Developing a Positive Psychology Intervention to Promote Health Behaviors in Heart Failure: proof-of Concept Trial
Phase: NA
Conditions: Congestive Heart Failure, Emotions, Patient Compliance
Sponsor: Massachusetts General Hospital

Developing a positive psychology intervention to promote health behaviors in heart failure: proof-of concept trial 
Christopher Celano, MD – Detailed Protocol – 3.28.2017 
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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, 

Developing a positive psychology intervention to promote health behaviors in heart failure: proof-of concept trial 
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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 is adapted to this specific population and that has the greatest likelihood of 
providing benefit to these high risk patients. The focus of this study is to examine the feasibility, 
acceptability, and preliminary impact of our customized PP-based health behavior intervention in a 
group of patients with mild to moderate HF. 
 
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 is 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 

Developing a positive psychology intervention to promote health behaviors in heart failure: proof-of concept trial 
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feasible and acceptable. Currently, Dr. Celano is the Principal Investigator of a study to develop a 
telephone-based PP intervention for psychiatric inpatients with bipolar depression and has 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 has 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. 
Preliminary results from this study suggest that higher levels of gratitude and optimism are 
prospectively associated with greater self-reported physical activity, heart-healthy diet, and medication 
adherence 6 months later. 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.43 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 better understand the links between positive psychological states and health 
behaviors in patients with New York Heart Association (NYHA) class II or III HF. He has reached his 
enrollment goal 32 participants (follow-up is ongoing), and preliminary results suggest that patients 
with HF identify bidirectional links between positive psychological states and health behavior 
performance. Dr. Celano has used the information from these interviews to create an 8-week PP-based 
health behavior intervention for this population. Dr. Celano’s involvement in these ongoing studies has 
provided him with information about the links between positive states and outcomes in cardiac patients 
and experience with the outcome measures, accelerometers, and electronic pill bottles 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 
 
Creation of an intervention to increase positive emotions and promote health behaviors in 
cardiac patients. There is clear evidence linking positive emotions with superior cardiac 
outcomes.21,25,44 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,45,46 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 

Developing a positive psychology intervention to promote health behaviors in heart failure: proof-of concept trial 
Christopher Celano, MD – Detailed Protocol – 3.28.2017 
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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).47 
To address this gap in knowledge, we aim to test the feasibility and immediate impact of a 
novel PP-based health behavior intervention that is adapted 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.48 In the first phase of treatment development (IRB # 2015P000069), we aimed to 
adapt our prior PP-based interventions to patients with HF. We successfully 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. 
In the current phase of treatment development (Phase 2: Refining the intervention), we will 
perform a small (N=11) proof-of-concept trial to ensure our intervention’s initial feasibility and to 
refine the intervention prior to a larger pilot study. 
 
In this project, we hope to do the following: 
1. Test a 10-week, telephone-delivered health behavior intervention utilizing PP exercises and 
systematic goal-setting in a brief, non-randomized, proof-of-concept trial (N=11). 
2. Determine whether this initial intervention is feasible in a small cohort of HF patients. 
3. Explore potential benefits of the intervention on outcomes of interest (e.g., optimism, positive 
affect). 
  
II. SPECIFIC AIMS 
 
Specific Aim #1 (Feasibility; primary aim): To assess the feasibility of the PP-based health behavior 
intervention, adherence methods, and outcome assessments in patients with NYHA class I-III HF. 
 
Hypothesis: The PP exercises and goal-setting sessions will be feasible (i.e., 5 of the 9 
exercises/sessions will be completed by a majority of patients). Furthermore, we will obtain complete 
objective follow-up data in at least 80% of enrolled participants at 10 weeks for both the medication 
and activity measurement methods. 
 
Specific Aim #2 (Acceptability and immediate impact): To assess whether the intervention is 
acceptable to participants, as measured by ratings provided before and after each exercise, as well as its 
immediate impact on optimism. 
 
Hypothesis: The intervention will be 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 
optimism (post-exercise ratings of optimism will be higher than pre-exercise ratings).  
 
Specific Aim #3 (Intermediate outcomes): To assess whether this preliminary intervention appears to 
result in improvement of psychological well-being (as measured by dispositional optimism, positive 
affect, anxiety, and depression). 

Developing a positive psychology intervention to promote health behaviors in heart failure: proof-of concept trial 
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Hypothesis: The intervention will lead to improvements in optimism and positive affect and reductions 
in depression and anxiety at 10 weeks compared to baseline. 
 
Exploratory Aim (adherence and functional outcomes): To examine the impact of the intervention 
on physical activity, medication adherence, sodium intake, HF-related QoL, and generic HRQoL. 
 
Hypothesis: The intervention will lead to improvements in adherence and functional outcomes at 
follow-up.  
 
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.49 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 SAS)50 items regarding 
diet/exercise/medications. The MOS SAS has been used in multiple prior studies assessing 
adherence in cardiac patients, including our own studies in this population.40,51,52 This 
threshold score on the MOS SAS 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.53 
 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, quality of life, 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 

Developing a positive psychology intervention to promote health behaviors in heart failure: proof-of concept trial 
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because they may be too physically impaired to perform some of the PP 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 quality of 
life.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. 
 
