Trial Outcomes & Findings for Researching Emotions And Cardiac Health: Phase III (NCT NCT03220204)

NCT ID: NCT03220204

Last Updated: 2021-08-30

Results Overview

Feasibility will be measured by examining the number of completed exercises for individuals randomized to the Positive Psychology (PP)-based intervention.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: Change between baseline and 12 weeks
• Results posted on: 2021-08-30

Participant Flow

Participant milestones

Measure	PP-based Health Behavior Intervention Participants will undergo a 12-week, Positive Psychology (PP)-based health behavior intervention. Each weekly session will include (a) a review of the week's PP exercise, (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. PP-based health behavior intervention: The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence.	MI-based Educational Control Condition Participants will undergo 12 weekly phone sessions to learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. Motivational Interviewing (MI)-based educational control condition: The MI-based educational program includes information on five topics: (1) information about heart disease and risk factors for worsening heart disease, (2) physical activity, (3) a heart-healthy diet, (4) medication adherence, and (5) stress management.	Treatment as Usual (TAU) Participants in the Treatment as Usual (TAU) group will not receive any interventions between the baseline visit and follow-up visits.
Overall Study STARTED	15	15	15
Overall Study COMPLETED	14	13	12
Overall Study NOT COMPLETED	1	2	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Researching Emotions And Cardiac Health: Phase III

Baseline characteristics by cohort

Measure	PP-based Health Behavior Intervention n=15 Participants Participants will undergo a 12-week, Positive Psychology (PP)-based health behavior intervention. Each weekly session will include (a) a review of the week's PP exercise, (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. PP-based health behavior intervention: The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence.	MI-based Educational Control Condition n=15 Participants Participants will undergo 12 weekly phone sessions to learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. Motivational Interviewing (MI)-based educational control condition: The MI-based educational program includes information on five topics: (1) information about heart disease and risk factors for worsening heart disease, (2) physical activity, (3) a heart-healthy diet, (4) medication adherence, and (5) stress management.	Treatment as Usual (TAU) n=15 Participants Participants in the Treatment as Usual (TAU) group will not receive any interventions between the baseline visit and follow-up visits.	Total n=45 Participants Total of all reporting groups
Age, Continuous	65.9 years STANDARD_DEVIATION 8.5 • n=5 Participants	74.6 years STANDARD_DEVIATION 10.4 • n=7 Participants	71.8 years STANDARD_DEVIATION 10.6 • n=5 Participants	70.8 years STANDARD_DEVIATION 10.3 • n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	12 Participants n=4 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants	33 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	15 Participants n=7 Participants	15 Participants n=5 Participants	45 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	12 Participants n=7 Participants	14 Participants n=5 Participants	39 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	15 participants n=5 Participants	15 participants n=7 Participants	15 participants n=5 Participants	45 participants n=4 Participants
Positive and Negative Affect Schedule (PANAS)	31.53 units on a scale STANDARD_DEVIATION 7.95 • n=5 Participants	33.93 units on a scale STANDARD_DEVIATION 7.21 • n=7 Participants	32.33 units on a scale STANDARD_DEVIATION 5.81 • n=5 Participants	32.60 units on a scale STANDARD_DEVIATION 6.96 • n=4 Participants
