The Effectiveness of Life Story Book on Depression and Meaning in Life for Mentally Alert Residents of Nursing Homes
Phase: NA
Conditions: Depressive Symptoms, Quality of Life
Sponsor: University of Houston

FULL PROTOCOL TITLE:   The Effectiveness of Life Story Book on Depression and  
Meaning in Life for Mentally Alert Residents of Nursing Homes 
MOD00002110 
Page 1 of 20 
Revised: June 27, 2019 
UH IRB Approved 
6/28/2019 - 2/5/2020 
 
 
 
Title:  Life Story Book With Mentally Alert Residents of Nursing Homes  
 
NCT Number:  NCT03851016  
 
Document Date:  June 28, 2019 
 
 

FULL PROTOCOL TITLE:   The Effectiveness of Life Story Book on Depression and  
Meaning in Life for Mentally Alert Residents of Nursing Homes 
MOD00002110 
Page 2 of 20 
Revised: June 27, 2019 
UH IRB Approved 
6/28/2019 - 2/5/2020 
PRINCIPAL INVESTIGATOR: 
Theresa C. Chrisman, LMSW, Doctoral Student 
Graduate College of Social Work  
713-447-3334 
tcchrism@central.uh.edu  
Submission deadline – January 23, 2019; review February 6, 2019.  IRB #3      

FULL PROTOCOL TITLE:   The Effectiveness of Life Story Book on Depression and  
Meaning in Life for Mentally Alert Residents of Nursing Homes 
MOD00002110 
Page 3 of 20 
Revised: June 27, 2019 
UH IRB Approved 
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Table of Contents 
1.0 Objectives ................................................................................................................................. 3 
2.0 Background ............................................................................................................................... 4 
3.0 Inclusion and Exclusion Criteria .............................................................................................. 5 
4.0 Vulnerable Populations ............................................................................................................. 6 
5.0 Number of Subjects .................................................................................................................. 6 
6.0 Recruitment Methods ............................................................................................................... 7 
7.0 Multi-Site Research Communication ....................................................................................... 7 
 
8.0 
Study Timelines....................................................................................................................6 
9.0 
Study Endpoints....................................................................................................................7 
10.0 
Procedures Involved .............................................................................................................7 
11.0 
Setting.................................................................................................................................11 
12.0 
Drugs or Devices ………………………………………………………………………….11   
13.0 
Risks to Subjects.................................................................................................................12 
14.0 
Potential Benefits to Subjects.............................................................................................12 
15.0 
Provisions to Monitor Data to Ensure the Safety of Subjects ............................................12 
16.0 
Withdrawal of Subjects.......................................................................................................13 
17.0 
Costs/Payments to Subjects................................................................................................13 
18.0 
Compensation for Research-Related Injury........................................................................13 
19.0 
Confidentiality....................................................................................................................13 
20.0 
Provisions to Protect the Privacy Interests of Subjects ......................................................14 
21.0 
Informed Consent Process..................................................................................................15 
22.0 
Process to Document Consent in Writing...........................................................................15 
23.0 
HIPPA..................................................................................................................................15 
24.0     FERPA…………………………………………………………………………………………… 16 
25.0 
Data Management...............................................................................................................15 
27.0 
Community-Based Participatory Research.........................................................................16 
28.0 
Sharing of Results with Subjects........................................................................................17 
29.0 
Resources............................................................................................................................17 
30.0 
Additional Approvals..........................................................................................................18 
 
1.0 
Objectives 
The purpose of this research is to test quantitatively the effectiveness of the Life Story Work 
(LSW) intervention, with a book product (LSB), for reducing depression and increasing 
meaning in life (MIL) for mentally alert nursing home (NH) residents.   
The overall objective is to improve the quality of life for residents of NHs by determining 
whether the LSB intervention will have a greater and longer lasting effect compared with care 
as usual (i.e., decreased depression and increased meaning in life).  
Hypothesis I  LSB will lead to greater reductions in depressive symptoms than care 
as usual. 

FULL PROTOCOL TITLE:   The Effectiveness of Life Story Book on Depression and  
Meaning in Life for Mentally Alert Residents of Nursing Homes 
MOD00002110 
Page 4 of 20 
Revised: June 27, 2019 
UH IRB Approved 
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Hypothesis II  LSB will lead to a greater increase in MIL than care as usual.   
My central hypothesis, formulated from my preliminary research, is that the LSB intervention 
will improve the quality of life for mentally alert NH residents and will have longer lasting 
effects than care as usual.  If effective, it may offer a non-pharmacological intervention for 
improving care and quality of life for NH residents.  
 2.0 
Background 
Depression and lack of MIL are major concerns for residents of NHs. Residents have been shown 
to be at an increased risk for depression [1], [2]; with approximately 50% having a diagnosis of 
depression [3]. Although nearly half of NH residents are diagnosed with depression, depression 
still remains poorly recognized because it often co-occurs with other chronic medical conditions 
[3]. 
The consequences of depression can be devastating for residents which include decreased 
physical, cognitive and social functioning, greater self-neglect, and an increased risk of 
morbidity and the risk of suicide [4], [5]. In addition, untreated depression may result in the 
development of, or the worsening of, medical conditions [6]. 
Meaning in life has been shown to be a protective factor against depression [7]. Whereas a 
decrease in MIL has been shown to also have a relationship with deterioration of physical health, 
cognitive decline, and mortality [8], [9]. 
Pharmacological interventions for depression are the strategies that are typically used to treat 
depression in NHs.  Furthermore, antidepressant medications have been shown to increase an 
older adults’ risk for falls [10] and despite the many other undesirable side effects for older 
adults, they are often the first line of treatment for depression [11]. 
NH policies and programs have emphasized a medical model of care that has focused on quality 
of care and pharmacological interventions [12].  Unquestionably, quality of care is extremely 
important, but quality of life is also critical to health [13], [14], and non-pharmacological 
psychosocial interventions are often undervalued [15].  This common, long-standing practice of 
using antipsychotic medications is causing serious harm to these frail older adults [16], [17].  
The Centers for Medicare & Medicaid Services has led a nationwide directive to reduce the use 
of antipsychotic medications [18].      
The personalization of interventions that allow for exploring autobiographical memories, such as 
the reminiscence intervention LSB has been shown to have significant effects on depression and 
psychological well-being.  
LSB is a reminiscence intervention designed to provide a person with the opportunity to review 
their past and capture their life story into something tangible. It involves another person listening 
and assisting the person to review and sometimes evaluate their life [19].    

