Researching Emotions And Cardiac Health: Phase III: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Researching Emotions And Cardiac Health: Phase III (NCT03220204), a randomized na study. The primary outcome is Feasibility of the PP-based Health Behavior Intervention.

2. Clinical Question

The study is framed as a randomized, controlled pilot trial intended to examine feasibility, acceptability, and preliminary impact. Its comparison is therefore broader than a question about clinical effectiveness: it asks whether the positive psychology program can be delivered and engaged with, and it includes an active educational comparison as well as usual care. The registry record does not report a numerical comparison of outcomes between these groups, so it cannot establish whether the intervention changed behavior, psychological measures, or functional status.

The record lists secondary outcomes relating to exercise acceptability and immediate impact, psychological scales, and a heart-failure questionnaire. It does not report numerical results for these outcomes. Thus, the question that can be answered from the registry description is what the trial set out to assess and how it was organized; whether any group experienced a measured change, and how precise any difference was, are not reported in the registry record.

3. Trial Design

This was a randomized, parallel-group study with single masking. The registry record lists enrollment of 50 and marks the study completed. The study phase is recorded as NA. The sponsor is Massachusetts General Hospital. The record gives a start date of 2017-09-01 and a primary completion date of 2019-05-20.

The three groups described in the record were a positive psychology-based health-behavior intervention, a motivational interviewing-based educational control condition, and treatment as usual. The positive psychology program was described as a 12-week intervention with weekly sessions by telephone. The motivational interviewing condition was also described as 12 weekly phone sessions, covering health behavior topics related to cardiac health. The treatment-as-usual group was described as receiving no intervention between baseline and follow-up visits. The record does not report the allocation ratio or group-specific enrollment.

Random allocation is intended to assign participants to study groups by chance, reducing the opportunity for systematic selection into a group. In a parallel design, participants remain in their assigned group rather than crossing between the interventions. These general features do not guarantee that groups will be similar in a pilot study, particularly when the number enrolled is limited; the registry record does not report baseline comparisons or adjusted analyses.

Single masking is recorded, but the registry record does not state which people involved in the study were masked. It also does not describe the allocation concealment method or give further details about implementation of randomization. The record’s summary states that the trial examines feasibility, acceptability, and preliminary impact, but it does not report a statistical analysis plan, a sample-size justification, or an interim-analysis plan. These details should not be inferred from the randomized design or from the enrollment figure.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

Population: While 50 participants enrolled in this study, only 45 participants were randomized to a condition as 2 participants withdrew consent, 1 participant terminated consent, 1 participant was lost to follow-up, and 1 participant did not provide the data necessary to be randomized.

6. Primary Endpoint

The registry lists the primary outcome as Feasibility of the PP-based Health Behavior Intervention, measured over Change between baseline and 12 weeks.

The primary endpoint is titled “Feasibility of the PP-based Health Behavior Intervention.” Its unit is listed as sessions completed out of 12 sessions, with a mean and standard deviation as the planned summary. The timeframe is described as change between baseline and 12 weeks. The accompanying description says feasibility will be measured by examining the number of completed exercises among people randomized to the positive psychology intervention.

These descriptions point to engagement with the intervention as the intended focus: completing sessions or exercises can indicate whether participants took part in the activities the program offered. Feasibility is useful in a pilot trial because it addresses whether an intervention can be delivered and completed, rather than establishing whether it changes health outcomes. Completion is an implementation measure and should not be interpreted as proof of a clinical benefit.

There is a wording difference within the registry record: the listed unit refers to sessions completed, whereas the endpoint description refers to completed exercises. The record does not clarify whether each exercise corresponds to a session, how completion was defined, or how the stated change from baseline was calculated for a count of completed sessions or exercises. It also does not report the observed mean, standard deviation, or any participant-level distribution for this endpoint.

Because the endpoint is described for participants randomized to the positive psychology intervention, the record does not specify a direct between-group contrast for the primary endpoint. Without a reported result or fuller definition, the endpoint can be described as a planned measure of intervention engagement, but its observed level and precision are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does the endpoint’s mean and standard deviation describe?

