Adaptability and Resilience in Aging Adults-2
Phase: NA
Conditions: Aging, Chronic Low-back Pain
Sponsor: University of Florida

IRB Project #: 201901927  
IRB Version: 12/16/2021 
 
Protocol 
 
1. Project/Grant Title: Adaptability and Resilience in Aging Adults (ARIAA)-2B  
 
2. Investigators:  Emily J. Bartley, Ph.D. (PI)  
 
3. Trial Registration: NCT04068922 
 
4.   Abstract: Growing evidence supports the presence of dysregulated pain modulation in older adults, 
an effect which may heighten age-associated risk for chronic pain. While persistent pain is common in 
older adults, chronic low back pain is the leading cause of disability in this population and results in 
significant impairment in psychosocial and physical functioning. Given reports of suboptimal treatment 
of pain in older adults, improvements in pain management in this cohort are of critical importance. 
Resilience is characterized as a dynamic process resulting in positive adjustment and adaptation after 
exposure to adversity. The benefits of resilience in health-related functioning are manifold, and evidence 
suggests that resilience plays an important role in fostering adaptive physiological and affective 
responses to pain. Given this, capitalizing on positive resources is a promising target for enhancing pain 
adaptation, and is especially salient to older adults given the burden of high-impact pain in this group. 
Therefore, the aim of this project will be to conduct a Stage I pilot study and examine the feasibility and 
acceptability of a resilience intervention for chronic low back pain among older adults. Using a Science 
of Behavior Change approach, the proposed study will examine intervention-related benefits in 
psychosocial and physical functioning, and assess whether changes in targeted resilience mechanisms 
result in improvement in pain-associated outcomes. Achievement of these aims will provide a rich 
platform for future intervention research and will forge a path toward investigating psychological 
therapies of resilience that improve pain and disability among geriatric populations. 
 
5.   Background: Chronic low back pain (cLBP) is the leading cause of disability worldwide (1, 2) and 
represents the most therapeutically-challenging pain condition among older adults (3), affecting 
approximately 12 million individuals over the age of 65 (4, 5). It is one of the top reasons for seeking 
healthcare and is frequently associated with impairments in psychological, cognitive, and physical 
functioning (6-8). Further, evidence suggests that the prevalence of disabling back pain increases with 
age (9), thus adding to its tremendous disease burden. Because older adults are among the fastest 
growing cohorts in the United States, both the incidence and burden of cLBP is expected to increase 
considerably. Despite this, pain management is frequently suboptimal among older adults as 
pharmacological therapies show limited clinical efficacy and a greater risk of side effects, polypharmacy 
can result in adverse drug reactions, and multimorbidities common to geriatric populations complicate 
pharmacological treatment (3). As such, the demand for safe and effective therapeutic targets to reduce 
pain burden in later life is of critical importance. 
 
Historically, research has been hampered by a predominant emphasis on the exploration of risk factors 
for chronic pain and relative inattention to identifying protective factors that facilitate optimal pain 
outcomes. This represents a significant knowledge gap as emerging literature suggests that individuals 
with chronic pain have the ability to exhibit resilience (10). Conceptualized as a dynamic, multilevel 
construct, resilience is a process through which dispositional resources (e.g., trait positive affect, social 
ties) and mechanisms (e.g., state positive affect, positive social interactions) enhance functioning, 
thereby promoting recovery, sustainability, and growth (11). In essence, resilience is the ability to sustain 
adaptive functioning despite exposure to adversity. Extant evidence signifies that resilience (and its 
underlying facets) is associated with attenuated experimental pain sensitivity (12), lower clinical pain 
and disability (13), and higher levels of psychological functioning (14).  
 