FULL PROTOCOL TITLE:   The Effectiveness of Life Story Book on Depression and  
Meaning in Life for Mentally Alert Residents of Nursing Homes 
MOD00002110 
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Revised: June 27, 2019 
UH IRB Approved 
6/28/2019 - 2/5/2020 
Each life story is recounted in chronological order, from childhood to their current age, and 
involves compiling the person’s history, stories, information, photographs, texts, memorabilia, 
into something tangible [20], [21], [22].  This tangible product is then a reminder or visual aid of 
the individual’s life history. 
LSB’s premise is that every person has a story - a personal history - with events, people, 
circumstances, actions, feelings, insights, thoughts, learning, and milestones that define who they 
are [23], [20], [24].    
  
Previous studies for LSB for persons with dementia reported positive outcomes on aspects of 
cognition and mood [25], [26].  However, there is a gap in the literature regarding the effects of 
LSB on depression and MIL for residents of NHs who are mentally alert [27], [28].  Mentally 
alert residents of NHs, who make up almost 50% of the population of NHs, also need effective 
interventions that maintain their health and well-being.    
Improving quality of care and quality of life for older adults living in NHs, while reducing the 
use of pharmacological interventions, is a critical need [18].  The proposed research has the 
potential to provide a non-pharmacological psychosocial intervention for reducing depressive 
symptoms and increasing meaning in life for mentally alert nursing home residents. This 
research is aligned with the mission of National Institute on Aging to support research related to 
the problems and needs of older Americans and to develop effective interventions that maintain 
their health and well-being [29].   
3.0 
Inclusion and Exclusion Criteria 
Two Medicare and Medicaid certified NHs, located in Harris and Fort Bend Counties, and 
freestanding, or ones that are not a part of a hospital or a continuing care retirement community, 
will be invited to participate in this research.   
Residents of the two selected NHs, ages 57  and older and who have the ability to speak English, 
will be invited to complete an eligibility screening to participate in this study.  Eligibility will be 
determined using the Six-Item Screener (SIS), as measured by a score of 4 or higher for 
cognitive impairment.  
The Six Item Screener (SIS) was specifically developed from the Mini-Mental State  
Examination (MMSE) to screen subjects for cognitive ability to participate in research studies.  
The SIS was found to have good test-retest reliability (.705), internal consistency (.82) and 
sensitivity (.90) [29].  The scale is unobtrusive, only takes 1-2 minutes to complete and can 
easily be incorporated into the initial eligibility assessments [30]. (Please see attached screener).   
Exclusion criteria will consist of residents who scored less than 4 on the SIS, indicating cognitive 
impairment; individuals who do not speak English; and individuals who are not residents of the 
participating NH.  

FULL PROTOCOL TITLE:   The Effectiveness of Life Story Book on Depression and  
Meaning in Life for Mentally Alert Residents of Nursing Homes 
MOD00002110 
Page 6 of 20 
Revised: June 27, 2019 
UH IRB Approved 
6/28/2019 - 2/5/2020 
4.0 
Vulnerable Populations 
Mentally alert residents of the two NHs are eligible to participate in this study with safeguards 
included to protect the welfare, safety, privacy and confidentiality of this vulnerable population.   
The NH administration will assist in identifying potential participants, but the research team will 
assure the residents that participation is completely voluntary, and that refusal to participate will 
not compromise their relationship with the staff or their care.    
Due to institutionalization residents are more susceptible to coercion.  There is the potential that 
residents may feel that they cannot refuse participation when asked by staff, due to the fact that 
residents depend upon that staff for food shelter, health and social services [31].  Again, 
assurances by the research team will be made that participation is completely voluntary and that 
they may decline participation.  
Using the SIS for screening eligibly also ensures that the participants have the cognitive ability to 
understand what will happen in the research, what risks may be involved, and that participation 
is voluntary. In addition, the research team will conduct all eligibility screening in private and 
the results of the SIS will be kept confidential and will not be shared with the potential 
participant or the NH staff.  Potential participants who do not meet the inclusion criteria will be 
informed that for this study they are not eligible.  No identifying information will be collected 
from them.  
All scoring of instruments administered will be kept confidential and will not be shared with the 
NH staff.   
Residents may have hearing or vision problems and may therefore require more time to 
have the study explained to them.  Information flyers and informed consents will be read to 
the residents, along with using larger font.  
Although this population is vulnerable, this research proposes minimal risk and will directly 
benefit participants in providing them with a life story book of their own and has the potential to 
reduce depressive symptoms and increase MIL.       
  
5.0 
Number of Subjects 
Two nursing homes will be recruited for comparison of LSB with care as usual. A power 
analyses for a MANOVA, with 2 groups and 2 dependent variables, was conducted in G*Power 
Version 3.1.9.2 [32] to determine a sufficient sample size. Using an alpha (ɑ) of .05, and a large 
effect size of d = .94 [33], a sample size of 20 could achieve a power of 95% to detect between 
group differences.   
Prior research in long-term care facilities indicates that oversampling by 15-20 percent is an 
efficient way to deal with attrition.  This study will recruit 24 residents, or 12 residents per NH, 
to ensure a sample size of 20.  From these two NHs, a minimum of 20 NH residents (10 per NH) 
and a maximum of 24 NH residents (12 per NH) will be recruited.    

