A Positive Psychology Intervention to Promote Health Behaviors in Heart Failure: a Randomized, Controlled Pilot Trial
Phase: NA
Conditions: Congestive Heart Failure, Emotions, Patient Compliance
Sponsor: Massachusetts General Hospital

 
A positive psychology intervention to promote health behaviors in heart failure: a randomized 
controlled pilot trial 
 
NCT03220204 
 
3/2/2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
I. BACKGROUND & SIGNIFICANCE 
 
A. Historical Background 
 
The scope of the problem: Heart failure (HF) is a common and progressively debilitating 
illness that affects nearly 6 million Americans.1 It has been associated with increased medical 
morbidity, including repeated hospitalizations, poor functioning, and reduced quality of life 
(QoL).2-5 Furthermore, it is costly; in 2010, it led to approximately $39 billion in direct and 
indirect costs in the United States.1 Finally, HF is lethal, with studies estimating that 50% of HF 
patients die within 5 years of diagnosis.4 
The role of health behaviors in HF outcomes: Health behaviors significantly impact 
prognosis for patients with HF. Maintenance of a low sodium diet, adherence to medications, and 
increased physical activity have been associated with improved health, reduced hospital 
readmissions, and lower rates of mortality in HF patients.6-12 Exercise is particularly important, 
as exercise training programs have been associated with improved exercise capacity, QoL, and 
survival in randomized, controlled trials.6,8 As a result, the American Heart Association (AHA) 
recommends exercise training for all patients with chronic, stable HF.10 
However, many HF patients struggle with adherence to health behavior 
recommendations.13,14 Fifteen to 33% of patients with HF consume more sodium than is typically 
recommended.14 Up to 54% of HF patients have suboptimal adherence to their cardiac 
medications,9 and one-third to one-half of HF patients engage in physical exercise less than once 
a week.15,16 In sum, despite clear evidence that adherence may help to improve outcomes, 
patients with HF still struggle to complete health behaviors. 
Interventions to improve health behaviors in HF: Interventions designed to increase 
adherence to health behaviors in HF have had mixed success,17-20 with systematic reviews 
suggesting that only half of interventions lead to improvements in QoL or hospitalizations.17,18 
Less complex interventions in particular often have failed to impact readmissions or number of 
days in the hospital.19 Unfortunately, the intensity of more complex interventions (that require 
significant provider time) may make them cost-prohibitive. 
Impact of psychological states on cardiac outcomes and health behaviors: Positive 
psychological states such as positive affect or optimism have been linked to improved long-term 
health outcomes, including reduced mortality, in healthy individuals and in those with 
cardiovascular disease. Numerous studies have confirmed the prospective association between 
positive states and mortality, oftentimes independent of negative emotional states and relevant 
medical factors.21-24 In one study of over 6,000 patients, greater positive affect was linked to a 
reduced risk of heart disease, even after controlling for health behaviors and depression.25 
Similarly, in a study of over 97,000 women, baseline optimism was prospectively and 
independently associated with lower rates of incident coronary heart disease and mortality.23 
The impact of positive states on cardiac outcomes may be mediated in part by health 
behaviors. In a study of 773 elderly men, dispositional optimism was prospectively linked to 
more physical activity and higher intake of fruits and vegetables.26 Other studies confirm the 
relationship between positive states and diet,27,28 physical activity,29,30 and medication 
adherence.31 Given these links, an intervention to boost positive emotional states has the 
potential to improve health behaviors and medical outcomes in the HF population. 
Positive psychology (PP): PP is an area of study that aims to boost positive psychological 
states (e.g., optimism, gratitude, positive affect) through systematic exercises, such as 

 
performing kind acts, writing a letter of gratitude, or using a strength in a new way.32,33 These 
exercises are easily delivered and completed, require minimal provider training, and can be 
delivered easily via telephone. In non-cardiac patients, these interventions increase well-being 
and reduce depression consistently and substantially.34,35  
Research suggests that PP interventions may be effective in cardiac populations. Positive 
affect induction, though not a formal PP exercise, has been associated with increased medication 
adherence and greater physical activity in hypertensive patients and in post-percutaneous 
coronary intervention patients, respectively.36,37 Furthermore, in a pilot trial by our group, a 
formal, 4-week PP intervention for cardiac inpatients was feasible, acceptable, and associated 
with greater numerical improvements in psychological outcomes compared to relaxation 
response and attentional control groups.38 In a second preliminary study in patients who had 
suffered an acute coronary syndrome (ACS), a PP intervention led to improvements in 
depression, anxiety, and positive affect compared to treatment as usual.39 
However, aside from our research group’s work, no studies have evaluated formal PP 
interventions to promote health behaviors in cardiac patients in general or HF patients in 
particular. Such interventions have the potential to leverage positive psychological states to 
improve health behaviors in this high-risk group of patients. Further study of these interventions 
is critical to determine how they can be applied to HF patients. 
To address this question, we recently completed qualitative interviews with 32 HF 
patients (IRB # 2015P000069) to better understand their HF symptoms, examine the 
relationships between positive psychological constructs and health behaviors, and identify 
barriers and facilitators to completing health behaviors. The information gained from these 
interviews allowed for the creation of an intervention that was adapted to this specific 
population. Next, we performed a single-arm, proof-of-concept trial (N=11, IRB#2016P001443) 
to examine the feasibility of the intervention and our outcome measures, as well as to gain 
preliminary feedback from participants.  Based on this information, we have created an 
optimized, 12-week, telephone-delivered, PP-based health behavior intervention and aim to 
examine its feasibility, acceptability, and preliminary impact in a group of patients with mild to 
moderate HF in a randomized, controlled pilot trial. 
 
B. Preliminary Studies 
 
Dr. Celano is ideally suited to complete the proposed study given his prior research 
experience. He has been co-investigator for both observational and intervention studies focusing 
on positive psychological states in cardiac patients, and he was the principal investigator (PI) of a 
PP intervention trial in psychiatric inpatients with bipolar depression. The studies below 
demonstrate his ability to perform the proposed trial. 
Preliminary Studies #1: Observational and Intervention Studies in Cardiovascular 
Disease. As part of the Cardiac Psychiatry Research Program (CPRP) team, Dr. Celano has 
served as a co-investigator for a number of intervention studies to investigate the use of 
psychological interventions in hospitalized patients with cardiac disease. This includes a large 
(N=175) collaborative care depression management trial40,41 and a recently completed 
collaborative care study (N=183) for depression or anxiety disorders in patients with HF and 
other cardiac diseases.42 These two studies have provided experience with the recruitment, 
enrollment, and retention of participants with heart disease and with many of the outcome 
measures that will be used in the proposed study. 

 
Preliminary Studies #2: Positive Psychology Interventions. Dr. Celano also has 
experience with PP interventions in non-cardiac populations. He served as a co-investigator for a 
study involving the systematic administration of PP exercises to psychiatric inpatients (N=61) 
with suicidal ideation. In this study, 189/213 (88.7%) assigned exercises were completed, 
suggesting that the intervention was feasible and acceptable. More recently, Dr. Celano was the 
Principal Investigator of a study to develop a telephone-based PP intervention for psychiatric 
inpatients with bipolar depression, and he successfully recruited 45 participants over the first two 
phases of the study. He also has served as the Project Director for two PP intervention trials—
one in depression, the other in diabetes. These studies introduced Dr. Celano to the measurement 
of positive psychological states using the same tools as those for the proposed study (e.g., LOT-
R, PANAS), gave him experience with delivering PP interventions via telephone, and 
demonstrated our team’s ability to retain a high percentage of patients despite their level of risk 
and psychiatric illness.  
Preliminary Studies #3: Positive Psychological States in Cardiovascular Disease. 
Finally, Dr. Celano’s work as a co-investigator in the CPRP has exposed him to the study of 
positive psychological states in patients with cardiovascular disease. In a pilot study, our team 
developed and tested an 8-week PP intervention to cultivate gratitude, optimism, and kindness in 
30 cardiac inpatients (N=9 in the PP group) and found the PP intervention to be feasible and 
well-accepted.38 Furthermore, Dr. Celano played an active role in a prospective, observational 
study (N=212) to examine the associations between positive psychological states and health 
behaviors in post-ACS patients. Results from this study suggest that higher levels of optimism 
are prospectively associated with greater physical activity and reduced cardiac readmissions 6 
months later 43. Dr. Celano also serves as the Project Director of a study to examine the use of PP 
interventions in post-ACS patients. Results from the first stage of this study suggest that in the 
post-ACS period, patients view positive emotions as promoters of health behaviors.44 In the 
second phase of this study, an 8-week, telephone-based PP intervention led to greater 
improvements in depression, anxiety, and positive affect, compared to treatment as usual.39  
Finally, Dr. Celano is the PI of an ongoing study to examine the feasibility and potential 
utility of a PP- based intervention to improve health behavior adherence in patients with New 
York Heart Association (NYHA) class I, II, or III HF (IRB# 2016P001443). After successfully 
completing qualitative interviews in 32 HF patients, Dr. Celano developed a 10-week PP-based 
health behavior intervention for this population, and tested it in a proof-of-concept trial.  Though 
follow up for this trial is still ongoing, preliminary analyses involving the first five participants 
revealed that the intervention was feasible (with 100% of exercises completed), easy to 
complete, and subjectively helpful.  Furthermore, the intervention led to numerical 
improvements in both positive affect and daily moderate to vigorous physical activity.  Now, Dr. 
Celano is using the information from the first two phases of this trial to inform his proposed 
randomized-controlled trial of this PP-based health behavior intervention for HF patients.  Dr. 
Celano’s involvement in these studies has provided him with information about the links 
between positive states and outcomes in cardiac patients, experience with developing and 
delivering a PP-based health behavior intervention, and experience with the outcome measures 
and accelerometers to be used in the proposed study.  
 