 
 
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 

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confirm NYHA class, and assessment of adherence status with the MOS SAS. 
 
 
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 RPDR at MGH. 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.54  
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. 
2.) Study staff then will obtain permission for initial contact from each potentially eligible 
patient’s cardiologist 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 cardiologist (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 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.) Should study staff receive no reply within 2 weeks, 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 directly contact them via phone to inform them about the project. 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. 

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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.  
 
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 approach the patient, 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 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. In addition, patients will be informed that they will receive $100 for completing the study 
(including the 10-week follow up phone call) and returning the ActiGraph GT3X+ device, mailed to 
them as a check at the end of the study. For tax reasons, we require a social security number in order to 
issue the full $100. However, if you are uncomfortable giving that information, we can compensate 
you with a $50 check without requiring your social security number. 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 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 

Developing a positive psychology intervention to promote health behaviors in heart failure: proof-of concept trial 
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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 
 
There is no randomization procedure required for this trial.  
 
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, in the 
outpatient cardiac clinic, in a designated private office within the CPRP suite (for those contacted via 
opt-out letter), or over the phone (if a participant prefers to not come to the hospital for an in-person 
visit). Participants will meet with a member of the study staff (the study “trainer”) and complete self-
report questionnaires. These questionnaires assess optimism (Life Orientation Test-Revised; LOT-R),55 
anxiety/depression (Hospital Anxiety and Depression Scale; HADS),56 positive emotions (Positive and 
Negative Affect Schedule; PANAS),65 health-related quality of life (MOS Short Form-12; SF-12),57 
cardiac symptoms and heart failure-related quality of life (Kansas City Cardiomyopathy Questionnaire; 
KCCQ),58,59 medication adherence (Self-Reported Medication Adherence [adapted from the Heart and 
Soul Study]; SRMA),60 and sodium intake (Scored Sodium Questionnaire; SSQ).61 Participants will 
also answer questions about their alcohol (using the AUDIT-C)62 and cigarette use. In sum, these 
scales should take approximately 30 minutes to complete. 
 
 
After completion of the questionnaires, participants will be provided with a treatment manual, 
with weekly PP exercises and information to teach participants about the importance of health 
behaviors and set goals to improve these behaviors. They also will receive a copy of Learning to Live 
with Heart Failure,63 a practical guide which is provided by MGH to all HF patients admitted to a 
cardiology unit at MGH. 
 
 
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. We anticipate that this portion of the visit will take approximately 20 minutes. 
 
 
After assigning the first week’s PP and goal-setting exercises, 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 10-week assessment (we will send 
participants the ActiGraph in the mail at the appropriate time). In contrast to the pedometer, which is 
used for participants to monitor their activity, the ActiGraph accelerometer provides no information to 

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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 an appointment to call the participant in 1 week to review the first exercise. In total this 
initial visit will take approximately 50-60 minutes. 
 
 
 
Weekly phone sessions (Weeks 1-10). All participants will be asked to complete 9 weekly PP 
exercises and will be asked to speak with a study trainer weekly. In addition, in Week 10, 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 30 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 MI 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 three-
week modules focusing on a different psychological state: 
 
Module 1: Gratitude-based activities 
Week 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. 
 
Week 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. 
 
Week 3: Integrating gratitude-based activities into daily life.  
Participants work to be more aware of positive things 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. 

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Module 2: Strength-based activities 
 
Week 4: 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. 
 
Week 5: Using personal strengths.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. 
 
Week 6: 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 
Week 7: Enjoyable and meaningful activities.65  
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.  
 
Week 8: Performing acts of kindness.  
Participants complete three acts of kindness in one day. 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 act made them feel.  
 
Week 9: Integrating meaning-based activities into daily life. 
Participants work to perform enjoyable and meaningful acts for themselves and others in daily 
life. Trainers help participants create a plan for using these skills on their own in the near 
future. 
 
Week 10: 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 three-
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 

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will involve tracking participants’ progress towards their health behavior goals, the educational 
components will vary from week to week: 
 
Module 1: Physical activity 
Week 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. 
 
Week 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. 
 
Week 3: Physical activity resources. 
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. They will 
also discuss ways to problem solve around barriers to physical activity. 
 
Module 2: Heart-healthy diet 
Week 4: 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. 
 
Week 5: 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. 
 
Week 6: 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. 
 
Module 3: Medication adherence 
Week 7: Introduction to medication adherence. 
The trainer will review with participants the importance of medication adherence, as well as 
participants’ current medication adherence. Participants will be encouraged to monitor their 
medication adherence over the next week. 
 
Week 8: Setting a SMART medication goal. 
Participants will be encouraged to set a goal related to medication adherence and to continue to 
monitor their medication adherence. 

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Week 9: Medication resources. 
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. 
 
Week 10: 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 
 
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,63 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 5 PP exercises / goal-setting sessions. In other words, if a participant completes at least 5 
sessions, missed sessions will not be considered a deviation from the protocol. 
 