The primary endpoint is designated as a continuous measure summarized by a mean and standard deviation. In general, a mean gives the arithmetic average of the observed values, while a standard deviation describes how spread out those values are around the average. These summaries can help describe the distribution of a count-like measure, but they do not show every individual value or how many people completed a particular number of sessions or exercises.

The record lists sessions completed out of 12 sessions as the unit, while the description refers to completed exercises. It also labels the timeframe as change between baseline and 12 weeks. The registry record does not explain how that change is defined or how it relates to the count of sessions or exercises. No observed mean or standard deviation is reported, so those summaries cannot be interpreted for this trial.

What does randomization contribute?

In general, randomization uses chance to assign participants to study groups. It can reduce systematic differences between groups at assignment, including differences that investigators may not have measured. It does not ensure that every group will have the same baseline characteristics, and it does not prevent differences that arise after assignment, such as missing outcome data or departures from the assigned intervention.

The registry identifies the study as randomized and parallel, and describes three groups. It does not report the allocation ratio, the random sequence method, allocation concealment, group-specific enrollment, or baseline characteristics. Those omissions mean that the practical details of the randomization cannot be evaluated from this record. The fact that randomization was used should not be taken as evidence that groups were balanced in the observed data.

What can single masking tell readers?

Masking can reduce the influence of expectations on some aspects of trial conduct or outcome assessment. Which people are masked matters: participants, care providers, outcome assessors, and analysts may have different opportunities to influence measurements. The registry records single masking but does not identify who was masked or explain how masking was maintained. That limitation is especially relevant when the intervention involves telephone sessions and exercises, because participants necessarily encounter different program content across groups. No further conclusion about masking can be drawn from the registry entry.

Why do uncertainty estimates matter?

In general, a confidence interval expresses the range of values compatible with an estimate under a specified statistical procedure and its assumptions. A narrower interval indicates greater precision than a wider interval, but the interval does not eliminate uncertainty or establish that a result is important. A p-value, when reported, addresses compatibility with a specified null hypothesis under a model; it does not measure the probability that the null hypothesis is true or the size of an effect.

The registry record does not report primary or secondary outcome estimates, confidence intervals, or p-values. It also reports no analyses. There is therefore no trial-specific estimate whose magnitude or precision can be interpreted, and no basis for describing a result as statistically significant or not statistically significant.

How should planning calculations be understood?

General sample-size planning asks how much information might be needed to detect an effect under stated assumptions. The record describes planning illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It also states that the effect to detect is a stated fraction of the observed effect. These are planning assumptions, not reported analyses of trial outcomes.

Such planning illustrations are conditional on the assumptions used and do not represent observed power. They do not show that the trial had a particular probability of detecting an effect after the data were collected. No numerical observed effect or planning estimate is reported in the registry record, so readers cannot evaluate the size of those illustrations from the record. The stated approach also describes equal allocation between two arms, whereas the trial record describes three groups; no further explanation of the planning setup is reported.

For continuous outcomes, planning calculations generally depend on the effect to be detected, the variability of the measure, the significance level, and the desired power. Changes in those assumptions can alter the planning result. That general relationship does not allow a new estimate to be calculated for this study, because the necessary trial-specific estimates are not reported in the registry record. Any planning illustration should be understood as a design aid rather than as evidence of an observed treatment effect.

What is the role of outcome definitions and analysis plans?

Clear outcome definitions state what is measured, in whom, at what time, and how the result is summarized. They help distinguish a planned endpoint from other measures and make it possible to assess whether the statistical method matches the data. Here, the primary endpoint’s unit and description refer to sessions and exercises, respectively, and the record does not explain the relationship between them. The record’s timeframe refers to change between baseline and 12 weeks but does not describe a baseline value for the completion measure.

A statistical analysis plan would ordinarily clarify the target comparison, treatment of missing observations, analysis population, model, and any adjustments or multiplicity procedures. Such a plan is not reported in the registry record. It would be inappropriate to infer these details from the use of randomization, the primary endpoint title, or the presence of secondary outcomes.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("PP-based Health Behavior Intervention")
n   <- c(15)
m   <- c(8.7)
sp  <- c(4.9)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  PP-based Health Behavior Intervention  15  8.700  4.900  5.986  11.414

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 16 outcome measures and identifies secondary outcomes concerning acceptability of the exercises, immediate impact of the exercises, psychological scales, anxiety and depression scores, and a heart-failure questionnaire. It does not report numerical results for these outcomes. The record lists no analyses, and it does not report a statistical plan describing how multiple outcomes or comparisons were handled.