Relevance of Preliminary Work to the Proposed Project: Dr. Celano now has 
experience recruiting and retaining patients at Massachusetts General Hospital (MGH) who have 
HF and other cardiac illnesses, measuring psychological and medical variables effectively, and 

 
developing interventions to increase positive psychological states. These experiences make him 
well-positioned to successfully and efficiently complete the proposed project. 
 
C. Rationale/Potential Benefits/Overview of Proposed Research 
 
Intervention to increase positive emotions and promote health behaviors in cardiac 
patients. There is clear evidence linking positive emotions with superior cardiac outcomes.21,25,45 
Despite this, there has been minimal study of interventions in cardiac patients that specifically 
focus on the cultivation of positive emotional states. Though some programs have utilized 
relaxation or mindfulness,46,47 PP interventions had never been used in patients with HF until our 
pre-pilot study, despite their well-documented overall efficacy.35 Indeed, aside from our team’s 
work to develop a PP-based intervention for post-ACS patients, we are aware of only one other 
trial that used PP in any cardiac population (outpatients with hypertension or undergoing 
angioplasty).48 
To address this gap in knowledge, we have created and optimized a novel PP-based 
health behavior intervention for patients with HF. A treatment cultivating positive emotions in 
this vulnerable population could provide broad and significant health benefits, and may have 
distinct—and more powerful—effects than simply attempting to dampen negative emotions.49 In 
the first phase of treatment development (IRB # 2015P000069), we performed qualitative 
research (N=32) to: (a) assess barriers to health behavior completion, (b) identify the causes and 
extent of positive emotional deficits, (c) examine potential links between positive emotional 
deficits and impaired health behaviors, and (d) inquire about the utility of potential PP and goal-
setting exercises in participants with NYHA class II or III HF. Using this information we 
developed a customized, PP-based health behavior intervention based on these results and the 
existing literature, which we tested during phase two of this project (IRB # 2016P001443). 
Though follow-up is ongoing, preliminary analyses after 5 participants revealed that the 
intervention was feasible, subjectively helpful, and associated with significant immediate 
improvements in happiness and numerical improvements in positive affect and moderate to 
vigorous physical activity.  Using feedback from participants and the data from this proof-of-
concept trial, we have created an optimized version of the intervention.  We now wish to test the 
feasibility and efficacy of the optimized intervention in a three-arm, randomized pilot trial. 
 
In this project, we hope to do the following: 
1. Test a 12-week, telephone-delivered health behavior intervention utilizing PP exercises 
and systematic goal-setting in a three-arm, randomized, controlled pilot trial in patients 
with mild to moderate HF (N=75). 
2. Determine whether this optimized intervention is feasible in a small cohort of HF 
patients. 
3. Explore potential benefits of the intervention on outcomes of interest (e.g., psychological 
health, functioning, and health behavior adherence) compared to a motivational 
interviewing- (MI) based education condition and treatment as usual (TAU). 
 
II. SPECIFIC AIMS 
 
Specific Aim #1 (Feasibility [primary outcome], acceptability, immediate impact): To assess 
the feasibility, acceptability, and immediate impact of the PP-based health behavior intervention 

 
on optimism and happiness in a three-arm (N=75), randomized, controlled pilot trial.  
 
Hypothesis: The PP intervention will be feasible (the majority of participants will complete at 
least 7 of 12 sessions/exercises) and acceptable (mean score of at least 6 out of 10 on ratings of 
ease of completion and subjective helpfulness of the exercises) and will have adequate immediate 
impact on positive affect and optimism (post-exercise ratings of positive affect and optimism will 
be higher than pre-exercise ratings (measured by pre- and post- measurements on a Likert 
scale).  
 
Specific Aim #2 (overall impact on psychological health): to examine the intervention’s 
overall impact on both positive (positive affect, optimism) and negative (depression, anxiety) 
psychological health, compared to TAU and an MI-based educational control condition. 
 
Hypothesis: The intervention will lead to significant pre-post increases in positive affect and 
optimism and significant reductions in depression and anxiety. Compared to the control 
conditions, the PP-based intervention will lead to greater numerical improvements in all 
psychological outcomes. 
 
Specific Aim #3 (adherence and functional outcomes): To examine the impact of the 
intervention on physical activity (steps, as measured by accelerometer; primary health behavior 
outcome), medication adherence, sodium intake, HF-related QoL, and generic HRQoL, 
compared to TAU and an MI-based educational control condition. 
 
Hypothesis: The intervention will lead to significant pre-post improvements in adherence and 
functional outcomes at follow-up and will lead to greater numerical improvements in these 
outcomes compared to the treatment as usual and the MI-based control condition.  
 
III. PARTICIPANT SELECTION 
 
A. Inclusion/Exclusion Criteria 
 
 
Inclusion criteria: 
• Adult patients with NYHA class I, II, or III HF admitted to an MGH inpatient unit or 
outpatients at the MGH Heart Center or MGH-affiliated primary care clinic.50 
Patients with NYHA class IV HF have ongoing HF symptoms at rest, making it 
difficult for them to increase physical activity and other health behaviors; therefore, 
they will not be included. HF diagnosis will be confirmed via chart review and with 
the patient’s treatment team as needed. NYHA class will be confirmed with the 
patient and adjudicated by Dr. Januzzi or the patient’s treatment team when 
necessary. 
• Suboptimal adherence to health behaviors. This will be defined as a total score of ≤15 
on three Medical Outcomes Study Specific Adherence Scale (MOS)51 items regarding 
diet/exercise/medications. The MOS has been used in multiple prior studies assessing 
adherence in cardiac patients, including our own studies in this population.40,52,53 This 
threshold score on the MOS will ensure that all participants will have the potential to 
improve their health behaviors.  

 
 
 
Exclusion criteria: 
• Cognitive deficits impeding a participant’s ability to provide informed consent or 
participate, assessed via a 6-item cognitive test that is sensitive and specific for 
screening for cognitive impairment in research participants.54 
• Medical conditions precluding interviews or likely to lead to death within 6 months. 
• Inability to speak English, inability to read or write, inability to walk, or lack of a 
telephone. 
 
 
 
Justification for inclusion and exclusion criteria: We will recruit individuals over age 
18 that have NYHA class I, II, or III HF and endorse suboptimal adherence to physical activity, 
diet, and/or medication use. We will study HF because it is extremely common1 and has been 
associated with poor functioning2-5 and high rates of mortality (50% of individuals with HF die 
within 5 years of diagnosis).4 We chose NYHA class I, II, and III HF patients because class II 
and III patients comprise the majority of participants in studies that identify links between 
physical activity and improved exercise capacity, QoL, and survival6,8 and because class I 
patients also likely would benefit from increases in physical activity and health behaviors. We 
did not include NYHA class IV patients because they may be too physically impaired to perform 
some of the PP and health behavior exercises included in the intervention.  
 
 
We will focus on adherence to health behaviors in HF for several reasons. First, 
adherence to health behaviors is associated with better HF outcomes, including lower rates of 
mortality,6-10 but patients with HF often struggle to adhere to these behaviors.13,14 Second, 
existing interventions to improve health behaviors are costly and have had limited impact on 
medical outcomes and QoL.17-20 Finally, positive psychological states have been associated with 
improved adherence to health behaviors in healthy and other medically ill populations,26-31 
suggesting that an intervention to boost these states in HF patients may be an effective way to 
improve these behaviors and medical outcomes in general. We will enroll only those patients 
who have at least mild deficiencies in health behaviors. 
 
 
Exclusion criteria will include cognitive deficits, medical conditions that preclude 
participation in the intervention or are likely to lead to death within 6 months, inability to walk, 
inability to speak English, and lack of a telephone. The main purpose of these exclusion criteria 
is to ensure that all participants are able to fully participate in intervention procedures and 
provide outcome data. Children under age 18 will be excluded because they often are not directly 
responsible for their adherence to health behaviors (e.g., medication adherence) and because they 
will not be able to provide informed consent. Individuals with cognitive deficits may have 
difficulty recalling their affective states or providing informed consent for the study. Patients 
who have medical impairments that lead to a high risk of dying within 6 months likely will 
struggle to complete the intervention and other study procedures. Potential participants without a 
telephone will be unable to perform the intervention and therefore will be excluded.  
 