Life Orientation Test-Revised (LOT-R)	17.33 units on a scale STANDARD_DEVIATION 3.64 • n=5 Participants	18.13 units on a scale STANDARD_DEVIATION 4.55 • n=7 Participants	15.73 units on a scale STANDARD_DEVIATION 4.77 • n=5 Participants	17.07 units on a scale STANDARD_DEVIATION 4.37 • n=4 Participants
State Optimism Measure (SOM)	26.33 units on a scale STANDARD_DEVIATION 4.85 • n=5 Participants	26.93 units on a scale STANDARD_DEVIATION 5.54 • n=7 Participants	27.67 units on a scale STANDARD_DEVIATION 4.51 • n=5 Participants	26.98 units on a scale STANDARD_DEVIATION 4.90 • n=4 Participants
Hospital Anxiety and Depression Scale (HADS) anxiety subscale	6.47 units on a scale STANDARD_DEVIATION 3.72 • n=5 Participants	6.33 units on a scale STANDARD_DEVIATION 4.01 • n=7 Participants	5.60 units on a scale STANDARD_DEVIATION 4.56 • n=5 Participants	6.13 units on a scale STANDARD_DEVIATION 4.04 • n=4 Participants
Hospital Anxiety and Depression Scale (HADS) depression subscale	5.07 units on a scale STANDARD_DEVIATION 3.35 • n=5 Participants	5.40 units on a scale STANDARD_DEVIATION 3.92 • n=7 Participants	5.13 units on a scale STANDARD_DEVIATION 4.02 • n=5 Participants	5.20 units on a scale STANDARD_DEVIATION 3.69 • n=4 Participants
Kansas City Cardiomyopathy Questionnaire (KCCQ)	75.36 units on a scale STANDARD_DEVIATION 19.16 • n=5 Participants	68.91 units on a scale STANDARD_DEVIATION 24.35 • n=7 Participants	78.15 units on a scale STANDARD_DEVIATION 14.99 • n=5 Participants	74.14 units on a scale STANDARD_DEVIATION 19.81 • n=4 Participants
Medical Outcomes Study Short Form-12 (SF-12) Physical Health Composite Score	42.13 units on a scale STANDARD_DEVIATION 10.05 • n=5 Participants	37.94 units on a scale STANDARD_DEVIATION 13.68 • n=7 Participants	40.14 units on a scale STANDARD_DEVIATION 10.40 • n=5 Participants	40.07 units on a scale STANDARD_DEVIATION 11.36 • n=4 Participants
Medical Outcomes Study Short Form-12 (SF-12) Mental Health Composite Score	42.21 units on a scale STANDARD_DEVIATION 11.20 • n=5 Participants	50.26 units on a scale STANDARD_DEVIATION 8.72 • n=7 Participants	48.22 units on a scale STANDARD_DEVIATION 9.99 • n=5 Participants	46.90 units on a scale STANDARD_DEVIATION 10.38 • n=4 Participants
Medical Outcomes Study Specific Adherence Scale (MOS SAS)	11.87 units on a scale STANDARD_DEVIATION 2.33 • n=5 Participants	12.60 units on a scale STANDARD_DEVIATION 2.10 • n=7 Participants	12.73 units on a scale STANDARD_DEVIATION 1.28 • n=5 Participants	12.40 units on a scale STANDARD_DEVIATION 1.95 • n=4 Participants
Scored Sodium Questionnaire (SSQ)	71.10 units on a scale STANDARD_DEVIATION 29.09 • n=5 Participants	64.90 units on a scale STANDARD_DEVIATION 27.79 • n=7 Participants	64.37 units on a scale STANDARD_DEVIATION 21.15 • n=5 Participants	66.79 units on a scale STANDARD_DEVIATION 25.82 • n=4 Participants
Self-Reported Medication Adherence (SRMA)	95.33 percentage STANDARD_DEVIATION 5.16 • n=5 Participants	96.67 percentage STANDARD_DEVIATION 4.88 • n=7 Participants	96.67 percentage STANDARD_DEVIATION 6.17 • n=5 Participants	96.22 percentage STANDARD_DEVIATION 5.35 • n=4 Participants
Physical Activity	3465 steps/day STANDARD_DEVIATION 1484 • n=5 Participants	3458 steps/day STANDARD_DEVIATION 1616 • n=7 Participants	4195 steps/day STANDARD_DEVIATION 2375 • n=5 Participants	3706 steps/day STANDARD_DEVIATION 1857 • n=4 Participants
Moderate to Vigorous Physical Activity	7.5 minutes/day STANDARD_DEVIATION 6.8 • n=5 Participants	5.9 minutes/day STANDARD_DEVIATION 6.9 • n=7 Participants	15.2 minutes/day STANDARD_DEVIATION 19.8 • n=5 Participants	9.5 minutes/day STANDARD_DEVIATION 13.1 • n=4 Participants
Feasibility of Actigraph	15 Participants n=5 Participants	15 Participants n=7 Participants	15 Participants n=5 Participants	45 Participants n=4 Participants