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While aging is commonly viewed as a period of frailty, disability, and decline, there is evidence that older 
adults have the capacity to improve resilience in later life despite ongoing stressors (e.g., pain) (15). 
Given the rapid growth of the older adult population and the general losses commonly associated with 
aging, recent years have witnessed a burgeoning interest in promoting adaptive functioning in this 
population through interventions that augment resilience and successful aging. In the context of pain, 
this offers advantages over conventional psychological interventions that focus primarily on the 
reduction of negative symptoms, an approach that does not necessarily lead to optimal functioning. 
While limited, a growing body of literature supports the use of resilience-based interventions in chronic 
pain, with positive outcomes observed in affect regulation, clinical pain severity, physical and 
psychosocial disability, functional performance, well-being, and pharmacological use (16-19). Despite 
the public health importance of chronic pain in older adults, research examining the effectiveness of 
psychosocial interventions in this cohort remains limited. 
 
6.   Hypotheses and Specific Aims: Chronic pain is one of the leading causes of disability, affecting 
over 100 million people in the United States and resulting in tremendous health care costs and 
psychological burden. Older adults are disproportionately impacted by pain, with an estimated 60-70% 
of people over the age of 65 reporting persistent pain. Given the rapidly expanding aging population, the 
identification of viable interventions to reduce pain burden in later life is a chief directive. Moreover, in 
light of the current opioid crisis, initiatives to produce safe and effective nonpharmacological approaches 
to pain management are urgently needed.   
 
Using a Stage Model approach (20), the primary aim of this study is to examine the feasibility and 
acceptability of a resilience intervention for chronic pain among older adults. Intervention modules will 
specifically engage hope, self-efficacy, positive affect, and pain acceptance as these factors 
demonstrated the strongest relationships with clinical pain, disability, and psychological functioning from 
the PI’s previous work (NIH K99 Award). Chronic low back pain (cLBP) will be the targeted population 
given that it represents the most debilitating and therapeutically-challenging pain condition among 
geriatric populations. We will conduct a pilot study to test the feasibility and acceptability of the 
intervention in this patient population (primary aim), explore whether the intervention engages the 
proposed resilience targets (i.e., hope, self-efficacy, positive affect, pain acceptance), and assess 
whether changes in these factors result in improvements in pain outcomes (i.e., NIH Science of Behavior 
Change approach (21)). Achievement of these aims will provide a strong framework for future 
intervention research examining mechanisms that promote adaptive health and pain-related functioning 
in aging populations.  
 
Specific Aim 1: Conduct a pilot test to examine feasibility, acceptability, and tolerability of a resilience 
intervention for older adults with cLBP. We will assess adherence and retention rates, and evaluate 
ratings of acceptability through brief assessments and eliciting qualitative feedback from participants at 
post-intervention. Hypothesis 1. Individuals in the resilience intervention will report high adherence to 
and satisfaction with the intervention.  
 
Specific Aim 2: Assess whether a resilience intervention facilitates improvements in hope, self-efficacy, 
positive affect, and pain acceptance and whether changes in these processes result in improved pain-
related outcomes. Intervention modules will be adapted from the existing positive psychology literature 
and validated self-report measures will be used to verify engagement in the specific resilience targets. 
Hypothesis 2. We hypothesize that a resilience intervention will improve pain severity, pain interference, 
negative affect, and quality of life by increasing hope, self-efficacy, positive affect, and pain acceptance. 
 
7. Research Plan:  
 

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General Overview of Procedures. All potential participants will undergo an initial phone screening 
interview, via telephone or in person. The initial screening will include questions regarding pain, age, and 
additional health history information to ensure that no exclusion criteria are present. Those who meet study 
inclusion criteria will also be screened for COVID-19 using the COVID-19 phone screening form. If still 
eligible, participants will be scheduled for an individual baseline assessment during which informed consent 
will be reviewed, medical and demographic history will be obtained to ensure eligibility, questionnaires will 
be administered, and a physical performance battery will be conducted to examine lower extremity 
function.  At the completion of the baseline assessment, eligible participants will be scheduled for a 7-week 
program (90 min/session) in which participants’ complete activities designed to enhance hope, positive 
affect, pain acceptance, and self-efficacy. Participants will complete weekly home activities and will be 
asked to bring the home assignments into each session. Participants can miss only one session without 
making it up or up to two sessions if made up with individual sessions in person, over the phone, or using 
a PHI Zoom call. Given evidence that intervention effects on pain and psychological outcomes in older 
adults are strongest when delivered using group-based approaches (relative to an individual format) (22), 
we have chosen to administer our protocol via groups. 
 
