or older.  
 
 
TARGETED/PLANNED ENROLLMENT: Number of Subjects 
Ethnic Category 
Sex/Gender 
Females 
Males 
Total 
Hispanic or Latino 
6 
3 
9 
Not Hispanic or Latino 
144 
147 
291 
Ethnic Category: Total of All Subjects * 
150 
150 
300 
Racial Categories 
 
American Indian/Alaska Native 
0 
0 
0 
Asian 
2 
2 
4 
Native Hawaiian or Other Pacific Islander  
0 
0 
0 
Black or African American  
21 
21 
42 
White 
127 
127 
254 
Racial Categories: Total of All Subjects * 
150 
150 
300 
 

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c) Inclusion Criteria: age ≥ 60 yrs; English speaking; endorse social disconnectedness, as measured by 
feeling lonely and/or like a burden on others (in an initial screen in primary care practices); a score of 2 
errors or fewer on the 6-item screener (a brief cognitive functioning scale) in the initial phone screen. 
Social disconnectedness is determined by responses to two questions extracted from the Interpersonal 
Needs Questionnaire (INQ). Response options for both are “not at all true for me”, “somewhat true for 
me”, and “very true for me”. Item one reads: “These days I feel like a burden on the people in my life.” 
(Positive = “somewhat” or “very true for me”). Item two reads: “These days, I feel lonely” (Positive = 
“somewhat” or “very true for me”). My objective in using these criteria is to identify a group of subjects 
who report feelings consistent with burdensomeness and/or loneliness and who therefore are members 
of an at risk group appropriate for preventive intervention. Subjects will have sufficient cognitive 
functioning to provide informed consent and to understand the study requirements and procedures 
(additional details below). 
 
d) Exclusion Criteria are presentation at the baseline interview with any of the following: imminent risk for 
suicide (thoughts of death or suicide are not cause for exclusion as long as the subject is not at 
imminent risk); active psychosis; significantly impaired cognitive functioning (i.e., MOCA <20 and/or 3 
or more errors on the 6-item cognitive functioning screener); active substance abuse in the last year 
(AUDIT score of 5 or more for men and 5 or more for women); hearing loss that precludes comfortable 
communication with an interviewer (and therapist); residence in a long-term care facility. Literacy is not 
an inclusion or exclusion criterion. I will restrict subjects to those who can speak English because the 
population of non-English speaking seniors in my region is far too small to enable meaningful analysis, 
and because several key measures have not been translated and validated in other languages. There 
is no exclusion for medical conditions or functional impairment other than severe hearing loss, and no 
exclusion for current or lifetime mental disorders (other than mentioned above regarding psychosis and 
alcohol abuse). Neither will I restrict participation if a subject is receiving psychopharmacological 
treatment or psychotherapy.  
 
e) Vulnerable Subjects: Individuals who are 60 years of age and older with social risk factors for poor 
mental and physical health outcomes will be included. The results of this study will inform future 
research and clinical interventions aimed and improving mental health treatment for older adults. 
 
III. METHODS AND PROCEDURES 
a) Design: The design is a randomized controlled trial. Subjects will all be randomly assigned to either the 
intervention condition (ENGAGE) or care-as-usual with their primary care physician (CAU). Those 
subjects assigned to ENGAGE will receive a 10-session course of psychotherapy delivered in-home 
over 10 weeks, with the option of phone sessions if necessary. All subjects will receive baseline, mid-
treatment (3 and 6 weeks) and post-treatment (10 weeks) assessments. The mid-treatment 
assessments will be done over the phone. 
b) Setting: Those randomly assigned to the ENGAGE condition will receive the intervention in their 
homes (or in an office at URMC if they prefer). Subjects will be recruited from the Greater Rochester 
Practice Based Research Network.  The GR-PBRN is a network of primary care practices coordinated 
by the University of Rochester’s Clinical Translational Science Institute to provide access to subjects 
and community-based practices for research. The 31 family medicine and internal medicine practices 
that constitute the network care for approximately 217,000 patients, of which approximately 50,000 are 
over age 60 and therefore eligible for initial screening for the study.  
Having received prior approval for the study from the GR-PBRN executive committee (see attached 
Letter of Support), we will approach individual practices for their permission to contact patients on their 
rolls who are ages 60 years and over. These recruitment procedures are already in place for 
another of our studies—Social Connections and Healthy Aging (The Senior Connection)—and 
procedures for this study will be coordinated. As part of these coordinated procedures, we intend to 
purposefully select practices, rather than approach them in a random order, so that we can assure the 
sample is generally representative of the race/ethnicity of the entire network (i.e., 78% White, 14% 
African American, 3% Hispanic.) Practices will be added sequentially until sufficient subjects have been 

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recruited into the study. The practices are part of the Strong Health care system, which will allow for 
access to the electronic medical record for review of antidepressant use (see measures); no paper 
chart review will be needed.  
 
At the start of the study, one practice had been added—Geriatrics and Medicine Associates (see 
attached Letter of Support). During the course of the study, we added Highland Family Medicine and 
UR Medicine Geriatrics (see Letters of Support).  
 
When additional practices have agreed to participation, we will submit letters of agreement from 
individual practices to the RSRB as protocol amendments for review and RSRB approval prior 
to subject recruitment from any site. 
 
c) Recruitment Procedures: Recruitment will consist of three stages. First, screening; second, 
informational phone call; third, home visit for assessment of exclusion criteria and written informed 
consent. Several strategies will be used for the first stage (screening). Each stage and strategy is 
described below.  
STAGE ONE: SCREENING 
• 
Strategy 1: Primary care office recruitment:  
o A study staff member, identified by their UR name tag, will introduce him or herself to older adults in 
the waiting rooms of participating primary care practices, show them the study letter and 
questionnaire, and ask if they have an appointment that day. For individuals who respond that they do 
indeed have an appointment, the study staff member will explain that we are approaching everyone 
who is 60 or older (and who has an appointment) with an opportunity to hear more about a study. The 
staff member will say that "the office is cooperating with the study and your doctor has asked us to 
hand this information out about it directly to their patients who may qualify." The letter, printed on the 
letterhead of the practice, will briefly explain that the increasing social engagement. With assurances 
that participation is voluntary, it will include a card on which the four screening questions are written 
(one regarding burdensomeness, one regarding belonging, one regarding sadness and a fourth 
regarding lack of interest in activities), with instructions that if the subject is interested in completing 
the survey, he/she should approach the study personnel seating in the waiting room with a sign 
denoting, “Social Connections and Healthy Aging.” The letter will also indicate that a study 
coordinator may approach them to assess their interest in participating. 
o Individuals interested in participating will then be taken to a private part of the waiting room and 
provided with a brief description of the study, encouraged to ask questions, reminded that 
participation is voluntary, and asked to complete the form and to provide information about their age, 
gender, and race. We will ask them to only complete the survey once. The questionnaire will be 
completed with research staff in a quiet, private area of the waiting room. Those who screen positive 
to the screening questions (meet inclusion criteria), and who give verbal consent to have research 
staff call them with additional information about the study will then be invited to provide their name 
and contact information so that study personnel may contact them to provide additional information 
about the study (i.e., Stage 2 of the study, the interview component). Participants will provide verbal 
consent for the telephone contact (see “in office script” for exact wording) and also verbally 
acknowledge that by providing their contact information they agree to be contacted by phone by study 
personnel. No name or other contact information is gathered until the patient is determined to meet 
inclusion criteria and to be willing to be called with additional information and an invitation to 
participate. These patients will then be provided with a brief brochure that explains the name of the 
study and relevant names of key study personnel who will be contacting them. 
o Participants who do not screen as positive on the inclusion criteria questions on the screening form 
will be thanked for their interest and be provided with community resources related to increasing or 
maintaining social connections.  
• Strategy 2: Letter recruitment:  