PRIMARY outcome

Timeframe: Change between baseline and 12 weeks

Feasibility will be measured by examining the number of completed exercises for individuals randomized to the Positive Psychology (PP)-based intervention.

Outcome measures

Measure	PP-based Health Behavior Intervention n=15 Participants Participants will undergo a 12-week, PP-based health behavior intervention. Each weekly session will include (a) a review of the week's PP exercise, (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. PP-based health behavior intervention: The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence.	MI-based Educational Control Condition Participants will undergo 12 weekly phone sessions to learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. Motivational Interviewing (MI)-based educational control condition: The MI-based educational program includes information on five topics: (1) information about heart disease and risk factors for worsening heart disease, (2) physical activity, (3) a heart-healthy diet, (4) medication adherence, and (5) stress management.	Treatment as Usual (TAU) Participants in the Treatment as Usual (TAU) group will not receive any interventions between the baseline visit and follow-up visits.
Feasibility of the PP-based Health Behavior Intervention	8.7 sessions completed out of 12 sessions Standard Deviation 4.9	—	—

SECONDARY outcome

Timeframe: 12 weeks

Participants receiving the PP-based health behavior intervention will provide ratings of ease and utility after each exercise, measured on a 10-point Likert scale.

Outcome measures

Measure	PP-based Health Behavior Intervention n=15 Participants Participants will undergo a 12-week, PP-based health behavior intervention. Each weekly session will include (a) a review of the week's PP exercise, (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. PP-based health behavior intervention: The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence.	MI-based Educational Control Condition Participants will undergo 12 weekly phone sessions to learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. Motivational Interviewing (MI)-based educational control condition: The MI-based educational program includes information on five topics: (1) information about heart disease and risk factors for worsening heart disease, (2) physical activity, (3) a heart-healthy diet, (4) medication adherence, and (5) stress management.	Treatment as Usual (TAU) Participants in the Treatment as Usual (TAU) group will not receive any interventions between the baseline visit and follow-up visits.
Acceptability of the Exercises Ease	7.5 rating out of 10 Standard Deviation 1.7	—	—
Acceptability of the Exercises Utility	7.5 rating out of 10 Standard Deviation 1.6	—	—

SECONDARY outcome

Timeframe: Weekly, up to 12 weeks

Participants receiving the PP-based health behavior intervention will provide ratings of optimism and positive affect, before and after each exercise, measured on a 10-point Likert scale.

Outcome measures

Measure	PP-based Health Behavior Intervention n=15 Participants Participants will undergo a 12-week, PP-based health behavior intervention. Each weekly session will include (a) a review of the week's PP exercise, (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. PP-based health behavior intervention: The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence.	MI-based Educational Control Condition Participants will undergo 12 weekly phone sessions to learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. Motivational Interviewing (MI)-based educational control condition: The MI-based educational program includes information on five topics: (1) information about heart disease and risk factors for worsening heart disease, (2) physical activity, (3) a heart-healthy diet, (4) medication adherence, and (5) stress management.	Treatment as Usual (TAU) Participants in the Treatment as Usual (TAU) group will not receive any interventions between the baseline visit and follow-up visits.
Immediate Impact of the Exercises Optimism	0.64 units on a scale Standard Deviation 1.14	—	—
Immediate Impact of the Exercises Positive Affect	0.97 units on a scale Standard Deviation 1.38	—	—

SECONDARY outcome

Timeframe: Baseline, 12 weeks, and 24 weeks

Population: Not all participants provided follow-up data at both timepoints.

The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with HF, will be used to measure positive affect (Range: 10-50). Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher levels of positive affect.

Outcome measures

Measure	PP-based Health Behavior Intervention n=14 Participants Participants will undergo a 12-week, PP-based health behavior intervention. Each weekly session will include (a) a review of the week's PP exercise, (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. PP-based health behavior intervention: The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence.	MI-based Educational Control Condition n=14 Participants Participants will undergo 12 weekly phone sessions to learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. Motivational Interviewing (MI)-based educational control condition: The MI-based educational program includes information on five topics: (1) information about heart disease and risk factors for worsening heart disease, (2) physical activity, (3) a heart-healthy diet, (4) medication adherence, and (5) stress management.	Treatment as Usual (TAU) n=14 Participants Participants in the Treatment as Usual (TAU) group will not receive any interventions between the baseline visit and follow-up visits.
Change in PANAS Scores (Primary Psychological Outcome) 12 weeks	5.38 units on a scale Standard Deviation 7.84	2.50 units on a scale Standard Deviation 8.26	2.50 units on a scale Standard Deviation 5.60
Change in PANAS Scores (Primary Psychological Outcome) 24 weeks	5.43 units on a scale Standard Deviation 5.15	-0.46 units on a scale Standard Deviation 7.29	3.75 units on a scale Standard Deviation 7.44

SECONDARY outcome

Timeframe: Baseline, 12 weeks, and 24 weeks

Population: Not all participants provided follow-up data at both timepoints.

Life Orientation Test-Revised (LOT-R) is a well-validated 6-item instrument used to measure dispositional optimism (Range: 0-24). Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher levels of dispositional optimism.

Outcome measures

Measure	PP-based Health Behavior Intervention n=14 Participants Participants will undergo a 12-week, PP-based health behavior intervention. Each weekly session will include (a) a review of the week's PP exercise, (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. PP-based health behavior intervention: The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence.	MI-based Educational Control Condition n=14 Participants Participants will undergo 12 weekly phone sessions to learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. Motivational Interviewing (MI)-based educational control condition: The MI-based educational program includes information on five topics: (1) information about heart disease and risk factors for worsening heart disease, (2) physical activity, (3) a heart-healthy diet, (4) medication adherence, and (5) stress management.	Treatment as Usual (TAU) n=14 Participants Participants in the Treatment as Usual (TAU) group will not receive any interventions between the baseline visit and follow-up visits.
Changes in LOT-R Scores 12 weeks	2.43 units on a scale Standard Deviation 4.18	1.29 units on a scale Standard Deviation 3.05	2.93 units on a scale Standard Deviation 5.92
Changes in LOT-R Scores 24 weeks	3.50 units on a scale Standard Deviation 3.35	1.23 units on a scale Standard Deviation 4.66	2.83 units on a scale Standard Deviation 6.62

SECONDARY outcome

Timeframe: Baseline, 12 weeks, and 24 weeks

Population: Not all participants provided follow-up data at both timepoints.

