Development and Preliminary Trial of a Brief, Portable Health Intervention for Rural Sexual Minority Emerging Adults: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Development and Preliminary Trial of a Brief, Portable Health Intervention for Rural Sexual Minority Emerging Adults (NCT03751020), a randomized na study. The primary outcome is Change in Depression..

2. Clinical Question

This is a feasibility-oriented preliminary trial, not a registry record with a reported estimate of how the groups differed in depression. Its listed primary outcome is a continuous score from the Center for Epidemiological Studies -- Depression Scale (CESD). The outcome description identifies the time points and how the scale score is formed, but does not provide group means, changes, or a comparison estimate.

The clinical question therefore has two parts that should not be conflated. The stated purpose concerns whether tailored writing interventions can be tested for feasibility in this population and whether they are aimed at outcomes including depression, suicidality, substance abuse, and HIV risk behaviors. The primary outcome is a depression measure. The registry record does not give a feasibility result or a treatment-effect result, so neither can be concluded from the posted information.

3. Trial Design

The registry record describes a randomized, double-masked, parallel-group study. It lists three behavioral or writing conditions: expressive writing, self-affirmation, and control. Enrollment is reported as 108, and the study status is completed. The phase is listed as not applicable. Yale University is named as the sponsor.

The interventions differ in the writing task. Expressive writing prompts participants to write about personally stressful events, with the stated rationale that this may enable cognitive processing of unresolved psychological and physiological stressors. Self-affirmation prompts participants to write advice for a hypothetical person with a similarly stigmatized identity about coping with stigma-related stress. The control activity is a neutral account of what participants had done since waking that morning, completed for 20 minutes across 3 consecutive days.

The registry lists depression, suicidality, substance abuse, HIV, and minority stress among the conditions. It also lists secondary outcomes covering self-injury, rumination, perceived support, hopelessness, LGB identity, change in cortisol, change in stress, and change in impulsiveness total score. The record reports 30 outcome measures and 6 analyses, but does not explain how each measure was assigned to an analysis or how all outcomes were handled statistically.

The primary outcome description specifies baseline, post intervention (day 5), and 3 months as assessment times. The record does not report the allocation ratio, the method used to generate or conceal random assignments, or what double masking meant in practice for participants, intervention staff, or outcome assessors. These details should not be inferred from the design labels alone. The record also does not report protocol details beyond the intervention descriptions, nor a sample-size justification for the original trial.

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.

Before assignment: Participants completed a brief online survey to confirm eligibility, defined as: age 18 -29; identifying as sexual minority; currently living in one of the eligible counties; and having daily personal Internet access. Participants emailed a photo of an identification card(e.g. a driver's license), as proof of age. 108 people were randomized.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Data were analyzed intention to treat.

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.

6. Primary Endpoint

The registry lists the primary outcome as Change in Depression., measured over Baseline, Post Intervention (day 5), and 3 Months..

The primary endpoint is change in depression, measured with the Center for Epidemiological Studies -- Depression Scale (CESD). The registry describes an overall score based on 20 items. Items 3, 11, 14, and 16 are reversed. If some items are unanswered, the record says the score is computed by multiplying the sum of answered items by the number of items on the scale divided by the number actually answered.

The CESD score ranges from 0-60, with higher scores indicating more depressive symptomatology during the past week. The endpoint is expressed in units on a scale, and its summary parameter is the mean, with standard deviation as the dispersion measure. This makes the outcome continuous: its values can be described by a group average and the spread of scores around that average.

Measuring the outcome at baseline and after the intervention, as well as at 3 months, allows assessment of depression at the stated follow-up points. In general, repeated assessment can describe how scores change over time, but the registry record does not report the model or comparison used to analyze these time points. Nor does it give the observed scores or changes. The outcome’s name and measurement schedule establish what was intended to be measured; they do not establish whether either writing intervention changed depression.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a randomized, double-masked, parallel-group design and identifies the CESD mean as the primary outcome summary. It does not report the statistical model used for the primary comparison. The design description and outcome definition therefore permit an explanation of the concepts involved, but not a reconstruction of the sponsor’s analysis.

What a mean represents

General explanation: for a continuous outcome, the mean is the arithmetic average of participant scores in a group. It gives a concise description of the group’s typical score, while the standard deviation describes how spread out individual scores are around that average. Neither statistic alone describes the uncertainty in a comparison between groups. The registry identifies mean and standard deviation as the intended summary, but does not post the observed values.

What change over time can mean

The CESD was scheduled at baseline, post intervention (day 5), and 3 months. General explanation: a change score describes the difference between measurements taken at separate times for the same outcome. A comparison can focus on changes within groups, differences between groups at a follow-up time, or a modeled contrast across time. Those approaches answer related but not identical questions. The registry record does not say which approach was used, so no particular change model or group contrast should be attributed to this trial.