Multiplicity is the general issue that arises when several hypotheses or outcomes are examined: the chance of at least one apparently unusual finding can increase as the number of tests grows. Possible approaches include identifying a primary outcome in advance, adjusting inference, or treating secondary results as exploratory. The registry record does not state which approach was planned or used. The presence of several outcome measures does not establish that any correction was applied, and no such correction should be assumed.

Missing-data handling is also not reported in the registry record. The entry does not give the amount or pattern of missing outcome data, reasons for missingness, or methods for addressing it. In general, missingness can affect the interpretation of an average or group contrast if the people with observed measurements differ from those without measurements. Without information about missingness and the analysis method, the risk and direction of such influence cannot be assessed.

The analysis population is not reported in the registry record. In general, an intention-to-treat analysis aims to analyze participants according to their randomized assignment, whereas other analysis populations may apply different eligibility or adherence rules. This record does not identify an analysis population or report whether any participants were excluded from an analysis. No analysis should be attributed to the trial on the basis of the design description alone.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: flu and pneumonia (6.7%), altered mental state (6.7%), urinary tract infection (6.7%).

The safety record lists three groups: the positive psychology intervention, the motivational interviewing educational control condition, and treatment as usual. For each group, the registry lists 15 participants at risk for serious adverse events and 15 at risk for other adverse events. The serious-event affected count is 1 in each group. The other-event affected counts are 3 for the positive psychology group, 5 for the motivational interviewing group, and 1 for treatment as usual. Deaths are listed as 0 in each group.

These are descriptive registry counts. They do not show whether an event was caused by an intervention, how severe or prolonged each event was, or whether people experienced more than one event. The record does not provide event-level narratives or a statistical comparison. It would therefore be inappropriate to interpret the raw counts as evidence that one group was safer or more harmful than another.

The registry also lists “Flu and pneumonia,” “Altered mental state,” and “Urinary Tract Infection” among the top serious adverse event terms, each with a reported 6.7%. The record does not link those terms to a particular group in the information available, and it does not provide further context for their classification. These percentages should be read as registry-reported figures, not as estimates of causal risk.

Counts of people affected and counts of events are not necessarily interchangeable. The record labels affected participants, but does not describe recurrence or the counting rules in further detail. It also does not report confidence intervals or a safety analysis plan. The absence of deaths in the registry entry does not establish the absence of other risks.

13. What the Result Does, and Does Not, Mean

The registry record establishes that a randomized pilot trial was completed, describes its three study groups, and identifies feasibility as the primary endpoint. It also states the intended intervention duration and lists secondary outcomes. These details help readers understand the study’s purpose and structure, but they are not outcome findings.

The most important interpretive limitation is that numerical results for the primary endpoint are not reported in the registry record. The record does not state how many sessions or exercises participants completed on average, how variable completion was, or how the result differed across groups. It also does not report estimates or uncertainty for the secondary outcomes. The posted record therefore cannot answer whether participants completed the intervention as intended or whether measured psychological or functional outcomes changed.

Even if numerical outcome results were available, a feasibility measure would answer a different question from a clinical outcome. Completion can describe engagement with the program; it does not by itself establish a change in health behavior, symptoms, or function. Likewise, the inclusion of motivational interviewing and usual-care groups does not prove that the trial demonstrated a difference between them and the positive psychology intervention.

The adverse-event counts provide descriptive information, but do not establish causality or comparative safety. The counts do not include a reported statistical comparison or uncertainty interval, and the registry entry does not provide the context needed to interpret individual events. They should not be turned into a claim that an intervention caused or prevented an event.

Accordingly, the appropriate conclusion is limited: the record describes a completed, randomized pilot study with a feasibility-focused primary endpoint and several secondary outcomes, but numerical analyses are not reported. It does not demonstrate an effect, rule out an effect, or establish the precision of any group difference. Any stronger conclusion would require results and analysis details not reported in the registry record.