 
As physical activity (as measured by accelerometer) is our primary health behavior 
outcome measure, those patients who cannot walk will be excluded, as the accelerometers were 
primarily designed for step-based activities. Finally, individuals who do not speak or read 
English will be excluded because our current proposed interventional materials are only available 
in English and because it is unclear whether the intervention and study assessments could be 
effectively administered over the phone using interpreter services—certainly this would add an 
additional potential barrier to assessment and might result in inaccurate conclusions about the 

 
course of illness when in fact the language barrier/interpreter presence may have been a 
confounding factor. If our results suggest that the intervention is promising, we will work to 
expand our study to non-English-speaking populations. All potential participants will be 
evaluated for exclusion criteria prior to enrollment, in concert with their treatment team. 
 
B. Sources of participants and recruitment methods 
 
 
All participants will be adults with NYHA class I, II, or III HF admitted to an inpatient 
unit at MGH or seen as outpatients at the MGH Heart Center or one of MGH’s primary care 
clinics. 
 
 
 
In hospital recruitment. Potential participants will be identified through daily reviews 
of the inpatient unit censuses and contact with (and subsequent clearance by) an inpatient team 
member (physician, nurse, or nurse practitioner). If a potential participant is identified, the study 
staff member will ask the treatment provider to inquire whether it would be okay for a study staff 
member to inform the patient about an optional study. If the patient were amenable, a study staff 
member would meet with the patient, confirm that it is okay to describe an optional study, and 
then discuss the study with the patient and inquire about inclusion/exclusion criteria. Interested 
patients will undergo cognitive evaluation (with the six-item screen), discussion of medical 
history to review for exclusion criteria and confirm NYHA class, and assessment of adherence 
status with the MOS. 
 
 
Sociodemographic and medical data (age, gender, medical and psychiatric diagnoses, 
NYHA class, ejection fraction, alcohol consumption, and smoking history), and baseline 
assessments on self-report measures (including health behaviors), will be obtained at enrollment. 
 
Outpatient recruitment via Research Patient Database Registry (RPDR). All 
participants will be adults with NYHA class I, II, or III HF listed in their electronic medical 
record. Participants can be referred to the study by an outpatient treatment team member 
(physician, nurse, or nurse practitioner) or through systematic searches using the Partners 
Healthcare RPDR. The RPDR is a centralized clinical data registry that gathers data from various 
hospital legacy systems and stores it in one place. Researchers access this data using the RPDR 
online Query Tool. They may query the RPDR data for aggregate totals and, with proper IRB 
approval, obtain medical record data. The RPDR ensures the security of patient information by 
controlling and auditing the distribution of patient data within the guidelines of the IRB and with 
the use of several built-in, automated security measures.55  
To identify potentially eligible patients: 
1.) An RPDR query will be performed to identify those patients with a diagnosis of HF. 
Study staff will review the medical record to confirm potential participant eligibility 
and to identify their linkage to a cardiologist in the MGH Heart Center or primary 
care physician located in an MGH primary care clinic. 
2.) Study staff then will obtain permission for initial contact from each potentially 
eligible patient’s cardiologist or PCP via e-mail or by having providers review letters 
and discard ones that they do not approve. 
3.) For physician-approved patients, study staff will send a study introduction letter from 
the patient’s physician (with the clinician’s name at the bottom) and a study opt-out 
letter signed by Christopher Celano, MD (PI). The letter from the cardiologist or PCP 
informs the patient that he or she is allowing the study to contact patients with HF in 

 
case they are interested in learning about the trial. Dr. Celano’s letter is an opt-out 
letter describing the study, the procedure to opt out of further contact, and whom to 
call for further information. These letters will be sent from a central location at MGH. 
4.) For patients who were contacted for the previous phase of the study and agreed to be 
contacted in the future, study staff will send an opt-out letter from Dr. Celano 
describing this new phase, the procedure to opt out of further contact, and whom to 
call for further information.  
5.) Should study staff receive no reply within 10 days, staff members will call the patient 
on the phone to assess interest in the study and to describe the study over the phone. 
If the patient remains interested, staff will confirm eligibility and assess for exclusion 
criteria. If the patient remains interested and appears eligible, study staff will set up 
an appointment time to go through the consent procedures and conduct the initial 
study visit. We will then mail or e-mail participants a consent form to look over ahead 
of time, so that they may prepare questions for the first visit. Note: If a participant 
prefers to perform all study visits by phone, a consent form will be mailed to the 
participant. This will be reviewed over the phone, and if the patient remains 
interested, he or she will sign the consent form and mail it back to study staff at 
MGH. Once the signed consent form is received, study staff will mail study materials 
to the participant, and the participant will be called for the first study visit. 
 
For potentially eligible patients who are enrolled in the MGH Research Options Direct to 
You (RODY) Program, we will send them an opt-out letter and call 10 days later to inform them 
about the study. RODY identifies patients who are willing to be contacted directly about research 
studies. Patients who have agreed to be contacted directly are identifiable through the RPDR 
search; each patient’s RODY status is available in the demographics table included in the RPDR 
output.  
 
Future Studies. For participants approached either inpatient or outpatient, we will 
inquire at the end of the screen about whether they are interested in being contacted for future 
studies. This will allow us to create a database for contacting patients regarding any research 
studies we conduct in the future. In this phase, we will be contacting potential participants who 
were approached for the previous phases of REACH for Health, and who were interested in 
being contacted in the future. 
 
IV. PARTICIPANT ENROLLMENT  
 
A. Methods of Enrollment 
 
We will enroll participants through the recruitment procedures, described above, and the 
informed consent procedures, described below.  
 
B. Procedures for obtaining informed consent 
 
If the patient is interested in the study after the discussion/assessment for exclusion 
criteria as mentioned above, a licensed physician, psychologist, social work investigator, medical 
student, or research assistant will verbally discuss the study in detail and give the patient 

 
adequate time to read a written IRB-approved consent form and to ask questions. If they desire, 
participants will have at least 24 hours to consider enrollment. To ensure that participants have 
the capacity to provide informed consent, we will ask potential participants to describe their 
understanding of the study’s purpose and their role (e.g., that they understand the timing of the 
intervention and its purpose, audiotaping of phone sessions and the purpose for the audiotaping, 
confidentiality and its limits, our focused review of medical records, and their ability to end 
participation in the study at any time for any reason). Patients will be given at least 24 hours if 
desired to consider participation in the study.  
Participants also will be informed that they will receive a check for $40 after completing 
the week 12 follow-up assessment in addition to wearing and returning the step counter. 
Participants will receive an additional check for $60 after completing the week 24 follow-up 
assessment and returning a second worn step counter. Participants must return the step counter in 
good condition and with at least 5 days of usable data in order for remuneration to be 
appropriated. For tax reasons, a social security number is required in order to issue the full $100. 
However, if a participant is uncomfortable giving that information, they can be compensated 
with a $50 check after the completion of both follow-up assessments. Outpatient participants 
who come to MGH for an initial in-person visit also will be informed that they will be 
reimbursed for parking. 
It is exceedingly unlikely that a potential participant will be a patient currently in an 
investigator’s clinical practice. However, if an investigator discovers that a potential participant 
is a member of his/her clinical practice, an alternate investigator will be substituted to provide a 
description of the study and obtain informed consent.  
Finally, once a participant signs the consent form, the investigator will perform a focused 
review of the participant’s medical record (including laboratory data) to again confirm that the 
patient has HF, and will consult with the study cardiologist in the event that there is any need for 
further clarification. If there is a question about the patient’s medical prognosis (to assess 
whether the patient has a condition likely to lead to death within 6 months) the study team will 
consult with the patient’s inpatient or outpatient team and/or the study cardiologist. Participants 
will be asked to sign a release form at the time of consent to allow study staff to discuss their 
diagnosis and aforementioned medical variables during the study. 
Partners Healthcare has an electronic system that lets the participants’ study doctors 
know if they are admitted to a Partners Hospital, or if they visit a Partners Hospital Emergency 
Department. We will use this system to ensure that the study doctors know about any possible 
problems or side effects participants experience while taking part in the study. 
 
C. Treatment assignment/randomization 
 
Participants will be randomized to receive one of three conditions: (1) the PP-based 
intervention, (2) an MI-based educational control condition, or (3) TAU.  They will be 
randomized by a random-number generator and will be assigned a condition after Actigraph data 
is checked and has been found to be adequate at in-hospital Visit #2. The research assistant 
(RA)/blinded assessor who will conduct the follow-up assessments will be blind to the study 
condition. The interventionist and subjects will not be blind to the study condition. 
 
V. STUDY PROCEDURES 
 

 
A.  Study visits/evaluations (See Table 1) 
 
 
 
Initial visit (Week 1; in person). The initial visit will occur in an MGH inpatient unit 
(for those recruited inpatient), in an office on the MGH main campus (for those recruited via opt-
out letter), or over the phone (if a participant prefers to not come to the hospital for an in-person 
visit). Height and weight will be recorded (measured in person or taken from the medical record 
if inpatient). Participants then will meet with a member of the study staff (the study “trainer”) 
and complete self-report questionnaires. These questionnaires assess state optimism (State 
Optimism Measure; SOM), general optimism (Life Orientation Test-Revised; LOT-R),56 
anxiety/depression (Hospital Anxiety and Depression Scale; HADS),57 positive emotions 
(Positive and Negative Affect Schedule; PANAS),65 HRQoL (Medical Outcomes Study; MOS, 
Short Form-12; SF-12),58 cardiac symptoms and heart failure-related QoL (Kansas City 
Cardiomyopathy Questionnaire; KCCQ),59,60 medication adherence (Self-Reported Medication 
Adherence [adapted from the Heart and Soul Study]; SRMA),61 and sodium intake (Scored 
Sodium Questionnaire; SSQ).62 Participants will also answer questions about their alcohol (using 
the AUDIT-C)63 and cigarette use. In sum, these scales should take approximately 30 minutes to 
complete. 
 