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o We will approach practices that are part of the Greater Rochester Practice-Based Research Network 
to request their partnership in this recruitment effort. We have approval from the GR-PBRN. After 
obtaining approval from a given practice, the study coordinator will perform a (secure) data request 
for patients over age 60 in that practice. The data request will occur via eRecord and will only involve 
patients within the covered entity. This data pull may be done by the eRecord and Analytics team 
(EARS) or the study staff (via a tool called i2b2). The research coordinator will review and clean the 
data on a secure device with enforced password protection. He or she will then give a designee from 
the practice the opportunity to review the list and exclude patients as needed. These letters, prepared 
by University Mail Services, will describe the study and invite those who may be interested to call 
research staff. These letters will state that participation in the study is entirely voluntary, and that 
participation or non-participation will not influence one’s medical care. The letter will also notify the 
patient that they will be contacted by phone by a research assistant within 2 weeks of the date when 
the letter was sent out. This strategy was developed in coordinator with Co-Investigator, Dallas 
Nelson, MD, who is Medical Director of UR Medicine Geriatrics Group. We have found that only a 
small percentage of potentially eligible subjects call the research coordinator (approximately 2-3%) 
and of those only 30% are eligible (i.e., most are not socially isolated or depressed). Thus, to reach 
socially isolated and depressed older subjects, a follow-up phone call is a necessary step to improve 
recruitment.   
o Between 1 and 2 weeks after a letter is sent out, the research assistant will initiate a phone call with 
potentially eligible patients. The research assistant will follow the phone script, which will reference 
the letter that was sent. The research assistant will then explain the main points of the study and ask 
the patient if he or she might be interested in the study. If the patient is interested in the study, the 
research assistant will conduct the brief phone screen (see Telephone Call below), answer any 
questions he or she has about the study, and set up a time to meet the patient in his/her home (or 
URMC office) for the baseline interview. If the patient is not interested, the research assistant will ask 
the patient whether he or she may be interested in the future. If the patient does not think so, the 
research assistant will thank the patient and tell the patient he or she will not be contacted again. In 
order to make sure no more letters are sent out to the same patient in the future (i.e. if the patient is 
once again identified as potentially eligible using the methods described above), the patient’s name 
will be retained in a secure file until the end of study recruitment. The research assistant will check 
the list of potentially eligible patients against the names of patients who previously refused to ensure 
that the patient does not receive another letter. At the close of the study, this list will be securely 
discarded. 
 
• Strategy 3: Behavioral Health Clinic recruitment 
o Identical recruitment strategies to those described above under the section Primary care office 
recruitment will be used at the geriatric mental health clinic of Strong Behavioral Health (Older 
Adults Service [OAS]), which serves adults aged 60 or older with behavioral health problems such 
as depression and anxiety. Further, OAS clinicians who screen potential clients for services will 
provide information about the study to those patients, including verbal information and brochures; no 
client information will be given to researchers, rather, clients will be given the contact information for 
the study coordinator and can call if interested in learning more.  
• Strategy 4: Direct referral 
o Care managers and physicians at participating practices will have the option of telling subjects about 
the project by handing out the approved informational letter (see above for letter recruitment) and 
suggesting patients call the study coordinator to learn more about the project.  
o In coordination with Dallas Nelson, MD, the Medical Director of UR Medicine Geriatrics Group, we 
have also refined this recruitment method based on her experience with similar studies. Recruitment 
will involve identification of potential patients (of physicians who have agreed to participate) through 
coordination with the practice scheduler or the program i2b2; potential patients will be patients with 
diagnoses of depression or anxiety, without diagnoses of dementia, and scheduled within the next 
week to see his/her PCP. The scheduler will share dates, times, and locations (the senior living 

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facility) for appointments that meet eligibility criteria (as these are in-home physician visits); 
researchers will not have access to names of potentially eligible patients. Research staff will share 
with the physician the appointment times for which potentially eligible patients are being seen; the 
physician will thus be prompted to share information about the study with potentially eligible patients. 
The physician will emphasize to the patient that research staff are not aware of the patient’s name 
and if they decline to learn more about the study, their information will not be released to researchers. 
If the patient is interested in learning more about the study and gives permission, study staff will join 
the physician at the end of the visit to share information about the study, conduct the initial screening 
(if the patient is willing) and schedule a baseline assessment. Research staff will only join the visit if 
the physician indicates the patient has agreed to this.   
• Strategy 5: Advertisement  
o Subjects can also learn of the study through ads in local newspapers. For potential subjects who call 
study staff, additional information will be provided to the potential subject, the screening conducted 
(see Stage 2 below), and if interested, an in-person interview will be scheduled.  
 
STAGE 2: Telephone call:  
• 
Participants who provide their contact information will be called by a member of the study team who will 
explain the study in more detail, including the randomized, controlled aspect of the study. 
• 
Participants who hear about the study from a letter will call research staff. A member of the study team will 
then screen the potential subject for eligibility, and explain the study in more detail, including the 
randomized, controlled aspect of the study. 
• 
If the participant agrees to an interview with the CRC, an appointment will be made for that interview, in the 
person’s home. 
STAGE 3: In-home interview: 
• 
A Clinical Research Coordinator (CRC interviewer) will conduct two home visits for the baseline interview. 
First, the CRC interviewer will explain the study and obtain written, informed consent for the subject to 
participate. The process of obtaining informed consent also involves completing procedures to ensure the 
potential subject has the capacity to provide informed consent (see document “Determination of Capacity 
for Informed Consent). These procedures involve asking the potential subject a series of questions to 
ensure they understand the purpose of the study as well as risks and benefits, as well as the fact that 
participation is voluntary. These procedures are described in detail below in the section on “Informed 
Consent Procedures” (p. 15). It is at this point in the process that the person is considered to be an 
identified subject in the study. An additional Behavioral and/or Medical release will be signed and initialed 
at this time so that the PI will be able to contact the subject’s mental health provider in the event that a 
subject’s presentation indicates the presence of a research diagnosis of depression, or if the subject 
reports suicidal thoughts. If such a release form is not signed, the PI will not contact subjects’ mental health 
providers (this includes those subjects who were consented prior to beginning this process) but will contact 
the primary care provider. Our exclusionary screens will be completed. Next, the CRC will explain the need 
to interview the subject alone (to assure unbiased responses). She will then administer an additional set of 
baseline research measures that document standard demographic information; social and financial 
resources; physical health (providers, pain assessment, assistive devices), functioning (ADL/IADL ratings), 
well-being, depression, anxiety, suicide risk, and social connectedness. If during the interview, research 
staff suspects elder abuse or severe neglect, or identifies unsafe living conditions (lack of heat in the winter 
months), the CRC will provide the subject with information about care management services and the option 
of the CRC making a referral for case management (if consent to release the subject’s name and contact 
information to case management services is provided). Breaking the interview into two parts is done for two 
reasons: first, to minimize participant fatigue; second, to allow the CRC to discuss eligibility with the PI 
before randomization. In the second interview, the remainder of the measures will be administered followed 
by assignment of the subject by random selection to ENGAGE or CAU. Finally, the CRC will again explain 
the follow-up interview schedule, answer any remaining questions, and end the home visit. 

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• 
Audio-taping of assessments: The in-person assessments will be audio-recorded because of the need to 
examine inter-rater reliability for the depression assessments and ensure that the assessors are providing 
unbiased assessments. This information is included in the consent form. The PI will review the audiotapes. 
• 
Assessment information provided to physicians: As a service to the physicians who will be assisting 
with recruiting, we will provide a brief letter describing clinical information gathered from the assessments 
to PCP’s and mental health providers (if subjects provide this additional permission). Specifically, 
depression symptoms, anxiety symptoms, scores on neuropsychological measures, alcohol use, functional 
impairment, and suicide risk. Subjects will be informed of this in the consent form. Based on provider 
preference, information will be provided via eRecord (for URMC practices), secure email, or hard copy 
letter.  
• 
Follow-up assessments: Subjects will be maintained in the study, either in the ENGAGE or CAU arm, for 
10 weeks. For subjects assigned to ENGAGE, the intervention will begin within two weeks of the baseline 
assessment and study enrollment. Follow-up research assessments will be conducted for both ENGAGE 
and CAU groups by phone at 3 weeks and 6 weeks and in-person at 10 weeks. For subjects with 
significant sensory impairment that precludes scheduling via phone, a separate email consent form will be 
used to allow the coordinator and subject to communicate via email. All emails will be encrypted using 
University of Rochester encryption procedures.  
 
