Harnessing Mobile Technology to Reduce Mental Health Disorders in College Populations: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Harnessing Mobile Technology to Reduce Mental Health Disorders in College Populations (NCT04162847), a randomized na study. The primary outcome is Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing the Number of Individuals With Mental Health Disorders..

2. Clinical Question

3. Trial Design

This was a randomized, parallel-group trial with no masking. The registry record lists enrollment of 6205 and identifies Washington University School of Medicine as the sponsor. The trial is marked completed. Its start date is 2019-10-07, and the primary completion date is 2023-12-31. The phase is listed as NA.

Participants were assigned to either the Mobile Coached Intervention or Referral to Counseling Center group. The mobile intervention group was to have access to the platform for 6 months, while the referral group was to receive information on making an appointment at its counseling center and encouragement to do so. Random allocation helps make groups comparable on average at the point of assignment, but the record does not describe the allocation sequence or concealment procedures. The trial was unmasked, so participants and relevant study personnel were not masked to group assignment according to the registry entry.

The primary outcome description identifies assessments at baseline, 6 weeks, 6 months, and 2 years, and specifies 2 years as the primary endpoint. It describes a positive screen for at least one of anxiety, depression, or an eating disorder as the clinical-case outcome. Ten outcome measures and 25 analyses are listed in the registry record, alongside secondary outcomes concerning treatment received on the platform, disorder-specific symptoms, quality of life, and functioning.

The record does not report the detailed protocol, eligibility criteria, allocation implementation, adherence, crossover, or the statistical analysis plan. It also does not explain the trial-specific sample-size justification. The stated enrollment is not, on its own, evidence about the precision or strength of an unreported treatment comparison.

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:

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 Effectiveness of the Mobile Mental Health Platform, Compared to Usual Care, in Changing the Number of Individuals With Mental Health Disorders., measured over baseline, 6 weeks, 6 months, and 2 years.

The primary endpoint concerns the number of participants who meet the registry’s definition of a clinical case: a positive screen for at least one of anxiety, depression, or an eating disorder. The description says this measure is intended to reflect the number of individuals with mental health disorders and to assess whether the mobile platform changes that number compared with usual care. It names separate screening instruments for generalized anxiety disorder, social anxiety disorder, panic disorder, depression, and eating disorders: GAD-Q-IV, SPDQ, PDSR, PHQ-9, and the Stanford-Washington University Eating Disorders Screen.

The primary endpoint is at 2 years. Assessments are also specified at baseline, 6 weeks, and 6 months, and the description says the outcome is assessed at 6 months and 2 years. A multi-condition screen can capture the presence of any targeted condition rather than focusing on one diagnosis alone. As a general statistical point, a binary clinical-case outcome simplifies each participant’s status to positive or not positive under the specified screening definition; it does not, by itself, describe symptom severity, service use, or changes in a particular disorder.

The registry record does not report the observed endpoint counts, group comparison, uncertainty interval, or analysis method. It therefore does not establish whether the groups differed at the primary endpoint, or how precisely any difference was estimated.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The record identifies randomization, no masking, and a parallel-group design. These features describe how the study was structured, but do not fully specify its statistical methods. The statistical analysis plan, the model used for the primary endpoint, the contrast definition, and the method for combining or comparing repeated assessment times are not reported in the registry record.

What randomization contributes

General statistical explanation: Random assignment is intended to distribute measured and unmeasured participant characteristics across groups by chance. This makes a between-group comparison a reasonable way to estimate the effect of assignment, provided outcome ascertainment and analysis are appropriate. Randomization does not guarantee identical groups in a particular trial, and it does not ensure that every randomized participant has an observed endpoint. The registry entry does not report the allocation sequence, concealment procedures, or baseline results needed to describe these features in detail.

What the endpoint represents

The primary outcome is a count of participants meeting a binary screening definition: a positive screen for at least one of anxiety, depression, or an eating disorder. The endpoint is described at multiple assessment times, with the primary endpoint designated at 2 years. General statistical explanation: A count or proportion for a binary outcome can be compared across groups using a range of methods. The method matters because it determines the effect measure, the way repeated observations are handled, and the assumptions used to quantify uncertainty. The registry record does not name the method used for this outcome, so a particular model or effect measure should not be presumed.

How to read uncertainty

General statistical explanation: An uncertainty interval describes a range of effect values compatible with the data and the statistical model. Its width conveys precision, while its location helps show the direction and size of an estimated contrast. A p-value, if reported, addresses compatibility with a specified null hypothesis under the assumptions of the test; it does not measure the probability that the null hypothesis is true or the practical importance of an effect. No primary effect estimate, confidence interval, or p-value is reported in the registry record.