Participants. We will recruit adults, ages 50+ years, from the community and physician referral. To permit 
sex-stratified exploratory analyses, an equal number of men and women will be targeted (23). Participants 
must endorse pain in the lower back region (i.e., space between the lower posterior margin of the rib cage 
and the horizontal gluteal fold) (24), and report pain of a moderate intensity (rating of >3 on a numeric 
rating scale ranging from 0-10) occurring on at least half of the days in the past 6 months. Pain must 
moderately interfere with their daily activities (rating of >3 on a numeric rating scale ranging from 0-10). In 
order to generalize results more broadly, study entry will not be restricted to low back pain although 
participants must identify low back pain as their primary pain condition. Exclusion criteria are as follows: 
1) current participation in another psychological treatment; 2) severe psychiatric illness not adequately 
controlled by medication (e.g., schizophrenia, bipolar disorder) or other conditions anticipated to impair 
intervention engagement (e.g., substance abuse/dependence); 3) presence of chronic, malignant pain 
(e.g., HIV, cancer) or systemic inflammatory disease (e.g., rheumatoid arthritis, ankylosing spondylitis, 
systemic lupus erythematosus, etc.); 4) significant cognitive impairment on the Montreal Cognitive 
Assessment (25);  5) inability to read and write English; and 6) if currently taking prescription analgesic or 
psychotropic medication, must be stabilized on these treatments for >4 weeks prior to the baseline 
assessment. Participants are also encouraged to refrain from starting any new treatments for pain while 
participating in the study. These include, but are not limited to, seeing a new chiropractor, physical 
therapist, massage therapist, psychiatrist, or counselor, taking new opioid medications for pain or receiving 
epidural or cortisone injections, or using medical marijuana or CBD oil. If a participant begins a new pain 
treatment during study participation, the study PI will evaluate and decide whether or not it is cause for 
exclusion. All participants will be required to wear Personal Protective Equipment (PPE) during in-person 
visits. PPE (masks) will be provided by study staff upon participant arrival or participants may bring their 
own. If intervention sessions are conducted through PHI Zoom, study staff will ensure participants have 
access to Zoom as well as a stable internet connection. During Zoom intervention sessions, participants 
must have access to a working camera and microphone and have them both turned on in order to 
participate. Study staff will also ask participants if they have access to a space that will provide 
confidentiality (e.g. not conducting Zoom call where other people may overhear, inform other household 
members about confidentiality expectations, ensure no identifying information is visible through camera). 
Zoom tutorials will be provided during the Baseline Session.  
 
Participant payments will be made according to the following schedule: Baseline Assessment ($60), 
Intervention Sessions 1-6 ($20), Intervention Session 7 ($60), and an additional $15 for completion of the 
3-month follow-up assessment (total max payment=$255). This is comparable to subject remuneration for 
studies of similar time commitment and invasiveness at our institution. Participants will receive partial 
payment if they do not complete the entire study. In addition, for participants traveling more than 25 miles 

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each way to complete study visits, we will reimburse some travel expenses at up to the federal mileage 
rate (total max travel reimbursement=$300). Payments for participation will occur after completion of each 
study session and will be handled through the University of Florida’s Human Subject Payment Program. 
 