 
After completing the baseline questionnaires, participants will receive an Actigraph 
GT3X+ accelerometer, and its use will be demonstrated by the trainer. We will measure activity 
at baseline (for 7 days) and in the 7 days following the 12 and 24-week assessments (we will 
send participants the ActiGraph in the mail at the appropriate time). In contrast to the pedometer, 
which is used by participants to monitor their activity, the ActiGraph accelerometer provides no 
information to participants about their physical activity and will only be used by the study team 
to measure physical activity as an outcome. 
 
 
ActiGraph accelerometers are validated as measures of physical activity and have been 
used in numerous studies of physical activity in patients with medical illness.64 The 
accelerometer is a small 1.5” square device that can be worn on an elastic band (around the lower 
waist) or clipped onto a belt. It tracks the number of steps taken. After explaining how to use the 
accelerometer, the study trainer will schedule a time for the participant to come in for the second 
in person visit one week after the initial visit. In total this initial visit will take approximately 45 
minutes. 
 
Second Visit (Week 2; in person). 
 
 
At the second in person visit, which will take place one week after the initial visit, we 
will collect the Actigraph from participants, and check to ensure participants had at least 5 valid 
days of data. At this point, participants will be randomized to one of the three conditions noted 
above.  Patients in the TAU group will receive no further intervention and will be scheduled for a 
follow-up appointment in 12 weeks.   Participants in the PP and goal-setting or MI-only 
conditions will be provided with a manual corresponding to their treatment condition, as well as 
a copy of Learning to Live with Heart Failure,65 a practical guide which is provided by MGH to 
all HF patients admitted to a cardiology unit at MGH. 
 
 
PP and goal-setting intervention: The trainer then will introduce the participant to the PP 
and goal-setting portions of the intervention. For the PP portion, participants will be assigned the 
first exercise (Gratitude for Positive Events) and will be instructed to perform the exercise within 
the next week. Prior to completing the exercise, participants will be asked to rate their current 
level of happiness and optimism, using a 10-point Likert scale. Immediately after completing the 

 
exercise, participants will rate the ease of exercise completion, overall utility of the exercise, and 
their current levels of happiness and optimism, all using 10-point Likert scales. For the first goal-
setting session, the trainer will discuss the importance of physical activity in HF. Participants 
will be given a pedometer, which participants will use to monitor the number of steps they take 
daily over the following week. The trainer will instruct them in its use and set a goal for 
monitoring their baseline physical activity over the next week. This pedometer will not be used 
as an outcome measure but simply will be a tool that participants can use to monitor their 
activity. 
 
 
MI-based educational intervention: Participants in the MI-only control group will 
similarly have the rationale of the MI-based health behavior program explained to them, and will 
be assigned the first exercise. They also will be given a pedometer for their personal use.  We 
estimate that this portion of the visit will take approximately 20 minutes. 
 
PP-based Health Behavior Intervention: 
 
 
 
Weekly phone sessions (Weeks 1-12). All participants will be asked to complete 12 
weekly PP exercises and will be asked to speak with a study trainer weekly. In addition, in the 
final week, there will be a wrap-up phone call that focuses on the progress the participant has 
made in the program and makes a plan for continuing to use PP skills and engage in healthy 
activities in the future. Weekly phone sessions will last approximately 45 minutes. These calls 
will be recorded so that a percentage (10%) of these recordings can be reviewed to ensure that 
the PP and goal-setting portions of the intervention are being delivered as described in the 
protocol and trainer manual. 
 
 
 
Program Content. All phone sessions will include (a) a review of the week’s PP exercise 
(including the participant’s ratings of pre- and post-exercise happiness, ease and helpfulness of 
the exercise, and optimism related to the future), (b) a discussion of the rationale of the next 
week’s PP exercise through a guided review of the PP manual, and (c) assignment of the next 
week’s PP exercise. Additionally, for the goal-setting portion, participants will (a) review their 
goals and behaviors from the prior week, (b) discuss techniques for improving health behavior 
adherence (e.g., monitoring physical activity, reading nutrition labels), and (c) set goals for the 
next week. The exercises and content for both PP and goal-setting portions of the program will 
be assigned in the same order for all participants receiving them. During the calls, the trainer and 
participant will also review the next section of the treatment manual and prepare for the 
upcoming week’s exercise. 
 
 
 
Positive Psychology Exercises. The PP exercises used in this study were selected based 
on their superior performance in our pre-pilot research and others’ work. They will be grouped 
into four-week modules focusing on a different psychological state: 
 
Module 1: Gratitude-based activities 
Session 1 (in-person visit): Gratitude for positive events.33  
Participants recall three events, small or large, in the preceding week that were associated 
with satisfaction, happiness, pride, or other positive states. 
 
Session 2: Expressing gratitude.33  

 
Participants write a letter of gratitude thanking a person for an act of kindness; 
participants may, at their discretion, share the letter with the other person. 
 
Session 3: Capitalizing on positive events. 66,67  
Participants identify three good events over the course of the week and then boost the 
positive feelings gained from them by sharing the events with others, or recording or 
celebrating the events in some way.   
 
Session 4: Integrating gratitude-based activities into daily life.  
Participants work to integrate one or more of the gratitude-based skills into their daily 
lives over the course of the week. 
 
Module 2: Strength-based activities 
 
Session 5: Recalling a past success.33 
Participants recall a prior event in which they experienced success. They write about the 
event, their contribution to the success, and the positive feelings evoked by recalling it. 
Finally, they consider how they might use the experience to be successful in the future. 
 
Session 6: Using personal strengths, part 1.33  
Participants choose a personal strength that is important to them and then find a new way 
to use that strength over the following week. 
 
Session 7: Using personal strengths, part 2.33  
Participants choose a second personal strength that is important to them and then find a 
new way to use that strength over the following week. 
 
Session 8: Integrating strength-based skills into daily life. 
Participants work to be more aware of successes that occur in their daily life and how 
they can use their strengths on an everyday basis. 
 
Module 3: Meaning-based activities 
Session 9: Enjoyable and meaningful activities.68  
Participants complete a series of self-selected activities that vary between those that bring 
immediate boosts in mood and those that are more deeply meaningful.  
 
Session 10: Performing acts of kindness.  
Participants complete three acts of kindness. The acts can be small or large, planned or 
spontaneous, but must be expressly completed to be kind to another. Participants then 
write how doing the acts made them feel.  
 
Session 11: The “Good Life”. 69 
Participants write about their ideal life over the next year in one or more life domains. 
 
Session 12: Integrating meaning-based activities into daily life. 
Participants work to perform enjoyable and meaningful acts for themselves and others in 
daily life. 

 
 
Wrap-up session: Planning for the Future. 
Participants review the skills they have used in the program and make a plan for using 
these skills in everyday life moving forward. 
 
 
 
Goal-setting. The goal-setting portion of the program aims to provide patients with 
knowledge about important HF-related health behaviors and assist them with setting goals to 
become more adherent to these health behaviors. This intervention will focus on three distinct 
health behaviors: physical activity, low-sodium diet, and medication adherence. These also will 
be divided into four-session modules, which will be completed in parallel to the PP exercises. 
 
 
Each session follows the same structure. Study trainers will: (a) ask participants about 
their health goals, (b) provide education about a health behavior and/or refer them to their 
treatment team if clarification is needed, and (c) set a health behavior goal for the next week. 
Health behavior goals will be individualized to the participant, and participants will be 
encouraged to speak with their treatment team if they have any questions about appropriate goals 
for diet or physical activity. While all sessions will involve tracking participants’ progress 
towards their health behavior goals, the educational components will vary from week to week: 
 
Module 1: Increasing physical activity  
Session 1 (in-person visit): Introduction to increasing physical activity. 
The trainer will review with participants the potential health benefits of physical activity, 
as well as participants’ current physical activity. Participants will receive a pedometer 
and set a goal of monitoring their physical activity (through steps measured by the 
pedometer) over the next week. 
 
Session 2: Setting a SMART physical activity goal. 
Participants will learn about setting goals that are SMART (specific, measurable, 
attainable, relevant, and time-based) and will be encouraged to set a small behavioral 
goal related to physical activity. 
 
Session 3: Barriers and problem-solving related to physical activity. 
Participants will discuss ways to problem solve around barriers to physical activity. 
 
Session 4: Reviewing and reflecting on physical activity. 
Participants will reflect on their physical activity in the past few weeks and their progress 
to their overall physical activity goal.  Based on their experience, they will revise their 
overall physical activity goal, if needed. Finally, participants will be mailed a graph of 
their weekly step counts to date. 
 
