The Positive Piggy Bank - A Positive Activities Intervention for Improving Functional Status in Patients With Back Pain
Phase: NA
Conditions: Low Back Pain
Sponsor: University of Michigan

Study Title: The Positive Piggy Bank - A Positive Activities Intervention for Improving Functional Status 
in Patients with Back Pain
PI: Afton Hassett, Psy.D
Study ID: HUM00100068
NCT#: NCT02476812
Protocol Version IRB Approval Date: 6/4/2024

PROTOCOL: The Positive Piggy Bank – A Positive Activities Intervention for Improving 
Functional Status in Patients with Back Pain 
1 
A. BACKGROUND
Chronic back pain is the leading cause of disability in Americans under 45 years old and data suggest
that the problem is growing. One recent study showed that the prevalence in North Carolina alone had
increased from 3.9% to 10.2% over a 14-year period.1 Additionally, chronic back pain is associated with
significant disability;2 for example, the Global Burden of Disease Study reported that low back pain was among
the top ten high burden diseases with an average number of disability-adjusted life years greater than HIV,
tuberculosis, lung cancer, and chronic obstructive pulmonary disease.3 Thus, improving pain management,
which includes promoting and enabling patient self-management, is a public health priority.4
Epidural steroid injections are one of the most common interventions used to treat back pain; however, the role 
of ESI in the management of spine pain has been questioned of late.5 While ESI often lead to a short-term 
analgesic response, evidence supportive of long-term relief is lacking and an estimated 25 to 45% of patients 
fail to achieve clinically meaningful improvement in pain.6-10 Studies have shown that the salutary effects are 
particularly small for the treatment of axial low back pain11 or spinal stenosis,12,13 while the best indicator for 
success for ESI is radicular pain secondary to a herniated disc.6 To boost the effectiveness of such an 
intervention, the addition of patient self-management strategies has been proposed. 
Although there are strong data supporting pain self-management approaches for functional restoration 
in chronic back pain patients,14-17 such interventions are greatly underutilized. Barriers to broader 
integration of highly effective behavioral self-management techniques include limited access to 
psychologists/social workers, difficulties integrating psychological practices into medical settings, and poor 
reimbursement. Plus, the stigma associated with mental health interventions decreases enthusiasm for 
adopting some of these approaches in medical populations.18-20 More specifically, Bair and colleagues noted 
that self-management programs for chronic musculoskeletal pain are also hindered by lack of resources, 
physical limitations (i.e., demanding activities), and time constraints or other priorities.21 
Although rarely used in chronic pain populations, positive activities interventions have been used 
successfully in many other clinical settings. Not only have positive activities interventions been found to be 
more appealing than standard interventions (e.g., medication, cognitive-behavioral therapy),22,23 but two meta- 
analyses have shown that these interventions have been used to treat a range of healthy and clinical 
populations with a mean effect size for improving well-being ranging from 0.34 to 0.61 (Cohen’s d).24,25 Positive 
activities interventions are thought to function by increasing positive affect, which in turn, enables creativity, 
problem-solving, perspective-taking, and myriad other beneficial states.26 Such states are conducive to better 
mood,22,27 behavioral activation/increased physical activity,28-31 healthier habits30,32,33 and physiological changes 
(e.g., improved vagal tone, lower blood pressure, more adaptive immune responses).28,34-37 Such changes 
reflect psychological and physiological resilience38 – improved ability to “bend” under stress, but not 
“break.”39,40 Recent studies have successfully adapted positive activities interventions for use in a variety of 
clinical populations, including depressed adults,22 suicidal inpatients,41 schizophrenic outpatients,42 individuals 
who are quitting smoking,43 patients with cardiovascular disease,44 those recently diagnosed with HIV,45 adults 
with type 2 diabetes,46 and individuals with mild to moderate bodily pain.47 Positive activities may be 
particularly helpful for patients with chronic low back pain given that depression is a frequent comorbidity48-50 
and our pilot data show that they have very low levels of positive affect, as well. Finan and Garland posed that 
higher levels of positive affect attenuate both the perception of and the negative affective response to pain.51 
The Positive Piggy Bank. Our intervention is based on the principles of Positive Psychology and Positive 
Psychotherapy as developed by Seligman and Parks (Co-I).22,52 Positive activity interventions target increasing 
positive affect and life satisfaction, while decreasing negative affect. These are the core factors in subjective 
well-being.53-55 Changes in subjective well-being are thought to result in functional restoration and improved 
symptoms including depressive symptoms, sleep disturbances and pain.24,25,45 
The structure and content of the Positive Piggy Bank intervention are based on the Broaden and Build Theory 
of positive emotions.26 This theory proposes that in contrast to negative emotions which narrow our 
perceptions, positive emotions broaden awareness and encourage fresh, diverse, and exploratory thoughts 
and behaviors. This positive perspective broadens one’s behavioral repertoire and helps build skills (e.g., more 
effective coping) and resources (e.g., increased social support). The Positive Piggy Bank is built on the 