Session 1 (Baseline):  
 
Demographic and Medical History Questionnaire. All participants will complete a through demographic 
and medical history form. We will assess self-reported duration of back pain, comorbid conditions, and 
current medication use. This medical history information will be reviewed with the participant by the study 
PI or other training study staff to ensure eligibility and that items are completed accurately. Health status 
will also be reviewed with each participant during subsequent study sessions to ensure eligibility.  
 
Vitals/Physical Measurements. Height will be assessed to the nearest cm using a wall stadiometer and 
body weight to the nearest 0.1 kg using a digital scale. Calculation of BMI will be determined by weight in 
kilograms divided by height in meters squared. Blood pressure will also be recorded for all participants.  
 
Cognitive Testing. The Montreal Cognitive Assessment (MoCA) (25) is a widely used screening 
assessment for detecting cognitive impairment. It was validated in the setting of mild cognitive impairment 
and has subsequently been adopted in numerous other settings clinically. Participants with scores <26 will 
be excluded from participation as this could interfere with completion of the study intervention. The 
alternative/equivalent version of the MoCA (Version 7.2) will be used to decrease possible learning effects 
when the MoCA (Version 7.1) has been administered within the past 3 months of study participation. This 
will serve as a safeguard for test-retest effects for participants who may have recently participated in 
studies requiring the administration of this instrument. 
 
Physical Performance Battery. The Back Performance Scale (BPS) (26) consists of five tests (i.e., sock 
test, pick-up test, roll-up test, fingertip-to-floor test, lift test) to assess mobility-related activities in individuals 
with back pain. Each test is scored from 0 to 3, and a total summed score ranging from 0 to 15 is computed 
(higher scores equal worse functioning). 
 
 
Sessions 2-8 (Intervention Delivery): 
 
Intervention Procedure. All sessions will be administered by the PI, Co-I, and/or interventionist 
(masters/PhD level psychologists). Due to COVID-19, intervention sessions (Week 1 – Introduction and 
Background through Week 7 – Review of Skills and Wrap-Up) may be delivered online through PHI Zoom. 
To standardize the application of the intervention and ensure treatment fidelity, the resilience intervention 
is manualized and includes interventionist and client workbooks with materials and handouts for 
discussion. Client workbooks are written at the 6th grade reading level as measured by Flesh-Kinkaid 
Grade Level estimates. These intervention workbooks have been reviewed in an earlier phase of this trial 
(ARIAA 2A), whereby we conducted semi-structured focus groups and key informant interviews with 
approximately 47 older adults with cLBP to provide feedback on the treatment manual (IRB201802729). 
Interventionists will be provided with a checklist of procedures specific to each session, and each checklist 
will be reviewed to ensure treatment adherence. Participants who miss a group visit will be allowed to 
complete an individual make-up session, with the stipulation that only two missed sessions will be 
permitted. 
 
Intervention Content.  All activities were adapted from the positive psychology literature and selected 
due to their strong empirical evidence (27-30), ease of completion, and applicability to the targeted 
resilience constructs. Each session will follow the same format including a review of the previous week’s 
content (i.e., homework review), an overview and discussion of the session objectives including didactic 