d) Assessment Measures & Administration Schedule: 
The following tables specify the measures we propose to use in the study: 
 
Screening measures 
Measure Name and 
Citation 
Construct Measured 
Description & Psychometric Data  
Estimated Administration Time 
Demographic 
characteristics 
Not applicable 
Age, gender. 
1 minute 
INQ Screener  
Social 
disconnectedness 
These two items ask about feelings 
of loneliness and being a burden on 
others. 
1 minute 
PHQ-228 
Depression 
These two items ask about feelings 
of sadness and anhedonia. 
1 minute 
6-Item Screener 
Cognitive functioning 
These 6 items ask questions 
measuring orientation and short-
term memory. 
1-2 minutes 
 
Descriptive measures, and psychiatric/medical covariates 
Measure Name and 
Citation 
Construct Measured 
Description & Psychometric Data  
Estimated Administration Time 
Demographic 
characteristics 
Not applicable 
Age, race/ethnicity, gender, 
education, living situation, marital 
status, PCP name, emergency 
contact. 
3 – 5 minutes 
WHOQOL-BREF29 
Health-related quality 
of life 
This brief 36 item measure assesses 
several domains of health related 
functioning and quality of life. It has 
excellent psychometric properties 
and can be used cross culturally. 
5 – 10 minutes  
baseline and final interview 
Medical conditions and 
medications30 
 
Physical health 
This measure is checklist of self-
reported medical conditions derived 
from the Minimum Data Set Version 
2.0. Data on medications will be 
10 – 15 minutes 
baseline only 

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used to create the Composite 
Antidepressant Scale (CAD), a 
measure of antidepressant dosage. 
Questions about adherence to 
medicines will also be asked to 
determine if the prescribed dosage 
is being taken. 
WHO Disability 
Assessment Schedule 
2.0 WHODAS 2.0 
 
Functional 
impairment 
Functional impairment will be 
measured by client self-reporting of 
six domains: cognition, mobility, self-
care, social, life activities, and 
participation. In order to adequately 
characterize our sample, we will 
obtain the degree to which subjects 
experience functional impairment.  
5 – 20 minutes 
baseline and final interview 
Pittsburgh Sleep 
Quality Index (PSQI)31 
Sleep problems 
The PSQI is a self-report index of 
sleep difficulties. Research has 
demonstrated good internal 
consistency of the items and high 
sensitivity in the detection of 
clinically significant sleep problems.  
5 – 10 minutes 
baseline and final interview 
  
Audit-C32,33 
 
Alcohol abuse 
The Audit-C is validated for use as a 
screener for substance use 
disorders.32,33 This measure will be 
used as an exclusion screen. 
3 – 7 minutes 
baseline only 
Modified Cornell 
Services Index (CSI) 34 
Formal & informal 
health/ social 
services usage. 
Adequate test-retest (r=.54-1.00) 
and inter-rater (modal intraclass 
coefficient for all items was 1.00) 
reliabilities are reported 34. 
3 – 7 minutes 
baseline and final interview 
Structured Clinical 
Interview for DSM-IV 
(SCID-IV), Mood 
disorders & psychosis 
module35 
Mental disorders 
The SCID-IV is the current gold 
standard for diagnosis of mental 
disorders as defined by the DSM-IV. 
The mood disorders module will be 
used as an inclusion criteria 
measure and the psychosis module 
will be used as an exclusion criteria 
screen. The SCID is only 
administered at the baseline 
interview 
10 – 35 minutes 
baseline only 
Quick Inventory of 
Depressive 
Symptomatology 
(QIDS)36 
Depression severity 
This assessor-rated scale involves 
16 items rated on a 0 to 3 point 
scale. The scale was designed to be 
sensitive to change for use in clinical 
trials. 
5-7 minutes 
at all interviews 
GAD-737 
Anxiety 
This self-report scale is brief and 
has been found to be sensitive to 
clinically significant symptoms of 
generalized anxiety disorder.  
3-5 minutes 
baseline and final interview 
SHARE ALLIANCE 
Mood Improvement 
Protocol (MIP) 
Self-perceived 
distress (before and 
after interview) and 
coping strategy (i.e., 
mood improvement 
activity) 
The research interview may elicit 
negative reactions in individuals who 
are having difficulties in areas of 
their life related to questions in the 
assessment. Thus, this measure, 
adapted from procedures designed 
by Linehan and colleagues, is 
designed to enhance retention and 
5 – 10 minutes 
only in-person, unless needed 
during phone interviews 

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improve subjects’ experience in the 
research assessments.30 
Ten Item Personality 
Inventory 38 
Personality traits 
This very brief self-report measure 
(10 items) assesses the “Big Five” 
personality traits. This measure is 
included because personality may 
moderate (or effect) treatment 
outcome. 
3-5 minutes 
baseline only 
PHQ-939 
Depression symptom 
severity 
This brief depression screening 
measure has been found to be 
sensitive in detecting clinically 
significant depression. 
3-5 minutes 
intervention sessions only 
Total estimated time 
for this portion of 
interview 
 
 
70 – 141 minutes 
 
Social connectedness measures 
Measure Name and 
Citation 
Construct Measured 
Description & Psychometric Data 
Estimated Administration 
TIme 
Berkman Social Network 
Index (SNI)40 
Social network size 
and frequency of 
contact. 
This set of self-report questions 
has been shown to predict 
premature mortality. 
3 – 5 minutes; 
baseline and final interview 
Interpersonal Needs 
Questionnaire (INQ) 41 42 
Thwarted 
belongingness (TB), 
perceived 
burdensomeness 
(PB). 
Van Orden et al. 41 report high 
internal consistency coefficients 
for the thwarted belongingness 
(=.85) and perceived 
burdensomeness subscales 
(=.89). In support of construct 
validity, both subscales were 
found to positively correlate with 
suicidal ideation. 
5 – 7 minutes 
at all interviews 
Perceived 
Burdensomeness 
Questionnaire43 
The type and nature of 
relationships 
characterized by 
perceptions of 
burdensomeness. 
Jahn and Cukrowicz report 
acceptable reliability and 
convergent validity (i.e., with 
suicidal ideation) for scores 
derived from this measure. 
1 – 2 minutes 
at all interviews 
Interpersonal Support 
Evaluation List44 
Social support 
This brief self-report scale 
measures three components of 
social support: tangible, 
belonging, and self-esteem. 
3-5 minutes 
baseline and final interview 
National Social Life, 
Health, and Aging Project 
Social Network Module 
(NSL-SN)45 
Social network density 
and quality 
(closeness). 
Cornwell et al.45 report that these 
measures of the social network 
were designed for use with older 
adults. In support of their construct 
validity, density and quality were 
significantly related, but the 
magnitude was small (r=.27), as 
would be expected. 
10-15 minutes  
baseline and final interview 
Behavioral Activation Scale 
for Depression (BADS)46 
Social and behavioral 
activation. 
Kanter and colleagues46 present 
evidence of the scale’s 
psychometric properties, including 
solid factor structure, internal 
consistency, and test-retest 
reliability. 
5-10 minutes. 
baseline and final interview 

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UCLA Loneliness Scale, 
short form47 
Loneliness 
Hughes and colleagues present 
acceptable psychometric 
properties for this shortened form 
of the UCLA Loneliness Scale; 
this short form was designed for 
telephone administration, 
1-3 minutes 
at all interviews 
The Anticipatory and 
Consummatory 
Interpersonal Pleasure 
Scale (ACIPS)48 
Social anhedonia 
Gooding and colleagues48 49 report 
acceptable internal consistency 
and evidence for convergent 
validity of the ACIPS. 
5-10 minutes. 
baseline and final interview 
 
Jacelon Attributed Dignity 
Scale50 
Dignity 
Jacelon50 reports convergent and 
divergent validity as well as high 
internal consistency. 
3-5 minutes. 
baseline and final interview 
Total time for this portion 
of the interview 
 