PROTOCOL: The Positive Piggy Bank – A Positive Activities Intervention for Improving 
Functional Status in Patients with Back Pain 
 
2  
 
The Positive Piggy Bank 
Every evening think about the people, things or events that made you happy that day. You may make a list if you like. 
Pick one of these and spend a moment savoring it. What made it so special to you? Now, write down this moment on a 
“currency” slip. Use enough detail that you can immediately recall what happened later. Next, add the date, fold up your 
happy memory “currency,” and drop it in the piggy bank. You will make these happy memory “deposits” in the same way 
every evening for the next 30 days. 
 
At the end of 30 days, you will “close your account.” This means that you will withdraw all of the “currency” from your 
piggy bank and read each and every one of the deposited happy memories. As you read them, try to recall details of the 
happy event and what made it so special to you at the time. Enjoy! 
premise that engaging in a daily activity that promotes reviewing positive occurrences can help individuals 
become more aware of positive events (broadens perspective). Not only are individuals called upon to review 
positive events that took place that day, but they also can develop a habit of scanning the environment for 
positive events throughout the day in anticipation of noting them later. Moreover, new coping skills are learned 
(thinking about the good things in life) and social support is enhanced as positive emotions draw people in. 
The intervention itself involves noting at least one positive event each day, writing it down on a slip of paper 
and then depositing this piece of paper in a piggy bank. This practice is to take place at the end of the day, 
every day over a circumscribed period of time. At the end of the “deposit period,” in the case of this study after 
30 days, the participant “closes the account” and makes a full withdrawal by taking all of the slips out of the 
piggy bank and reading each one. This intervention builds on eliciting other well-studied concepts such as 
positive daily reflection,22,27,44,47 gratitude,45,46,56,57 and savoring.22,27,45-47,58 
 
Figure 1. Positive Piggy Bank Instructions. 
 
 
B. OBJECTIVE & HYPOTHESIS 
The objective of this study is to assess the efficacy of a positive activities intervention, Positive Piggy Bank, for 
improving functional status in adults with back pain undergoing an epidural steroid injection. We hypothesize 
that participants in the intervention group will demonstrate a greater improvement in functional status 
compared to a wait list control group. 
 
C. METHODS 
Overview of the Study Procedures. We will conduct a randomized controlled trial of a 30-day positive 
activities intervention, Positive Piggy Bank, compared to a Wait-List control group (Figure 2). Prior to their 
scheduled appointment to undergo epidural steroid injection, all patients meeting study criteria will be 
contacted by research staff to be invited to participate in this study. Patients will be recruited from University of 
Michigan’s Back and Pain Center as well as the Physical Medicine and Rehabilitation Clinic. Those interested 
will be asked to arrive 45 minutes before their regularly scheduled appointment. At that time they will learn 
more about the study and provide informed consent if they choose to participate. Participants will then 
complete the study questionnaires and be randomized 1:1 to the Positive Piggy Bank condition (n=100) or the 
Wait List control group (n = 100). All participants will receive the usual treatment provided at the Back & Pain 
Center at the University of Michigan, Department of Anesthesiology and Physical Medicine and Rehabilitation 
Clinic (e.g., maintenance of medication regimen, standard office visits). Post-intervention (Day 30) and 2 
months after that (Day 90), participants will complete the same questionnaires by mail. The primary outcome 
will be improved functional status, while secondary outcomes will be symptomatic (i.e., pain, fatigue and sleep) 
and related to mood and well-being. After the study period, the patients in the Wait List control will be offered 
the Positive Piggy Bank intervention and will be asked to complete one more set of questionnaires at 30 days 
by mail. 