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in-session activities, and assignment of homework. The intervention will be comprised of the following 
activities. Week 1: Introduction and Background. Participants will be provided with instruction on group 
therapy guidelines (e.g., confidentiality, respect, privacy), an overview of the purpose and structure of the 
program, and rationale for the use of resilience-enhancing activities for the management of cLBP. 
Participants will also be given education on cLBP etiology and symptoms and provided the opportunity to 
discuss their own personal experiences associated with chronic pain. As a home exercise, participants will 
be asked to complete a character strengths survey. Week 2: Pleasant Activities. During the second 
session, participants will be given instruction on how to increase the number of pleasant events in their life 
and will be provided with a list of pleasant activities to choose from (31). For their home practice, 
participants will be encouraged to engage in three pleasant activities over the week and to record things 
they are grateful for. Week 3: Pain Acceptance. Participants will receive instruction on valued activity, 
psychological flexibility, and mindfulness-based exercises for enhancing pain acceptance and awareness. 
A values assessment will be administered to assist participants in identifying important values in their life 
(32). Week 4: Hope and Goal-Setting. Based on Snyder’s theory of hope (27), participants will focus on 
their personal strengths and learn ways in which to create attainable goals through the development of 
pathways and agency thinking. Participants will be asked to develop a goal that they would like to achieve 
over the course of the intervention to facilitate hopeful thinking and goal-directed behavior, and to identify 
areas in their life that inspire hope (33). Week 5: Positive Events and Reappraisal. To increase 
attentional focus on positive events, participants will be taught ways in which to minimize the impact of 
adverse events and to downregulate negative emotions and thoughts through positive reappraisal (34). 
As a home-based activity, participants will be encouraged to record, at minimum, one positive event that 
occurred every day, as well as negative events in which they had to practice positive reappraisal (35). 
Week 6: Pain Self-Efficacy. While it is anticipated that self-efficacy will gradually be fostered throughout 
the course of the intervention (i.e., skills mastery experiences, feedback on progress, social persuasion 
through group support), this session will complement ongoing training by targeting problem-solving skills 
and confidence building, as well as empowering participants to promote adaptive pain management 
behaviors. Participants will be asked to engage in diaphragmatic breathing as a form of relaxation and to 
note areas of accomplishment over the course of the intervention (36, 37). Week 7: Review of Skills and 
Wrap-Up: Skills learned in the previous sessions will be reviewed and specific plans for maintenance of 
resilience activities will be discussed. Participants will also complete post-treatment outcome 
questionnaires and provide feedback on the intervention program. 
 
3-Month Follow-Up Assessment 
 
Questionnaires will be administered via REDCap approximately 12 weeks after completion of the 
intervention to be completed online at home. These questionnaires will assess pain intensity and 
interference, mood, quality of life, and use of intervention materials and skills since the conclusion of the 
group sessions.  
 
Study Questionnaires: 
 
Several questionnaires will be administered to assess general health, pain-related symptoms, and 
psychological functioning. In order to distribute participant burden, some of the questionnaires 
administered during Visit 1 and Visit 8 will be dispensed either during the session or at home between 
sessions (either via our secure internet-based data collection system [i.e., REDCap] or on paper, 
depending on the participant’s preference). 
 
Measures of Treatment Acceptability. Treatment credibility questions (38) were adapted for the current 
study as a treatment expectancy measure and will be administered during Visit 1 and Visit 2 consisting of 
the following items: 1) reasonableness of treatment, 2) willingness to undergo treatment, 3) confidence in 
recommending the treatment to others, 4) confidence that the treatment will help with pain coping, 5) 

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confidence that the treatment will decrease pain, 6) confidence that the treatment will eliminate pain, and 
7) expectation for improvement.  
 
The 8-item Client Satisfaction Questionnaire (CSQ-8) (39) will be administered after the intervention as an 
assessment of treatment satisfaction. Items are rated on a 4-point Likert scale and measure aspects 
related to the quality of treatment, willingness to recommend the treatment, and general satisfaction with 
the treatment.  
 
As a treatment evaluation and to better understand their perceptions of the intervention, participants will 
be queried at posttreatment on their satisfaction with the intervention components, contentment with the 
structure of the intervention, and recommendations for intervention improvement. Participants will also be 
asked to indicate the usefulness of each intervention session module and home activity on a 5-point Likert 
scale ranging from 0 (“not at all”) to 4 (“extremely”). 
 
Treatment engagement questions were adapted for the current study (40) to assess the participants’ effort 
exerted during group activities, completion of homework, and engagement in group discussions. This 
questionnaire will be completed by the study therapist upon the completion of every group session for 
each attendee. A modified version of this scale will also be completed by each participant at the end of 
every session to assess their perceptions of engagement and interest in the session content. At the 
beginning of each group session (starting with Visit 3), participants will also be administered a 7-item 
questionnaire assessing ease and quantity of home activity completion.  
 