FULL PROTOCOL TITLE:   The Effectiveness of Life Story Book on Depression and  
Meaning in Life for Mentally Alert Residents of Nursing Homes 
MOD00002110 
Page 7 of 20 
Revised: June 27, 2019 
UH IRB Approved 
6/28/2019 - 2/5/2020 
6.0 
Recruitment Methods 
Upon IRB approval, the two NHs will be contacted by telephone and email to provide follow-up 
information about this research study, its objectives and their role in recruitment. (Please see 
attached).  A meeting will be scheduled with the request to meet as many of the NH’s 
management team as possible. For these face-to-face meetings informative flyers with 
background information and simplified research procedures will be provided. (Please see 
attached).  In addition, every effort will be made to recognize the NH’s contribution to the study 
including:  a plaque for participation, a presentation of the results of the study, and an LSB 
toolkit donated for continued use with other residents.  This toolkit will include: portable 
scanner, scrapbook albums, audio recorder, USB flash drives and pad and pens.    
NH administrators will be asked for the name of a staff member who might serve as an on-site 
point of contact. This site coordinator would be the research team’s point of contact for 
scheduling, data collection and other communication between the research team, participants and 
the facility.  NH staff have many demands for their time, so this site coordinator will be offered a 
stipend of $300.00; $150.00 halfway through the data collection (or at post-test 1) and $150.00 
when the data collection is complete (or at post-test 2).   
Non-probability voluntary sampling method will be used to recruit participants from these two 
NHs.  The NH administration, together with the PI, will identify potential participants. If there is 
an active resident council at the NH, this group may be contacted in order to introduce the study 
and recruit potential participants. Every NH, certified by Medicare and Medicaid, must provide a 
space for councils to meet. Resident councils are a group of residents that meet on a regular basis 
to discuss concerns, provide suggestions and plan activities for the NH [34].   
Additional information meetings will be arranged, as needed, with the assistance of the NH 
administration, to describe the study and to answer residents’, staff, and any family members’ 
questions.  (Please see attached information flyer).  
7.0 
Multi-Site Research Communication   
N/A 
8.0 
Study Timelines 
• (1) Eligibility screening – 10 minutes 
• (1) Initial visit, consents, study overview and instruments    60-90 minutes 
• (5) Intervention visits – 60-90 minutes 
• (1) Potential visit for NH-B if any edits were required to their LSB    30-60 minutes 
Total maximum time for participation after screening = 10 hours   

FULL PROTOCOL TITLE:   The Effectiveness of Life Story Book on Depression and  
Meaning in Life for Mentally Alert Residents of Nursing Homes 
MOD00002110 
Page 8 of 20 
Revised: June 27, 2019 
UH IRB Approved 
6/28/2019 - 2/5/2020 
Immediately upon IRB approval, recruitment will begin and will continue until a 
minimum of 10 and a maximum of 12 from each NH are recruited (Total for both NHs- 
20 minimum and 24 maximum).  The intervention will begin as soon as recruitment levels 
are met.  Transcription will begin after the first LSB visit and will continue until all LSBs 
are complete.  The intervention will take 10 weeks to complete. At the conclusion of all 
data collection and transcription activities, data analyses will be conducted.  We 
anticipate that that we will be able to conduct the intervention within four months 
following IRB approval.  Primary analyses should be completed within six months 
following IRB approval.  (See attached timeline). 
    
 
9.0 
Study Endpoints 
This is a minimal risk study.  There are no safety endpoints given, because there are no safety 
risks associated with the study.  
 
10.0 
  Procedures Involved 
Study Design:  
A quasi-experimental switching replication design will be employed to examine the effects of 
LSB on depressive symptoms and MIL for residents of NHs who are mentally alert by 
comparing post-test scores, while controlling for pretest scores. Two comparable NHs will be 
randomly allocated to NH-A or NH-B, indicating which home will begin LSB first, whereas the 
other home will receive care as usual.  Participants in the same NH will receive the same 
intervention.  A summary of the design is as follows: 
Nursing Home A (NH-A):    Pretest     LSB           Post-test     
CAU           Post-test 
Nursing Home B (NH-B):    Pretest     CAU          Post-test               LSB             Post-test  (CAU 
= care as usual) 
Both NHs will eventually receive the LSB intervention, which will provide another opportunity 
to test outcome measures and allow for two independent implementations of the LSB 
intervention.  This is one of the more ethically feasible designs because all participants will 
eventually receive the intervention.   Furthermore, the additional post-test for NH-A, after one 
month, will examine the lasting effects of the LSB intervention.  
  
Description of all research procedures being performed and when they are performed:  
After identifying potential participants, private informational meetings with the research team 
which will include the PI and two research assistants -will be conducted with each potential 
participant where initial screening, using the SIS, will be administered by the PI. (Please see 
attached screening script/tool).  If the resident is eligible, and would like to participate, the 
research team will further explain the study, including the length of the study-10 weeks with six 
visits, length of the visits 1- hour, three weeks with no visits, and the measures that will be 