How to interpret a confidence interval

General explanation: a confidence interval describes statistical uncertainty around an estimated effect under the assumptions of the analysis. A narrower interval indicates greater precision, while a wider interval indicates more uncertainty. The interval must be read with the estimate and the outcome scale; it does not by itself establish clinical importance. No confidence interval for the primary outcome is reported in the registry record, so the precision of a depression comparison cannot be evaluated.

What a p-value can and cannot say

General explanation: a p-value measures how compatible observed data are with a specified null hypothesis and statistical model. It is not the probability that the null hypothesis is true, and it does not measure effect size. Interpretation also depends on the analysis plan and the number of outcomes and comparisons considered. No primary-outcome p-value is reported in the registry record.

Why variation and model choice matter

General explanation: continuous scores can vary substantially among individuals. A model’s assumptions about that variation, repeated measurements, and the relation among observations can affect estimates and uncertainty. Over-dispersion is a concern when the variability in data is greater than a model expects; accounting for it can prevent uncertainty from being understated. The registry describes a continuous CESD measure but does not report a model, diagnostics, or an over-dispersion assessment. This means those choices cannot be evaluated for the trial.

How to read planning illustrations

General explanation: a sample-size calculation estimates the number of participants needed under specified assumptions about an effect, variability, allocation, significance level, and desired power. A planning illustration based on an observed effect is not the same as the trial’s original design justification. It is also not observed power, which does not provide a useful substitute for examining the estimated effect and its uncertainty. The registry record does not report the trial’s own sample-size justification. Any planning illustration should therefore be read as conditional on its stated assumptions, rather than as proof that the study was adequately powered or that an effect was present.

The record states that its planning assumptions use a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. These are calculation assumptions, not evidence about the original protocol. The record does not identify an interim-analysis plan, and none should be inferred.

10. Multiplicity, Missing Data and Analysis Populations

The record lists 30 outcome measures and 6 analyses. It does not report a multiplicity adjustment, a hierarchy of outcomes, or which comparisons were designated primary beyond naming change in depression as the primary outcome. When many outcomes or comparisons are examined, the chance of at least one apparently unusual result can increase. General explanation: a prespecified testing strategy or an adjustment can help control that risk. Without the registry’s analysis details or posted results, it is not possible to determine how multiplicity was addressed or to interpret any secondary finding in that context.

The primary outcome description says that the data were analyzed intention to treat. The registry does not explain the operational definition of that population or report how many participants had usable measurements at each time point. It also does not report whether participants with missing follow-up scores were included through imputation, a likelihood-based model, or another method. The endpoint description does specify an item-level procedure for an incomplete CESD questionnaire: the sum of answered items is scaled by the number of items on the scale divided by the number answered. That rule concerns missing items within a scale, not missing visits or participant-level outcome data.

General explanation: missing data can affect both the composition of the analyzed sample and the uncertainty of an estimated effect. The implications depend on why observations are missing and on the assumptions made by the analysis. The registry does not report missingness by group, reasons for missing data, sensitivity analyses, or a fuller missing-data strategy. These omissions limit assessment of whether the stated intention-to-treat analysis preserved the planned comparison and how robust any estimate would be. No estimate is posted to assess in the first place.

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 registry’s adverse-event information lists Control, Expressive Writing (EW), and Self-Affirmation (SA) as the groups. For each group, the record lists 36 participants at risk for serious adverse events and 0 serious adverse events. It also lists 36 at risk for other adverse events and 0 other adverse events in each group. Deaths are listed as 0 in each group, and no serious adverse-event terms are listed.

These are the posted counts, not proof that no adverse experiences occurred outside the registry’s reporting definitions or observation process. The record does not explain the event-collection procedures, observation period for safety reporting, or criteria used to classify events. The group counts in this safety listing should not be treated as a complete account of trial follow-up or as an explanation of the enrollment allocation.

General explanation: zero events in a recorded dataset do not establish zero underlying risk. Interpretation depends on the number observed, the completeness of surveillance, and how events were defined and reported. The registry information supports a narrow description of the listed counts only. It does not support broader conclusions about safety.

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

The registry record documents a completed randomized trial of writing activities tailored to rural sexual minority emerging adults. It describes expressive writing, self-affirmation, and a control writing task, and identifies change in CESD depression score as the primary outcome. It also gives the intended assessment times and the scale’s scoring description. These details clarify what the trial set out to study.