Measures of Treatment Fidelity. Therapist adherence to the treatment protocol, appropriateness of the 
therapist’s behavior, and quality of treatment delivery will be assessed using an adapted CT Adherence 
and Competence Scale (CTACS) (41). Adherence will be evaluated for a randomized selection of 50% of 
the sessions conducted and reviewed by the study PI and Co-I. Fidelity indicators are measured on a 0 
(“poor”) to 4 (“excellent”) scale, with higher ratings indicative of greater adherence, appropriateness, and 
quality of treatment delivery.  
 
Psychosocial and Pain Questionnaires. Several measures from the PROMIS short form (24, 42, 43) 
will be administered to assess self-reported pain intensity, pain interference, physical function, sleep 
impairment, and emotion (e.g., depression, anxiety). The World Health Organization Quality of Life–Brief 
(WHOQol-Bref) (44) scale consists of 26 items assessing quality of life over the past week in four domains: 
physical health, psychological health, social relationships, and environment. The Roland-Morris Disability 
Questionnaire (RMDQ) (45) is a 24-item self-report measure that assesses health status and disability 
related to low back pain. Respondents are instructed to indicate which of the statements (e.g., “I stay at 
home most of the time because of my back”) describe their current experience. The 13-item Pain 
Catastrophizing Scale (PCS) (46) assesses patient report of catastrophic thinking about pain, with scores 
ranging from 0 (not at all) to 4 (all the time). The Brief Resilience Scale (BRS) is a 6-item questionnaire 
(47) that examines the ability to bounce back and recover from stress. Items are rated on a 5-point scale 
(1=strongly disagree, 5=strongly agree), with higher scores indicating greater levels of resilience. The 14-
item Pain Resilience Scale (PRS) (48) is a pain-specific measure assessing perceived ability to regulate 
emotions and cognitions, as well as behavioral and motivational tenacity in the face of intense or prolonged 
pain. Items are rated on a 5-point scale (0=not at all, 4=all the time). The Modified Differential Emotions 
Scale (mDES) (49) is a 20-item scale that measures the extent to which positive and negative emotions 
have been experienced within the past few days. Items are rated on a 5-point scale ranging from 0 (not at 
all) to 4 (extremely). The Multidimensional Scale of Perceived Social Support (MSPSS) (50) is a 12-item 
scale with 4 items for each source of support (i.e., family, friends, and a significant other). Each item is 
rated on a 7-point scale ranging from “very strongly disagree” to “very strongly agree.” The Perceived 
Stress Scale (PSS) (51, 52) is a 10-item measure examining the degree to which situations in one’s life 
are appraised as stressful, with scores ranging from 0=never to 4=very often. The Graded Chronic Pain 

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Scale (GCPS) is a 7-item measure assessing pain intensity and pain-related disability (53). The Life 
Orientation Test-Revised (LOT-R) is a 10-item scale measuring positive and negative thoughts about the 
future (54). 
 
Treatment Target Measures. To assess whether the intervention engages the proposed resilience 
targets (i.e., hope, self-efficacy, positive affect, pain acceptance), the following questionnaires will be 
administered. The Adult State Hope Scale (ASHS) (55) taps into state levels of hope. Two subscale scores 
assessing agency (i.e., sustained movement towards goals) and pathways (i.e., generation of workable 
routes to goals) thinking are derived, as well as a total score consisting of a sum of these two scales. Pain-
related self-efficacy will be examined with the 10-item Pain Self-Efficacy Questionnaire (PSEQ) (56). 
Scores range from 0 (not at all confident) to 6 (completely confident to undertake an activity), and higher 
scores indicate a greater level of self-efficacy in the midst of chronic pain. The Positive and Negative Affect 
Schedule (PANAS) (57) is a 20-item scale assessing positive affect (PA) and negative affect (NA). Items 
are rated on a 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely) resulting in scale 
scores for PA and NA. The Chronic Pain Acceptance Questionnaire (CPAQ) (58) is comprised of 20 items 
measuring acceptance of pain. This measure has two subscales: activity engagement (i.e., pursuit of life 
activities regardless of pain) and pain willingness (i.e., disengaging from pain avoidance and control). 
Items are rated on a 7-point scale (0=never true, 6=always true). 
 