The State Optimism Measure (SOM) will be used to measure state optimism (Range: 7-35). Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher levels of state optimism.

Outcome measures

Measure	PP-based Health Behavior Intervention n=14 Participants Participants will undergo a 12-week, PP-based health behavior intervention. Each weekly session will include (a) a review of the week's PP exercise, (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. PP-based health behavior intervention: The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence.	MI-based Educational Control Condition n=14 Participants Participants will undergo 12 weekly phone sessions to learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. Motivational Interviewing (MI)-based educational control condition: The MI-based educational program includes information on five topics: (1) information about heart disease and risk factors for worsening heart disease, (2) physical activity, (3) a heart-healthy diet, (4) medication adherence, and (5) stress management.	Treatment as Usual (TAU) n=14 Participants Participants in the Treatment as Usual (TAU) group will not receive any interventions between the baseline visit and follow-up visits.
Changes in SOM Scores 24 weeks	2.00 units on a scale Standard Deviation 4.61	1.38 units on a scale Standard Deviation 5.74	-0.17 units on a scale Standard Deviation 5.61
Changes in SOM Scores 12 weeks	2.14 units on a scale Standard Deviation 4.38	1.29 units on a scale Standard Deviation 4.63	2.36 units on a scale Standard Deviation 3.97

SECONDARY outcome

Timeframe: Baseline, 12 weeks, and 24 weeks

Population: Not all participants provided follow-up data at both timepoints.

The Hospital Anxiety and Depression Scale (HADS)-anxiety subscale was be used to measure anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-21). Change was calculated by subtracting the score at baseline from the score at 12 weeks and 24 weeks. Higher scores indicate higher levels of anxiety.

Outcome measures

Measure	PP-based Health Behavior Intervention n=14 Participants Participants will undergo a 12-week, PP-based health behavior intervention. Each weekly session will include (a) a review of the week's PP exercise, (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. PP-based health behavior intervention: The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence.	MI-based Educational Control Condition n=14 Participants Participants will undergo 12 weekly phone sessions to learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. Motivational Interviewing (MI)-based educational control condition: The MI-based educational program includes information on five topics: (1) information about heart disease and risk factors for worsening heart disease, (2) physical activity, (3) a heart-healthy diet, (4) medication adherence, and (5) stress management.	Treatment as Usual (TAU) n=14 Participants Participants in the Treatment as Usual (TAU) group will not receive any interventions between the baseline visit and follow-up visits.
Changes in HADS-Anxiety Subscale Scores 12 weeks	-1.79 units on a scale Standard Deviation 3.42	-2.00 units on a scale Standard Deviation 2.54	-2.07 units on a scale Standard Deviation 3.85
Changes in HADS-Anxiety Subscale Scores 24 weeks	-2.21 units on a scale Standard Deviation 1.72	-1.69 units on a scale Standard Deviation 3.47	-2.50 units on a scale Standard Deviation 4.44

SECONDARY outcome

Timeframe: Baseline, 12 weeks, and 24 weeks

Population: Not all participants provided follow-up data at both timepoints.

The Hospital Anxiety and Depression Scale (HADS)-depression subscale was be used to measure depression. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-21). Change was calculated by subtracting the score at baseline from the score at 12 weeks and 24 weeks. Higher scores indicate higher levels of depression.

Outcome measures

Measure	PP-based Health Behavior Intervention n=14 Participants Participants will undergo a 12-week, PP-based health behavior intervention. Each weekly session will include (a) a review of the week's PP exercise, (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. PP-based health behavior intervention: The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence.	MI-based Educational Control Condition n=14 Participants Participants will undergo 12 weekly phone sessions to learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. Motivational Interviewing (MI)-based educational control condition: The MI-based educational program includes information on five topics: (1) information about heart disease and risk factors for worsening heart disease, (2) physical activity, (3) a heart-healthy diet, (4) medication adherence, and (5) stress management.	Treatment as Usual (TAU) n=14 Participants Participants in the Treatment as Usual (TAU) group will not receive any interventions between the baseline visit and follow-up visits.
Change in HADS-Depression Subscale Scores 12 weeks	-1.57 units on a scale Standard Deviation 2.47	-0.93 units on a scale Standard Deviation 2.53	-1.00 units on a scale Standard Deviation 2.63
Change in HADS-Depression Subscale Scores 24 weeks	-1.57 units on a scale Standard Deviation 2.24	-0.38 units on a scale Standard Deviation 5.12	-1.00 units on a scale Standard Deviation 3.33

SECONDARY outcome

Timeframe: Baseline, 12 weeks, and 24 weeks

Population: Not all participants provided follow-up data at both timepoints.