FULL PROTOCOL TITLE:   The Effectiveness of Life Story Book on Depression and  
Meaning in Life for Mentally Alert Residents of Nursing Homes 
MOD00002110 
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Revised: June 27, 2019 
UH IRB Approved 
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collected.  Full disclosure and written consents will be explained with plenty of time for any 
questions or clarification before consent forms are signed. The consent form will include the 
purpose, procedures, risks and costs of participating in the LSB. Again, there will be no costs for 
participating in the study and the research team will receive no monetary income from the LSB.  
In addition, the LSB will be the property of the participant, along with any scanned photos or 
stories written. This will be signed by each participant, each RA, and the PI.  A copy of the 
consent form will be given to each participant. Additional information will be provided for those 
participants who would like to request their family’s cooperation to secure photos and/or 
memorabilia. (See attached information sheet). 
Although the recruitment of participants is for mentally alert residents, if they have given durable 
power of attorney to others, it may be necessary, per their NH regulations, to obtain informed 
consent from their designated durable powers of attorney [35], [36], [37]. The durable power of 
attorney will be contacted, permission sought, and the consent form signed. The consent form 
will also include an agreement that the LSB ownership will be with the participant. [38] A copy 
of the consent form will be given to the durable power of attorney.   
Participants will be notified for scheduling of the LSB intervention, by their preferred method of 
notification, once recruitment is completed.  When participant recruitment levels are met, the 
research team will contact the participants to schedule their first visit.  LSB visits for all 
participants will begin the same week.  
Potential participants who do not meet the inclusion criteria will be informed that for this study 
they are not eligible.  No identifying information will be collected. They will also be informed 
that a presentation of the study results will be presented at their NH at a later date, to which they 
are invited to come and hear the results.    
Two RAs will be randomly assigned six participants from each of the two NHs.  Each will 
conduct individual LSB sessions with these six participants per NH, or twelve from both homes. 
For the first visit, all 24 participants will be individually visited by the PI and the RA assigned to 
those participants.  Each RA will only visit those participants whom they will be providing the 
intervention.   An overview of the study will be reviewed, as well as information regarding the 
number of visits and length of time for each visit (1 hour). This first visit will also be a time for 
the participants to get acquainted with their RA. Participants will review the consent form signed 
in the initial screening interview which will include the purpose, procedures, risks and costs of 
participating in the LSB, as well as the protection of confidentiality from the RA and the PI. 
They will also be reminded of their rights as participants. The participants, at the beginning of 
each visit, will be told that they can stop and rest at any time or may reschedule the session if 
they become too fatigued to continue. 
The PI will administer all measures face-to-face on a tablet, which will include the MLQ and the 
GDS-12R. In addition, the PI will collect orally from the participants their demographic 
information and their functional status (Katz ADL) onto a tablet.    

FULL PROTOCOL TITLE:   The Effectiveness of Life Story Book on Depression and  
Meaning in Life for Mentally Alert Residents of Nursing Homes 
MOD00002110 
Page 10 of 20 
Revised: June 27, 2019 
UH IRB Approved 
6/28/2019 - 2/5/2020 
At this first visit, a written reminder card will be given to each participant with the date, time and 
contact information of their RA and their next scheduled visit. (Please see attached).  Scheduled 
visits will be done at the most convenient time for the participant with careful consideration of 
scheduled activities, i.e. meals, naps, medicine.  All future visits will be scheduled at this time, 
with the understanding that the RA will be flexible to the needs of the participant.   
NH-B participants will be scheduled for post-tests in 4 weeks, which will include repeating an 
overview of the study, including the number of sessions and length of time for each session. A 
written postcard will be given to each participant with the date, time and contact information of 
their RA for their scheduled post-test. A follow-up postcard will be sent to the participant each 
week until week # 4, when a reminder phone call will also be made by their RA the day before 
their visit is scheduled.  Until that time, the resident will continue to receive care as usual in their 
NH.   
Description of the Intervention: 
Life Story Book.  LSB provides a person the opportunity to chronologically share their life 
experiences and memories [25].  The LSB will include a combination of written information, 
photographs of significant people, places or events, and personal narratives from the stages of 
life that the participant would like to include.   
The duration of the intervention will be three-1-hour visits, not including the visits for the pretest 
and the post-tests measures collected, for a total of five visits. Each visit will begin with the RA 
assessing the environment and the participant’s needs, making sure that the participant can hear 
and see the RA, and that the seating arrangement is comfortable before beginning.  Assessing the 
environment will include:  assessing for privacy, lighting, noise level, temperature and seating 
arrangement [39].  It will be important to monitor the participant’s needs for any other 
difficulties assessed that may need to be tended to and adjustments or accommodations made.  
This is crucial to adequately accommodate the older adults’ needs.  Again, the RAs will remain 
flexible in regard to the length of time per visit for the sake of the older participants. For 
example, two 30-minute sessions may be used, as could rescheduling for health issues, or other 
creative ways to accommodate the needs of the participant as much as possible.   
Each resident will be guided by their RA through memories of their life using extracted questions 
from the Life Review and Experiencing Form (LRF) created by Haight & Haight and based on 
Erik Erikson’s life stages model [39]. (Please see attachment).  The purpose of using these 
questions from the LRF is to achieve some structure for gathering memories across the life span; 
beginning with childhood and adolescence, moving onto family, home and finally adulthood and 
a summary of the life review [39].  Reviewing life from childhood until the present enables the 
participant the opportunity to think about recalled and reconstructed memories, related facts and 
significant experiences [39].  Birren & Cochran suggest [21] reminding the older adult of their 
five senses-touch, sight, taste, hearing and smell- for obtaining details of a story; for example, at 
a holiday event was their food? Dancing? Singing?  While the RA will have the list of questions 
to guide the participant through life stages, they will use the questions as prompts or suggestions. 
The RA will listen closely and respond to the participant while encouraging the participant to 

FULL PROTOCOL TITLE:   The Effectiveness of Life Story Book on Depression and  
Meaning in Life for Mentally Alert Residents of Nursing Homes 
MOD00002110 
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6/28/2019 - 2/5/2020 
lead the dialogue and continue talking and recalling [21], [39]. Participants will be free to decline 
to answer any questions.  
  