Statistical Methods. The goal of the study will be to target 50 participants for the pilot intervention. 
Accounting for a conservative 20% attrition rate, we will recruit an additional 10 participants (Total N=60). 
This sample size is feasible and will provide stable estimates of dropout rates, feasibility, and acceptability 
of the intervention protocol. We anticipate screening an additional 70 participants who may not meet 
eligibility criteria (i.e., screen failures). Data Analysis: Specific Aim 1. The analysis of feasibility, 
tolerability, and acceptability outcomes will be predominantly conducted with descriptive statistics, with 
means and standard deviations reported. To assess feasibility, we will calculate a ratio between 
participants enrolled versus the number of participants commencing treatment. Tolerability will be 
examined by measuring completion rates (i.e., participants completing all seven sessions of the 
intervention). Participant acceptability of the intervention will be assessed through treatment credibility 
ratings and satisfaction with the program (59). Chi-square tests and between-group t-tests will be used to 
compare group differences in baseline characteristics between completers and participant dropouts. 
Specific Aim 2. To assess change in primary study outcomes (i.e., pain severity, pain interference, 
negative affect, quality of life), mean differences from pre- to post-intervention will be calculated using 
paired samples t-tests. Clinical significance of treatment changes will be determined by identifying 
participants whose raw change score for each outcome variable is greater than one-half of a standard 
deviation from their baseline score (60, 61). Using residualized change scores (i.e., difference between 
the post-intervention value with the pre-intervention score covaried out), Pearson correlations will be 
computed to examine associations between outcome and treatment target change scores.  
 
Data and Safety Monitoring. Because this is not a formal clinical trial, a data and safety monitoring 
board (DSMB) will not be required. In order to ensure data integrity and safety of human subjects, 
adverse events reported by participants to staff members or the PI will be recorded on the “Adverse 
Event and Unanticipated Problems form” developed by the University of Florida’s Institutional Review 
Board. This form requires a description of the event, the course of action taken, and specification 
regarding whether or not the event was: 1) serious (e.g., life threatening, requiring or prolonging 
hospitalization, resulting in significant disability/incapacity or death); 2) unexpected (e.g., consistent with 
anticipated potential risks outlined in the study protocol/informed consent); or 3) causally related to the 
study interventions/procedures. All serious and unexpected adverse events are to be reported to the 
University of Florida IRB (within 5 working days) and the study’s sponsor. Other types of adverse events 
will be monitored and reported to the University of Florida IRB in the study’s annual progress review. 

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The investigators will review the reported adverse events on a weekly basis to minimize the risk to the 
study subjects. 
 
Confidentiality. All trained personnel assisting with the study will be instructed on the importance of 
protecting participants’ confidentiality and will have successfully completed the required education on 
protection of human research participants. All paper and computer records will be identified only by 
subject number rather than by name. All study records will be stored in locked file cabinets and will only 
be available to the PI or other project staff. Computer data files (without subject identifiers) will be stored 
on computer servers with secure passwords and electronic storage devices will be encrypted. All study 
records will be stored in locked file cabinets and will only be available to the PI or other project staff. 
Study staff will be instructed to not record any information (e.g., responses to back pain criteria) obtained 
during the phone screen. Each intervention group will be audio-recorded (and video-recorded via Zoom) 
for the evaluation of therapist adherence to the protocol, and a random selection of 50% of all sessions 
conducted will be reviewed by the study PI and Co-I. No identifying information will be transcribed as 
the purpose of this digital recording is to assess treatment integrity. Once the audio recordings are 
reviewed and adherence is discussed with the study therapist, the recordings will be destroyed. Prior to 
destruction, the recordings will be kept in a locked filing cabinet in the laboratory of the PI. Video 
recordings via Zoom will only be used to extract an audio file, and video files will be promptly destroyed 
after each intervention visit. 
 