The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a well-validated questionnaire of health status in HF. 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 (QoL score range: 0-100; total symptom score range: 0-100). Change was calculated by subtracting the score at baseline from the score at 12 weeks and 24 weeks. Higher QoL scores indicate better HF specific health-related QoL, and higher total symptom scores indicate fewer symptoms.

Outcome measures

Measure	PP-based Health Behavior Intervention n=14 Participants Participants will undergo a 12-week, PP-based health behavior intervention. Each weekly session will include (a) a review of the week's PP exercise, (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. PP-based health behavior intervention: The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence.	MI-based Educational Control Condition n=14 Participants Participants will undergo 12 weekly phone sessions to learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. Motivational Interviewing (MI)-based educational control condition: The MI-based educational program includes information on five topics: (1) information about heart disease and risk factors for worsening heart disease, (2) physical activity, (3) a heart-healthy diet, (4) medication adherence, and (5) stress management.	Treatment as Usual (TAU) n=14 Participants Participants in the Treatment as Usual (TAU) group will not receive any interventions between the baseline visit and follow-up visits.
Changes in KCCQ Scores (Primary Functional Outcome) 12 weeks HRQoL	7.74 units on a scale Standard Deviation 24.99	4.76 units on a scale Standard Deviation 23.28	10.12 units on a scale Standard Deviation 13.94
Changes in KCCQ Scores (Primary Functional Outcome) 12 weeks Total Symptom	2.31 units on a scale Standard Deviation 21.39	-1.19 units on a scale Standard Deviation 10.89	2.60 units on a scale Standard Deviation 16.65
Changes in KCCQ Scores (Primary Functional Outcome) 24 weeks HRQoL	1.19 units on a scale Standard Deviation 22.13	7.05 units on a scale Standard Deviation 26.75	10.42 units on a scale Standard Deviation 12.87
Changes in KCCQ Scores (Primary Functional Outcome) 24 weeks Total Symptom	1.93 units on a scale Standard Deviation 18.49	-5.37 units on a scale Standard Deviation 14.14	0.87 units on a scale Standard Deviation 16.66

SECONDARY outcome

Timeframe: Baseline, 12 weeks, and 24 weeks

Population: Not all participants provided follow-up data at both timepoints.

The Medical Outcomes Study Short Form-12 (SF-12) will be used to measure quality of life. This is an instrument which has been used in multiple cardiac studies in the past (SF-12 Mental Composite Score and Physical Composite Score Range: 0-100 each). Change was calculated by subtracting the score at baseline from the score at 12 weeks and 24 weeks. Higher scores indicate higher level of health related QoL.

Outcome measures

Measure	PP-based Health Behavior Intervention n=14 Participants Participants will undergo a 12-week, PP-based health behavior intervention. Each weekly session will include (a) a review of the week's PP exercise, (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. PP-based health behavior intervention: The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence.	MI-based Educational Control Condition n=14 Participants Participants will undergo 12 weekly phone sessions to learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. Motivational Interviewing (MI)-based educational control condition: The MI-based educational program includes information on five topics: (1) information about heart disease and risk factors for worsening heart disease, (2) physical activity, (3) a heart-healthy diet, (4) medication adherence, and (5) stress management.	Treatment as Usual (TAU) n=14 Participants Participants in the Treatment as Usual (TAU) group will not receive any interventions between the baseline visit and follow-up visits.
Changes in SF-12 Scores 12 weeks Mental Health Composite Score	7.03 units on a scale Standard Deviation 9.94	1.51 units on a scale Standard Deviation 8.39	5.19 units on a scale Standard Deviation 5.73
Changes in SF-12 Scores 12 weeks Physical Health Composite Score	1.88 units on a scale Standard Deviation 9.22	0.42 units on a scale Standard Deviation 7.18	0.83 units on a scale Standard Deviation 10.61
Changes in SF-12 Scores 24 weeks Mental Health Composite Score	7.54 units on a scale Standard Deviation 9.61	-1.36 units on a scale Standard Deviation 11.32	8.28 units on a scale Standard Deviation 8.73
Changes in SF-12 Scores 24 weeks Physical Health Composite Score	2.13 units on a scale Standard Deviation 10.07	1.00 units on a scale Standard Deviation 8.27	0.75 units on a scale Standard Deviation 11.30

SECONDARY outcome

Timeframe: Baseline, 12 weeks, and 24 weeks

Population: Not all participants provided follow-up data at both timepoints.

Three Medical Outcomes Study Specific Adherence Scale (MOS SAS) items assessing medication, diet, and exercise, will be measured individually and as a composite score (Range: 3-18). Change was calculated by subtracting the score at baseline from the score at 12 weeks and 24 weeks. Higher scores indicate better adherence to health behaviors.