The RA will act as a scribe but will also use an audio recorder.  The use of an audio recorder will 
free the RA up to listen attentively and respond appropriately to their participant’s stories. Audio 
recording will also aid the RA in accurately writing their participant’s stories.  A professional 
transcriber will be hired to assist, as needed, for transcription of stories. 
Any pictures and/or memorabilia chosen by the participant will be scanned at the NH using a 
portable scanner.  This will ensure that no photos and/or memorabilia are removed from the 
participants’ NH. The research team will print (using a portable printer) and insert these photos 
into the participant’s LSB.  The RA may help the participant to create a short caption, in the 
participant’s own words, to be placed under each photo.  Again, the resident’s family may be 
contacted, with the approval of the resident, to assist with the collection of newspaper clippings, 
photographs, and/or other memorabilia. Substitute photos of relevant places may be located on 
the internet by the RA as requested or needed. For example, a picture of their high school located 
and printed for their book.   
After post-test measures are administered, when the LSB is completed, both the participant and 
their RA will review the book, obtain clarification and/or corrections and remove anything the 
participant would rather not have in their book, and finalize the details of the book. The 
participant will own their own LSB and will have the final say of what is, or is not, included 
[19], [40].  To ensure that the LSB can be added to and updated, an expandable scrapbook album 
will be used with additional blank pages added. This also reflects that a person’s life story is 
never finished [41].  If there are corrections to be made, the book will be corrected and returned 
to the participant as soon as possible.   
All audio files will be destroyed immediately after transcription.     
A presentation of results will be scheduled where each nursing home will receive a plaque and 
life story kit for participating in this research.  The presentation will include the components of 
videotaping and/or photographs.  A supplemental informed consent form indicating preference to 
be video recorded and/or photographed at the presentation of results, including a UH Media 
piece, will be obtained by those participants willing to be identified as participants.  Every effort 
will be made to ensure that participants know this is completely optional and would nullify their 
previous research consent form signed, in which it was stated that they would not be identified as 
participants 
What data will be collected, including long-term follow-up? 
At the first visit the PI will administer the following instruments in face-to-face interviews with 
each screened participant. Residents’ characteristics measures will include socio-demographic 
data and a functional status survey.  The socio-demographic data that will be collected for each 
participant will include: year born, gender, marital status, level of education, ethnicity, religion, 
and length of residence in the NH.  (Please see attached instruments).  

FULL PROTOCOL TITLE:   The Effectiveness of Life Story Book on Depression and  
Meaning in Life for Mentally Alert Residents of Nursing Homes 
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Katz Index of Independence in Activities of Daily Living (ADLs) will be administered 
in order to assess the functional status of the participant’s ability to perform activities of 
daily living independently.  This tool is one of the most commonly used tool to measure 
an older adult’s functional status.  The Index ranks the adequacy of performance in six 
areas of function: bathing, dressing, toileting, transferring, continence, and feeding. 
Persons are scored yes/no for independence in each of the six functions. A score of 6 
indicates full function, 4 indicates moderate impairment, and 2 or less indicates severe 
functional impairment. The instrument is used effectively among older adults in the 
community and all care settings. This is a scale of the six activities of daily living [42]. 
Geriatric Depression Scale (Residential) (GDS-12R) is a shortened version of the 
30item Geriatric Depression Scale which has been shown to effectively distinguish 
depressed from non-depressed older adults [43].  In 1986, a short form of 15-items (GDS-
15) was developed for older adults, from the original 30-item questionnaire, primarily for 
brevity and for use with older adults with health issues or those with dementia.  It was 
found to have a high correlation with depressive symptoms in previous validation studies 
[44].  Three items were found to not be reflective of residents of nursing homes and these 
three were omitted from the GDS-15 to create the GDS-12R, which increased the alpha 
from .76 to .81 [45].  The GDS-12R was found to have good internal consistency and test-
retest reliability [45].  It is a self-report scale of depressive symptoms and uses a yes/no 
format.  The scale measures how the person has felt during the previous week and usually 
takes 5 to 7 minutes to complete, making it ideal for older adults in residential facilities.  
Scores ≥ 5 are significant for depressive symptoms [46].   
Meaning in Life Questionnaire (MLQ) will be used to measure MIL.  Steger et al. MLQ 
[47]  has two subscales which assess the presence of meaning (how much a person feels 
their life has meaning) and the search for meaning (how much a person strives to find 
meaning and understanding in their life) [48].  The two-subscale measure consists of 10 
items on a 7-point Likert scale, ranging from 1-absolutely true to 7-absolutely untrue: five 
items for presence of meaning and five items for search for meaning.  This questionnaire 
has been shown to have high convergent and discriminant validity and has been tested 
across age, gender, race, and national groups [47], [48].  The MLQ questionnaire does 
not have cut off scores like the Geriatric Depression Scale, but based on numerous 
studies, a score > 24 indicates a person feels their life has meaning and purpose [48]. 
The GDS-12R and MLQ will be administered by the PI at three times; pre-test, post-test 1, 
and post-test 2.  These measures will be administered orally to each participant and 
answers recorded by the PI on a tablet.   
One open-ended feedback, qualitative, question will be asked of participants at post-test 2:  
“What did you think of the experience of participating in Life Story Book?”  This 
question will be documented in writing with no names or ID numbers recorded.      
(See attached intervention table/timeline). 

FULL PROTOCOL TITLE:   The Effectiveness of Life Story Book on Depression and  
Meaning in Life for Mentally Alert Residents of Nursing Homes 
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11.0 
Setting 
An  IRB modification will be submitted once the nursing homes’ information and letters of 
cooperation are obtained.   
   