PROTOCOL: The Positive Piggy Bank – A Positive Activities Intervention for Improving 
Functional Status in Patients with Back Pain 
 
3  
 
 
 
Figure 2. Study Diagram 
 
Participants – Inclusion Criteria 
Subjects to be entered in this study will have a primary diagnosis of back pain and schedule to undergo an 
epidural steroid injection. Participants will be recruited from the Back & Pain Center and the Physical Medicine 
and Rehabilitation Clinic. In addition, participants must also meet the following criteria (verified by chart review 
when applicable): 1) ages 18 to 80; 2) able to read/understand English and give consent; 3) willing and able to 
comply with all aspects of study procedures; 4) if on antidepressants, medications stable for ≥4 weeks prior to 
study; 5) no plan to initiate a new non-pharmacological pain intervention during the 30-day study period (e.g., 
back surgery, physical therapy, cognitive-behavioral therapy [CBT]); and 6) if on pain medications, medications 
stable for ≥4 weeks prior to study and no plans to switch medications during the 30-day study period. 
 
Participants – Exclusion Criteria 
Participants may meet all criteria above, but will be excluded under the following additional conditions: 1) 
having a known psychotic disorder or the presence of another psychiatric condition (e.g., severe depression 
[HADS scores ≥15], suicidal ideation) or cognitive impairment (e.g., severe dyslexia, traumatic brain injury) 
limiting ability to give consent and/or participate fully in the study; 2) currently undergoing psychotherapeutic 
care at the Back & Pain Center because many of the concepts that are the focus of this study are already 
employed in that treatment; and 3) other factors that at the discretion of the investigators would adversely 
affect study participation. We will not exclude participants who undergo unanticipated changes in treatment, 
but will handle these data as described later. 
 
Assessment Measures 
Primary Outcome Measure: Functional Restoration: Oswestry Disability Questionnaire (ODI [version 2.1a]): 
The ODI consists of 10 items that query pain intensity and areas of disability (e.g., personal care, walking, 
sitting, standing, lifting, traveling).59,60 Each item is scored 0 to 5 and scores from all ten items are totaled 
(range 0-50). The total is then divided by 50 and multiplied by 100 to produce a percentage score (range 0- 
100%). Low percentage scores suggest little or no disability, while high percentage scores indicate increased 
disability (e.g., disability: 0-20% minimal; 21-40% moderate; 41-60% severe; 61-80% crippling; and 81-100% 
bed-bound). The ODI has good test-retest reliability59 (e.g., one week, r = 0.83)61 and acceptable internal 
consistency (Cronbach’s alpha 0.87).62 Face and content validity are also acceptable, including assessments 
using patient behavior as the comparator (sitting and walking tests).59,62,63 The ODI is responsive to change64-66 
and is often superior to other commonly used measures including the SF-36.66-69 
Secondary Outcome Measure: Pain – Brief Pain Inventory (BPI). The BPI will be used to assess pain severity 
(4 items). The BPI, validated for chronic, non-malignant forms of pain, asks patients to rate their current pain 
intensity, as well as their worst, least and average pain in the last week (0-10 numeric rating scale). 
Secondary Outcome Measure: Fatigue - PROMIS Fatigue-Short Form 4a.70,71 This measure consists of 4 items 
that assess the impact and experience of fatigue in the past week. It uses a 5-point Likert-like scale with 
response options that range from “Not at all” to “Very much.” A raw score is calculated by summing scores 
across items then a conversion table is used to calculate T-scores with higher scores indicating greater fatigue. 
Secondary Outcome Measure: Perceived Sleep Problems - PROMIS-Sleep Disturbance (PROMIS-SD4a).70,71 
To assess sleep disturbances the 4-item static form will be used. It uses a 5-point Likert-like scale with 
response options that range from “Very poor” to “Very good.” A raw score is calculated by summing scores 
across items then a conversion table is used to calculate T-scores with higher scores indicating greater sleep 

PROTOCOL: The Positive Piggy Bank – A Positive Activities Intervention for Improving 
Functional Status in Patients with Back Pain 
 
4  
 
disturbance. 
 