Outcome measures

Measure	PP-based Health Behavior Intervention n=14 Participants Participants will undergo a 12-week, PP-based health behavior intervention. Each weekly session will include (a) a review of the week's PP exercise, (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. PP-based health behavior intervention: The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence.	MI-based Educational Control Condition n=14 Participants Participants will undergo 12 weekly phone sessions to learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. Motivational Interviewing (MI)-based educational control condition: The MI-based educational program includes information on five topics: (1) information about heart disease and risk factors for worsening heart disease, (2) physical activity, (3) a heart-healthy diet, (4) medication adherence, and (5) stress management.	Treatment as Usual (TAU) n=14 Participants Participants in the Treatment as Usual (TAU) group will not receive any interventions between the baseline visit and follow-up visits.
Changes in MOS SAS Scores 24 weeks	2.29 units on a scale Standard Deviation 2.81	2.23 units on a scale Standard Deviation 3.56	1.42 units on a scale Standard Deviation 1.73
Changes in MOS SAS Scores 12 weeks	2.50 units on a scale Standard Deviation 2.59	2.64 units on a scale Standard Deviation 2.27	1.14 units on a scale Standard Deviation 2.38

SECONDARY outcome

Timeframe: Baseline, 12 weeks, and 24 weeks

Population: Not all participants provided follow-up data at both timepoints.

The Scored Sodium Questionnaire (SSQ) is a self-report scale that assesses the frequency with which participants consume a variety of sodium-containing foods, ranging from "Rarely or Never Eaten" to "At Least Once Daily." It is used to calculate daily sodium intake (Range: 0-215). Change was calculated by subtracting the score at baseline from the score at 12 weeks and 24 weeks. Higher scores indicate higher sodium intake.

Outcome measures

Measure	PP-based Health Behavior Intervention n=14 Participants Participants will undergo a 12-week, PP-based health behavior intervention. Each weekly session will include (a) a review of the week's PP exercise, (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. PP-based health behavior intervention: The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence.	MI-based Educational Control Condition n=14 Participants Participants will undergo 12 weekly phone sessions to learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. Motivational Interviewing (MI)-based educational control condition: The MI-based educational program includes information on five topics: (1) information about heart disease and risk factors for worsening heart disease, (2) physical activity, (3) a heart-healthy diet, (4) medication adherence, and (5) stress management.	Treatment as Usual (TAU) n=14 Participants Participants in the Treatment as Usual (TAU) group will not receive any interventions between the baseline visit and follow-up visits.
Changes in Sodium Intake (as Measured With the SSQ) 12 weeks	-18.25 units on a scale Standard Deviation 17.62	-12.93 units on a scale Standard Deviation 15.90	-11.68 units on a scale Standard Deviation 19.77
Changes in Sodium Intake (as Measured With the SSQ) 24 weeks	-13.18 units on a scale Standard Deviation 20.14	-14.65 units on a scale Standard Deviation 20.26	-0.63 units on a scale Standard Deviation 23.95

SECONDARY outcome

Timeframe: Baseline, 12 weeks and 24 weeks

Population: Not all participants provided follow-up data at both timepoints.

The Self-Reported Medication Adherence (SRMA) asks what percent of the time (in 10% increments) participants took all of their medications as prescribed in the past week and in the past 2 weeks (Range: 0-100). Change was calculated by subtracting the score at baseline from the score at 10 weeks.

Outcome measures

Measure	PP-based Health Behavior Intervention n=14 Participants Participants will undergo a 12-week, PP-based health behavior intervention. Each weekly session will include (a) a review of the week's PP exercise, (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. PP-based health behavior intervention: The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence.	MI-based Educational Control Condition n=14 Participants Participants will undergo 12 weekly phone sessions to learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. Motivational Interviewing (MI)-based educational control condition: The MI-based educational program includes information on five topics: (1) information about heart disease and risk factors for worsening heart disease, (2) physical activity, (3) a heart-healthy diet, (4) medication adherence, and (5) stress management.	Treatment as Usual (TAU) n=14 Participants Participants in the Treatment as Usual (TAU) group will not receive any interventions between the baseline visit and follow-up visits.
Changes in Self-Reported Medication Adherence (SRMA) 12 weeks	43 percentage of time Standard Deviation 51	0 percentage of time Standard Deviation 39	21 percentage of time Standard Deviation 70
Changes in Self-Reported Medication Adherence (SRMA) 24 weeks	36 percentage of time Standard Deviation 50	8 percentage of time Standard Deviation 64	8 percentage of time Standard Deviation 100

SECONDARY outcome

Timeframe: Baseline, 12 weeks, and 24 weeks

Population: Not all participants provided wore Actigraph GT3X+ step counters or provided follow-up data at both timepoints.

Assessed by ActiGraph GT3X+ step counters which are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness. We will measure both number of steps per day (primary physical health outcome). Change scores will be calculated by subtracting the number of steps per day at baseline from number of steps per day at 12 weeks and 24 weeks.