 
36-64 minutes 
 
Suicide Risk Measures 
 
Geriatric Suicidal Ideation 
Scale (GSIS)20 
Death ideation (DI), 
suicidal ideation (SI), 
personal/ social worth 
(PSW), meaning in life 
(ML) 
Heisel and Flett 21 report high 
internal consistency for both the 
death ideation (=.82) and suicide 
ideation subscales (=.82), as 
well as significant criterion validity 
(i.e., positive correlations with 
another measure of suicide 
ideation, depression, & 
hopelessness). 
5 – 10 minutes 
baseline and final interview 
(shorter 5 item version only 
for phone interviews) 
Columbia Suicide Severity 
Rating Scale (CSSRS)51 
History of suicidal 
ideation and 
behaviors. 
The CSSRS is an interview that 
assesses for worst-point lifetime 
and past month suicidal ideation 
and behavior. It has been shown 
to predict future suicidal 
behavior51 and is the current gold 
standard for assessing suicide risk 
in clinical trials. 
5 –15 minutes 
at all interviews (time 
frame is “since last visit” 
for follow-up interviews)  
Acquired Capability for 
Suicide—Fearlessness 
about Death Scale52 
Perceived fear of 
death and perceived 
pain tolerance. 
The ACSS is a 7-item self-report 
scale designed to measure 
fearless about death and 
perceived level of pain tolerance 
and is posited to be a distal risk 
factor for suicidal behavior.  
1 – 3 minutes 
baseline only 
Communication about 
Suicidal Thoughts 
Willingness and 
evidence of 
communication about 
suicide risk with 
others. 
This is a measure that is under-
development and is being pilot 
tested in the current study 
1-3 minutes 
baseline only 
Firearm Safety 
Management Form 
Presence of firearms 
in the home 
This measure assesses for the 
presence of firearms and 
ammunition in the home for the 
purposes of suicide risk 
assessment and management. 
1-3 minutes  
baseline only 
Total estimated time for 
this portion of interview 
 
 
11 – 28 minutes 
 
Cognitive functioning measures 
Measure Name and 
Citation 
Construct Measured 
Description & Psychometric Data 
Estimated Administration 
TIme 

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Montreal Cognitive 
Assessment (MOCA)53 
Global cognitive 
functioning 
The Montreal Cognitive Assessment 
(MoCA) was designed as a rapid 
screening instrument for mild 
cognitive dysfunction. It assesses 
different cognitive domains: attention 
and concentration, executive 
functions, memory, language, 
visuoconstructional skills, conceptual 
thinking, calculations, and 
orientation. Time to administer the 
MoCA is approximately 10 minutes. 
The total possible score is 30 points; 
a score of 26 or above is considered 
normal. Nasreddine and colleagues 
report high sensitivity and specificity 
for MOCA scores in detecting MCI.53 
The MOCA has three alternate forms 
in English to prevent practice effects 
with repeat administration, as well as 
a form for blind individuals. 
10 – 15 minutes 
baseline and final interview 
(alternate form used at final 
interview) 
Delis-Kaplan Executive 
Function System54 
Executive 
Dysfunction 
This brief neuropsychological battery 
assesses executive functioning. Only 
select tests will be used to minimize 
subject burden.  
30-45 minutes 
baseline only 
Total estimated time 
for this portion of 
interview 
 
 
40 –60 minutes 
 
 
 
 
 
Total estimated time for entire baseline 
interview (completed over 2 sessions) 
 
225 – 257 minutes 
 
e) Study Conditions: 
a) ENGAGE is a form of cognitive behavioral therapy (CBT) that specifically targets increased social 
activity. ENGAGE is relatively simple for patients and therapists to master55 and results in significant 
changes in depression in as few as 6-8 sessions.56 The study will use the ENGAGE manual 
developed by Drs. Alexopoulos, Arean and their colleagues,57 focusing the behavioral activation on 
activities that allow subjects to be social (targeting thwarted belongingness) or contribute to the 
well-being of others (targeting perceived burdensomeness). Sessions will be audio recorded for 
supervision of therapists and completion of ratings of fidelity to the ENGAGE protocol. Sessions will 
be rated for adherence by a certified ENGAGE therapist at the University of California San 
Francisco (UCSF) given that there are no trained ENGAGE therapists on site at the University of 
Rochester. A secure ftp server will be used to provide access to the tapes, described in detail 
below. This collaboration will only involve rating of audiotapes for fidelity and providing feedback to 
study therapists; the rater will not have access to other study data.  
Session 
Session Objectives (per Treatment Manual) 
1 
Obtain psychosocial history and build rapport. Meet with family. Socialize the patient to the 
ENGAGE intervention, including relating current feelings of loneliness and/or burdensomeness to 
social inactivity. Assess suicide risk and review the safety plan created by the assessor. Work 
with the patient to clarify values involved in a “valued life” and Make a list of rewarding social 
engagement goals that address chosen values. Develop an “action plan” with the patient 
consisting of activities that the patient should pursue between sessions. This session may last 
1.5 hours. 
2 
Continue making social engagement action plans. Highlight the relationship between social re-
engagement and improvement in mood.  
3 
Decision-making session:  Continue with action planning if patient is engaging well in the 
therapeutic task. If not, move to Step Two to address barriers to social re-engagement. 

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4-5 
Continue making social engagement action plans. Highlight the relationship between social re-
engagement and improvement in mood.  If patient has moved to Step Two, continue addressing 
barriers as well as creating action plans.  
6 
Decision-making session:  Continue with action planning if patient is engaging well in the 
therapeutic task. If not, move to Steps Two/Three to address barriers to social re-engagement. 
7 
Continue making social engagement action plans. Highlight the relationship between social re-
engagement and improvement in mood.  If patient has moved to Steps Two/Three, continue 
addressing barriers as well as creating action plans. 
8 
Begin discussing termination. Begin reviewing progress and creating a relapse prevention plan; 
meet with family. Continue with action planning and addressing barriers.  
9 
Continue making social engagement action plans. Highlight the relationship between social re-
engagement and improvement in mood.  If patient has moved to Steps Two/Three, continue 
addressing barriers as well as creating action plans. 
10 
Review relapse prevention plan with family and patient. Give additional copies of Action Planner, 
PHQ-9, and INQ-2. Congratulate patient on completing the Engage course. 
 
b) Care-as-Usual (CAU): CAU will involve care-as-usual in primary care with research 
assessments at baseline, 3-weeks, 6-weeks and 10 weeks. In other words, no psychotherapy 
will be provided. However, this condition will involve suicide risk management and depression 
symptom monitoring with the research assessor.  
c) Analytic Procedures: 
i) Overview. Linear mixed effect models (LMM) and weighted generalized estimating equations 
(WGEE) will be used to examine the longitudinal hypotheses concerning treatment differences across 
the 2 conditions, ENGAGE (n=50), and CAU (n=50).58 59 All subjects are assessed at 4 points: baseline, 
3 weeks, 6 weeks, and 10 weeks (i.e., end of ENGAGE treatment).. All measures are assessed at each 
point. For the hypotheses in Aim 3 concerning the interplay between the treatment conditions, social 
connectedness, and depression we will employ structural equation models (SEM).60  All statistical tests 
are two-sided with the significance level alpha = 0.05. 
LMM and WGEE are the two most popular approaches for investigating differences at the population 
level.58-60 Although both provide inference for fixed-effects—parameters describing the characteristics of 
interest such as treatment differences—WGEE provides valid inference under missing completely at 
random (MCAR) and missing at random (MAR), two conditions general enough to accommodate most 
missing data mechanisms arising in practice,59 61 while LMM does so only if the parametric distribution 
assumptions are met.62 Biased estimates may arise if missingness follows neither MCAR nor MAR. 
Although such non-ignorable non-response (NINR) is rare in practice and unanticipated in this study, 
we will examine this issue using the joint modeling approach.63 64 As this approach is not applicable 
under WGEE, we will perform sensitivity analyses by assuming some plausible NINR models.64 65  
Descriptive statistics such as mean and standard deviation for continuous variables and frequency and 
proportion for categorical variables will be used to depict the social-demographical and mental health 
characteristics for the study sample. The intervention groups will be compared to determine if 
imbalances occur in demographics and other pre-treatment measures, by conducting T-test/Wilcoxon 
rank sum test or chi-square tests, depending on the nature of the scale. Any potential confounders will 
be included in all subsequent analytic models. All analyses will be conducted for the intent-to-treat 
sample on the primary outcomes and other secondary outcomes of interest. Analyses will be conducted 
with SAS 9.2 for LMM and GEE/WGEE. The false discovery rate (FDR) will be used to control for 
study-wide type 1 error. 
ii) Power analysis: Since Aims 1 and 2 form the primary hypotheses, power was estimated for 
testing the hypotheses in these Aims.  With n = 50 for BA and n = 50 for CAU, power set at 0.8, a two-
sided alpha = 0.05 and 10% attrition rate, the minimum detectable effect size for comparing the two 
means is 0.51 (Cohen’s d) for comparing BA vs. CAU. 
iii) Analyses for Aim 1, to compare depressed older adults who receive either ENGAGE or CAU 
on levels of connectedness: this analysis proposes a longitudinal analysis on the effect of condition 
(i.e., ENGAGE, CAU) on social connectedness (i.e., loneliness, burden). 