The record does not report the primary outcome results. Therefore, it cannot establish the size or direction of a difference in depression between groups, or how precise such a difference might be. No conclusion about whether either intervention changed depression can be drawn from the registry information. The absence of posted results in this record is not evidence that the groups were the same; it means the relevant estimates are unavailable for interpretation.

The stated purpose includes testing feasibility and targeting outcomes beyond depression, including suicidality, substance abuse, and HIV risk behaviors. A list of outcomes is not a report of findings. The registry does not report feasibility findings or results for the listed secondary outcomes. Nor does the record describe the analysis well enough to assess outcome multiplicity, missing follow-up data, or the robustness of an estimate.

General explanation: a randomized design can support a comparative estimate when the analysis, outcome data, and uncertainty are reported. The design label alone does not provide that estimate. Enrollment, completion status, and the adverse-event counts are relevant descriptions of the study record, but they do not fill the gap in primary-outcome results. The appropriate conclusion is about what was documented: the trial was designed to examine these writing approaches and depression was the named primary endpoint, while comparative outcome findings are not reported in the registry record.

13. Why This Trial Matters Statistically

Statistically, this trial is notable for focusing on a defined population and contrasting two distinct writing approaches with a control writing activity. Its primary measure is a continuous depression score, specified at baseline, post intervention (day 5), and 3 months. Those features make clear the intended outcome and follow-up schedule, while the randomized parallel-group design indicates a comparative trial structure.

The record also illustrates why design information and results information must be distinguished. Randomization, masking, enrollment, and an explicitly defined outcome provide context for interpreting a trial, but they are not substitutes for group estimates and their uncertainty. Because the primary outcome results are not reported, readers cannot assess the magnitude, precision, or direction of a depression comparison. The record’s completed status does not resolve that statistical limitation.

The stated feasibility purpose is also important to interpretation. A preliminary trial can be designed to assess whether an intervention can be developed and tested in a particular population, while also measuring clinical outcomes. The registry description names both the feasibility aim and outcome targets, but does not post feasibility findings. That distinction prevents a planned aim from being mistaken for an observed result.

Finally, the record lists many outcome measures and analyses without explaining the multiplicity strategy, missing-data approach, or primary model. Those details matter because statistical conclusions depend not just on the endpoint definition but also on how comparisons are specified and uncertainty is estimated. The record is useful for identifying the intended question, but it does not contain enough results or analysis detail to judge an intervention effect.

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 most direct limitation is that the registry record does not report numerical results for the primary depression outcome. No group-level CESD summaries, comparative estimates, uncertainty intervals, or p-values are available in the record. This prevents assessment of effect magnitude, direction, and precision.

The record does not describe the primary statistical model, the planned contrast among groups, or how the measurements at baseline, post intervention (day 5), and 3 months were incorporated. It also does not report whether the analysis adjusted for baseline scores or used another approach. Such methods should not be assumed from the randomized design or from the term intention to treat.

Important implementation details are not reported in the registry record, including the allocation ratio, randomization and concealment procedures, and the practical meaning of double masking. The record gives an item-level CESD scoring rule for unanswered questions, but does not report missing follow-up by group, reasons for missingness, or the method used to address missing outcome assessments. These limits make it difficult to evaluate risk of bias in outcome measurement and analysis.

The record lists 30 outcome measures and 6 analyses but does not provide a complete account of the analysis plan or any multiplicity strategy. It also does not report the trial’s sample-size justification, protocol-specific interim analyses, or results for the secondary outcomes. The listed adverse-event counts lack detail about collection and classification procedures. These gaps restrict interpretation to the study’s stated design, interventions, outcome definitions, and recorded counts, rather than supporting conclusions about efficacy, feasibility, or safety.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Development and Preliminary Trial of a Brief, Portable Health Intervention for Rural Sexual Minority Emerging Adults — NCT03751020.
• Registry record last updated 2020-08-28; status last verified 2020-08.
• Results first posted 2020-08-28.
• 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

NCT03751020 is a completed randomized, double-masked, parallel-group preliminary trial sponsored by Yale University. The registry reports enrollment of 108 and lists expressive writing, self-affirmation, and control writing activities for rural sexual minority emerging adults. The stated study purpose was to test feasibility of writing interventions designed for LGB emerging adults and aimed at outcomes including depression, suicidality, substance abuse, and HIV risk behaviors.

Change in depression was the primary outcome, measured with the CESD at baseline, post intervention (day 5), and 3 months. The record describes its scoring and reports intention-to-treat analysis, but does not report primary-outcome findings, the analysis model, or a sample-size justification. It lists 30 outcome measures and 6 analyses. Its adverse-event listing records 0 serious adverse events, 0 other adverse events, and 0 deaths in each group.