Outcome measures

Measure	PP-based Health Behavior Intervention n=12 Participants Participants will undergo a 12-week, PP-based health behavior intervention. Each weekly session will include (a) a review of the week's PP exercise, (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. PP-based health behavior intervention: The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence.	MI-based Educational Control Condition n=13 Participants Participants will undergo 12 weekly phone sessions to learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. Motivational Interviewing (MI)-based educational control condition: The MI-based educational program includes information on five topics: (1) information about heart disease and risk factors for worsening heart disease, (2) physical activity, (3) a heart-healthy diet, (4) medication adherence, and (5) stress management.	Treatment as Usual (TAU) n=11 Participants Participants in the Treatment as Usual (TAU) group will not receive any interventions between the baseline visit and follow-up visits.
Change in Physical Activity 12 weeks	454 steps/day Standard Deviation 1066	409 steps/day Standard Deviation 1033	-412 steps/day Standard Deviation 1305
Change in Physical Activity 24 weeks	821 steps/day Standard Deviation 2232	-330 steps/day Standard Deviation 1287	76 steps/day Standard Deviation 1207

SECONDARY outcome

Timeframe: Baseline, 12 weeks, and 24 weeks

Population: Not all participants provided wore Actigraph GT3X+ step counters or provided follow-up data at both timepoints.

Assessed with ActiGraph GT3X+ step counters, which are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness. Change was calculated by subtracting the MVPA at baseline from the MVPA at 12 weeks and 24 weeks.

Outcome measures

Measure	PP-based Health Behavior Intervention n=12 Participants Participants will undergo a 12-week, PP-based health behavior intervention. Each weekly session will include (a) a review of the week's PP exercise, (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. PP-based health behavior intervention: The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence.	MI-based Educational Control Condition n=13 Participants Participants will undergo 12 weekly phone sessions to learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. Motivational Interviewing (MI)-based educational control condition: The MI-based educational program includes information on five topics: (1) information about heart disease and risk factors for worsening heart disease, (2) physical activity, (3) a heart-healthy diet, (4) medication adherence, and (5) stress management.	Treatment as Usual (TAU) n=11 Participants Participants in the Treatment as Usual (TAU) group will not receive any interventions between the baseline visit and follow-up visits.
Change in Moderate to Vigorous Physical Activity 12 weeks	5.72 minutes/day Standard Deviation 10.58	0.27 minutes/day Standard Deviation 2.85	-4.11 minutes/day Standard Deviation 19.02
Change in Moderate to Vigorous Physical Activity 24 weeks	5.18 minutes/day Standard Deviation 15.02	-2.66 minutes/day Standard Deviation 4.48	-1.32 minutes/day Standard Deviation 6.23

SECONDARY outcome

Timeframe: Baseline, 12 weeks and 24 weeks

Population: Not all participants provided wore Actigraph GT3X+ step counters or provided follow-up data at both timepoints.

Feasibility will be measured by examining the number of participants who provide adequate Actigraph data, defined in this study as at least 480 minutes for 5 days, at each time point.

Outcome measures

Measure	PP-based Health Behavior Intervention n=15 Participants Participants will undergo a 12-week, PP-based health behavior intervention. Each weekly session will include (a) a review of the week's PP exercise, (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. PP-based health behavior intervention: The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence.	MI-based Educational Control Condition n=15 Participants Participants will undergo 12 weekly phone sessions to learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. Motivational Interviewing (MI)-based educational control condition: The MI-based educational program includes information on five topics: (1) information about heart disease and risk factors for worsening heart disease, (2) physical activity, (3) a heart-healthy diet, (4) medication adherence, and (5) stress management.	Treatment as Usual (TAU) n=15 Participants Participants in the Treatment as Usual (TAU) group will not receive any interventions between the baseline visit and follow-up visits.
Feasibility of Actigraph 24 weeks	12 Participants with adequate activity data	11 Participants with adequate activity data	10 Participants with adequate activity data
Feasibility of Actigraph 12 weeks	11 Participants with adequate activity data	13 Participants with adequate activity data	11 Participants with adequate activity data

Adverse Events

PP-based Health Behavior Intervention

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

MI-based Educational Control Condition

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Treatment as Usual (TAU)