 
Follow-up phone call (Week 10). At Week 10, a member of the study staff will call participants to 
repeat the self-report questionnaires that were administered at baseline. These questionnaires assess 
optimism (LOT-R), positive emotions (PANAS), overall health behavior adherence (MOS SAS), 
anxiety/depression (HADS), health-related quality of life (SF-12), cardiac symptoms and heart failure-
related quality of life (KCCQ), medication adherence (SRMA), and sodium intake (SSQ). Participants 
will also be asked about alcohol use (AUDIT-C), cigarette smoking, cardiac-related hospital 
readmissions, and cardiac rehabilitation, and to rate their overall satisfaction with the treatment they 
received for their cardiac condition over the last 10 weeks 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) and Carol Mastromauro (LICSW) have 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,33,65-68 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 and Ms. Mastromauro will engage in several training exercises prior to study initiation. 
Together, they will review the treatment manual and our team’s prior training manuals related to these 
exercises. They then will complete all exercises together to gain experience performing and reviewing 
each exercise.  

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Dr. Celano and Ms. Mastromauro also have 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, and Ms. Mastromauro serves as an interventionist for that same study. The goal-
setting portion of the intervention aims to improve health behaviors that studies have shown to be 
critical for cardiac health in patients with HF.6-12 Similar to their training related to the PP exercises, 
Dr. Celano and Ms. Mastromauro will review the treatment manual for this project and complete each 
exercise together to gain experience providing education and setting goals related to physical activity, 
sodium restriction, and medication adherence. 
 
 
Table 1. Schedule of study events. 
 
Pre-enroll-ment 
Baseline and 
Initial Visit 
Phone Sessions 
(Weeks 2-10) 
Follow-up Phone 
Call (Week 10) 
Cognitive screen 
X 
 
 
 
Chart review to 
confirm eligibility 
X 
 
 
 
Assessment of inclusion criteria 
(MOS SAS, NYHA class)  
X 
 
 
 
Chart review for 
baseline characteristics 
 
X 
 
 
PP exercise 
 
X 
X 
 
Goal-setting exercise 
 
X 
X 
 
Exercise ratings 
 
X 
X 
 
Self-report measures 
(SSQ, LOT-R, PANAS, HADS, 
KCCQ, SRMA, SF-12) 
 
X 
 
X 
Objective adherence data 
(ActiGraph step counter) 
 
X 
 
X 
 
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 SAS, SSQ, LOT-R, PANAS, HADS, 
KCCQ, SRMA, and SF-12 in person and will receive an Actigraph  accelerometer. They will be asked 

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to begin wearing the accelerometer after their initial. Using the accelerometer in this phase of the study 
will allow us to test its feasibility and identify any potential problems with its use. 
Baseline information about enrolled participants will also be obtained from the patients, care 
providers, and the electronic medical record as required for characterization of our population. This 
information will include data regarding medical history (history of acute coronary syndrome, coronary 
artery bypass graft, hypertension, diabetes mellitus, hyperlipidemia, 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). 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 5 of 9 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 patients69,70 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.71,72 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.73,74 In 
this trial, participants will wear the accelerometer (for 1 week at baseline and 1 week at follow-up) to 
assess the feasibility of doing so and to ensure adequate capture of physical activity. We will measure 
the number of steps taken daily for the last 7 days they wore the device to ensure that this will provide 
us with adequate information for subsequent trials. 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, 

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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.60 
 (c) Dietary adherence. We will assess sodium intake over the past month using the Scored 
Sodium Questionnaire (SSQ).61  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.61 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 10-week follow up.  
(d) Self-reported adherence. We will assess self-reported adherence using the MOS SAS50 
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 SAS has been used in multiple prior studies assessing adherence in cardiac patients, 
including our own studies in this population.40,51,52 
 
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) Dispositional optimism (primary psychological outcome measure) will be measured using 
the Life Orientation Test-Revised (LOT-R), a well-validated 6-item instrument. Dispositional 
optimism is the positive psychological state most linked to cardiac outcomes,23,75,76 and the LOT-R has 
been used to measure optimism in many studies of cardiac patients.77-79 Though dispositional optimism 
theoretically would be stable over time, research suggests that LOT-R scores can change quickly in 
response to psychological interventions.38,80,81  
(b) Positive affect will be measured using the positive affect items on the Positive and 
Negative Affect Schedule (PANAS),82 a well-validated scale used in other intervention trials and in 
patients with HF.83,84 
(c) Anxiety and depression will be measured using the anxiety and depression subscales of the  
Hospital Anxiety and Depression Scale (HADS).85 This well-validated scale has been used in many 
studies of patients with heart disease (including our group’s studies),38,40,85-87 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 

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measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ), a well-validated 
questionnaire of health status in HF.58 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 HF58,59 and is strongly 
correlated with NYHA class.59 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),57 an instrument which has been used in multiple cardiac studies in the past, including our 
work.38,40,80,88-93 The SF-12 also is a reliable marker of QoL in HF94 and has been associated with 
mortality in this high-risk cohort.95  
 
VI. BIOSTATISTICAL ANALYSIS 
 
A and B. Specific data variables and study endpoints 
 
Aim #1 (Feasibility; primary aim): To assess whether PP exercises administered over the phone are 
feasible in patients with NYHA class I-III HF. 
 