Secondary Outcome Measure: Depression and Anxiety. The well-validated 14-item Hospital Anxiety and 
Depression Scale (HADS) will be used to assess symptoms of both depression and anxiety.72,73 
Secondary Outcome Measure: Subjective Happiness Scale. The subjective happiness scale is a 4-item 
validated measure of overall happiness. A 7-point Likert scale is used to create a total score. Higher scores 
indicate greater levels of happiness. Item 4 is reversed scored.74 
Secondary Outcome Measure: Subjective Well-Being Scores: Theory and research suggest that subjective 
well-being has at least three components: positive affective appraisal, negative affective appraisal, and life 
satisfaction.53,75 Composite scores for well-being will be calculated using scores obtained on the measures 
below. For each case, negative affect will be subtracted from positive affect and life satisfaction score will be 
added to that for a single global well-being score. Well-being scores derived in this manner have been shown 
to be sensitive to change and are the most commonly used outcome measure in positive activities 
interventions.53 
Well-Being – Affect: Positive and Negative Affect Scale (PANAS). The PANAS consists of two mood 
scales with 10-items each rated on a 5-point scale for assessing positive (e.g., inspired, strong) and 
negative affect (e.g., guilty, scared).76 Each scale has a range of 10-50 with higher scores indicating 
greater positive or negative affect. Both scales are internally consistent, uncorrelated, and stable over a 
2-month time period; good convergent and discriminant validity have also been demonstrated.76,77 
Well-Being – Life Satisfaction: Satisfaction with Life Scale (SWLS). The SWLS is a global measure of 
life satisfaction consisting of 5 items rated on a 7-point scale.54 The SWLS is a reliable and valid 
measure of life satisfaction showing large correlations with reports by family/friends of the person's life 
satisfaction, number of memories of satisfying experiences and other similar scales.54,55,75 
Secondary Outcome Measure - Fibromyalgia Survey Criteria:  Close to half of low back pain patients we see 
also have widespread pain and these patients may be even more likely to respond to this intervention based 
on our previous work. The survey criteria assess the degree to which fibromyalgia-like symptoms are present 
using a continuous scale with a range 0-31.78-80 These criteria have been found to be reliable and valid.81-83 
Secondary Outcome Measure (Follow up only): Patient Global Assessment. Consistent with IMMPACT 
recommendations, the Patient Global Assessment of Change (PGIC) will be used as a secondary measure of 
response.84 PGIC consists of a 7-point scale with response options ranging from “Very much improved” to “No 
different” to “Very much worse.” 
 
Secondary Outcome Measure (Follow up only): Patient Satisfaction Numeric Rating Scale. An 11-point 
numeric scale will be used that instructs, “Please rate your overall satisfaction with the care you received at the 
Back & Pain Center.” The scale is anchored by 0 = “Extremely dissatisfied” to 10 “Extremely satisfied.” 
 
Exploratory Outcome: Holmes-Rahe Life Stress Inventory (HRLSI) (Follow up only).85 We will use this very 
brief and well-validated measure of psycho-social stress to evaluate the potential impact of remarkable events 
that could occur during the intervention period. Participants indicate what stressful events have taken place 
over the last month by endorsing a series of 42 items with an “X.” The measure takes about 2 minutes to 
complete. 
 
Exploratory Outcome:30 Day Post Intervention Follow Up Questionnaire (Follow up only). We will use this brief 
questionnaire to assess if the patient plans to do the intervention on his or her own. This questionnaire will be 
included in the 30 day follow up packet. Patients who are randomized to the control group and chose to do the 
intervention after the initial study period will also be given this questionnaire after 30 days of positive noting. 
 
Exploratory Outcome:90 Day Post Intervention Follow Up Questionnaire (Follow up only). We will use this 
brief questionnaire to assess if the patient continued to do the intervention on his or her own. This 
questionnaire will be included in the 90 day follow up packet. 
 
Randomization. A random numbers generator will be used to create the randomization schedule. Participants 
will be assigned in equal numbers to one of the two groups. 