8.   Possible Discomforts and Risks: The risks for this study are minimal and appropriate safeguards 
are planned and in place to handle risks in a timely and appropriate manner.  
 
Protection against potential risks:  
Physical Performance Exam. The back performance test may cause participant discomfort as a result 
of the exam. The examiner will monitor the response of participants in order to gauge the need to 
discontinue the exam. Participants may stop at any time. 
Questionnaires. Participants will fill out several questionnaires about themselves. While these generally 
carry no associated risks, it is possible that participants might experience some feelings of discomfort or 
unease when reading or responding to survey questions that are personal. Throughout each 
questionnaire, participants will be reminded that participation is completely voluntary, and they can 
refuse to answer any question or can stop at any time. The PI, Co-I, and study interventionists are 
psychologists and are trained to deal with depression. Any participants whose responses during the 
group sessions or on the PROMIS Depression Short Form (raw score >33) indicate severe psychological 
distress (such as severe depression) will be interviewed by the site PI, Co-I, or other appropriately 
trained professionals for suicide risk and risk of harm to self and others. Participants will be assisted to 
the emergency room if danger is imminent or referred to either their physician or a mental health 
professional if necessary.  
Intervention Integrity. To protect participants and maintain treatment integrity, the PI will thoroughly 
train research assistants/interventionists on the intervention protocol. The intervention will be 
manualized to augment treatment fidelity and the study PI will be available for consultation/supervision 
during intervention sessions and will hold weekly supervision meetings with interventionists to review 
the protocol and ensure treatment compliance. In addition, the Co-I (Kimberly Sibille) is a licensed 
clinical psychologist who will be available for consultation/supervision during the intervention sessions. 
9.   Possible Benefits: While persistent pain is common in older adults, chronic low back pain is the 
leading cause of disability in this population and results in significant impairments in psychosocial and 
physical functioning. Participation in this research will provide the participant with a first-hand look at 
pain research and provide them with the opportunity to participate in a new self-management treatment 

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for chronic low back pain. Participants who complete the resilience intervention are expected to show 
improvement in pain severity, interference, negative affect, and quality of life. Overall, it is believed that 
the data will provide important insight into the effects of resilience-based interventions on clinical pain 
and functioning. Ultimately, such knowledge may enhance quality of life and reduce pain in the targeted 
population, as well as lead to advances in the treatment of pain in older adults.   
 
Importance of the Knowledge to Be Gained. Chronic low back pain results in significant impairment in 
older adults, as well as tremendous individual and societal burden. The data obtained from the current study 
has the potential to advance treatment strategies for the management of chronic low back pain in older 
adults and may have broader implications for other medical populations likely to suffer from chronic pain. 
Moreover, our findings will enhance the understanding of underlying mechanisms contributing to treatment-
related effects in our proposed pain and psychological outcomes.  
 
Inclusion of Women and Minorities. Both male and female subjects will be recruited with the goal of 
equal gender distribution. It is planned that adult minorities (50+ years) will be included in the study 
sample in proportion to census levels in the Gainesville, Florida community including: 20% African-
American, 6% Asian, 5% Hispanic or Latino, and 3.6% More than One Race. To ensure that the study 
sample includes census levels of minorities, we will assess their representation periodically over the 
course of the study and adjust recruitment or over-sample as needed. 
 
10.   Conflict of Interest: There is no conflict of interest involved with this study beyond the professional 
benefit from academic publication or presentation of the results.  
 
References: 
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