Repeated measurements and analysis choices

Measurements are scheduled at baseline, 6 weeks, 6 months, and 2 years. General statistical explanation: When outcomes are recorded repeatedly for the same participants, those measurements are related rather than independent. An analysis may account for this dependence, focus on a prespecified time point, or use another planned summary. The appropriate approach depends on the protocol and estimand. The registry record identifies the primary time point but does not state how repeated observations were incorporated, whether baseline values were used for adjustment, or how the other time points were treated in the primary analysis.

The outcome is based on several named screening instruments, each associated with a disorder category. The registry description does not report screening thresholds, rules for incomplete instruments, or the operational details used to combine these measures into the clinical-case outcome. Those details matter for reproducibility and for understanding exactly which participant records count as positive.

Planning assumptions are not results

The record describes a sample-size planning illustration using a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is described as a stated fraction of the observed effect. It also notes that non-time-to-event planning quantities are expressed as participants per arm, while time-to-event quantities use total events. General statistical explanation: Planning calculations explore what sample size could be required under stated assumptions; their interpretation depends on the assumed effect and other design choices. They are not observed power, and they do not show whether the trial’s actual result was statistically significant. The trial-specific sample-size justification is not reported in the registry record, and the primary effect estimate needed to interpret an observed-effect-based illustration is not reported.

Over-dispersion and model fit

General statistical explanation: For count outcomes, over-dispersion means that observed variability is greater than a simple model assumes. If present and ignored, standard errors and uncertainty intervals can be misleading. The primary outcome is described as a count of participants, but the registry record does not report a dispersion estimate, the fitted model, or an assessment of model fit. No conclusion about over-dispersion or its handling can therefore be drawn from the entry.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 10 outcome measures and 25 analyses. Its primary outcome description includes several assessment times, and the secondary outcomes cover treatment received on the mobile platform, disorder-specific symptoms, quality of life, and functioning. Multiple outcomes, time points, and analyses create opportunities for selectively emphasizing results if the analysis plan is not prespecified and reported transparently.

The registry record does not report whether the investigators used a multiplicity adjustment, a hierarchy of hypotheses, or a prespecified distinction between confirmatory and exploratory analyses. The number of listed analyses alone does not reveal how many hypotheses were tested, which analyses were primary, or how the risk of false-positive findings was addressed. It would be inappropriate to assume either that an adjustment was used or that none was used.

Missing-data handling is not reported in the registry record. The entry does not describe how participants with missing endpoint assessments were treated, whether reasons for missingness were recorded, or whether sensitivity analyses were planned. This is important because outcome availability at the primary 2-year assessment may affect which participants contribute to an estimate and how representative that estimate is.

The analysis populations are also not reported. In particular, the registry entry does not state whether the primary analysis followed randomized assignment for all participants, included only participants with available outcomes, or used another population definition. The reported enrollment and safety at-risk counts do not identify the population used for efficacy analyses. Without the analysis plan, missingness information, and endpoint results, the robustness of any treatment comparison cannot be evaluated.

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 5% reporting threshold.

The registry lists zero serious adverse events and zero deaths in both groups. It also lists zero other adverse events in both groups. The recorded at-risk counts are 3103 for the Mobile Coached Intervention group and 3102 for the Referral to Counseling Center group. The registry entry does not provide serious adverse event terms; none are listed among the top serious terms.

These are registry-recorded event figures, not a complete narrative of safety monitoring. The entry does not describe event definitions, collection procedures, observation duration for safety outcomes, or whether events were reviewed for possible relation to the intervention. It also does not provide comparative estimates or uncertainty intervals.

General statistical explanation: When no events are recorded, a relative comparison based on observed events may be uninformative, and the data cannot establish that the true event risk is zero. A zero count can reflect no events during the observed period, incomplete ascertainment, or the limits of the recorded safety information. The registry figures should therefore be read as no events reported in these categories, not as proof that the intervention has no risks or that safety is equivalent between groups.

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

The registry record establishes the broad question and design: a randomized, unmasked, parallel-group comparison of a mobile coached intervention with referral to a counseling center. It describes a primary outcome based on screening positive for at least one of anxiety, depression, or an eating disorder, with the primary endpoint at 2 years. These details clarify what the trial set out to evaluate.

The record does not report the primary outcome results. It therefore cannot establish whether the mobile intervention group had a different number of clinical cases from the referral group, nor how large or precise a difference might be. Lack of a posted estimate is not evidence that the groups were the same, just as the design description alone is not evidence that the intervention changed outcomes.