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H1a: There will be a condition effect on both loneliness and burdensomeness (higher scores indicate 
disconnectedness), at 3 months and 6 months, indicating differing levels of disconnectedness in the 
direction: CAU > ENGAGE. Longitudinal models described above will be employed to examine the 
hypothesis, with loneliness (or burden) as the response, and treatment group, time and their interaction 
as the predictors, controlling for the covariates (depression and cognitive decline).  If a significant 
difference exists (as indicated by a significant time by group interaction), appropriate linear contrasts 
will be followed to confirm the hypothesized directional effects.    
H1b: This hypothesis proposes to examine the role of gender as a potential moderator of the 
intervention’s effectiveness. The moderation analysis will be examined by including gender and the 
interaction of condition and gender in the GLMM/GEE or WGEE analyses for each of the primary 
outcomes (i.e., loneliness and burden) described in H2a. A significant interaction indicates that gender 
moderates the effect of treatment condition on the primary outcomes.  
 
iv) Analyses for Aim 2, to compare ENGAGE and CAU on indicators of suicide risk. 
H2a/b: As with H1a, longitudinal models will be employed to examine the condition effect, but with 
depression severity (H2a) and death ideation severity (H2b) as the dependent variables. 
v) Analyses for Aim 3, to examine connectedness as a mechanism whereby BA reduces 
depression. 
H3a/b:  A latent growth model with concurrent growth processes66 and cross lagged components67 will 
examine the hypotheses for Aim 3. First, that growth in connectedness (slope loneliness; Slon) will be 
associated with decrements in depressive symptoms (slope depression, Sdep; H3a), while accounting 
for baseline influences of cognition (H3b). The directional hypothesis (H3c) will be examined with the 
cross-lag component of the model; specifically, whether level of connectedness at 3 months (after the 
acute phase of BA) predicts depressive symptoms at 6 months. Finally, to model the effect of 
experimental condition (H3d), a multiple group model68 will be specified to test whether the parameters 
of interest differ significantly as a function of condition. Separate models will be run for loneliness and 
burdensomeness. Cognitive functioning at baseline will be added as a time-invariant covariate to the 
model.  
d) Data and Safety Monitoring Plan: The purpose of the Data and Safety Monitoring Plan 
(DSMP) is to specify the procedures and rationales of the current study to ensure the safety of 
participants and the validity and integrity of the data. This specifies who will look at the data and 
review any adverse events, how often, and what they are authorized to do. The use of Data and 
Safety Monitoring Boards (DSMBs) may be indicated if the studies have multiple clinical sites, 
are blinded (masked), and/or employ particularly high-risk interventions or vulnerable 
populations. This study on the other hand will be conducted at one site utilizing a low risk 
intervention. Therefore, we have chosen to include a modified DSMB that, while constituted by 
individuals connected to the study, will systematize monitoring safety issues throughout its 
duration. 
DSMB Membership: Nancy Talbot, Ph.D. will chair the DSMB. Other members will include Kimberly 
Van Orden, Ph.D., Yeates Conwell, M.D and Jeffrey Lyness, MD.  Dr. Talbot is Associate Professor of 
Psychiatry, in the Department of Psychiatry at the University of Rochester. Dr. Talbot has directed two 
NIMH-funded clinical trials among depressed women with trauma histories -- a population at high risk 
for self-harming and suicidal behaviors. Dr. Van Orden is the principal investigator of the project and Dr. 
Conwell is the primary mentor. Dr. Lyness is the outside member of the DSMB and is Associate 
Professor of Psychiatry at URMC and an expert in research and clinical care of older adults. 
DSMB Responsibilities and Actions: The DSMB will maintain an overview of the quality of the 
accumulating data and provide guidance to the PI on interim analyses and stopping rules. The DSMB 
will also serve as liaison among study investigators and the University of Rochester Medical Center 
Research Subjects Review Board (RSRB) and the NIH. It will review and approve, disapprove, or 
suggest modifications to the study protocol and/or consent documents to assure both scientific integrity 
and that studies adhere to human subject protection policies. It will monitor, provide feedback, and 
report on scientific and ethical issues related to study implementation for the protection of human 
subjects and advise on ethical issues related to adverse events. The DSMB will monitor adverse event 
reports for purposes of determining whether their nature, frequency and severity are consistent with 

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expectations. It will report to the RSRB and NIH any unanticipated problems involving risks to subjects 
(per 45CFR46). If considered related to the study, unanticipated adverse events involving risks to 
subjects or to others must be reported by the P.I. and/or DSMB to the RSRB. The RSRB will promptly 
inform NIH. Along with the RSRB and NIH staff, the DSMB can recommend remedies or other 
appropriate actions such as introducing new monitoring protocols, altering inclusion or exclusion 
criteria, or recommending changes in the informed consent documents.  As well, the DSMB will be 
charged with ensuring that the study protocol maintains subjects’ confidentiality in a manner that is 
appropriately balanced with issues of clinical care and safety, where relevant, and will monitor data 
management activities. The DSMB will review requests for interim analyses and approve, disapprove, 
require additional information, or defer decisions. The DSMB will be kept apprised of all severe adverse 
events on an ongoing basis and will serve as the final arbiters of whether individual subjects should be 
removed from the protocol. The DSMB will be called upon whenever possible to render judgments in 
the advent of a severe adverse event. We acknowledge that there may be rare instances where some 
emergent situation occurs that was unanticipated regarding the welfare of the subject. In these 
situations, the University of Rochester Medical Center's RSRB or the DSMB may be contacted to help 
resolve the situation. 
Meeting Schedule: At a minimum, the DSMB will convene on an annual basis. DSMB conferences will 
be assembled in-person, and conducted in accordance with federal and state health privacy legislation 
and relevant standards. The Chair and the P.I. will determine meeting logistics based upon urgency 
and the availability of DSMB members. 
e) Data Storage & Confidentiality:  
Study data will be collected on hard-copy forms of the measures during the in-home interviews. 
These hard copies will remain in the possession of the CRC for immediate transport back to the 
University site and placed in a locked file drawer in a locked office.   
Data will be entered into a password protected, secure web-based application called REDCap 
(Research Electronic Data Capture). The electronic data capture system provides a secure, HIPAA-
compliant web-based application that is flexible enough to be used for a variety of types of research, 
provides an intuitive interface for users to enter data and has real time validation rules (with automated 
data type and range checks) at the time of entry. 
REDCap servers are housed in a local data center at the University of Rochester and all web-based 
information transmission is encrypted.  REDCap was developed in a manner consistent with HIPAA 
security requirements and is recommended to University of Rochester researchers by the URMC 
Research Privacy Officer and Office for Human Subject Protection.  
No protected health information will be stored on portable media, including laptop computers or 
removable hard drives.  The data (including names and all identifiable information) will be encrypted 
using SSL.  Only authorized study personnel and regulatory personnel (e.g. auditors) will be allowed 
access to data.  All access to the database will be controlled by passwords with varying levels of 
security and access.   The data on the audio recorder will be identified only by an ID number, with no 
PHI. In the case that a study subject states information during the sessions that would be considered 
PHI, the audio recorder will be password protected and the audio recording deleted immediately upon 
transfer to the hard drive of the PI’s desktop computer. Audio recordings for the ENGAGE sessions will 
be uploaded onto a secure, HIPAA compliant FTP server behind the UCSF (University of California San 
Francisco) firewall. The UCSF Psychiatry Cerberus FTP Server is HIPAA compliant; it provides the 
necessary access controls to ensure that data is not accessed by unauthorized users. Cerberus FTP 
Server provides full logging of all FTP activity.  
Users will be assigned access to the application by personnel in the Department of Biostatistics and/or 
study personnel.   REDCap also tracks who enters the data.   
In addition, all applications, projects, and user accounts are stored on mirrored disks. If one disk should 
fail, the remaining disk of the mirror is used, and no data loss or downtime is experienced. Weekly, a 
backup is removed from the site and stored in a secure location. Only specific users are allowed access 
to projects; the system administrator specifies these users.  Watcher programs are used to keep a 
close eye on disk utilization, rogue, user and daemon processes, as well as rogue system alterations.  

