Evaluation of MoodRing on Improving the Quality of Depression Management in Adolescents: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Evaluation of MoodRing on Improving the Quality of Depression Management in Adolescents (NCT05376358), a randomized na study. The primary outcome is Change From Baseline in Self-management at 3 Months.

2. Clinical Question

3. Trial Design

The registry describes a randomized, single-masked, parallel-group trial comparing MoodRing with usual care. The phase is listed as NA, and enrollment is 73. The record lists the study status as terminated. The reason for termination is not reported in the registry record. The identity of the masked parties is not reported in the registry record.

The MoodRing intervention combined a mobile application for adolescents with an accompanying web-based clinician portal, and the intervention description also refers to parents. The application was intended to support mood monitoring using passively collected smartphone data. Participants in both arms used AWARE, which the record describes as non-interactive and for data collection. Participants assigned to MoodRing had access to the MoodRing application; participants assigned to usual care received no interactive intervention and continued treatment as usual through their mental health services provider.

The primary outcome was change from baseline in self-management score at 3 months. The reported primary endpoint counts are 26.0 for usual care and 25.0 for MoodRing. These arm counts are smaller than the overall enrollment, but the reason for the difference and the handling of participants without endpoint data are not reported in the registry record. Outcome-specific participant counts also vary across the posted secondary results.

The registry lists secondary outcomes covering depression symptom reassessment, medication and therapy adherence, healthcare utilization, depression severity, sleep-related impairment, sleep disturbance, and self-efficacy. It lists 40 outcome measures and 21 posted secondary outcomes. The record does not provide a reason for trial termination, further detail about the randomization procedure, or a fuller account of the masking arrangements.

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: Both the adolescent and the parent were required to complete the baseline survey to enter the study. Out of 73 adolescent and parent dyads consented for the study, 68 (93.1%) of adolescents completed the baseline survey while, despite multiple contacts, only 63 (86.3%) of parents completed the baseline. Therefore 63 adolescent parent dyads were able to start the study and were randomized.

3 Month Timepoint Data Collection

Reasons for not completing this period:

6 Month Timepoint Data Collection

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: The pre-specified statistical analysis was not scientifically appropriate due to insufficient enrollment.

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: For age: Adolescents and Parents are reported separately because providing a total average age across adolescents and parents is not indicated.

6. Primary Endpoint

The registry lists the primary outcome as Change From Baseline in Self-management at 3 Months, measured over From baseline to 3 months.

The primary endpoint is change from baseline in self-management at 3 months, measured as a score on the revised Partners in Health Scale. The scale assesses a patient’s active involvement in managing a chronic condition. Its total score ranges from 0 to 96, and higher scores indicate worse self-management. The registry explains that a larger negative change represents improvement.

Using change rather than a score at a single time point expresses how the measured score moved over the stated follow-up period. Comparing the average change between randomized groups can describe the difference in observed mean change associated with assignment to the two arms. The posted results are group means and standard deviations, with a between-arm mean difference and confidence interval.

The endpoint is relevant to the stated study question because the intervention was designed to support depression management, and the scale measures self-management rather than depression symptoms alone. It is not itself a direct measure of symptom severity, medication adherence, or therapy adherence; those topics appear among the secondary outcomes. The registry states that the pre-specified statistical analysis was not scientifically appropriate because of insufficient enrollment. The reason for selecting the scale, and any additional protocol-level rationale for the endpoint, are not reported in the registry record.

7. Results Posted in the Registry

• MoodRing: mean -1.84 versus 12.00 on control; difference -13.84 (95% CI -22.19 to -5.49), standardized effect d = -0.91; z-test p = 0.001.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Quality of Depression Management: Depression Symptom Reassessment

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • MoodRing: 85.7% (24/28) versus 69.0% (20/29) on control; risk difference 16.7 percentage points (95% CI -4.5 to 38.0), risk ratio 1.24 (0.93–1.66); unadjusted two-proportion z-test p = 0.132.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between MoodRing and the control. The interval gives the range of effects that remain compatible with the data.

Quality of Depression Management: Medication Adherence

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • MoodRing: 75.0% (12/16) versus 100.0% (16/16) on control; risk difference -25.0 percentage points (95% CI -46.2 to -3.8), risk ratio 0.75 (0.57–1.00); unadjusted two-proportion z-test p = 0.033.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the proportion with the event is statistically lower for MoodRing than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Quality of Depression Management: Therapy Adherence

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • MoodRing: 87.5% (14/16) versus 83.3% (15/18) on control; risk difference 4.2 percentage points (95% CI -19.5 to 27.8), risk ratio 1.05 (0.80–1.39); unadjusted two-proportion z-test p = 0.732.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between MoodRing and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes address several aspects of depression management and related functioning, including symptom reassessment, medication and therapy adherence, healthcare utilization, depression severity, sleep, and self-efficacy. Across the posted comparisons, the estimates do not form a uniformly consistent pattern. Their directions and precision vary, so they offer mixed context rather than a coherent set of findings that independently confirms the primary result.

The primary outcome concerns change in self-management score, while the secondary outcomes measure different behaviors, events, or symptoms. A result on one construct need not move in lockstep with another. Differences across outcomes may reflect the distinct questions and measurement scales, as well as uncertainty in the estimates. The registry does not report a framework for combining these outcomes into a single conclusion.

