MBCT Delivered Via Group Videoconferencing for ACS Patients With Elevated Depression Symptoms: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for MBCT Delivered Via Group Videoconferencing for ACS Patients With Elevated Depression Symptoms (NCT03878160), a non-randomized na study. The primary outcome is Number of Participants Reporting Changes After ACS.

2. Clinical Question

3. Trial Design

This was a completed, non-randomized, parallel study sponsored by Massachusetts General Hospital. The registry lists enrollment of 27 and identifies the activity as an individual interview. The study dates are 2018-07-01 for start and 2020-02-01 for primary completion. The registry does not report a phase beyond “NA.”

The stated objective was to identify ACS patients’ needs and preferences for depression treatment through individual interviews, with the aim of guiding mindfulness-based cognitive therapy (MBCT) adaptation. The interviews were also intended to identify barriers and facilitators to group videoconferencing delivery and to blood spot data collection. Participants were to discuss physical, cognitive, and behavioral symptoms that might be targeted in an intervention, as well as their views on participating in a video-conference treatment program and completing blood spot procedures.

The listed groups distinguish participants with elevated depression symptoms after a more recent or more distant ACS, and participants with a lifetime history of ACS without elevated depression symptoms. These are interview-group descriptions, not treatment assignments. The record does not describe random allocation, masking, or a treatment-control comparison; it identifies allocation as non-randomized and masking as none. Thus, the design is best read as an interview-based qualitative investigation rather than a trial estimating whether MBCT changes a clinical outcome.

The record describes a one 30-90-minute session and semi-structured telephone interviews. Three independent coders conducted qualitative thematic analysis, with results analyzed within each group. The registry record does not report recruitment procedures, the interview guide itself, coder training, how disagreements were resolved, or whether data collection continued until a specified qualitative stopping point. These details should not be inferred from the study title or the description of the analysis.

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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: We explored the different types of changes patients might experience after ACS. We analyzed the data to identify the common themes regarding changes after ACS. We report the identified themes and the number of participants who expressed each theme.

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: Participants were healthy volunteers with a lifetime history of an acute coronary syndrome (ACS; e.g., MI, unstable angina).

6. Primary Endpoint

The registry lists the primary outcome as Number of Participants Reporting Changes After ACS, measured over one 30-90-minute session.

The primary outcome is the number of participants reporting changes after ACS. Its stated purpose is to characterize the kinds of changes patients describe, including psychosocial and health behavior changes. Rather than defining a single clinical event or a numerical score change, the outcome is based on themes identified through interviews; the count for a theme is the number of participants who endorsed it.

This approach is useful for an exploratory question about what experiences may matter to patients. Qualitative themes can organize varied accounts into recognizable topics, while participant counts indicate how many interviewees expressed each theme. Those counts describe the interview group and the coding framework; they are not, by themselves, estimates of how common a change is among all people with ACS. Such interpretation would require information about recruitment, sampling, and representativeness that the registry record does not report.

The registered interview description says that three independent coders conducted thematic analysis and that findings were analyzed within each group. However, the registry record does not report the theme names, the number of participants endorsing each theme, or other primary-outcome results. It therefore documents what the endpoint was designed to capture, but does not permit a reader to assess which changes were identified or how frequently interviewees mentioned them.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The methods should be interpreted in light of the question being asked. This record describes individual, semi-structured interviews followed by qualitative thematic analysis. It does not describe a randomized efficacy comparison. General statistical concepts can help distinguish what the design can address from what it cannot: a randomized comparison is commonly used to estimate differences between assigned interventions, whereas qualitative interviews are used to elicit experiences, explanations, and preferences. The record’s stated objective belongs to the latter category.

What thematic analysis contributes

Thematic analysis organizes interview material into recurring ideas or topics. In this study, the stated primary outcome is the number of participants who endorsed each identified theme. A count makes the reporting more concrete than a list of themes alone, but it still depends on how the theme is defined and how interview material is coded. The registry says that three independent coders conducted the analysis. It does not report the coding framework, the process for combining or separating themes, how disagreements were handled, or any measure of agreement. Those details cannot be assumed.