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These programs help to tune the system for maximum performance and help maintain the reliability of 
the system.  Security monitoring programs are used to alert us to possible security holes, which may be 
exploited by would-be crackers. The University of Rochester Medical Center also maintains a firewall in 
front of their Enterprise network, providing an additional level of security. 
In order to protect the confidentiality of subject information, we will take a number of precautions. These 
include training of research interviewers in confidentiality procedures; entry and storage of data using 
coded identification labels; maintenance of project computers (both PRN and clinical research 
hardware) in secure locations with restricted access by enforced password protection. 
 
IV. RISK BENEFIT ASSESSMENT 
1. Risk Category 
Greater than minimal risk. 
 
2. Potential Risks 
For the questionnaires and interviews, the primary risk is invasion of privacy, breach of confidentiality (if 
high risk for suicide, elder abuse, or other safety issues are detected), or mild reactions of distress or 
fatigue. Given that assessments and treatment are conducted/provided in the subjects’ homes, others 
could be present, which risks revealing the subject's participation in the study; subjects will have full 
discretion in having others present. All assessment measures and procedures have been safely used in 
previous research with older adults; no sustained negative effects from assessments are expected, but 
negative outcomes cannot be ruled out. Subjects were selected due to the presence of social 
disconnectedness and depression, which are risk factors for suicide. Therefore, all subjects are at higher 
than average risk for suicide. However, that risk is moderated by the fact that we will exclude all potential 
subjects at imminent risk for suicide and initiate indicated interventions to assure their safety, which might 
include referral to a comprehensive geriatric psychiatry clinic that provides both psychopharmacology and 
psychotherapy and/or emergency psychiatric services, including the psychiatric emergency department at 
Strong Memorial Hospital (the Comprehensive Psychiatric Emergency Room, CPEP).  
The treatment, ENGAGE, carries the risk of worsening subjects’ moods or causing emotional distress. 
ENGAGE has been used in numerous studies with suicidal and/or depressed older adults with overall good 
effects. No sustained negative effects are expected, but negative outcomes from psychotherapies cannot 
be ruled out. The study therapists are experienced in working with depressed and socially disconnected 
older adults. Progress notes for each session must include a suicide risk assessment. Subjects who exhibit 
or describe heightened distress during treatment or assessments will be immediately assessed for safety 
and suicide risk by therapists or assessors. All subjects will have access to hospital crisis intervention 
services, evaluation in the psychiatric emergency department (CPEP). Subjects who describe active 
suicidal ideation with intent to act will be evaluated for inpatient or partial hospital admission. Decisions 
about suicidal intent will be based on the risk assessment protocol (described below).  
Regarding alternative interventions, subjects will not be prohibited from seeking out supportive social 
services, or volunteering their services to others (for ethical reasons). If a subject in the ENGAGE group does 
engage these services, he/she will be followed for the duration of the study, with documentation of the nature 
and extent of that engagement, and evaluation of its impact on the outcomes of interest.  
 
No restriction on medications or concurrent psychotherapy is made for subjects in either arm, but subjects 
will be asked to refrain from initiating new psychotherapeutic treatment during the 10-week trial. 
 
 
3. Protection Against Risks 
• 
We propose to manage potential distress elicited by the research assessment with implementation of a 
“Mood Improvement Protocol” (MIP) adapted from procedures designed by suicide prevention researchers 
at the University of Washington. The MIP is designed to enhance retention and improve subjects’ experience 
in the research assessments. The researchers at UW found that some subjects become distressed when 
answering questions about suicide risk, and in similar studies, we have received feedback from subjects that 

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they find the suicide questions distressing. While these subjects are in the minority, we propose to include 
procedures to help such subjects manage distress that arises during the research assessments. Specifically, 
the MIP involves the research assessor (study staff) collaboratively creating a coping plan for managing 
distress with the subject prior to completing the interview. Such coping strategies include: engaging in chit 
chat with study staff, sharing a cup of tea, etc. (please see attached MIP for other activities). The protocol 
also involves having the subject rate his/her level of distress at the start of the interview and after the 
interview,. This will allow study staff to better manage the risk of distress by providing a gauge of subjects’ 
change in level of distress at the conclusion of the interview.. If a subject remains highly distressed after the 
interview (highly unlikely), study staff will engage in a coping activity with the subject and/or call the Project 
Director, a clinical psychologist, for guidance.  
• 
The CRC’s will be trained in the study’s suicide risk screening protocol, which involves the Columbia Suicide 
Screening form, Geriatric Suicide Ideation Scale, Firearm Safety Management Form, and clinical interview. 
Any subject who endorses death or suicidal ideation will be asked additional questions to assess his/her 
safety. Any endorsements of active suicidal ideation will involve notifying Dr. Van Orden (or Dr. Conwell) for 
review of risk and protective factors and consideration of emergency psychiatric services.  
• 
Subjects in the ENGAGE arm will be monitored for increases in depressed mood each week and discussed 
at a meeting with the study therapist and PI each week. These meetings will be held to promote subject 
safety and well-being. Further, after the research assessments a standardized review process will be 
conducted for each subject, including a review of depression symptom change (or lack thereof), treatments 
received (both pharmacological and behavioral), and suicide risk.  
 
• 
Informed Consent Procedures: A CRC will obtain verbal consent from subjects before beginning the phone 
screening. At the conclusion of the phone screening, the CRC will explain that written informed consent will 
be obtained at the next assessment in the home, and that if they have privacy concerns the consent process 
can be completed in an office at the medical center (with transportation reimbursement provided). The CRC 
will obtain written consent from subjects before the baseline in-person assessment only after subjects have 
received both verbal and written explanations of the study and indicated their full understanding. They will 
be informed that the study is designed to examine the effects of counseling on social supports of older adults 
in the community. They will be informed of their rights as research subjects, including the right to refuse to 
participate in the study, and to withdraw their consent at any time, as well as potential risks and benefits of 
participation, including financial compensation, and rights to privacy and confidentiality. Specifically, 
individuals will be told that questions asked may cause them to feel uncomfortable or upset. They will be 
informed that: they may withdraw from an assessment at any time for any reason and still receive full 
reimbursement for that assessment; and they may withdraw from the research study at any time without 
negative consequences to their treatment in the Strong Memorial Hospital healthcare system. Moreover, 
participants will be informed that they will be asked to participate in assessments whether or not they 
complete treatment, that they will be financially compensated for participation in assessments whether or not 
they complete treatment, that they have the right to refuse to participate in any study assessment session. 
Subjects will be compensated for the assessment sessions for their time and effort ($40 for each baseline 
interview, $10 for phone follow-ups and $20 for follow-up in person interviews). Data storage and safety will 
also be described to them. Informed consent will also include information about costs of psychotherapy (i.e., 
no cost). Subjects will be informed that psychotherapy during the trial will be provided free of charge in the 
subject’s home. Subjects will be asked to provide a release of information for relevant medical records and 
social services records if referred for case management. The process of random assignment will be 
described to subjects as “the flip of a coin.” 
o Subjects will be informed that study staff will perform an immediate evaluation of their dangerousness 
towards self or others should safety concerns arise during assessments or treatment sessions. 
Subjects will also be informed that their confidentiality may be breached should concerns arise about 
their dangerousness to self or others. Finally, they will be informed that suspected child abuse will be 
reported, as mandated by law. 
o A small minority of participants may experience elder abuse. In the case of suspected elder abuse, 
subjects will be given an immediate referral to the Elder Abuse Prevention Program (EAPP) of 
Rochester, which provides crisis intervention services. A phone call will be made to the primary care 
provider. Any suspected cases of elder abuse will be immediately reviewed with the PI before the 

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CRC leaves the home. The PI will also be in contact with Dr. Conwell regarding potential imminent 
dangerousness, which may involve the use of emergency services and law enforcement authorities.  
o When obtaining informed consent, a “Determination of Capacity for Informed Consent” protocol 
developed will be utilized. The consent form will be read aloud to subjects, who will be encouraged 
to ask questions throughout the process. At the conclusion of the consent process and prior to 
requesting that they sign the form, all clients are asked the following questions: 
 
Could you please tell me what this study is about? 
 