Measures: 
 Rates of completion of exercises (recorded by study trainer). 
 Successful use of ActiGraph accelerometer. 
 
The intervention will be considered feasible if 5 of the 9 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 10 weeks.  
 
Aim #2 (Acceptability and immediate impact): To assess whether PP exercises administered over the 
phone are acceptable and lead to improvements in optimism in patients with NYHA class I-III HF. 
 
Measures: 
 Patient rating of immediate outcomes on 10-point Likert scale: Ease of completion, overall utility, 
change in optimism from pre- to post-exercise. 
 
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 optimism significantly higher post-exercise 
than pre-exercises across exercises (via one-sample t test). 
 
Aim #3 and Exploratory Aim (Impact on psychological outcomes, functional outcomes, and health 
behaviors): To determine whether the PP intervention is linked to improvements in psychological well-
being, functioning, and health behavior adherence from baseline to 10 weeks. 
 
Measures: 

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 Optimism: LOT-R (primary measure for this aim) 
 Positive emotions: PANAS 
 Anxiety/depression: HADS 
 HF-related QoL: KCCQ 
 Health related quality of life: SF-12 
 Self-reported adherence: MOS SAS 
 Physical activity: ActiGraph accelerometer 
 Medication adherence: SRMA  
 Sodium intake: SSQ   
 
We will consider the PP intervention to show promise for improving psychological well-being if mean 
scores on all psychological outcome measures are superior at 10 weeks compared to baseline. Given 
that this small trial is focused primarily on feasibility, we have set a low bar for improvement (i.e., 
even slight pre-post improvement). If these basic pre-post improvements did not occur, it would be 
important to reassess the intervention before moving on. We will move to a next-step trial once we 
have developed an intervention that appears to be feasible, to match hypotheses generated by our 
qualitative research, and to have some impact on optimism/positive affect based on a very small 
sample. Similarly, we will consider the intervention to show promise for improving other outcomes if 
there are pre-post improvements in the medical/functional outcomes.  
 
C. Statistical methods  
 
Data will be downloaded from REDCap into the Stata statistical package. For Aims 1 and 2 
(feasibility, acceptability, and immediate impact), descriptive statistics will be used to report 
proportion of exercise completion and mean scores on exercise ratings. Differences between pre- and 
post-optimism scores will be compared using paired t tests.  
 
To compare mean scores on outcome variables for Aim 3 and the exploratory aim, paired t tests will be 
used to explore mean differences between baseline and 10 week values. All statistical tests will be two-
tailed and p<.05 considered significant, though this study will not be powered to detect statistically 
significant differences between baseline and follow-up points. 
 
 
D. Power analysis 
 
 
This exploratory proof-of-concept study with 11 patients (maximum 15 patients enrolled to 
obtain 10 completers), as noted, will not be powered to detect statistically significant differences 
between baseline and follow-up points, and is designed to assess feasibility of methods. 
 
VII. RISKS AND DISCOMFORTS  
 
A. Complications of surgical/non-surgical procedures 
 
No procedures will be conducted as part of this study 
 

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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. 
However, we are using an accelerometer 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 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 technical support to resolve any device issues. A log of all technical 
difficulties will be maintained. 
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, the PI) will liaise with 
participants regarding any battery problems or technical advice on the Actigraph accelerometer, step 
counter, and related equipment. 
 
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, 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 Warren 1226. 
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 

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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. 
 
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. 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 
 
It is possible that participants will not receive benefit from participation. Patients 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 

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is associated with superior medical outcomes. Therefore, participating individuals may benefit by 
having improvements in these important and clinically relevant outcomes. Overall, contact with study 
trainers and the systematic follow-up assessments may also provide support and social connection for 
participants at a time of recent medical crisis. This may be an improvement over no such contact or 
systematic evaluation, as is current standard practice.  
Patients will be given the opportunity to identify positive emotions and consider ways to 
enhance their own positive emotions. Description of the PP exercises may enlighten them as to 
potential means of improving their own emotional states. Furthermore, they will have the opportunity 
to consider possible barriers to adherence to health-related behaviors. 
 
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. 

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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, weekly journal clubs are held with the study team; 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., storage of identifiable information in locked cabinets, 
ensuring study databases have no personal identifying information, use of 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 proof-of-concept trial to determine if all aspects of the protocol 
are feasible, acceptable, and effective. After 5 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 10 
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 

Developing a positive psychology intervention to promote health behaviors in heart failure: proof-of concept trial 
Christopher Celano, MD – Detailed Protocol – 3.28.2017 
23 
 
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. 
 