14. Why This Trial Matters Statistically

This trial is statistically informative as an example of the distinction between a study’s design and its evidence. Randomization, a parallel structure, and a named primary endpoint describe how a study is organized and what it intends to measure. They do not substitute for outcome estimates. Without numerical results, readers cannot assess the direction, magnitude, or precision of an effect.

The feasibility focus also highlights the value of defining outcomes carefully. The record describes completed exercises but gives a unit of sessions completed out of 12 sessions. It also labels the timeframe as change between baseline and 12 weeks. These descriptions leave questions about the precise construct and calculation. In general, clear definitions support reproducibility and make it easier to judge whether the selected summary is appropriate.

The three-group structure raises a further statistical distinction. A planning approach described as using equal allocation between two arms does not, by itself, explain how a three-group trial was planned or which pairwise comparison was intended. The registry record does not provide that explanation. This is not a basis for inferring a flaw in the trial; it is a limit on what can be evaluated from the record.

The listed secondary outcomes also illustrate why a prespecified analysis plan matters. When a study evaluates several outcomes, readers need to know which questions were primary, how other analyses were treated, and how missing data were handled. Those details are not reported in the registry record, and no numerical analyses are listed. The result is that the design and measurement aims can be described, but the inferential evidence cannot be appraised.

For biostatistical interpretation, the lesson is to separate protocol-level intentions from reported findings. A completed trial and a set of defined outcomes are not equivalent to a reported estimate. Transparent outcome definitions, analysis populations, missing-data methods, multiplicity handling, and uncertainty estimates are essential for moving from a study description to an interpretable statistical result.

15. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The registry record leaves several trial-specific details unclear. The primary endpoint description refers to completed exercises, while its unit refers to sessions completed out of 12 sessions. The record does not explain whether these are equivalent measures, whether both were assessed, or how completion was defined. It also describes the endpoint timeframe as change between baseline and 12 weeks without explaining how that change applies to the completion measure.

The study summary describes participants with mild to moderate heart failure, but the population field for the primary outcome is blank. Further eligibility characteristics, recruitment details, and participant characteristics are not reported in the registry record. Group-specific enrollment and the allocation ratio are also not reported, limiting assessment of how the enrolled participants were distributed among the three groups.

The masking description identifies the study as single masked but does not say who was masked. The randomization method and allocation concealment are not reported in the registry record. The intervention descriptions give broad outlines, but the complete intervention content, adherence procedures, and any criteria for defining completion are not reported.

The record does not report numerical primary or secondary outcome results, analyses, confidence intervals, p-values, baseline outcome data, or analysis populations. It does not report the amount or handling of missing data, the statistical analysis plan, multiplicity procedures, or a sample-size justification. These omissions prevent evaluation of the outcome estimates, their precision, and the methods used to produce them.

Finally, the adverse-event listing is descriptive and does not include event narratives, causality assessments, or a comparative analysis. These are limitations of the information reported in the registry record; they should not be treated as proof that the underlying study did or did not collect further information.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Researching Emotions And Cardiac Health: Phase III — NCT03220204.
• Registry record last updated 2021-08-30; status last verified 2021-08.
• Results first posted 2020-04-03.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

19. Record Summary

NCT03220204 is a completed randomized, single-masked, parallel pilot trial sponsored by Massachusetts General Hospital. The registry lists enrollment of 50, a start date of 2017-09-01, and a primary completion date of 2019-05-20. The study compared a 12-week telephone-delivered positive psychology health-behavior intervention with a motivational interviewing-based educational control condition and treatment as usual.

The primary endpoint is feasibility of the positive psychology intervention, described through completed exercises and listed in units of sessions completed out of 12 sessions. Secondary outcomes include exercise acceptability and immediate impact, psychological measures, and a heart-failure questionnaire. The record lists no analyses and does not report numerical outcome results, so no intervention-effect estimate or measure of its precision can be assessed.

Adverse-event counts are reported by group, with no deaths listed. The registry does not report further event context or a comparative safety analysis. Details about missing data, analysis populations, multiplicity, and the statistical analysis plan are not reported in the registry record.