Module 2: Maintaining gains related to physical activity   
Session 5: Finding new routes. 
Participants will explore their neighborhood and brainstorm new places to walk 
 
Session 6: Using resources and making small changes. 
Participants will be asked to identify resources (community, friends/family, equipment) 
for engaging in physical activity and how they can use them to work toward their goals.  

 
Participants also will think of ways to introduce small amounts of physical activity into 
their daily schedules. 
 
Session 7: Continuing progress and managing slips. 
Participants will learn about managing ‘slips’ or times when they get off track from their 
goals. 
 
Session 8: Reviewing and reflecting on physical activity. 
Participants will reflect on their physical activity in the past few weeks and their progress 
to their overall physical activity goal.  Based on their experience, they will revise their 
overall physical activity goal, if needed. Finally, participants will be mailed a graph of 
their weekly step counts to date. 
 
Module 3: Other important healthy behaviors 
Session 9: Introduction to a heart-healthy diet. 
The trainer will review with participants the potential health benefits of a low sodium 
diet, as well as participants’ current dietary habits. Participants will be encouraged to 
keep track of their salt intake over the next week and contact their physician if they are 
unsure how much sodium they should be consuming daily. 
 
Session 10: Setting a SMART heart-healthy diet goal. 
Participants will be encouraged to set a small behavioral goal related to diet and to 
continue to monitor their sodium intake. 
 
Session 11: Heart-healthy diet resources. 
Participants will be asked to identify resources (community, friends/family, low sodium 
diet recipes/books) for having a low sodium diet and how they can use them to work 
toward their goals. They will also discuss ways to problem solve around barriers to a 
heart-healthy diet. 
 
Session 12: Medication adherence and resources. 
The trainer will review with participants the importance of medication adherence, as well 
as participants’ current medication adherence.  Trainers and participants will discuss 
different resources (e.g., medication pill boxes, electronic reminders) that can help 
participants remember to be adherent to their medications. They will also discuss ways to 
problem solve around barriers to medication adherence 
 
Session 13: Planning for the future. 
Trainers will assist participants with reviewing their accomplishments and benefits 
gained from health behavior adherence thus far, and help them to create a plan for 
physical activity, heart-healthy diet, and medication adherence for the near future. 
Finally, participants will be mailed a graph of their weekly step counts to date. 
 
At each session, health behavior goals will be reviewed with the participant, and if there are any 
concerns about the goals, participants will be encouraged to speak with their outpatient treatment 
team for clarification. Educational information will be based on the Learning to Live with Heart 

 
Failure guide,65 which is provided to all patients with HF who are admitted to an MGH 
cardiology unit. Study staff will confer with the study cardiologist if any other questions arise. 
 
Given the results of our prior PP studies, and given that this is a feasibility study (i.e., we want to 
assess participants’ willingness to complete the exercises), we will expect participants to 
complete at least 7 PP exercises / goal-setting sessions. In other words, if a participant completes 
at least 7 sessions, missed sessions will not be considered a deviation from the protocol. 
 
MI-based educational control condition: 
The MI-based educational intervention was selected as the active control condition for several 
reasons.  The inclusion of MI and education regarding key cardiac health behaviors aims to 
increase the retention of participants included in this condition.  However, the focus of this 
intervention on multiple health behaviors and the lack of specific goal-setting make it less likely 
that this control intervention will significantly impact physical activity (our primary health 
behavior outcome) and our other health behaviors of interest.  Finally, as an attentional control, it 
has a parallel structure to the experimental arm with a treatment manual, weekly exercises, and 
weekly calls to review exercises. 
 
Each week, participants will learn about a different health behavior topic related to cardiac 
health. They will also be introduced to motivational interviewing topics in concert with the 
health behavior education topics.  The intervention is divided into five sections, focusing on five 
different important cardiac health-related topics: 
 
Part One: A Healthy Heart 
 
Understanding Heart Disease and Its Risks (Session 1) 
Participants will review information about heart disease, including HF, as well as 
information about heart disease and its associated risk factors. 
 
How to Take Care of Your Heart (Session 2) 
Participants will review information about the importance of health behaviors to reduce 
the risk of heart disease.  
 
Part Two: Staying Active 
 
The Importance of Staying Active (Session 3) 
Participants will review the cardiovascular benefits of physical activity, questions to ask 
their physician prior to starting physical activity, and ways to set goals related to physical 
activity. 
 
 
How You Can Stay Active (Session 4) 
Participants will identify one way in which they wish to change their physical activity.  
They will discuss the importance of making the change and their confidence about being 
able to do so.  Finally, they will create a list of pros and cons for behavior change. 
 
 
Barriers to and Resources for Activity (Session 5) 

 
Participants will identify barriers to physical activity in their life and brainstorm ways to 
problem-solve around those barriers.  Furthermore, they will identify social, community-
based, and equipment resources available to help them with physical activity. 
 
Part Three: Heart-healthy Diet 
 
Benefits of a Heart-Healthy Diet (Session 6) 
Participants will learn about the cardiovascular benefits of a heart-healthy diet.  They will 
be encouraged to track their food intake over the next week to learn more about their diet. 
 
 
Reducing Sodium (Session 7) 
Participants will learn about the importance of reducing sodium in their diet.   Next, they 
will identify one way in which they wish to change their diet.  They will discuss the 
importance of making the change and their confidence about being able to do so.  Finally, 
they will create a list of pros and cons for behavior change. 
 
 
Barriers to and Resources for a Heart-healthy Diet (Session 8) 
Participants will review how to properly read a food label and learn techniques to make 
healthy decisions while food shopping.  They also will identify barriers to a healthy diet, 
problem-solve those barriers, and identify resources that can help to improve their diet. 
 
Part Four: Taking Medications 
 
Taking Medications Regularly (Session 9) 
Participants will review the importance of medication adherence and learn about 
medications typically prescribed for HF.  Participants will be encouraged to create a list 
of their current medications, as well as any questions they have for their physicians about 
their medications. 
 
 
Barriers to and Resources for Taking Medications Regularly (Session 10) 
Participants will identify barriers to taking medications, problem-solve those barriers, and 
identify resources to help them maintain adherence to medications. 
 
Part Five: Stress Reduction 
 
How Relaxation Can Help Your Heart (Session 11) 
Participants will learn about the risks of acute and chronic stress.  They will learn to 
recognize their reactions to stress and will be introduced to methods for relieving stress.  
 
 
How to Practice Relaxation Regularly (Session 12) 
Participants will learn about relaxation response exercises and ways to incorporate these 
exercises into daily life. 
 
 
Planning for the Future (Session 13) 
Participants will review the information learned over the course of the program and think 
of ways to remain healthy after the end of the program. 
 
Treatment as Usual (TAU): 

 
 
Participants in the TAU group will not receive any interventions between the baseline 
visit and follow-up visits.  The inclusion of this group will allow us to examine the overall 
impact of the PP-based intervention compared to TAU, as well as its impact compared to an 
active comparator. 
 
Follow Ups: 
 
Follow-up phone calls (Week 12 and Week 24 [post randomization]). At Weeks 12 
and 24, a member of the study staff will call participants to repeat the self-report questionnaires 
that were administered at baseline. These questionnaires assess state optimism (State Optimism 
Measure; SOM), general optimism (LOT-R), positive affect (PANAS), overall health behavior 
adherence (MOS), anxiety/depression (HADS), HRQoL (SF-12), cardiac symptoms and HF-
related QoL (KCCQ), medication adherence (SRMA), and sodium intake (SSQ). Participants 
will also be asked about cardiac-related hospital readmissions and cardiac rehabilitation, and to 
rate their overall satisfaction with the treatment they received for their cardiac condition over the 
course of the study on a scale of 0 (not at all satisfied) to 10 (completely satisfied). Finally, 
patients will be asked about their experience in the study, including any aspects of the 
intervention or study procedures that could be improved, during follow-up assessment. In sum, 
these scales should take approximately 30-40 minutes to complete. If participants would rather 
complete the follow-up questionnaires in written form rather than over the phone, we will send 
them a paper packet at the time of the follow-up. 
 
Training. Dr. Celano (PI) has substantial experience in explaining and delivering PP 
exercises from their studies in cardiac and psychiatric patients. The PP exercises for this trial 
have been identified via published literature,33,66,68,70,71 or directly from researchers, and modified 
appropriately for this population. Additional text outlining the rationale and instructions for each 
exercise are located in the written packets for each exercise that are provided to participants. Dr. 
Celano will engage in several training exercises prior to study initiation.  He will review the 
treatment manual and our team’s prior training manuals related to these exercises. He will then 
complete all exercises to gain experience performing and reviewing each exercise.  
Dr. Celano also has significant experience with providing guidance and motivation 
towards goal-setting from the ongoing work in cardiac patients. Dr. Celano currently is the 
Project Director of another study examining the efficacy of PP and goal-setting interventions in 
patients with ACS. This study utilizes a nearly identical MI-based control condition, with which 
Dr. Celano has experience. Both the goal-setting portion of the PP-based intervention and MI-
based control condition aim to improve health behaviors that studies have shown to be critical 
for cardiac health in patients with HF.6-12 Similar to his training related to the PP exercises, Dr. 
Celano will review the treatment manuals for this project and complete each exercise to gain 
experience providing education and setting goals related to physical activity, sodium restriction, 
and medication adherence. 
 