PROTOCOL: The Positive Piggy Bank – A Positive Activities Intervention for Improving 
Functional Status in Patients with Back Pain 
 
5  
 
 
Intervention Procedures – The Positive Piggy Bank. Patients randomized to this group will meet with a 
research assistant (RA) for an orientation session. The RA provides an overview of the intervention, explains 
the rationale for this treatment, and then gives the patients the instructions on a decorative card (text shown 
above in Figure 1), piggy bank, and currency slips (lined pieces of paper with a place for the date). Participants 
in this group will be instructed as detailed above in the Positive Piggy Bank instructions. At the end of the 
monitoring period, 30 days, they are to “close their account” by opening the piggy bank and reviewing all of the 
slips of paper. 
Participants will be instructed to put their piggy bank in a highly visible place, such as the kitchen counter or 
dinner table. They will also be instructed to create a reminder system be it setting a reminder alarm in their cell 
phones or hanging sticky notes on the refrigerator or bathroom mirror. Further, patients will be informed that if 
they ever have a difficult time finding something that made them happy that particular day, that it is OK to note 
this on a currency slip and put that in the piggy bank. We will add, ‘We all have bad days sometimes!” Study 
personnel will contact patients within 72 hours of beginning the study to answer questions and/or provide 
encouragement. Participants will also be contacted at 30 days to let patients know that they should read all of 
their currency slips in one sitting. They are also told that the intervention part of the study is over and are asked 
they complete the follow up questionnaires and return them by mail. Then, close to the 2-month assessment 
point, study personnel will call again to let the participant know that the questionnaires will be arriving by mail 
and encourage them to return them promptly. Calls will also be made as needed to remind patients to send 
back follow up questionnaires. 
Wait List Control Group. The control group will serve to show the relative benefits of the Positive Piggy Bank 
intervention. Those in the control group who meet study criteria will also receive regular care after their 
epidural steroid injection (e.g., physician visits, medication maintenance, standard patient education). These 
patients will follow the same questionnaire follow up procedures as listed above including phone calls. The 
phone call at 72 hours will be to simply thank them for their participation in the study. At the end of the study 
period, approximately three months, Wait List control patients will also be offered the Positive Piggy Bank 
intervention along with the supportive phone calls. Should they choose to try the Positive Piggy Bank 
intervention, they will be required to return to the center to pick up supplies and receive instruction. They will 
also complete study questionnaires by mail at 30 days to assess intra-individual change. 
Expectancy and Credibility. Since expectancy and credibility are considered key mechanisms in treatment 
outcomes,86 these factors will be measured using the Credibility and Expectancy Questionnaire (CEQ) for 
patients assigned to the Positive Piggy Bank group. The CEQ is a six-item self-report measure consisting of 
questions such as, “At this point, how logical does the therapy offered to you seem?” and “How confident 
would you be in recommending this treatment to a friend who experiences similar problems?” The CEQ will be 
administered at the orientation meeting.86,87 
Fidelity Checks. To assess the fidelity of the Positive Piggy Bank intervention, the slips of paper will be 
collected and counted. Patients are instructed to date the slips of paper and thus daily participation or non- 
participation can be logged by date. We will also ask patients if they continued to keep a Positive Piggy Bank 
on their own after the study ended or if they continued to reflect on the positive aspects of their day on a 
regular basis. 
 
Post-Intervention Assessments and Patient Payment. Participants complete a packet of questionnaires by 
mail after the end of the intervention period (post-intervention assessment, Day 30) and two months after that 
(2-month follow up, Day 90). They will be contacted by phone to alert them to watch for the study packets (for 
both follow up periods). Participants will also be contacted to affirm that the study questionnaires have been 
completed. Participants will be asked to return follow up questionnaires within 10 days of the assessment date 
(i.e., within 10 days of Day 30 or Day 90) Participants will complete the same questionnaires as used pre- 
intervention plus the PGIC, HRLSI, and a questionnaire assessing changes in medications, new diagnoses, 
and other interventions, including changes in exercise. Changes in medications, new diagnoses, and other 
interventions, including changes in exercise reported will be crossed to the EMR. Those in the Positive Piggy 
Bank arm will also complete the CEQ to assess credibility of the intervention. The currency slips are to be 
mailed back to study personnel along with the questionnaires. The currency slips will be mailed back to 

PROTOCOL: The Positive Piggy Bank – A Positive Activities Intervention for Improving 
Functional Status in Patients with Back Pain 
 