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	PP-based Health Behavior Intervention n=15 participants at risk Participants will undergo a 12-week, PP-based health behavior intervention. Each weekly session will include (a) a review of the week's PP exercise, (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. PP-based health behavior intervention: The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence.	MI-based Educational Control Condition n=15 participants at risk Participants will undergo 12 weekly phone sessions to learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. MI-based educational control condition: The MI-based educational program includes information on five topics: (1) information about heart disease and risk factors for worsening heart disease, (2) physical activity, (3) a heart-healthy diet, (4) medication adherence, and (5) stress management.	Treatment as Usual (TAU) n=15 participants at risk Participants in the TAU group will not receive any interventions between the baseline visit and follow-up visits.
General disorders Flu and pneumonia	0.00% 0/15 • Adverse event data were collected from each participant for 6 months, the entire duration of time when they were active in the study.	0.00% 0/15 • Adverse event data were collected from each participant for 6 months, the entire duration of time when they were active in the study.	6.7% 1/15 • Number of events 1 • Adverse event data were collected from each participant for 6 months, the entire duration of time when they were active in the study.
Psychiatric disorders Altered mental state	0.00% 0/15 • Adverse event data were collected from each participant for 6 months, the entire duration of time when they were active in the study.	6.7% 1/15 • Number of events 1 • Adverse event data were collected from each participant for 6 months, the entire duration of time when they were active in the study.	0.00% 0/15 • Adverse event data were collected from each participant for 6 months, the entire duration of time when they were active in the study.
Renal and urinary disorders Urinary Tract Infection	6.7% 1/15 • Number of events 1 • Adverse event data were collected from each participant for 6 months, the entire duration of time when they were active in the study.	0.00% 0/15 • Adverse event data were collected from each participant for 6 months, the entire duration of time when they were active in the study.	0.00% 0/15 • Adverse event data were collected from each participant for 6 months, the entire duration of time when they were active in the study.

Other adverse events

Measure	PP-based Health Behavior Intervention n=15 participants at risk Participants will undergo a 12-week, PP-based health behavior intervention. Each weekly session will include (a) a review of the week's PP exercise, (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. PP-based health behavior intervention: The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence.	MI-based Educational Control Condition n=15 participants at risk Participants will undergo 12 weekly phone sessions to learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. MI-based educational control condition: The MI-based educational program includes information on five topics: (1) information about heart disease and risk factors for worsening heart disease, (2) physical activity, (3) a heart-healthy diet, (4) medication adherence, and (5) stress management.	Treatment as Usual (TAU) n=15 participants at risk Participants in the TAU group will not receive any interventions between the baseline visit and follow-up visits.
Cardiac disorders Unexpected Shortness of Breath and Weight Gain	6.7% 1/15 • Number of events 1 • Adverse event data were collected from each participant for 6 months, the entire duration of time when they were active in the study.	0.00% 0/15 • Adverse event data were collected from each participant for 6 months, the entire duration of time when they were active in the study.	0.00% 0/15 • Adverse event data were collected from each participant for 6 months, the entire duration of time when they were active in the study.
Cardiac disorders Unexpected Chest Pain	0.00% 0/15 • Adverse event data were collected from each participant for 6 months, the entire duration of time when they were active in the study.	13.3% 2/15 • Number of events 2 • Adverse event data were collected from each participant for 6 months, the entire duration of time when they were active in the study.	6.7% 1/15 • Number of events 1 • Adverse event data were collected from each participant for 6 months, the entire duration of time when they were active in the study.
Cardiac disorders Unexpected Shortness of Breath	0.00% 0/15 • Adverse event data were collected from each participant for 6 months, the entire duration of time when they were active in the study.	6.7% 1/15 • Number of events 1 • Adverse event data were collected from each participant for 6 months, the entire duration of time when they were active in the study.	0.00% 0/15 • Adverse event data were collected from each participant for 6 months, the entire duration of time when they were active in the study.
Renal and urinary disorders Urinary Tract Infection	6.7% 1/15 • Number of events 1 • Adverse event data were collected from each participant for 6 months, the entire duration of time when they were active in the study.	0.00% 0/15 • Adverse event data were collected from each participant for 6 months, the entire duration of time when they were active in the study.	0.00% 0/15 • Adverse event data were collected from each participant for 6 months, the entire duration of time when they were active in the study.
General disorders Unexpected Arm Pain	6.7% 1/15 • Number of events 1 • Adverse event data were collected from each participant for 6 months, the entire duration of time when they were active in the study.	0.00% 0/15 • Adverse event data were collected from each participant for 6 months, the entire duration of time when they were active in the study.	0.00% 0/15 • Adverse event data were collected from each participant for 6 months, the entire duration of time when they were active in the study.
General disorders Fractured foot and ankle	0.00% 0/15 • Adverse event data were collected from each participant for 6 months, the entire duration of time when they were active in the study.	6.7% 1/15 • Number of events 1 • Adverse event data were collected from each participant for 6 months, the entire duration of time when they were active in the study.	0.00% 0/15 • Adverse event data were collected from each participant for 6 months, the entire duration of time when they were active in the study.
General disorders Unexpected Fall	0.00% 0/15 • Adverse event data were collected from each participant for 6 months, the entire duration of time when they were active in the study.	6.7% 1/15 • Number of events 1 • Adverse event data were collected from each participant for 6 months, the entire duration of time when they were active in the study.	0.00% 0/15 • Adverse event data were collected from each participant for 6 months, the entire duration of time when they were active in the study.

Additional Information

Dr. Christopher Celano

Massachusetts General Hospital

Phone: 617-726-6485

Email: ccelano@partners.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place