Table 1. Schedule of study events. 
 
 
Pre-
enrollment 
Initial 
Visit 
Second in 
Person 
Visit 
Phone 
Sessions 
(12 weeks) 
Follow-up 
Phone Call 
(Week 12) 
Follow-up 
Phone Call 
(Week 24) 
Cognitive screen 
X 
 
 
 
 
 

 
Chart review to 
confirm eligibility 
X 
 
 
 
 
 
Assessment of inclusion 
criteria (MOS, NYHA class)  
X 
 
 
 
 
 
Chart review for 
baseline characteristics 
 
X 
 
 
 
 
Randomization to PP or 
Control Condition 
 
 
X 
 
 
 
Weekly intervention 
exercises* 
 
 
X 
X 
 
 
Exercise ratings 
 
 
X 
X 
 
 
Self-report measures 
(SSQ, SRMA, MOS, LOT-
R, PANAS, HADS, KCCQ, 
SF-12, SOM) 
 
X 
 
 
X 
X 
Objective adherence data 
(ActiGraph step counter) 
 
X 
 
 
X 
X 
Satisfaction with Care 
 
 
 
 
X 
X 
Hospital Readmissions 
 
 
 
 
X 
X 
*Type of exercise assigned will depend on whether participant is in PP-MI or control condition 
B. Drugs to be used 
 
No specific medications are being studied or administered solely for research purposes in 
this study. 
 
C. Devices to be used 
 
No specific devices are being studied or administered solely for research purposes in this 
study. 
 
D. Procedures/ surgical interventions 
 
No procedures or surgical interventions will be performed solely for research purposes in 
this study.  
 
E. Data to be collected (See Table 1) 
 
Baseline Data: Participants will complete the MOS, SSQ, SOM, LOT-R, PANAS, 
HADS, KCCQ, SRMA, and SF-12 in person and will receive an Actigraph accelerometer. They 
will be asked to begin wearing the accelerometer after their initial visit and prior to in-person 
visit #2 to measure their baseline physical activity. 
Baseline information about enrolled participants will also be obtained from the 
participants, care providers, and electronic medical record as required for characterization of our 
population. This information will include data regarding medical history (history of coronary 
artery disease, acute coronary syndrome, coronary artery bypass graft, hypertension, diabetes 
mellitus, hyperlipidemia, body mass index, height, weight, and current smoking), current 
medical variables (renal function, N-terminal pro-B-type natriuretic peptide, left ventricular 
ejection fraction, NYHA class), medications, and sociodemographic data (age, gender, 

 
race/ethnicity, living alone, education). This information will help us to ensure that the 
population we recruit is a representative population of patients suffering from HF so that the 
health behavior intervention we are testing is applicable to the broadest population of patients. 
 
Feasibility (primary study aim): Feasibility will be measured by the number of PP 
sessions that were completed by participants. We will consider the intervention feasible if the 
majority of participants complete at least 7 of 12 exercises/sessions. 
 
 
 
Acceptability: Following each PP exercise, participants will be asked to rate the ease of 
completion and subjective helpfulness of the exercise on a scale of 0 (very difficult/not helpful) 
to 10 (very easy/very helpful).  
 
 
Immediate impact: To examine the immediate impact of the PP exercises on positive 
affect and optimism, participants will be asked to rate these psychological states before and after 
each exercise on a 10-point Likert scale (0 = not happy/optimistic, 10 = very happy/optimistic). 
 
Measurement of health behaviors. We will assess three main health behaviors in this 
trial.  
 
(a) Physical activity (primary health behavior outcome measure). We selected 
physical activity as our main health behavior outcome for several reasons. Physical activity is a 
key modifiable prognostic factor in HF patients72,73 and has been associated with improved 
exercise capacity, QoL, and survival in this population.6,8 Furthermore, there are established 
links between higher levels of positive emotions (particularly optimism) and increased physical 
activity,26,29,30 suggesting that a PP intervention could impact this behavior. Finally, increasing 
physical activity is likely to require a relatively broad approach, as compared to other behaviors, 
which may improve with simple interventions such as electronic reminders. 
Physical activity will be measured using the ActiGraph GT3X+ three-axis accelerometer 
(ActiGraph, LLC, Pensacola, FL). Accelerometers are often considered to be the standard for 
measuring habitual physical activity.74,75 ActiGraph GT3X+ step counters are validated as 
measures of physical activity and have been used in numerous studies of physical activity in 
patients with medical illness.64 We chose to use ActiGraph GT3X+ accelerometers because they 
are the most widely used monitors for research purposes and adequately discriminate between 
different levels of activity.76,77 In this trial, participants will wear the accelerometer (for 1 week 
at baseline and 1 week at each follow-up time point) to assess the feasibility of doing so, ensure 
adequate capture of physical activity, and examine the impact of the intervention on this health 
behavior. We will measure the number of steps taken daily and the amount of time spent in 
moderate to vigorous physical activity (MVPA) to examine the impact of the intervention on 
these important outcomes. We will turn off all notifications on the device prior to the start of the 
study. We will require at least 480 minutes of wear time to be considered a valid day, and at least 
5 valid days for a participant’s data to be considered complete. If a participant does not provide 
at least this much data, we will ask the participant to re-wear the step counter until information 
from at least 5 valid days has been captured. 
(b) Medication adherence. We will assess medication adherence using a self-report 
medication adherence (SRMA) measure.  Specifically, we will ask participants what percent of 
the time (in 10% increments) they took all of their medications as prescribed in the past week 

 
and in the past 2 weeks. These questions were adapted from the adherence measure used in the 
Heart and Soul Study.61 
 (c) Dietary adherence. We will assess sodium intake over the past month using the 
Scored Sodium Questionnaire (SSQ).62  This scale assesses the frequency with which 
participants consume a variety of sodium-containing foods, ranging from “Rarely or Never 
Eaten” to “At Least Once Daily.”  Total SSQ score has been shown to correlate significantly 
with 24-hour urinary sodium, and the SSQ has been validated in patients with significant medical 
illness.62 If participants are hospitalized, they will be asked to describe their sodium intake prior 
to admission, given that their diet in the hospital may be significantly different than their typical 
diet at home. The SSQ will be completed both at baseline and again at the 12 and 24-week 
follow ups.  
(d) Self-reported adherence. We will assess self-reported adherence using the MOS51 
items regarding diet/exercise/medications. Participants will be asked to rate how often they 
completed each health behavior over the last month, with choices rating from “none of the time” 
to “all of the time.” The MOS has been used in multiple prior studies assessing adherence in 
cardiac patients, including our own studies in this population.40,52,53 
 
Measurement of psychological outcomes. We will measure optimism, positive affect 
and other psychological constructs that may potentially be impacted by the PP-based health 
behavior intervention that will be tested in subsequent trials. Doing so in this study will allow us 
to evaluate the feasibility of using these scales in this specific patient population. 
 
(a) Optimism will be measured using the Life Orientation Test-Revised (LOT-R), a 
well-validated 6-item instrument, and the State Optimism Measure (SOM). Dispositional 
optimism is the positive psychological state most linked to cardiac outcomes,23,78,79 and the LOT-
R has been used to measure optimism in many studies of cardiac patients.80-82 Though 
dispositional optimism theoretically would be stable over time, research suggests that LOT-R 
scores can change quickly in response to psychological interventions.38,83,84 We also will be 
using a short scale developed by our team (SOM) to measure state optimism.  
(b) Positive affect (primary psychological outcome measure) will be measured using the 
positive affect items on the Positive and Negative Affect Schedule (PANAS),85 a well-validated 
scale used in other intervention trials and in patients with HF.86,87 
(c) Anxiety and depression will be measured using the anxiety and depression subscales 
of the Hospital Anxiety and Depression Scale (HADS).88 This well-validated scale has been used 
in many studies of patients with heart disease (including our group’s studies),38,40,88-90 and has the 
advantage of having few somatic symptom items that can confound mood/anxiety assessment in 
medically-ill patients. 
 
Measurement of physical outcomes. We will also assess selected physical outcomes.  
 
(a) Cardiac symptoms and HF-related QoL (primary functional outcome measure) will 
be measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ), a well-validated 
questionnaire of health status in HF.59 The full scale will be used to measure HF-specific health-
related QoL (HRQoL), and an eight-question subset of the KCCQ will be used as a measure of 
HF symptoms. The KCCQ is a valid, reliable, and responsive instrument in patients with HF59,60 
and is strongly correlated with NYHA class.60 We chose the KCCQ as our primary functional 

 
outcome measure because it likely would be affected by all three of our health behaviors of 
interest (physical activity, medication adherence, and diet). 
(b) Generic HRQoL will be assessed via the Medical Outcomes Study Short Form-12 
(SF-12),58 an instrument which has been used in multiple cardiac studies in the past, including 
our work.38,40,83,91-96 The SF-12 also is a reliable marker of QoL in HF97 and has been associated 
with mortality in this high-risk cohort.98  
 
VI. BIOSTATISTICAL ANALYSIS 
 
A and B. Specific data variables and study endpoints 
 
Aim #1 (Feasibility [primary outcome], acceptability, and immediate impact): To assess whether 
PP exercises administered over the phone are feasible, acceptable, and lead to improvements in 
positive affect and optimism in patients with NYHA class I-III HF. 
 