Counts of endorsements can describe the interview participants’ accounts, but they do not automatically function like rates from a population survey. For that broader interpretation, readers would need information about how participants were approached, who took part or declined, and how closely the interviewed group reflects the population of interest. The registry record does not report those details. A theme mentioned by many interviewees may be important to understand, but the count alone does not demonstrate that it is common among all ACS patients.

Why the design does not support a treatment-effect estimate

Random allocation is a design method used to make treatment groups comparable, on average, for estimating the effect of assigned treatments. This record identifies allocation as non-randomized and lists individual interviews as the intervention. Its groups are defined by ACS history and depression-symptom status, not by assignment to MBCT or a control treatment. As a result, a difference between those groups, even if group-specific findings were reported, would not by itself isolate a treatment effect. The record also identifies no masking.

The parallel model describes the registered study structure, but it should not be taken to mean that the interview groups form a controlled experiment. The registry explicitly cautions that the arms are not a like-for-like control comparison. The stated objective is to inform an adaptation and feasibility questions, while the primary outcome concerns themes about changes after ACS. There is no registered basis in the reported information for interpreting this record as a test of whether a therapy improves depression or another health outcome.

Outcome measures and analysis reporting

The registry lists 14 outcome measures, including the Five Factor Mindfulness Questionnaire- 15 Item, Perceived Stress Scale-4, Positive Affect Negative Affect Schedule, Rumination Response Scale, Self-Other Four Immeasurables Scale, Interpersonal Reactivity Index, Medical Outcomes Study - Specific Adherence Scale, and Patient Health Questionnaire-9. These names indicate the constructs the record associates with secondary outcomes. They do not provide values, directions of change, or evidence that an analysis was performed. The registry records 0 analyses, and it does not report statistical estimates or uncertainty for these measures.

General statistical interpretation distinguishes an estimate from its precision. A confidence interval, when reported, represents a range of values compatible with the data under the method used and conveys uncertainty around an estimate. No confidence intervals or effect estimates for the primary outcome are reported in the registry record. Because the primary endpoint is a set of theme counts, there is also no basis for inventing an interval, a test statistic, or a p-value. The absence of reported inferential statistics does not mean that a result is statistically null; it means the registry record does not present such a result.

Planning illustrations are not observed findings

The planning description says that sample-size illustrations use the observed effect, a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the detectable effect stated as a fraction of the observed effect. It also distinguishes total events for time-to-event settings from participants per arm for other settings. These are general planning assumptions, not evidence that this interview study used that design or allocation. The record does not report the numerical observed effect or numerical planning results alongside those assumptions. Any sample-size illustration should be understood as planning context, not as an observed outcome or observed power.

In general, a planning calculation asks how much information a proposed study might need under specified assumptions. Its answer depends on the assumed effect, variability, allocation, significance threshold, and analysis method. If those assumptions do not match a future study, the illustration may not transfer. For this record, the stated two-arm equal-allocation assumption should not be confused with the non-randomized interview groups. Sample-size planning cannot recover missing qualitative themes or establish the feasibility of a video-conference treatment program.

What cannot be reconstructed

The registry record does not report an analysis plan, a sample-size justification for the interview study, interim analyses, handling of incomplete interviews or missing questionnaire data, or defined analysis populations. It also does not report whether secondary measures were summarized descriptively or tested inferentially. General statistical practice may involve prespecifying these choices, but their use in this study cannot be claimed without documentation. Readers should rely on the study details and results that the registry actually records, and treat unreported analytic choices as unknown rather than filling them in by convention.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 14 outcome measures, with named secondary measures covering mindfulness, perceived stress, positive and negative affect, rumination, self-other responses, empathy-related responses, adherence, and depression symptoms. Having multiple outcomes raises a general multiplicity issue: when many statistical tests are conducted, the chance of at least one apparently noteworthy result can increase. Researchers may address this through prespecified priorities or statistical adjustments, but the registry record does not report a multiplicity strategy. It also records 0 analyses, so no adjustment or inferential result can be assessed from the posted record.