What are the potential risks to you of participating in this study?  
 
What are the benefits for participating in this study?  
 
Do you understand that your participation in this study is voluntary and that you may stop at 
any time or not answer any questions that you feel uncomfortable answering?  
 
Do you have any questions about the interview or the treatment?  
 
If in answering these questions the subject is unable to demonstrate an understanding or 
appreciation of the issues, the investigator and subject further review the consent form and 
repeat the pertinent questions. Subjects who achieve a demonstrated understanding of the 
study are determined to have capacity to provide informed consent. For those who do not, 
they are thanked for their time, informed that they are not eligible for the study, and provided 
reimbursement for the assessment.  Subjects’ answers are characterized on a checklist that 
is kept with the research record as documentation of the consent process. 
• 
In order to protect the confidentiality of subject information, we will take a number of precautions. These 
include training research interviewers in confidentiality procedures; entry and storage of data using coded 
identification labels; maintenance of project computers in secure locations with restricted access by 
enforced password protection. Back-ups of all study files will be made daily to allow for recovery of data 
due to disk failure. Risks associated with subject burden or distress will be minimized by employment of 
research personnel with appropriate backgrounds and experience and work with psychological factors and 
elderly subjects. The baseline research interview will last approximately two hours in total. Given the length 
of time involved for this assessment, and concerns regarding subject health and well-being, subjects will be 
reminded that if they become fatigued, they may terminate the interview at any time, and that the interview 
can be conducted over multiple sessions as needed. Research personnel will further be trained to 
recognize potential signs of fatigue among elderly subjects, and to actively suggest alternative data 
collection strategies (including telephone-based and mail-in interviews), in order to reduce the possibility of 
overwhelming study subjects and to ensure completeness of data collection. These strategies have been 
employed effectively in Dr. Van Orden’s and Conwell’s past research involving older adult populations.  
All patient data, including assessment measures and audiotaped sessions, will be obtained with the written 
consent of the patient. Information pertaining to individual participants will be released with the patient's 
informed and written consent only, except in unusual cases where withholding the information might pose a 
serious risk or danger to the participant or others. All patient data will be identified by a uniquely coded 
study number assigned to each participant. Access to the master list of study numbers will be restricted to 
Dr. Van Orden and the CRC. Confidentiality will be further maintained by the storage of "hard copy" data in 
locked files in a locked office. Access to computerized data is restricted and subject to review by Dr. Van 
Orden and Dr. Tu. Publications or presentations will report only cumulative data or descriptions certain to 
maintain participants' anonymity. 
All data collection involving human subjects will be HIPAA compliant. All data involving human subjects will 
be stripped of any identifiers; a unique ID will be generated to link to a file and will not be stored in the 
central database repository. The data will be encrypted by applying a special scrambling code that makes 
the data unreadable to anyone who does not have a decryption key. Authorized personnel with access to 
the this key can unscramble it. This file will be stored on a separate server and will only be accessible to 
database administrators with the appropriate permissions. 
In order to protect confidentiality during the provision of the intervention, subjects will be given information 
at the time of randomization that the ENGAGE sessions should be treated like any other medical 
appointment, including that if they have privacy concerns, they should arrange for others in the home to be 

Van Orden K23 18 
 
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out of the home at the time. As an alternative, subjects may complete ENGAGE sessions in an office at the 
medical center. 
• 
Monitoring of Subjects and Crisis Management Procedures 
Risk to study subjects will be minimized by only employing experienced and well-trained and clinically 
experienced interviewers, supervised by clinicians with expertise in geriatric mental healthcare. Subject well-
being will be carefully monitored throughout the study. If the clinical information obtained in the course of 
research assessments pertains to patient safety, (e.g., intent to harm one's self or others), then confidentiality 
will not be maintained and appropriate treating professionals will be informed. Previous studies by the 
investigators have successfully employed a risk management protocol that involves the assessment of elder 
research subjects for potential suicidality, including presence, frequency, and intensity of suicidal thoughts and 
impulses, and presence of a plan to harm one's self. See attached measures: Safety Protocol Worksheet and 
Firearm Safety Management Form. In the event that a subject reports either no suicidal thoughts or only transient 
or fleeting suicidal thoughts without a suicide plan or specific suicidal intent within the past month, they will be 
encouraged to discuss these issues with the physician or other healthcare professional(s). In the event that an 
older adult reports having seriously considered suicide in the past month or a strong desire or impulse to harm 
one's self, current risk will be assessed in terms of the subject's likely control over his or her suicidal thoughts 
and impulses. If the subject can convincingly demonstrate control over his or her suicidal thoughts and impulses 
to study staff, the staff member will contract for safety with the subject and will contact Dr. Van Orden (or Dr. 
Conwell) and report their concerns to them. Additional resources may then be notified, including the subject's 
physician or other healthcare professional(s), and/or family member(s). If the subject cannot convince the study 
personnel that they are capable of controlling their suicidal impulses, the study staff member will remain with the 
subject and will call Dr. Van Orden and/or other clinical backup for assistance. Additional clinical resources may 
be notified, including the subject's physician or other healthcare professional(s), a mobile crisis unit of the 
Department of Psychiatry of the University of Rochester, and/or emergency response services. Family 
member(s) may additionally be notified. 
 
• 
Monitoring Adverse Events (AEs) and Serious Adverse Events (SAEs).  
We will abide by the rules governing reporting of adverse events as defined in NIMH Policy on Data and 
Safety Monitoring in Clinical Trials (September 2002, revised 2007). Any event will be reported to the RSRB if it 
is “serious,” “unexpected,” and “related.” 
Reportable Events: Definition of terms 
• 
“Serious” means any event that causes a prolonged or permanent harm that is psychological, social, 
legal or financial. Examples most pertinent to this study include a subject’s death from any cause; a 
suicide attempt or hospitalization due to depression. 
• 
“Unexpected” means that the event was unforeseen and has not been previously encountered, known, 
or recognized and was not identified in nature, severity, or degree of incidence in the protocol, supporting 
documentation, the informed consent document, or the RSRB application. 
• 
“Related to the study” means that there is some aspect of the study (e.g., a research procedure, existence 
of a laptop database, etc.) that is directly related to the event. An example pertinent to this study is breach 
of confidentiality by which private information about the subject was made known to other community 
members. Events for which the relationship to the study cannot be clearly determined based on review 
of all available data will be classified as “possibly related to the study” and reported according to the same 
guidelines as for related events. 
• 
“Event” is an incident, experience, or outcome that occurs to a subject participating in an RSRB-approved 
research study. 
 