The interventions will be conducted at the nursing homes.   
12.0   Drugs or Devices      
N/A 
13.0   Risks to Subjects 
We will be administering instruments regarding mood.  Participants may experience mild 
psychological discomfort.  The Life Story Book intervention may result in some temporary mild 
psychological discomfort while discussing the past. The instruments will be administered by a 
Licensed Master Social Worker.  In addition, both RAs will be trained and supervised by the PI 
on skills for working with older adults-including gauging physical capabilities and the handling 
of disturbing memories.   
An additional foreseeable risk of fatigue for participants may occur during the intervention.   The 
plan for minimizing the fatigue risk is to let the participants, at the beginning of each visit, know 
that they can stop and rest at any time or may reschedule the session if they are too fatigued to 
continue. The research team will be extremely flexible and attentive as to adjusting intervention 
times, assessing for fatigue, being watchful for pain or other symptoms.   
Participant risk will be further reduced by conducting the intervention in the NHs which are 
providing physical and psychological services to the participants.  
Although every effort will be made to conduct the intervention in private, there is also the 
potential risk to the privacy for the participants as other residents or NH staff may hear the 
stories they are relaying.    
There is a minimal risk of violations of confidentiality associated with all research studies.  
However, safeguards have been established to protect participant confidentially.   
Inconveniences for participants will be closely monitored.  Scheduled visits will be done at 
the most convenient time for the participant with careful consideration of scheduled 
activities, i.e. meals, naps, medicine.  
Residents are members of residential communities and their involvement in a study may have 
implications for other members of the community [31].  One way to address this is to provide a 
LSB toolkit that can be used by the NH to enable other residents the same opportunity to make 
their own LSB.  A toolkit containing all of the essentials needed for making LSB and will be 
donated to each NH after the study is completed. 

FULL PROTOCOL TITLE:   The Effectiveness of Life Story Book on Depression and  
Meaning in Life for Mentally Alert Residents of Nursing Homes 
MOD00002110 
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14.0    Potential Benefits to Subjects 
Participants will receive a Life Story Book for participating, even if the participant ends 
participation before all data collection has finished. What has been recorded will be inserted into 
their own Life Story Book album.  Participants will receive the benefit of having their own Life 
Story Book.   
Furthermore, potential benefits participants may experience is lower depressive symptoms 
and increased meaning in life.    
15.0   Provisions to Monitor Data to Ensure the Safety of Subjects 
 This is a minimal risk study.  
16.0   Withdrawal of Subjects 
Participants may withdraw from the study at any time without risk of loss of receiving a book, 
even if it is blank, or only partially full of their stories.  Participants will receive their Life Story 
Book even if they are unable, or choose to stop participation, and/or not complete all measures. 
For example, if after one or two visits of sharing their life stories, a participant chooses, or is 
unable to complete the intervention, what has been shared will be transcribed and their LSB will 
be compiled and given to them.  
Individuals whose health is compromised, per advice of NH medical staff, will be withdrawn 
from the study. The research team, if possible, will advise the participant and have some closure.  
If appropriate, a book will be given to them, even if it is blank.    
17.0   Costs/Payments to Subjects 
There are no costs for participating.  Participants will receive their own Life Story Book at 
no cost to them.     
Participants will sign documentation to verify that they have received their LSB.  This 
documentation will be kept in a locked file separate from all de-identified study data so 
that no identifying information could be linked back to participation in this study.  (Please 
see attached form).  
18.0   Compensation for Research-Related Injury 
N/A 
19.0    Confidentiality 
Provisions will be made to protect all identifiable data in order to protect the privacy and 
maintain the confidentiality of all participants  from recruitment to maintaining the data.  These 
provisions will include the confidentiality of residents who did not meet the eligibility criteria; 
de-identification of each participant with a study number; a database created and files secured 
with passwords used only by the research team; components of the study data will be kept in a 
locked file cabinet; the research team will be well trained in how to maintain participant 

FULL PROTOCOL TITLE:   The Effectiveness of Life Story Book on Depression and  
Meaning in Life for Mentally Alert Residents of Nursing Homes 
MOD00002110 
Page 15 of 20 
Revised: June 27, 2019 
UH IRB Approved 
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confidentiality; and the research team will have completed the required CITI training on ethical 
conduct of research.  To ensure privacy, written agreements between the research team and the 
participants will be signed to ensure that no stories will be included in their LSB that do not have 
the express permission of the participants. The LSB will belong to the participant and any 
information or stories shared will not be disclosed to families or staff to protect the participant. 
(Please see attached). 
Paper Documentation of Screeners, Study Instruments and Receipt:  Eligibility screeners, 
consent documents, and documentation for receipt of the completed LSB will contain 
participants names (not ID numbers), and they will be kept separate from all other study 
information in a locked filing cabinet in the PI’s office (345A SOCW).  The code book with the 
name and the ID number of the participant will be kept in a separate locked filing cabinet in 
SOCW room 333, and will be destroyed following data collection.  Completed study instruments 
will only contain the participants’ ID number and will be kept on an encrypted and password 
protected file on the UH SharePoint site.  Any data or documentation relating to this study will 
not be accessed by anyone but the research team.     
Each participant will have a participant folder generated on a password protected file on  UH 
OneNote where their transcriptions, notes, photos and/or memorabilia will be stored. The 
research team will edit and organize the text into a cohesive narrative while adding any photos to 
the narrative.  The research team will make every effort to ensure that the facts are correct and 
verified with the participants with a first draft before a final printing of their LSB. If the 
participant would like to have an electronic copy in addition to their book, the research team will 
copy their LSB folder onto a USB flash drive and give that to the participant with their book.     
  