IX. REFERENCES 
 
1. 
Lloyd-Jones D, Adams RJ, Brown TM, et al. Heart disease and stroke statistics--2010 update: a 
report from the American Heart Association. Circulation 2010;121:e46-e215. 
2. 
Celano CM, Huffman JC. Depression and cardiac disease: a review. Cardiol Rev 2011;19:130-
42. 
3. 
Chen J, Normand SL, Wang Y, Krumholz HM. National and regional trends in heart failure 
hospitalization and mortality rates for Medicare beneficiaries, 1998-2008. JAMA 2011;306:1669-78. 
4. 
Roger VL, Go AS, Lloyd-Jones DM, et al. Heart disease and stroke statistics--2011 update: a 
report from the American Heart Association. Circulation 2011;123:e18-e209. 
5. 
Coelho R, Ramos S, Prata J, Bettencourt P, Ferreira A, Cerqueira-Gomes M. Heart failure and 
health related quality of life. Clin Pract Epidemiol Ment Health 2005;1:19. 
6. 
O'Connor CM, Whellan DJ, Lee KL, et al. Efficacy and safety of exercise training in patients 
with chronic heart failure: HF-ACTION randomized controlled trial. JAMA 2009;301:1439-50. 
7. 
Wright SP, Walsh H, Ingley KM, et al. Uptake of self-management strategies in a heart failure 
management programme. Eur J Heart Fail 2003;5:371-80. 
8. 
Belardinelli R, Georgiou D, Cianci G, Purcaro A. Randomized, controlled trial of long-term 
moderate exercise training in chronic heart failure: effects on functional capacity, quality of life, and 
clinical outcome. Circulation 1999;99:1173-82. 
9. 
Wu JR, Moser DK, Lennie TA, Burkhart PV. Medication adherence in patients who have heart 
failure: a review of the literature. Nurs Clin North Am 2008;43:133-53; vii-viii. 
10. 
Pina IL, Apstein CS, Balady GJ, et al. Exercise and heart failure: A statement from the 
American Heart Association Committee on exercise, rehabilitation, and prevention. Circulation 
2003;107:1210-25. 

Developing a positive psychology intervention to promote health behaviors in heart failure: proof-of concept trial 
Christopher Celano, MD – Detailed Protocol – 3.28.2017 
24 
 
11. 
Arcand J, Ivanov J, Sasson A, et al. A high-sodium diet is associated with acute decompensated 
heart failure in ambulatory heart failure patients: a prospective follow-up study. Am J Clin Nutr 
2011;93:332-7. 
12. 
Lennie TA, Song EK, Wu JR, et al. Three gram sodium intake is associated with longer event-
free survival only in patients with advanced heart failure. J Card Fail 2011;17:325-30. 
13. 
Corotto PS, McCarey MM, Adams S, Khazanie P, Whellan DJ. Heart failure patient adherence: 
epidemiology, cause, and treatment. Heart Fail Clin 2013;9:49-58. 
14. 
Lemon SC, Olendzki B, Magner R, et al. The dietary quality of persons with heart failure in 
NHANES 1999-2006. J Gen Intern Med 2010;25:135-40. 
15. 
Ni H, Nauman D, Burgess D, Wise K, Crispell K, Hershberger RE. Factors influencing 
knowledge of and adherence to self-care among patients with heart failure. Arch Intern Med 
1999;159:1613-9. 
16. 
Carlson B, Riegel B, Moser DK. Self-care abilities of patients with heart failure. Heart Lung 
2001;30:351-9. 
17. 
Ditewig JB, Blok H, Havers J, van Veenendaal H. Effectiveness of self-management 
interventions on mortality, hospital readmissions, chronic heart failure hospitalization rate and quality 
of life in patients with chronic heart failure: a systematic review. Patient Educ Couns 2010;78:297-315. 
18. 
Grady KL. Self-care and quality of life outcomes in heart failure patients. J Cardiovasc Nurs 
2008;23:285-92. 
19. 
Phillips CO, Singa RM, Rubin HR, Jaarsma T. Complexity of program and clinical outcomes 
of heart failure disease management incorporating specialist nurse-led heart failure clinics. A meta-
regression analysis. Eur J Heart Fail 2005;7:333-41. 
20. 
Grady KL, de Leon CF, Kozak AT, et al. Does self-management counseling in patients with 
heart failure improve quality of life? Findings from the Heart Failure Adherence and Retention Trial 
(HART). Qual Life Res 2013;23:31-8. 
21. 
Chida Y, Steptoe A. Positive psychological well-being and mortality: a quantitative review of 
prospective observational studies. Psychosom Med 2008;70:741-56. 
22. 
Rasmussen HN, Scheier MF, Greenhouse JB. Optimism and physical health: a meta-analytic 
review. Ann Behav Med 2009;37:239-56. 
23. 
Tindle HA, Chang YF, Kuller LH, et al. Optimism, cynical hostility, and incident coronary 
heart disease and mortality in the Women's Health Initiative. Circulation 2009;120:656-62. 
24. 
Giltay EJ, Geleijnse JM, Zitman FG, Hoekstra T, Schouten EG. Dispositional optimism and all-
cause and cardiovascular mortality in a prospective cohort of elderly Dutch men and women. Arch Gen 
Psychiatry 2004;61:1126-35. 
25. 
Kubzansky LD, Thurston RC. Emotional vitality and incident coronary heart disease: benefits 
of healthy psychological functioning. Arch Gen Psychiatry 2007;64:1393-401. 
26. 
Giltay EJ, Geleijnse JM, Zitman FG, Buijsse B, Kromhout D. Lifestyle and dietary correlates 
of dispositional optimism in men: The Zutphen Elderly Study. J Psychosom Res 2007;63:483-90. 
27. 
Kelloniemi H, Ek E, Laitinen J. Optimism, dietary habits, body mass index and smoking 
among young Finnish adults. Appetite 2005;45:169-76. 
28. 
Tinker LF, Rosal MC, Young AF, et al. Predictors of dietary change and maintenance in the 
Women's Health Initiative Dietary Modification Trial. J Am Diet Assoc 2007;107:1155-66. 
29. 
Browning C, Sims J, Kendig H, Teshuva K. Predictors of physical activity behavior in older 
community-dwelling adults. J Allied Health 2009;38:8-17. 