AEs are reported to the sponsor on an adverse events form as part of annual progress reports, regardless 
of whether they are considered study related. The date and time of onset and outcome, course, intensity, action 
taken, and causality to study treatment will be assessed. 
The Principal Investigator has the final decision regarding what is to be reported on the adverse event form, 
and has the option to reclassify an AE as a serious adverse event (SAE).  
In case of an SAE: The date and time of onset and outcome, course, intensity, action taken, and relationship 
to study treatment will be assessed. SAEs will be reviewed by the PI weekly.  SAE’s will be reported to the RSRB 
in the form of a written report per the URMC RSRB “Guidance for Reporting Reportable Events to the RSRB” 

Van Orden K23 19 
 
RSRB00047459 
document. SAE’s will only be reported to the RSRB when they are unexpected and related to participation in the 
study. In this case, the report will be made within 10 calendar days of the investigator's discovery of the event.  
Information about AEs and SAE’s will be obtained through ongoing interactions with the primary care 
providers of subjects in both arms of the study, and from the therapists of those subjects assigned to the 
intervention arm. 
 
• 
Confidentiality: Limits and Precautions 
The present study includes a documented plan for the collection, storage, protection and analysis of research 
data. The key components of this plan include restriction from unauthorized access to identifiable subject data, 
storage of data to protect against inadvertent loss, and use of appropriate database software tools to maintain 
integrity of data for subsequent analyses. All research files will be coded using a study identification number. 
Subject identifying information and PHI will be stored separately from other data collected for this study and will 
only be accessible by those investigators, Lifespan or University clinicians, or staff who have a need to know this 
information for the purpose of conducting the study. All identifying data will be stored in locked cabinets and 
locked offices or in password-encrypted files. Access to these files is limited to investigators and support 
personnel with the need to enter or analyze data. 
All research and clinical information obtained is kept confidential unless the subject is an immediate danger 
to him or herself or to others (Note: clinically relevant but not life threatening information may be shared with 
outside personnel with subject permission). During crisis situations, this clinical information may be provided to 
other clinicians (or family members) in order to facilitate appropriate treatment and minimize the risks of self-
harm or harm to others. This information may include the subject's clinical diagnosis, psychiatric and medical 
history, current medication and treatment status, response to psychiatric or substance abuse treatment, financial 
and social resources, and history of suicidal behavior, if known.  
If study personnel identify inappropriate treatment practices by an outside professional (e.g., inappropriate/ 
dangerous medication combinations given to a vulnerable elder) key study personnel will be consulted and a 
course of action will be planned that balances subject confidentiality with his or her safety. Normally, consent will 
be obtained from the subject to speak to the other treating professional and express concerns. If the subject 
refuses to provide consent to speak with the professional, the degree of danger to the subject will be the primary 
barometer to determine the appropriate steps. 
 
• 
Certification of Research Personnel in the Protection of Human Subjects  
In order to ensure appropriate human research knowledge, all study personnel interacting with subjects or 
with access to subject research will have completed mandatory training in the protection of human research 
participants per guidelines issued by the U. S. Department of Health and Human Services, Office for Human 
Research Protections (see http://ohrp.osophs.dhhs.gov/) and per guidelines of the University of Rochester 
Medical Center. Any additional personnel will complete this training before interacting with study subjects.  
Consistent with University of Rochester Research Subjects Review Board (RSRB) policy, all investigators 
and research staff will complete certification by the RSRB—required completion of a course that contains seven 
modules dealing with topics such as “Ethics and Federal Regulations,” “Roles and Responsibilities of the 
Investigator and the Study process,” and “Roles and Responsibilities of Institutions in Human Subjects 
Research,” among others. The program provides a substantial resource to the investigator for understanding the 
ethics and regulations governing research with human subjects.  
It is also University of Rochester policy that all research and clinical staff who may be in contact with protected 
health information (PHI) demonstrate a working understanding of the University of Rochester's Notification of 
Health Policies and Practices form. This information form describes to patients and research subjects the 
University's policies and procedures regarding PHI, consistent with the federal Health Insurance Portability and 
Accountability Act (HIPAA) and with other relevant university regulations and local, state, and national legislation. 
All investigators and research staff will complete an information and training session on HIPAA legislation, the 
University's Notification of Privacy Practices, and on ethical conduct of research in accordance with this 
legislation and with University regulations. This training session will be developed, in tandem, by training staff in 
the Department of Psychiatry and by the HIPAA compliance officer for Lifespan. 
 
4. Potential Benefits to the Subjects 

Van Orden K23 20 
 
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Half of the study subjects will receive a psychotherapy aimed to increase connectedness – an intervention 
that target significant risk factors for suicide, namely social isolation and depression. Thus, the potential 
benefit to the individual may be significant. Subjects may additionally benefit from participating in research 
interviews and completing the questionnaire measures, as these assessments provide them with the 
opportunity to be carefully listened to and comprehensively evaluated. They may further benefit from 
feelings of altruism connected with participation in research designed to better understand the mental 
health needs and experiences of community-residing older adults. Given the level of risks associated with 
the proposed research and the substantial gains both to the individual and older adults more broadly, 
benefits appear to outweigh the risks. 
 
5. Alternatives to Participation 
Regarding alternative interventions, as mentioned above, subjects assigned to ENGAGE or CAU will not be 
prohibited from seeking out medication for treatment for depression. We will ask that subjects assigned to 
the ENGAGE condition refrain from engaging in other psychotherapies while they are engaged in ENGAGE. 
 
VII. SUBJECT IDENTIFICATION, RECRUITMENT AND CONSENT/ASSENT 
1. Method of Subject Identification And Recruitment 
Recruitment strategies involve: 
1) initial contact: 
a. information and invitation letter in primary care practices;  
b. informational letter sent to home inviting interested individuals to call to learn more 
c. advertisement – newspaper ad, blog article, flyers, etc. 
d. Direct referral via providing an informational letter from physicians and care managers. 
2) informational phone call;  
3) home visit for written informed consent and assessment. 
As described in the Procedures section, 
2. Process of Consent 
 The CRC will obtain written consent from subjects before the baseline in-person assessment only after subjects 
have received both verbal and written explanations of the study and indicated their full understanding. They will 
be informed that the study is designed to examine the social supports of older adults in the community, and 
whether people receive benefit from companionship. They will be informed of their rights as research subjects, 
including the right to refuse to participate in the study, and to withdraw their consent at any time, as well as 
potential risks and benefits of participation, including financial compensation, and rights to privacy and 
confidentiality. Data storage and safety will also be described to them. Finally, the process of randomization to 
one of two conditions will be described; subjects will be told that if they choose to participate they will randomly 
assigned to one of two conditions: one condition that involves only the baseline and follow-up assessments, or 
a condition that involves participation in ENGAGE. 
 
3. Subject Comprehension and Capacity to Consent 
A Capacity for Informed Consent protocol will be implemented for all potential participants (see attached 
document: “Determination of Capacity for Informed Consent”). The capacity assessment will consist of a series 
of open ended questions administered to the subject that follow explanation of the study. It will address the 
subject’s knowledge and understanding of the study’s objectives, the voluntary nature of participation, ability to 
withdraw at any time, consequences of withdrawing, possible risks and benefits of participation. For subjects 
who have difficulty in one or more of these areas, further review of the relevant elements of the study will be 
provided in order to improve their knowledge and understanding to a level that enables them to make a 
meaningful choice about participation. A form (i.e., “Determination of Capacity for Informed Consent”) will be 
completed for each subject documenting the results of the decision-making capacity determination, a copy of 
which is maintained with the consent form.  
 
4. Debriefing Procedures 
Participants are given feedback about their level of depressive symptoms (and other psychiatric symptoms 
endorsed) in a manner that is understandable and useful (i.e., psychoeducation). At the end of the follow-up 

Van Orden K23 21 
 
RSRB00047459 
period, those assigned to CAU will be given information about ENGAGE and should they desire psychotherapy, 
referrals will be made to agencies providing these services. 
 
5. Consent Forms 
See attached. 
 
 
6. Documentation of Consent 
All signed consent forms will be stored in a locked file in a locked office, separate from other non-identifying 
subject data.  Only study staff will have access to these files.  All subjects will receive a signed copy of the 
consent form for their records. 
 
7. Costs to the Subject 
There are no costs to the subject. All assessments are completed in-home. 
 
8. Payment for Participation 
Participants will be paid $40 for the baseline interview and $20 for each in person follow-up interview, and 
$10 for phone follow-up interviews. Each participant, therefore, may be reimbursed a maximum of $80 for 
their time and effort. 
 
 

Van Orden K23 22 
 
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