Audio Recordings:  The LSB intervention visits will be audio recorded and members of the 
research team will transcribe the interviews.  A professional transcriber will be hired, as needed, 
to help with the transcriptions.  After transcription, the audio files will be destroyed.   
Intervention Notes:  LSB intervention notes, that each RA has written, will be used to add to, or 
supplement, interview audio recording transcripts.  Once these notes have been added to, or used 
to verify transcriptions, the notes will be destroyed.   
Scanned Photos and/or Memorabilia:  All photos and/or memorabilia will be scanned onto a 
microSD card which has the participant’s ID number on it. This microSD card will be uploaded 
onto the password protected file folder of the participant on the UH OneNote site.  The microSD 
card will then be wiped clean.   
Qualitative Question:  The answers from the one open-ended qualitative question will be 
documented in detailed notes and recorded onto a spreadsheet with no identifiable 
information.        
Video recorded and/or photographed for media:  There will be a presentation of the results of 
the study for all participants, nursing home residents, family members, and staff.  Participants  
who would like to be identified as participants and video recorded and/or photographed will have 

FULL PROTOCOL TITLE:   The Effectiveness of Life Story Book on Depression and  
Meaning in Life for Mentally Alert Residents of Nursing Homes 
MOD00002110 
Page 16 of 20 
Revised: June 27, 2019 
UH IRB Approved 
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the option to indicate their agreement on a supplemental consent form.     
20.0 Provisions to Protect the Privacy Interests of Subjects 
Participants will be provided with some examples of the Life Review and Experiencing  
Form questions as part of the informed consent process; in addition to the purpose of the  
study and the necessity of disclosing some personal information.  This will be clearly 
explained as part of the consent process.  Participants will be informed that only the 
research team will have access to the LSB intervention transcripts and survey 
instruments.  Participants will also be informed that they can refuse to answer any 
question or withdraw from the study at any time, without penalty, and without giving a 
reason for withdrawing from the study.   
All survey instruments will be administered by the PI, a licensed master social worker 
who has experience working with older adults in nursing homes.  The LSB intervention 
will be conducted by two social work/medical professionals who will be provided 
training, by the PI, for working with older adults in nursing homes.  In addition, 
participants can ask questions about their participation in the research process at any time.   
21.0    Informed Consent Process 
Once a potential participant is deemed eligible for participation, and agrees to participate, they 
will be informed that prior to participation an informed consent is required.  A member of the 
research team will obtain the informed written consent and provide a copy of the consent 
document with the contact information for the PI and the University of Houston IRB.  Although 
no measures for obtaining ongoing consent will be obtained, the consent form will be reviewed 
at the first visit of the intervention and again at posttest 1.  This protocol will be following the 
SOP:  Informed Consent Process for Research.  
Adults Unable to Consent 
As stated in the procedures, it may be necessary, per the NH requirements, to seek consent from 
durable powers of attorney.  Although the recruitment of participants is for mentally alert 
residents, if they have given durable power of attorney to others, it may be necessary to obtain 
informed consent from their designated durable powers of attorney.  Many residents execute a 
health care plan, including a durable power of attorney when they enter a NH and appoint a 
family member or someone to act on their behalf if they lack decision-making capacity.  If 
necessary, a member of the research team will meet with the durable power of attorney to 
explain the research study and obtain written consent.  
     
22.0   Process to Document Consent in Writing 
This study will follow the SOP:  Written Documentation of Consent (HRP-091).  (Please see the 
attached informed consent document).   
Supplemental consent form for media piece at presentation of results (Please see attached 
supplemental consent form).  

FULL PROTOCOL TITLE:   The Effectiveness of Life Story Book on Depression and  
Meaning in Life for Mentally Alert Residents of Nursing Homes 
MOD00002110 
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Revised: June 27, 2019 
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23.0    HIPAA 
 N/A  
24.0   FERPA  
N/A 
25.0   Data Management 
Data will be analyzed using IBM SPSS Version 25 [49] and a multivariate analysis of covariance 
(MANCOVA) will be performed. Descriptive analysis will be conducted to describe participants, 
including demographic characteristics and their functional status (ADL). Demographic variables 
will be assessed with t-tests for independent samples (continuous variables) and chi-squared 
(categorical variables) to determine baseline differences.  Prior to conducting the main analysis, 
data will be evaluated to ensure that assumptions for multivariate tests are fulfilled, including 
normality, linearity, univariate and multivariate outliers, homogeneity of variance-covariance 
matrices, and multicollinearity. Data will be inspected for any errors in data entry and for any 
missing data. Any reasons for withdrawal from the study and the loss to follow-up will be 
recorded.   
A one-way MANCOVA will be performed to test for differences between the experimental 
group (LSB) and the control group on the 2 outcome measures (GDS-12R and MLQ), while 
using pre-test scores as covariates.  Main effects from pre-test to post-test in both groups will be 
examined.  To look at long term effects, repeated t-tests will be conducted at post-test 2.  
Thematic analysis of the qualitative question will be conducted by the research team to identify 
themes in the data concerning the experience of participating in LSB.  
Only the research team will have access to the encrypted and password protected database on 
which the study information will be stored.  All members of the research team will be trained in 
appropriate data management techniques and the importance of maintaining confidentiality of 
data.  All data will be inputted by the PI and then independently reviewed for accuracy by 
another member of the research team.   
Eligibility screeners, consent documents, and documentation for receipt of the completed LSB 
will contain participants names (not ID numbers), and they will be kept separate from all other 
study information in a locked filing cabinet in the PI’s office (345A SOCW) until after the study 
where they will be scanned and kept on an encrypted and password protected file on SharePoint, 
and maintained by my faculty advisor.   
The code book with the name and the ID number of the participant will be kept in a separate 
locked filing cabinet in SOCW room 333, and will be destroyed following data collection.   
Completed study instruments will only contain the participants’ ID number and will be kept on 
an encrypted and password protected file on the UH SharePoint site.  Any data or documentation 
relating to this study will not be accessed by anyone but the research team.     