Developing a positive psychology intervention to promote health behaviors in heart failure: proof-of concept trial 
Christopher Celano, MD – Detailed Protocol – 3.28.2017 
25 
 
30. 
Steptoe A, Wright C, Kunz-Ebrecht SR, Iliffe S. Dispositional optimism and health behaviour 
in community-dwelling older people: associations with healthy ageing. Br J Health Psychol 
2006;11:71-84. 
31. 
Leedham B, Meyerowitz BE, Muirhead J, Frist WH. Positive expectations predict health after 
heart transplantation. Health Psychol 1995;14:74-9. 
32. 
Seligman ME, Rashid T, Parks AC. Positive psychotherapy. American Psychologist 
2006;61:774-88. 
33. 
Seligman ME, Steen TA, Park N, Peterson C. Positive psychology progress: empirical 
validation of interventions. American Psychologist 2005;60:410-21. 
34. 
Bolier L, Haverman M, Westerhof GJ, Riper H, Smit F, Bohlmeijer E. Positive psychology 
interventions: a meta-analysis of randomized controlled studies. BioMed Central Public Health 
2013;13:119. 
35. 
Sin NL, Lyubomirsky S. Enhancing well-being and alleviating depressive symptoms with 
positive psychology interventions: a practice-friendly meta-analysis. Journal of Clinical Psychology 
2009;65:467-87. 
36. 
Ogedegbe GO, Boutin-Foster C, Wells MT, et al. A randomized controlled trial of positive-
affect intervention and medication adherence in hypertensive African Americans. Arch Intern Med 
2012;172:322-6. 
37. 
Peterson JC, Charlson ME, Hoffman Z, et al. A randomized controlled trial of positive-affect 
induction to promote physical activity after percutaneous coronary intervention. Arch Intern Med 
2012;172:329-36. 
38. 
Huffman JC, Mastromauro CA, Boehm JK, et al. Development of a positive psychology 
intervention for patients with acute cardiovascular disease. Heart International 2011;6:e14. 
39. 
Huffman JC, Millstein RA, Mastromauro CA, et al. A positive psychology intervention for 
patients with an acute coronary syndrome: treatment development and proof-of-concept trial. J 
Happiness Stud 2015:1-22. 
40. 
Huffman JC, Mastromauro CA, Sowden GL, Fricchione GL, Healy BC, Januzzi JL. Impact of a 
depression care management program for hospitalized cardiac patients. Circ Cardiovasc Qual 
Outcomes 2011;4:198-205. 
41. 
Huffman JC, Mastromauro CA, Sowden GL, Wittmann C, Rodman R, Januzzi JL. A 
collaborative care depression management program for cardiac inpatients: depression characteristics 
and in-hospital outcomes. Psychosomatics 2011;52:26-33. 
42. 
Celano CM, Suarez L, Mastromauro C, Januzzi JL, Huffman JC. Feasibility and utility of 
screening for depression and anxiety disorders in patients with cardiovascular disease. Circ Cardiovasc 
Qual Outcomes 2013;6:498-504. 
43. 
Huffman JC, DuBois CM, Mastromauro CA, Moore SV, Suarez L, Park ER. Positive 
psychological states and health behaviors in acute coronary syndrome patients: a qualitative study. J 
Health Psychol 2014;21:1026-36. 
44. 
Rasmussen HN, Scheier MF, Greenhouse JB. Optimism and physical health: a meta-analytic 
review. Ann Behav Med 2009;37:239-56. 
45. 
Tacon AM, McComb J, Caldera Y, Randolph P. Mindfulness meditation, anxiety reduction, 
and heart disease: a pilot study. Fam Community Health 2003;26:25-33. 
46. 
Dusek JA, Hibberd PL, Buczynski B, et al. Stress management versus lifestyle modification on 
systolic hypertension and medication elimination: a randomized trial. J Altern Complement Med 
2008;14:129-38. 