The outcome is based on screening instruments and a combined positive-screen definition. General statistical explanation: Screening status is a defined measurement, not a complete account of an individual’s mental health, experience, or care. A change in the count meeting this definition would need to be interpreted in light of the screening rules, the time point, missing observations, and any uncertainty around the estimate. The registry entry does not report these results or analytic details.

The safety entries record zero serious adverse events, zero other adverse events, and zero deaths in both groups. This limited registry summary does not establish that no events occurred outside the recorded categories or observation process. It also does not provide enough information for a comparative safety estimate.

Consequently, the registry record supports a description of the trial’s planned comparison, not a conclusion about effectiveness, equivalence, or the size of any benefit or harm. Evaluating the result would require outcome data by group, an effect estimate and its uncertainty, and information about missing data and analysis choices.

13. Why This Trial Matters Statistically

Statistically, the trial addresses a broad outcome: a positive screen for at least one of anxiety, depression, or an eating disorder. That combined definition reflects a transdiagnostic question rather than a question about only one condition. It also makes clear why the outcome definition and the method used to combine screening results matter when interpreting a comparison.

The assessment schedule spans baseline, 6 weeks, 6 months, and 2 years, with the 2-year endpoint designated as primary. Repeated assessments can describe outcomes over time, but require clear specification of which comparison is primary and how observations from the same participants are handled. The registry record identifies the primary time point without reporting the corresponding analysis method or result.

The comparison also places a mobile intervention against a referral process, rather than describing the comparator as no care. The registry entry says the referral group would receive information about making an appointment at its counseling center and encouragement to do so. It does not report what care participants actually received, so the degree of separation between groups cannot be assessed from the record.

Finally, the registry lists multiple outcome measures and analyses, while leaving the analysis plan, missing-data approach, and multiplicity procedures unreported. These details affect how confidently readers can interpret any eventual findings. The importance of the trial’s statistical question is therefore paired with a need for transparent reporting of endpoint results and analysis decisions.

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.

Several trial-specific details needed to interpret the comparison are not reported in the registry record. Eligibility criteria and a fuller description of the enrolled college population are absent, so the population to which results might apply cannot be characterized from this entry alone. The mobile intervention description is incomplete regarding what participants could select when screening positive for multiple disorders.

The primary outcome combines positive screens across anxiety, depression, and eating disorders and refers to several different instruments. The registry description does not state the screening thresholds, how incomplete measures were handled, or precisely how results across instruments were combined. The primary endpoint is designated at 2 years, but no endpoint results or group-specific counts are reported.

The record does not describe intervention engagement, adherence, use of counseling services, crossover, or other care received by participants. Thus, the assigned comparison is clear at a broad level, but the extent to which participants’ actual experiences differed is not. Allocation procedures beyond the randomized designation, baseline characteristics, and analysis populations are also not reported.

The statistical analysis plan, missing-data approach, and multiplicity procedures are not reported. With 10 outcome measures and 25 listed analyses, those omissions limit assessment of prespecification and selective reporting. The registry record also gives no primary effect estimate or uncertainty interval. Its safety entries are limited to zero recorded events in listed categories and do not describe ascertainment methods or observation details. These limitations mean that the entry can characterize the design and planned outcomes, but cannot support a full evaluation of efficacy or safety.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Harnessing Mobile Technology to Reduce Mental Health Disorders in College Populations — NCT04162847.
• Registry record last updated 2025-04-23; status last verified 2025-04.
• Results first posted 2025-04-23.
• 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

NCT04162847, titled Harnessing Mobile Technology to Reduce Mental Health Disorders in College Populations, is listed as a completed, randomized, unmasked, parallel-group trial sponsored by Washington University School of Medicine. Enrollment is listed as 6205. The primary comparison is the Mobile Coached Intervention against Referral to Counseling Center.

The primary outcome is the number of participants screening positive for at least one of anxiety, depression, or an eating disorder, with a primary endpoint at 2 years. Assessments are specified at baseline, 6 weeks, 6 months, and 2 years. The registry record lists 10 outcome measures and 25 analyses, but does not report the primary outcome results, statistical analysis plan, missing-data approach, or multiplicity procedures.

The safety entry records zero serious adverse events, zero other adverse events, and zero deaths in both groups. These figures do not replace a detailed safety assessment or a comparative analysis. The record describes the trial question and design, but does not provide enough outcome information to determine the result of the primary comparison.