FULL PROTOCOL TITLE:   The Effectiveness of Life Story Book on Depression and  
Meaning in Life for Mentally Alert Residents of Nursing Homes 
MOD00002110 
Page 18 of 20 
Revised: June 27, 2019 
UH IRB Approved 
6/28/2019 - 2/5/2020 
Study transcripts will be de-identified with only the participant’s ID number and will be 
maintained for a period of three years, per UH policy, following the conclusion of data 
collection, in an encrypted and password protected file on SharePoint, and maintained by my 
faculty advisor.  
The PI will obtain a copy of the study data and documentation, with no identifiable information,   
on an encrypted CD  
 All data management procedures were more fully described in the previous section on 
‘Confidentiality’.  
26.0   Specimen Use and Banking 
N/A 
27.0   Community-Based Participatory Research 
N/A 
28.0   Sharing of Results with Subjects 
The PI contact information will be provided on the informed consent form if participants wish 
to receive a written copy of the study results.   
In cooperation with each NH, a presentation of the study results will be scheduled.  Each 
participant will be sent a personal invitation to this scheduled event.   
As detailed in the ‘Recruitment Methods’ section, every effort will be made to recognize 
the NH’s contribution to the study including:  a plaque for participation, the presentation 
of the results of the study, and a LSB toolkit donated for continued use with other 
residents.     
29.0   Resources  
The Graduate College of Social Work (GCSW) is one of fourteen academic colleges at the 
University of Houston.  Founded in 1967, it is a nationally recognized graduate social 
work program and offers multiple pathways to earn a Master of Social Work degree 
through traditional, online or hybrid study.  Its accredited program offers a range of 
academic courses, field practicum, numerous community projects, international 
experiences and five research centers.  The College is housed in its own four-story 
building on campus and includes twenty-four full-time faculty and fifteen adjunct faculty.      
The principal investigator, Theresa C. Chrisman has over 10 years of experience working 
with older adults living in nursing homes and in the community. She is currently licensed 
as a Licensed Master Social Worker (LMSW), specializing in gerontology.  In addition, 
she is also certified in Reminiscence and Life Story Work.  Theresa is currently a doctoral 
student and has defended her dissertation proposal.  She will be working under the 
guidance of Dr. Allen Rubin at the University of Houston Graduate College of Social 

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Meaning in Life for Mentally Alert Residents of Nursing Homes 
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Work.  In addition to overseeing the study, Theresa will serve as the eligibility screener 
and collector of all instruments.  
Rubin Allen, PhD, is a Professor of Social Work | Jean Kantambu Latting College 
Professorship of Leadership and Social Change at the University of Houston.  He is an expert 
on evaluating interventions and disseminating results to practitioners into how to practice 
guidelines.  Dr. Rubin is a well-known and respected expert in the field of social work 
research and education.  He has authored or co-authored over 100 publications in diverse 
areas.  He is the lead author of the bestselling research textbook, Research Methods for 
Social Work that has been adopted by approximately 40 percent of schools of social work, 
every year since 1989, and is in its ninth edition. He will serve as a consultant on this study.  
Sarah Narandorf, PhD is an Associate Professor of Social Work at the University of 
Houston.  As a licensed clinical social worker, Dr. Narandorf has provided direct clinical 
interventions to vulnerable populations.  In addition, she has developed interventions and 
is actively involved in promoting research among social work students. She will serve as a 
consultant on this study 
Cheryl Brohard, PhD is an Assistant Professor at the University of Houston College of 
Nursing and named a 2018 Salute to Nurses Top 15 winner. She has served as an oncology 
nurse for 37 years and is certified in gerontology.  In addition, Dr. Brohard is a certified 
instructor for Reminiscence and Life Story Work.  She will serve as a consultant on this 
study. 
The two NHs that will be recruited will be described upon their consent and letters of 
cooperation will be obtained.  The NHs will be comparable on the following five aspects: 
number of long-stay residents, overall quality rating, staff rating, type of ownership 
(private, public or government) and facility size.  Each of the NHs participating in this 
study will have a minimum of 85 residents.  According to the Vital Statistics report- 
Long-Term Care Services in the United States: 2013 Overview, there are about 49.6% of 
NH residents who are mentally alert [3].  With approximately 50% of NH residents being 
mentally alert, there will be approximately 42 residents to recruit from the NHs that 
house 85 residents.   
Two social work/medical professionals will be hired as research assistants.  Once they are hired, 
I will submit an IRB modification with their information.  
An IRB modification with the two site coordinators information, along with the nursing home 
letters of cooperation, will be added.  
Recruitment will begin immediately upon IRB approval and will continue until the 
minimum of 10 and maximum of 12 participants from each NH (Total 20 minimum and 24 
maximum) are recruited.  Transcription will begin immediately after each LSB visit with 
participants and data will be analyzed after all data collection is complete.  We anticipate 
that we will be able to complete the intervention three months following IRB approval.  
The LSB intervention and analyses should be completed within six months following IRB 
approval.   

FULL PROTOCOL TITLE:   The Effectiveness of Life Story Book on Depression and  
Meaning in Life for Mentally Alert Residents of Nursing Homes 
MOD00002110 
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Revised: June 27, 2019 
UH IRB Approved 
6/28/2019 - 2/5/2020 
Adequate psychological and/or medical resources are available and can be provided by 
the NHs for those who may need it as a result of an unanticipated consequence of research 
participation.   
The research team will communicate on an ongoing weekly basis to discuss any issues that 
may arise so as to ensure successful execution of this research study.  All of the key 
personnel listed in this study have read and understand this protocol. 
30.0 Additional Approvals 
Letters of cooperation from the two NHs will be obtained and a modification with IRB will 
be submitted.