Measures: 
• Rates of completion of exercises (recorded by study trainer). 
• Successful use of ActiGraph accelerometer. 
• Patient rating of immediate outcomes on 10-point Likert scale: Ease of completion, 
overall utility, change in positive affect and optimism from pre- to post-exercise. 
 
The intervention will be considered feasible if ≥7 of the 12 sessions are completed by a majority 
of patients. The objective assessment measures will be considered feasible if we obtain adequate 
physical activity data (at least 5 valid days of accelerometer wear time) in at least 80% of 
enrolled participants at one of the follow-up time points.  The PP exercises will be considered to 
be acceptable if participants have mean scores of at least 6/10 on the ratings of ease of 
completion and subjective helpfulness across exercises. The PP exercises will be considered to 
have adequate impact if participants rate positive affect and optimism significantly higher post-
exercise than pre-exercises across exercises (via mixed linear models). 
 
Aim #2 (overall impact on psychological health): To examine the intervention’s impact on both 
positive (positive affect, optimism) and negative (depression, anxiety) psychological health, 
compared to TAU and a MI-based educational control condition. 
 
Measures: 
• Optimism: LOT-R; SOM  
• Positive affect: PANAS (primary outcome measure for this aim) 
• Anxiety/depression: HADS 
 
We will examine between-group differences (PP-based condition vs. MI-informed educational 
control and PP-based condition vs. TAU) on changes in each of these psychological outcomes to 
assess the impact of the intervention compared to both an active control and TAU. The primary 
study endpoint will be 12 weeks, though we will secondarily assess the impact of the 
intervention on outcomes at 24 weeks as well. 
 

 
Aim #3 (Impact on functional outcomes and health behaviors): To examine the impact of the 
intervention on physical activity (steps, as measured by accelerometer; primary health behavior 
outcome), medication adherence, sodium intake, HF-related QoL, and generic HRQoL, 
compared to treatment as usual and an MI-based health behavior education intervention. 
 
Measures: 
• HF-related QoL: KCCQ 
• HF symptoms: KCCQ subscale 
• Health related quality of life: SF-12 
• Self-reported adherence: MOS 
• Physical activity: ActiGraph accelerometer 
• Medication adherence: SRMA  
• Sodium intake: SSQ   
 
We will examine between-group differences (PP-based condition vs. MI-informed educational 
control and PP-based condition vs. TAU) on changes in functional outcomes and health 
behaviors to assess the impact of the intervention compared to both an active control and TAU. 
 
C. Statistical methods  
 
Data will be downloaded from REDCap into the Stata statistical package. For Aim 1 (feasibility, 
acceptability), descriptive statistics will be used to report proportion of exercise completion and 
mean scores on exercise ratings of ease and utility.  To examine the immediate impact of the 
intervention on positive affect and optimism, we will use linear mixed models (to account for 
within-person correlations) to examine the improvement in these scores from pre- to post-
exercise. 
 
For our secondary aims, we will initially compare physical activity (# of steps/day) at 12 and 24 
weeks between groups using a Wilcoxon rank sum test, given that the distribution of the number 
of steps will likely be skewed.  In addition, we will compare between-group differences in 
change over time in all self-report measures (including psychological, functional, and health 
behavior outcomes) at the 12 and 24-week time points using random effects regression models 
with a random intercept for each patient.  All statistical tests will be two-tailed, with p<.05  
considered significant. 
 
D. Power analysis 
 
We have performed power analyses assuming 20 participants in each group. To account for 
potential drop outs between enrollment and randomization, we will enroll 75 participants with a 
goal of randomizing 60. This pilot trial is not designed to detect significant between-group 
differences in 12- or 24-week health behavior outcomes, but is powered to meet our primary 
aims of feasibility and immediate impact.  For feasibility, 75-80% of subjects have completed the 
majority of PP exercises in our prior work, and 90% completed the majority of PP exercises in 
our proof-of-concept trial in patients with HF.  With 20 PP participants, we will have at least 
80% power to detect a difference between our expected proportion of participants completing at 
least 5 out of 8 PP exercises (80%) and the null hypothesis (true proportion of 50% or less) at the 

 
two sided 0.05 level using a binomial proportion test.  In a prior study, we found that PP 
interventions led to a moderate (d=.52) improvement in optimism immediately post-exercise.99  
If we assume completion of ~140 exercises from 20 subjects and a within-person correlation of 
0.5 for change in pre-/post- ratings across exercises, our proposed study is powered at over 80% 
to detect a similar effect size improvement of optimism immediately post-exercise at the two-
sided 0.05 level. 
 
VII. RISKS AND DISCOMFORTS  
 
A. Complications of surgical/non-surgical procedures 
 
No procedures will be conducted as part of this study 
 
B. Drug side effects and toxicities 
 
No specific medications are being studied or administered solely for research purposes in 
this study. 
 
C. Device complications 
 
No specific devices are being studied or administered solely for research purposes in this 
study. We are using an accelerometer and step-counter that, although not determined to be a 
“device,” can malfunction.  The device utilized to measure physical activity should pose minimal 
risk. The accelerometer (ActiGraph GT3X+) used to measure activity is small, light, and without 
sharp edges. Immersing the device in water for a prolonged period may render it unusable but 
does not pose a shock risk. Participants will mail the device back after 7 days in a pre-paid 
envelope provided by the study team.  The Omron pedometer which we will provide participants 
to use in self-monitoring similarly poses minimal risk, given that it has no sharp edges, no shock 
risk, and no other known risks. 
We will provide explicit instructions regarding the use of the accelerometer and step 
counter to ensure safety and proper use, and to reduce inconvenience/distress associated with 
uncertainty about their safety or use. We will reduce technological failure by educating study 
participants and providing a technical help line as noted above. The scientific team (i.e., Dr. 
Celano or other study staff member) will liaise with participants regarding any battery problems 
or technical advice on the Actigraph accelerometer, step counter, and related equipment.  The 
participant will be instructed to contact study staff by phone should a problem develop with the 
accelerometer during the course of the study. If there is an irresolvable problem, the participant 
will send the device back to the research assistant, and be provided a new one. Study staff will 
work directly with Actigraph or Omron technical support to resolve any device issues. A log of 
all technical difficulties will be maintained. 
 
D. Psychosocial risks 
 
Confidentiality. As with any study, there is the risk of a breach of confidentiality; these 
risks will be minimized by using participant numbers rather than identifying personal data on 
study documents, and by using locked cabinets/offices and password-protected databases to store 

 
personal information. Only study staff (the PI, the research assistant entering data, co-
investigators delivering the intervention, and the research assistant doing follow-up assessments) 
will have any access to personally identifiable information about participants, and such access 
will be limited only to information necessary to complete study tasks.  
All data regarding the objective adherence devices will be encoded only with the study 
participant number that is linked to personal identifying information in the study database. The 
devices will not be marked with any personal identifiable information, and the database that will 
be used to monitor accelerometer data will only contain participant numbers. The accelerometers 
do not record or link participants’ names with their data, and accelerometer data will only be 
accessed from a locked Partners computer in a research team office. 
We will ensure that contact with participants is confidential by using only the phone 
numbers and other contact information that are specifically allowed by the participants and not 
leaving study-related messages for participants unless expressly allowed by participants. Upon 
enrollment, we ask all participants if it is acceptable to leave voice messages on their phones, as 
well as the appropriate times to call them. We adhere to any and all patient requests regarding 
contact. 
 
Partners Healthcare has an electronic system that lets study doctors know if participants 
are admitted to a Partners Hospital, or if a participant visits a Partners Hospital Emergency 
Department. This allows study doctors to know about any possible problems or side effects a 
participant experiences while taking part in the study. 
 
Informed consent process. With regard to the consent process, we will approach/recruit 
participants in the hospital only after patients’ treatment team members (who would not be 
associated with the consent process in any way) ask patients if they are interested in hearing 
more about an optional study. In the outpatient setting, we will only contact those participants 
who express interest in the study or do not opt out after receiving an opt-out letter. If an 
investigator is clinically caring for a potential participant, an alternate, trained study staff 
member will approach the patient and complete the informed consent process and all study 
procedures for that participant. When discussing the study, we will emphasize the study’s 
optional nature and participants’ ability to opt out/un-enroll at any time, for any reason.  
 