Developing a positive psychology intervention to promote health behaviors in heart failure: proof-of concept trial 
Christopher Celano, MD – Detailed Protocol – 3.28.2017 
26 
 
47. 
Charlson ME, Boutin-Foster C, Mancuso CA, et al. Randomized controlled trials of positive 
affect and self-affirmation to facilitate healthy behaviors in patients with cardiopulmonary diseases: 
rationale, trial design, and methods. Contemp Clin Trials 2007;28:748-62. 
48. 
Fredrickson BL. The role of positive emotions in positive psychology. The broaden-and-build 
theory of positive emotions. Am Psychol 2001;56:218-26. 
49. 
The Criteria Committee of the New York Heart Association. Nomenclature and Criteria for 
Diagnosis of Diseases of the Heart and Great Vessels. Boston: Little, Brown & Co; 1994. 
50. 
DiMatteo MR, Hays RD, Sherbourne CD. Adherence to cancer regimens: implications for 
treating the older patient. Oncology 1992;6:50-7. 
51. 
Ziegelstein RC, Fauerbach JA, Stevens SS, Romanelli J, Richter DP, Bush DE. Patients with 
depression are less likely to follow recommendations to reduce cardiac risk during recovery from a 
myocardial infarction. Arch Intern Med 2000;160:1818-23. 
52. 
Bauer LK, Caro MA, Beach SR, et al. Effects of depression and anxiety improvement on 
adherence to medication and health behaviors in recently hospitalized cardiac patients. Am J Cardiol 
2012;109:1266-71. 
53. 
Callahan CM, Unverzagt FW, Hui SL, Perkins AJ, Hendrie HC. Six-item screener to identify 
cognitive impairment among potential subjects for clinical research. Medical Care 2002;40:771-81. 
54. 
Research Information Services & Computing: Research Patient Data Registry. (Accessed June 
3, 2016, 2016, at https://rpdrssl.partners.org/partners/rpdrinfo/home/overview.htm.) 
55. 
Scheier MF, Carver CS, Bridges MW. Distinguishing optimism from neuroticism (and trait 
anxiety, self-mastery, and self-esteem): a reevaluation of the Life Orientation Test. J Pers Soc Psychol 
1994;67:1063-78. 
56. 
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand 
1983;67:361-70. 
57. 
Ware J, Jr., Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of 
scales and preliminary tests of reliability and validity. Med Care 1996;34:220-33. 
58. 
Green CP, Porter CB, Bresnahan DR, Spertus JA. Development and evaluation of the Kansas 
City Cardiomyopathy Questionnaire: a new health status measure for heart failure. J Am Coll Cardiol 
2000;35:1245-55. 
59. 
Garin O, Herdman M, Vilagut G, et al. Assessing health-related quality of life in patients with 
heart failure: a systematic, standardized comparison of available measures. Heart Fail Rev 
2014;19:359-67. 
60. 
Gehi AK, Ali S, Na B, Whooley MA. Self-reported medication adherence and cardiovascular 
events in patients with stable coronary heart disease: the heart and soul study. Arch Intern Med 
2007;167:1798-803. 
61. 
Mason B, Ross L, Gill E, Healy H, Juffs P, Kark A. Development and validation of a dietary 
screening tool for high sodium consumption in Australian renal patients. J Ren Nutr 2014;24:123-34 
e1-3. 
62. 
Bradley KA, DeBenedetti AF, Volk RJ, Williams EC, Frank D, Kivlahan DR. AUDIT-C as a 
brief screen for alcohol misuse in primary care. Alcohol Clin Exp Res 2007;31:1208-17. 
63. 
Learning to Live with Heart Failure. Chapel Hill, NC: University of North Carolina; 2016. 
64. 
Kelly LA, McMillan DG, Anderson A, Fippinger M, Fillerup G, Rider J. Validity of actigraphs 
uniaxial and triaxial accelerometers for assessment of physical activity in adults in laboratory 
conditions. BMC Med Phys 2013;13:5. 

Developing a positive psychology intervention to promote health behaviors in heart failure: proof-of concept trial 
Christopher Celano, MD – Detailed Protocol – 3.28.2017 
27 
 