The primary outcome is qualitative in form: the number of participants endorsing each theme. The record does not report theme counts, nor does it explain whether a hierarchy of themes or a threshold for reporting was prespecified. It states that findings were analyzed within each group, but does not give group-specific results. No claim about consistency across groups or selective reporting can be made from the information recorded.

Missing-data handling and analysis populations are also not reported in the registry record. The entry does not say whether all enrolled participants completed interviews, how incomplete interviews were treated, or whether the secondary measures had missing responses. It does not define a population for any quantitative analysis. The overall enrollment of 27 should not be assumed to be the denominator for every outcome, especially because the adverse-event entries list group-level at-risk figures that the record does not reconcile with enrollment.

These omissions do not establish that a particular method was or was not used. They limit what can be checked and how completely the results can be interpreted. For a qualitative endpoint, access to theme definitions and participant counts would be needed to evaluate the reported content; for quantitative measures, outcome values, analysis populations, missingness information, and analytic methods would be needed to assess estimates and their precision.

11. 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.

The adverse-event record lists three groups: participants with elevated depression symptoms whose ACS occurred within the past 2 years, participants with elevated symptoms whose ACS occurred more than 2 years ago, and participants with a lifetime ACS history without elevated symptoms. For each group, the record lists 23 participants at risk, 0 serious adverse events, 0 other adverse events, and 0 deaths.

These are the posted group-level counts, not evidence that the study compared safety between treatments. The registered activity was an individual interview, and the record does not describe treatment assignment to MBCT. The groups are not identified as randomized safety arms. The enrollment entry is 27, while each adverse-event group lists 23 at risk; the registry record does not explain the relationship between these figures. They should not be added together or treated as disjoint groups without clarification.

A zero count means that no events of that category are listed in the registry entry for the stated group. It does not, on its own, show how events were solicited, the period covered, or whether all participants contributed complete safety information. The registry record does not report those details. Therefore, the figures are best read narrowly as reported counts, not as proof that an interview or any future treatment approach is risk-free.

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

The record documents a qualitative study intended to learn about experiences after ACS and preferences relevant to depression-treatment adaptation. Its stated questions include what physical, cognitive, and behavioral symptoms participants might want addressed, what could hinder or support participation in group videoconferencing, and what could hinder or support blood spot data collection. This information could be relevant to designing later research, but the registry record does not report the interview themes or participant counts needed to describe what was learned.

The study does not, as registered, provide an estimate of the effect of MBCT. The listed intervention is an individual interview, and the study is non-randomized. There is no treatment-control contrast from which to infer whether MBCT changed depression symptoms, stress, mindfulness, adherence, or another outcome. The listed secondary measures are not accompanied by numerical results in the registry record. Consequently, neither benefit nor lack of benefit can be concluded from these entries.

The primary outcome’s intended counts would answer a descriptive question about how many interview participants endorsed each coded theme. Even if those counts were available, they would not automatically tell readers how prevalent each experience is among all people with ACS. That broader claim would depend on recruitment and sampling context, which is not reported. Theme counts also do not establish cause: participants’ accounts of changes after ACS are reports of experience, not in themselves evidence that ACS caused every reported change.

The record’s completion status and enrollment entry are study-description details, not substitutes for outcome reporting. Likewise, zero adverse-event entries are narrow registry counts, not a general safety guarantee. The evidence that can be stated is therefore about the study’s purpose, interview design, and intended analysis. Claims about specific themes, treatment acceptability, feasibility findings, or clinical effects go beyond what the posted record reports.