Medical & psychiatric emergencies. As with any program which promotes an increase 
in physical activity, there is an inherent potential physical risk imposed (e.g., falls, worsening 
cardiac symptoms). For those who enroll in the program and give us permission to communicate 
with their clinician, we will inform the clinician of their patient’s participation and offer to speak 
to them if they have any concerns or recommendations about setting goals related to physical 
activity or other health behaviors. If patients report acute medical symptoms, they will be 
directed to emergency medical care, and their primary medical physicians may be contacted as 
needed. If study staff have questions regarding medical symptoms and their urgency, Dr. Januzzi 
(co-investigator and cardiologist) and the PI will be available to consult (and call patient) as 
needed. 
This study utilizes a questionnaire that assesses depressive symptoms (HADS), and thus, 
participants might disclose information about suicidal thinking or behavior. Due to this 
possibility, the follow-up call will be performed at a time when a psychiatrist study investigator 
is available to intervene as needed. If participants report suicidal ideation, study staff will 
complete specific suicide risk assessment questions to assess immediate risk of self-harm, and 

 
the psychiatrist will immediately assess the situation/patient if there is either an acutely elevated 
risk of self-harm or if additional information is needed to clarify risk. If the patient is at 
imminent risk, the study psychiatrist will take all needed steps to ensure emergent evaluation, 
which may include ensuring evaluation in the nearest emergency room. Participants will be 
informed of all of these measures to ensure confidentiality—and the limits of confidentiality, 
such as arranging for emergent medical or psychiatric care if safety is at imminent risk—as part 
of the informed consent process. However given that this is a medical rather than a psychiatric 
population we anticipate the rate of suicidality in this population will be low. 
We will ask participants to report adverse events related to study participation they may 
have experienced at any time throughout the study. Any adverse events will be reported to the PI 
and to the IRB according to Partners HRC guidelines. 
 
E. Radiation risks 
 
There will be no radiation exposure in this study. 
 
VI.  POTENTIAL BENEFITS 
 
A. Potential Benefits to Participants 
 
Though it is possible that participants will not receive benefit from participation, they 
also may benefit significantly.  Participants in the PP-based intervention will undergo a series of 
exercises that are designed to increase optimism, improve well-being, and potentially improve 
cardiac health behaviors. Analyses of PP studies have been that these interventions are associated 
with improved psychological well-being and decreased depressive symptoms, and optimism is 
associated with superior medical outcomes. Therefore, participating individuals may benefit by 
having improvements in these important and clinically relevant outcomes.  Furthermore, 
participants in the PP-based health behavior intervention will be provided with information 
regarding health behaviors and will be encouraged to set goals related to physical activity, 
dietary adherence, and medication adherence.  These participants may make significant health 
behavior changes, which could help them feel better physically and reduce their risk for 
complications related to their heart disease. 
Participants receiving the MI-based health behavior education intervention also may 
benefit from the educational information provided to them and the MI-based intervention.  Like 
those individuals in the PP-based intervention, participants receiving MI may improve their 
health behaviors, which could lead to significant improvements in physical health and function. 
Finally, participants in the TAU group also may receive some benefits.  Contact with 
study trainers and the systematic follow-up assessments may also provide support and social 
connection for participants with significant medical illness. This may be an improvement over no 
such contact or systematic evaluation, as is current standard practice.  
 
B. Potential Benefits to Society 
 
Increasing positive psychological states in cardiac patients may have important public 
health benefits. Optimism and other positive affective states are prospectively associated with 
increased participation in healthy behaviors and with superior cardiac outcomes. The creation of 

 
a PP-based intervention—based on the previous qualitative research phase—targeted at 
improving positive emotional states in HF patients could lead to a novel approach to enhancing 
adherence in this population, which in turn might result in decreased morbidity and mortality in 
this population. Future studies could investigate the feasibility of implementing this intervention 
in a similar population and examine the impact on cardiac and psychological outcomes. If the 
PP-based health behavior intervention in this study proves to be feasible, well-accepted, and 
associated with improvements in physical activity and other key outcomes, it may well be 
possible to utilize these easily-delivered and completed exercises as part of a clinical care 
package for HF patients. Thus participation in this study may result in substantial benefit to 
future patients. 
 
VIII. MONITORING AND QUALITY ASSURANCE 
 
A. Independent Monitoring of Source Data 
 
All source data (e.g., chart review data and participant self-report) will be entered into the 
REDCap database. The PI (Dr. Celano) will review this data to ensure that it is being entered 
correctly and will perform ‘test downloads’ of the data to ensure that it can be captured in the 
statistical package to be used in this study. 
 
B. Safety Monitoring (e.g., DSMB) 
 
Safety monitoring will be performed by Dr. Celano (PI), who will ensure that the study 
team is adequately identifying, reviewing, and reporting adverse events and unanticipated 
problems to the Partners Institutional Review Board (IRB). Upon certification of IRB approval 
of this protocol, Dr. Celano will submit this document to the NHLBI Grants Management Officer 
prior to beginning any study procedures. Dr. Celano will also submit an annual progress report 
confirming adherence to the data and safety monitoring plan, including a summary of any data 
and safety monitoring issues that occurred since the previous reporting period, as well as any 
changes made to the protocol and any new and continuing IRB approvals since the last filed 
report. A more detailed description of monitoring mechanisms, intervals, and the information 
monitored is outlined below. 
Monitoring mechanism: Dr. Celano (PI) will take primary responsibility for the data 
safety monitoring. However, this study will have a formal data safety monitoring board (DSMB), 
which will be chaired by Dr. Jeff Huffman (psychiatry, primary mentor), and populated by Dr. 
Elyse Park (psychology, co-mentor), Dr. Hanna Gaggin (cardiology, external to study), and Dr. 
Bettina Hoeppner (psychology, external to study).  
Monitoring intervals: Monitoring of adverse events will occur on an ongoing basis with 
notification of Dr. Celano with any adverse study-related events. More systematic weekly 
meetings for review of feasibility/acceptability information and minor IRB deviations will be 
held between Dr. Celano and study staff, including the lead research coordinator. Dr. Celano will 
then discuss any potential issues regarding data safety or protocol deviations with Dr. Huffman 
during weekly supervision meetings. This allows the team to review this information and make 
adjustments to procedures as required. Furthermore, journal clubs are held with the study team 
regularly; these include discussions of related projects (e.g., studies of physical activity in 
cardiac patients, studies of positive psychological interventions) and the general psychiatry and 

 
cardiology literature. Finally, the formal DSMB will meet every four months to monitor patient 
safety outcomes. These ongoing, weekly, and intermittent reviews ensure that the study 
procedures minimize research-related risk by reviewing specific outcomes linked to the project 
and by reviewing relevant literature to ensure that interventions are best practice. Dr. Celano 
(study PI) is responsible for directly reporting serious study-related adverse events to the 
NIH/NHLBI, and even if there are no such events, a yearly report summarizing adherence to the 
DSMP, review of study-related enrollment and issues during the study period, and any relevant 
changes to the protocol, will be sent to NHLBI. 
Information to be monitored: Information to be monitored will include: (a) an 
evaluation of the progress of the research study, including assessments of data quality and 
timeliness and participant recruitment, accrual and retention consistent with plans for diversity 
and generalizability, (b) a review of study safety data—adverse event (and minor deviation) 
information—to determine whether the study should continue as originally designed, be 
changed, or be stopped, (c) review of procedures to maintain participant confidentiality (e.g., 
ensuring study databases have no personal identifying information, using study participant 
numbers on communications about the study), and (d) an assessment of external factors or 
relevant information (e.g., developments in the literature, results of related studies, etc.) that may 
have an impact on the safety of participants or on the ethics of the research study, such as 
through the journal club listed above. 
 
C. Outcomes Monitoring 
 
As noted above, this study is a pilot trial to determine if all aspects of the protocol are 
feasible, acceptable, and effective. After 12 participants have completed the trial, we will briefly 
review the study and our outcomes. If participants’ acceptability scores in the PP group are low 
(or optimism scores decrease following the exercises), or we sense more generally that some 
participants have been dissatisfied with the program, we will likely alter the protocol to address 
these issues. Similarly, if our rates of session completion are far below expected rates, we will 
reassess our protocol and likely make substantial changes. We will then complete the more 
formal data analysis once 60 participants have completed the trial. 
On a weekly basis, the research team will meet to review study progress. At that time, the 
principal investigator will review informed consent documents, study forms, and procedures 
completed that week, as well as all chart review forms performed that week for completeness and 
accuracy. The study team will also discuss any procedural difficulties, recruitment issues, and 
adverse events at this meeting (and before if needed). Investigators will also review consent 
documents and address acute issues in real time throughout the week. We will take several 
measures to ensure the integrity of data collection/entry/analysis and the fidelity of our 
intervention. Dr. Huffman will periodically review the recordings of weekly phone calls to 
ensure their fidelity.  
 
D. Adverse event reporting guidelines 
 
We will follow all PHRC guidelines with respect to reporting unanticipated problems, 
including adverse events. Specifically, when a serious or nonserious adverse event occurs, the PI 
will review the event to determine if it was possibly or definitely related to participation in the 
research. For all unanticipated problems and adverse events deemed related or possibly related to 

 
the research, we will complete and submit an Other Event report through Insight/eIRB as soon as 
possible and within 5 working days/7 calendar days (as defined in the March 2014 Reporting 
Unanticipated Problems Including Adverse Events report). At Continuing Review, we will 
provide a summary of all unanticipated problems as per PHRC protocol. Finally, if there are 
unanticipated problems, especially if serious or recurrent, the PI (Dr. Celano) will amend the 
protocol if it is deemed necessary to protect the safety and welfare of the participants. 
 
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