65. 
Krumholz HM, Peterson ED, Ayanian JZ, et al. Report of the National Heart, Lung, and Blood 
Institute working group on outcomes research in cardiovascular disease. Circulation 2005;111:3158-
66. 
66. 
Moskowitz JT, Hult JR, Duncan LG, et al. A positive affect intervention for people 
experiencing health-related stress: development and non-randomized pilot test. J Health Psychol 
2012;17:676-92. 
67. 
Gander F, Proyer RT, Ruch W, Wyss T. Strength-based positive interventions: Further 
evidence for their potential in enhancing well-being and alleviating depression. J Happiness Stud 
2013;14:1241-59. 
68. 
Emmons RA, McCullough ME. Counting blessings versus burdens: an experimental 
investigation of gratitude and subjective well-being in daily life. Journal of personality and social 
psychology 2003;84:377-89. 
69. 
O'Connor CM, Whellan DJ, Wojdyla D, et al. Factors related to morbidity and mortality in 
patients with chronic heart failure with systolic dysfunction: the HF-ACTION predictive risk score 
model. Circ Heart Fail 2012;5:63-71. 
70. 
Passantino A, Lagioia R, Mastropasqua F, Scrutinio D. Short-term change in distance walked 
in 6 min is an indicator of outcome in patients with chronic heart failure in clinical practice. J Am Coll 
Cardiol 2006;48:99-105. 
71. 
Westerterp KR. Assessment of physical activity level in relation to obesity: current evidence 
and research issues. Med Sci Sports Exerc 1999;31:S522-5. 
72. 
Westerterp KR. Assessment of physical activity: a critical appraisal. Eur J Appl Physiol 
2009;105:823-8. 
73. 
Welk G. Physical Activity Assessments for Health-related Research. Champaign, IL: Human 
Kinetics; 2002. 
74. 
Copeland JL, Esliger DW. Accelerometer assessment of physical activity in active, healthy 
older adults. Journal of Aging and Physical Activity 2009;17:17-30. 
75. 
Tindle H, Davis E, Kuller L. Attitudes and cardiovascular disease. Maturitas 2010;67:108-13. 
76. 
Tindle H, Belnap BH, Houck PR, et al. Optimism, response to treatment of depression, and 
rehospitalization after coronary artery bypass graft surgery. Psychosom Med 2012;74:200-7. 
77. 
Trivedi RB, Blumenthal JA, O'Connor C, et al. Coping styles in heart failure patients with 
depressive symptoms. J Psychosom Res 2009;67:339-46. 
78. 
Carroll SL, Arthur HM. A comparative study of uncertainty, optimism and anxiety in patients 
receiving their first implantable defibrillator for primary or secondary prevention of sudden cardiac 
death. Int J Nurs Stud 2010;47:836-45. 
79. 
Scheier MF, Matthews KA, Owens JF, et al. Optimism and rehospitalization after coronary 
artery bypass graft surgery. Arch Intern Med 1999;159:829-35. 
80. 
Huffman JC, DuBois CM, Mastromauro CA, et al. Positive psychological interventions in 
medical psychiatry patients. In: Academy of Psychosomatic Medicine Annual Meeting. Atlanta, GA; 
2012. 
81. 
Meevissen YM, Peters ML, Alberts HJ. Become more optimistic by imagining a best possible 
self: effects of a two week intervention. J Behav Ther Exp Psychiatry 2011;42:371-8. 
82. 
Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive 
and negative affect: the PANAS scales. Journal of Personality and Social Psychology 1988;54:1063-
70. 

Developing a positive psychology intervention to promote health behaviors in heart failure: proof-of concept trial 
Christopher Celano, MD – Detailed Protocol – 3.28.2017 
28 
 
83. 
McClure JB, Ludman E, Grothaus L, Pabiniak C, Richards J, Mohelnitzky A. Immediate and 
short-term impact of a brief motivational smoking intervention using a biomedical risk assessment: the 
Get PHIT trial. Nicotine Tob Res 2009;11:394-403. 
84. 
Brouwers C, Mommersteeg PM, Nyklicek I, et al. Positive affect dimensions and their 
association with inflammatory biomarkers in patients with chronic heart failure. Biol Psychol 
2013;92:220-6. 
85. 
Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the hospital anxiety and 
depression scale. An updated literature review. J Psychosom Res 2002;52:69-77. 
86. 
Frasure-Smith N, Lesperance F. Depression and anxiety as predictors of 2-year cardiac events 
in patients with stable coronary artery disease. Arch Gen Psychiatry 2008;65:62-71. 
87. 
Turner A, Phillips L, Hambridge JA, Baker AL, Bowman J, Colyvas K. Clinical outcomes 
associated with depression, anxiety and social support among cardiac rehabilitation attendees. Aust N 
Z J Psychiatry 2010;44:658-66. 
88. 
Lim LL, Fisher JD. Use of the 12-item short-form (SF-12) Health Survey in an Australian heart 
and stroke population. Qual Life Res 1999;8:1-8. 
89. 
Maurer MS, Cuddihy P, Weisenberg J, et al. The prevalence and impact of anergia (lack of 
energy) in subjects with heart failure and its associations with actigraphy. J Card Fail 2009;15:145-51. 
90. 
Muller-Nordhorn J, Roll S, Willich SN. Comparison of the short form (SF)-12 health status 
instrument with the SF-36 in patients with coronary heart disease. Heart 2004;90:523-7. 
91. 
Ni H, Toy W, Burgess D, et al. Comparative responsiveness of Short-Form 12 and Minnesota 
Living With Heart Failure Questionnaire in patients with heart failure. J Card Fail 2000;6:83-91. 
92. 
Thombs BD, Ziegelstein RC, Stewart DE, Abbey SE, Parakh K, Grace SL. Usefulness of 
persistent symptoms of depression to predict physical health status 12 months after an acute coronary 
syndrome. Am J Cardiol 2008;101:15-9. 
93. 
Wootton R, Gramotnev H, Hailey D. A randomized controlled trial of telephone-supported care 
coordination in patients with congestive heart failure. J Telemed Telecare 2009;15:182-6. 
94. 
Bennett SJ, Oldridge NB, Eckert GJ, et al. Comparison of quality of life measures in heart 
failure. Nurs Res 2003;52:207-16. 
95. 
Chamberlain AM, McNallan SM, Dunlay SM, et al. Physical health status measures predict all-
cause mortality in patients with heart failure. Circ Heart Fail 2013;6:669-75. 
 
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