18 and older, any sex, with Congestive Heart Failure or Emotions. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Feasibility of the PP-based Health Behavior InterventionPrimary· 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.
Group
Value
95% CI
PP-based Health Behavior Intervention
8.7
± 4.9
Acceptability of the ExercisesSecondary· 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.
Ease
Group
Value
95% CI
PP-based Health Behavior Intervention
7.5
± 1.7
Utility
Group
Value
95% CI
PP-based Health Behavior Intervention
7.5
± 1.6
Immediate Impact of the ExercisesSecondary· 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.
Optimism
Group
Value
95% CI
PP-based Health Behavior Intervention
0.64
± 1.14
Positive Affect
Group
Value
95% CI
PP-based Health Behavior Intervention
0.97
± 1.38
Change in PANAS Scores (Primary Psychological Outcome)Secondary· Baseline, 12 weeks, and 24 weeks
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.
12 weeks
Group
Value
95% CI
PP-based Health Behavior Intervention
5.38
± 7.84
MI-based Educational Control Condition
2.50
± 8.26
Treatment as Usual (TAU)
2.50
± 5.60
24 weeks
Group
Value
95% CI
PP-based Health Behavior Intervention
5.43
± 5.15
MI-based Educational Control Condition
-0.46
± 7.29
Treatment as Usual (TAU)
3.75
± 7.44
Changes in LOT-R ScoresSecondary· Baseline, 12 weeks, and 24 weeks
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.
12 weeks
Group
Value
95% CI
PP-based Health Behavior Intervention
2.43
± 4.18
MI-based Educational Control Condition
1.29
± 3.05
Treatment as Usual (TAU)
2.93
± 5.92
24 weeks
Group
Value
95% CI
PP-based Health Behavior Intervention
3.50
± 3.35
MI-based Educational Control Condition
1.23
± 4.66
Treatment as Usual (TAU)
2.83
± 6.62
Changes in SOM ScoresSecondary· Baseline, 12 weeks, and 24 weeks
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.
12 weeks
Group
Value
95% CI
PP-based Health Behavior Intervention
2.14
± 4.38
MI-based Educational Control Condition
1.29
± 4.63
Treatment as Usual (TAU)
2.36
± 3.97
24 weeks
Group
Value
95% CI
PP-based Health Behavior Intervention
2.00
± 4.61
MI-based Educational Control Condition
1.38
± 5.74
Treatment as Usual (TAU)
-0.17
± 5.61
Changes in HADS-Anxiety Subscale ScoresSecondary· Baseline, 12 weeks, and 24 weeks
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.
12 weeks
Group
Value
95% CI
PP-based Health Behavior Intervention
-1.79
± 3.42
MI-based Educational Control Condition
-2.00
± 2.54
Treatment as Usual (TAU)
-2.07
± 3.85
24 weeks
Group
Value
95% CI
PP-based Health Behavior Intervention
-2.21
± 1.72
MI-based Educational Control Condition
-1.69
± 3.47
Treatment as Usual (TAU)
-2.50
± 4.44
Change in HADS-Depression Subscale ScoresSecondary· Baseline, 12 weeks, and 24 weeks
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.
12 weeks
Group
Value
95% CI
PP-based Health Behavior Intervention
-1.57
± 2.47
MI-based Educational Control Condition
-0.93
± 2.53
Treatment as Usual (TAU)
-1.00
± 2.63
24 weeks
Group
Value
95% CI
PP-based Health Behavior Intervention
-1.57
± 2.24
MI-based Educational Control Condition
-0.38
± 5.12
Treatment as Usual (TAU)
-1.00
± 3.33
Changes in KCCQ Scores (Primary Functional Outcome)Secondary· Baseline, 12 weeks, and 24 weeks
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.
12 weeks HRQoL
Group
Value
95% CI
PP-based Health Behavior Intervention
7.74
± 24.99
MI-based Educational Control Condition
4.76
± 23.28
Treatment as Usual (TAU)
10.12
± 13.94
12 weeks Total Symptom
Group
Value
95% CI
PP-based Health Behavior Intervention
2.31
± 21.39
MI-based Educational Control Condition
-1.19
± 10.89
Treatment as Usual (TAU)
2.60
± 16.65
24 weeks HRQoL
Group
Value
95% CI
PP-based Health Behavior Intervention
1.19
± 22.13
MI-based Educational Control Condition
7.05
± 26.75
Treatment as Usual (TAU)
10.42
± 12.87
24 weeks Total Symptom
Group
Value
95% CI
PP-based Health Behavior Intervention
1.93
± 18.49
MI-based Educational Control Condition
-5.37
± 14.14
Treatment as Usual (TAU)
0.87
± 16.66
Changes in SF-12 ScoresSecondary· Baseline, 12 weeks, and 24 weeks
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.
12 weeks Mental Health Composite Score
Group
Value
95% CI
PP-based Health Behavior Intervention
7.03
± 9.94
MI-based Educational Control Condition
1.51
± 8.39
Treatment as Usual (TAU)
5.19
± 5.73
12 weeks Physical Health Composite Score
Group
Value
95% CI
PP-based Health Behavior Intervention
1.88
± 9.22
MI-based Educational Control Condition
0.42
± 7.18
Treatment as Usual (TAU)
0.83
± 10.61
24 weeks Mental Health Composite Score
Group
Value
95% CI
PP-based Health Behavior Intervention
7.54
± 9.61
MI-based Educational Control Condition
-1.36
± 11.32
Treatment as Usual (TAU)
8.28
± 8.73
24 weeks Physical Health Composite Score
Group
Value
95% CI
PP-based Health Behavior Intervention
2.13
± 10.07
MI-based Educational Control Condition
1.00
± 8.27
Treatment as Usual (TAU)
0.75
± 11.30
Changes in MOS SAS ScoresSecondary· Baseline, 12 weeks, and 24 weeks
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.
12 weeks
Group
Value
95% CI
PP-based Health Behavior Intervention
2.50
± 2.59
MI-based Educational Control Condition
2.64
± 2.27
Treatment as Usual (TAU)
1.14
± 2.38
24 weeks
Group
Value
95% CI
PP-based Health Behavior Intervention
2.29
± 2.81
MI-based Educational Control Condition
2.23
± 3.56
Treatment as Usual (TAU)
1.42
± 1.73
Changes in Sodium Intake (as Measured With the SSQ)Secondary· Baseline, 12 weeks, and 24 weeks
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.
12 weeks
Group
Value
95% CI
PP-based Health Behavior Intervention
-18.25
± 17.62
MI-based Educational Control Condition
-12.93
± 15.90
Treatment as Usual (TAU)
-11.68
± 19.77
24 weeks
Group
Value
95% CI
PP-based Health Behavior Intervention
-13.18
± 20.14
MI-based Educational Control Condition
-14.65
± 20.26
Treatment as Usual (TAU)
-0.63
± 23.95
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse event data were collected from each participant for 6 months, the entire duration of time when they were active in the study..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The focus of this study is to examine the feasibility, acceptability, and preliminary impact of a 12-week, telephone-delivered, positive psychology (PP)-based health behavior intervention in a group of patients with mild to moderate heart failure (HF), compared to a motivational interviewing- (MI-) based education condition and treatment as usual (TAU).
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Massachusetts General Hospital
Last refreshed: 30 August 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03220204.