13. Why This Trial Matters Statistically

Statistically, this study illustrates why the research question and the registered design must be read together. A title can foreground a proposed treatment approach, while the registered activity and outcome show that the work is exploratory and interview-based. Here, the individual interviews were intended to inform MBCT adaptation and to explore barriers and facilitators to group videoconferencing and blood spot procedures. They were not a randomized evaluation of treatment efficacy.

The primary endpoint also shows the value and limits of descriptive counts in qualitative research. Counting how many participants endorse a theme can help communicate whether an idea recurred in interview accounts. But the meaning of a count depends on transparent theme definitions, coding procedures, and an understandable denominator. The registry reports the use of three independent coders and within-group thematic analysis, yet does not report the themes or counts. That gap prevents readers from seeing the substantive findings or evaluating how the counts were interpreted.

The record also highlights a general distinction between outcomes named in a registry and results actually reported. It names multiple secondary measures, but lists 0 analyses and presents no numerical results for them. Outcome names alone cannot support claims about direction, magnitude, or precision. Similarly, planning assumptions do not turn into observed evidence, and a sample-size illustration is not observed power.

Finally, the different enrollment and adverse-event entries make denominator clarity important. Enrollment is recorded as 27, while each group’s safety entry lists 23 at risk. Without a registry explanation of how those figures relate, readers should preserve that uncertainty rather than infer group membership or totals. Clear reporting of participant flow, theme counts, outcome results, and analysis methods would make the study’s contribution easier to assess. The existing record still makes the intended research purpose and its non-randomized interview design identifiable.

14. 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 primary limitation for interpreting results is that the registry record does not report the primary findings. It describes thematic analysis and the intended count of participants endorsing each theme, but gives neither theme names nor counts. The reader therefore cannot assess the content, frequency, or distribution of reported changes after ACS.

The record is also limited in its description of qualitative procedures. It states that three independent coders conducted thematic analysis, but does not report how themes were generated, defined, or consolidated; how disagreements were resolved; or whether coder agreement was assessed. Recruitment, participation, and interview completion details are not reported, limiting assessment of whose perspectives are represented. The one 30-90-minute session and telephone format are described, but the registry does not report the interview guide or how interviews were conducted in practice.

The group descriptions distinguish ACS timing and depression-symptom status, but the record does not give group-specific enrollment or primary-outcome results. The overall enrollment is 27, while adverse-event entries list 23 at risk for each group; the relationship is unexplained. This makes it inappropriate to infer participant overlap, group composition, or outcome denominators.

There are no reported numerical results for the listed secondary measures, and the registry records 0 analyses. Analysis populations, missing-data handling, multiplicity procedures, and a statistical analysis plan are not reported. The record also does not report a sample-size justification for the qualitative study. These limitations concern what can be verified from the registry; they do not establish that a particular procedure was absent from the research itself.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: MBCT Delivered Via Group Videoconferencing for ACS Patients With Elevated Depression Symptoms — NCT03878160.
• Registry record last updated 2021-06-04; status last verified 2021-05.
• Results first posted 2021-06-04.
• 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.

18. Record Summary

The registry describes a completed, non-randomized, parallel study sponsored by Massachusetts General Hospital, with enrollment of 27. The study began 2018-07-01 and reached primary completion on 2020-02-01. Its registered intervention was an individual telephone interview using a semi-structured guide, not delivery of MBCT as a treatment assignment.

The objective was to explore changes after ACS and patients’ needs and preferences relevant to adapting depression treatment, group videoconferencing, and blood spot data collection. Three independent coders conducted thematic analysis, with results analyzed within each group. The primary outcome was intended to count participants endorsing each theme, but the themes and counts are not reported in the registry record. The record lists 14 outcome measures and 0 analyses; it does not provide numerical results for the primary or secondary outcomes.

Safety entries list 0 serious adverse events, 0 other adverse events, and 0 deaths in each of three groups, with 23 at risk listed for each group. The relationship of those entries to overall enrollment is not explained. The record supports a description of the study’s aims and design, but not conclusions about specific interview findings or treatment effects.