6  
 
participants after they have been photocopied (sent with Day 90 follow up questionnaires). Participants will be 
sent a $20 check after the first appointment and another $20 check after sending their first set of 
questionnaires back by mail and a third $20 check for returning their questionnaires by mail at 2 months post- 
intervention. Participants in the control group will complete questionnaires at the same time points and receive 
the same compensation on the same schedule. Should control group participants choose to try the Positive 
Piggy Bank intervention, they will receive $20 for the return trip to pick up supplies and $20 for completing the 
30-day follow up questionnaires. Any participant who completes the Positive Piggy Bank intervention will be 
able to keep his/her piggy bank (value < $15). Individuals who are screen failures will receive a $10 check for 
their time and effort. 
Data Management. All questionnaires and raw scores will be reviewed by the study coordinator and data 
manager before data entry. Data will be entered separately by two study personnel and the two sets of data 
will be compared for accuracy. SPSS Data Entry software will be used since it has the built-in functions to 
automatically compare for potential errors and logic discrepancies. The data files will be backed-up weekly and 
the computer storing the research data is password protected to ensure safety and confidentiality. 
 
Potential Participant Declines. A 'decline' is any potential participant that upon phone screen or being 
consented decides that she/he does not want to participate. Reason for declining and age, sex and race are 
collected and retained to later assess participation bias. 
 
D. STATISTICAL DESIGN 
Data will be analyzed by a qualified biostatistician who will remain blind to group assignment.  
Outcomes: The Primary Outcome will be functional restoration as measure the ODI. The Secondary Outcome 
measures will be pain severity, fatigue, sleep, and subjective well-being. 
Potential covariates: Demographics including Age, Sex, Race, and Education, as well as medical history 
including Medical and Psychiatric Co-morbidities (including other pain disorders [e.g., osteoarthritis]). 
Treatment changes will be carefully documented and controlled for including instances of minimally invasive 
procedures (e.g., epidural steroid injection), opioid use change (i.e., oral morphine equivalents), other 
medication changes (e.g., new antidepressant), physical therapy or new exercise regimen or major intervention 
(e.g., back surgery). Group differences between these possible covariates will be assessed using t-tests or chi- 
square tests as appropriate. 
 
Between group differences in the primary and secondary outcomes at the immediate post-intervention time 
point will be assessed using t-tests or chi-square tests as appropriate. Although significant differences between 
the potential covariates are not expected, any covariates that do differ will be controlled for in linear or logistic 
regression models. As a secondary analysis, longitudinal changes across the 3 time points will be assessed 
with a series of multivariate longitudinal mixed models to explore the effect of the group by time interaction on 
the primary response variable (subjective well-being) and secondary response variables. 
A modest fraction (up to 20%) of drop-outs and partially missing observations are expected in the study. 
Missing data will be handled by list-wise deletion. Failure to complete the positive activities intervention 
(Positive Piggy Bank) will also be handled with intent to treat (ITT) analyses. 
Power analysis. Hypotheses tests will be two-sided with an alpha of .05. Independent t-tests were used for 
power assessments comparing mean between-subject differences between the groups (Piggy bank vs. 
control). A set of power analyses using the range of previously report effects sizes (.34 to .59) was conducted 
using GPower 3.1. As seen in Figure 3 (below), a sample size of 200 will result in 80% power to detect an 
effect size of .40 between two independent group means. If we assume a 20% drop out rate, we will have a 
sample of 160 which results in 80% power to detect an effect of .44. 
 
Figure 3. Range of effect sizes plotted as a function of Power and Sample Size for differences between two 
independent samples 

PROTOCOL: The Positive Piggy Bank – A Positive Activities Intervention for Improving 
Functional Status in Patients with Back Pain 
 
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t tests - Means: Difference between two independent means (two groups) 
Tail(s) = Two, α err prob = 0.05, Allocation ratio N2/N1 = 1 
Effect size d 
0.9 
= 0.48 
0.8 
= 0.46 
= 0.44 
0.7 
= 0.42 
= 0.4 
0.6 
= 0.38 
0.5 
= 0.36 
= 0.34 
0.4 
100 
120 
140 
160 
180 
200 
220 
240 
Total sample size 
Power (1-β err prob) 

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