The secondary results are unadjusted, and the registry lists 21 posted secondary outcomes and 40 outcome measures. When many comparisons are examined, the chance of finding an apparently notable result by chance increases in general. A multiplicity procedure, a hierarchy for prioritizing outcomes, or a detailed plan for interpreting these comparisons is not reported in the registry record. A nominally notable unadjusted result should therefore be considered alongside the broader set of outcomes and the uncertainty around each estimate, rather than as stand-alone confirmation.

The varying participant counts across secondary outcomes also mean that the amount of information differs by outcome. Reasons for these differences, missing-data handling, and the populations used for each comparison are not reported in the registry record. Overall, the secondary results can describe additional observed patterns, but they carry less weight than a prespecified, fully reported analysis designed to account for the number of comparisons and the data available for each outcome.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Quality of Depression Management: Depression Symptom Reassessment
• Quality of Depression Management: Medication Adherence
• Quality of Depression Management: Therapy Adherence
• Healthcare Utilization for Acute Care or Primary Care (for Non Mental-health Reason)
• Depression Severity at 3 Months
• Sleep-Related Impairment at 3 Months
• Sleep Disturbance at 3 Months
• Self-Efficacy at 3 Months

9. Statistical Interpretation

10. Statistical Methods Explained

What does the mean change represent?

The primary endpoint is continuous: each participant’s result is a score, and the reported arm-level summary is a mean with a standard deviation. A mean describes the center of the observed scores. A standard deviation describes how spread out individual scores are around that mean. The primary result compares mean changes, so it describes an average difference between groups rather than the proportion of participants who improved.

The scale’s direction is important for interpretation. Higher total scores represent worse self-management, and the registry explicitly says that a larger negative change represents improvement. Accordingly, the negative posted mean difference is in the direction of greater improvement in the MoodRing arm. This direction does not by itself establish how important the size of the difference is to participants; a threshold for meaningful change is not reported in the registry record.

How should the between-arm estimate be read?

The posted mean difference is -13.84, with a confidence interval from -22.19 to -5.489. The comparison is expressed as MoodRing minus usual care. A negative value therefore means the mean change in the MoodRing arm was lower than the mean change in usual care. Given the scale’s direction, lower change is consistent with greater improvement. The estimate summarizes the observed contrast; it does not describe individual outcomes or account for any unreported adjustment.

The p-value is 0.001 and is identified as unadjusted. In general, a p-value measures how incompatible the observed data are with a specified null model, assuming that model and the analysis assumptions are appropriate. It is not the probability that the null hypothesis is true, and it does not measure the size or practical importance of an effect. The registry record does not provide a scientifically appropriate pre-specified statistical analysis for this endpoint, citing insufficient enrollment. The exact analysis method behind the registry’s posted p-value is not reported in the registry record.

What does a confidence interval contribute?

In general, a confidence interval communicates uncertainty around an estimate under a statistical procedure and its assumptions. The reported interval for the primary mean difference is entirely negative. It therefore gives a range of values consistent with the observed summary data under that procedure, all in the direction of lower mean change for MoodRing relative to usual care. The interval is not a guarantee that the true effect lies inside it, and it does not include uncertainty from design or reporting limitations that are not represented by the calculation.

The arm-level standard deviations, 14.3 and 16.04, describe variation in individual changes. General statistical reasoning recognizes that greater variability can make a mean difference less precise, while more observations can improve precision when other conditions are comparable. The primary endpoint group counts are 26.0 and 25.0. The record’s statement about insufficient enrollment cautions against treating these posted summaries as a complete answer to the planned scientific question.

Why can a binary outcome look different?

Some secondary endpoints are reported as counts of participants, with risk differences comparing the proportion with the recorded outcome between arms. A risk difference is expressed on an absolute scale: it describes the gap between the two observed proportions. General statistical interpretation considers both the estimate and its confidence interval. When an interval includes zero, the data are compatible with no difference as well as with differences in either direction under the stated interval method.

The secondary results also include ratios for some comparisons. In general, a ratio compares relative rather than absolute occurrence, and its interpretation depends on the event definition and reference group. Such measures can look different from risk differences because they use a different scale. The registry’s posted secondary comparisons are unadjusted; no additional model details or reported analyses are listed for these outcomes.

What does unadjusted mean in this context?

Unadjusted means that the reported comparison is not described as adjusted for other measured variables or for the number of outcomes examined. It does not imply that the groups were not randomized. Rather, it indicates that the reported numerical contrast should not be assumed to incorporate covariate adjustment or a correction for repeated statistical testing. The registry record does not report adjusted analyses for the posted results.

Multiple comparisons create a general interpretive challenge: when many outcomes are examined, some results can appear unusual by chance even if there is no underlying difference. A pre-specified outcome hierarchy or a multiplicity procedure can guide interpretation, but such details are not reported in the registry record. This is particularly relevant to the secondary results, which should not be treated as if each were the only comparison made.

What can the planning illustrations tell readers?

The sample-size illustrations use the observed effect, a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. They show participant requirements per arm for continuous and binary outcomes, with effect sizes set at 100%, 75%, and 50% of the observed effect. General statistical reasoning predicts that detecting a smaller effect with comparable assumptions requires more participants. These calculations are planning illustrations, not evidence about the trial’s original design or its achieved power.

The original trial’s sample-size justification and statistical assumptions are not reported in the registry record. The planning illustration therefore cannot be used to infer what enrollment the investigators originally intended, whether that target was met, or whether the trial had adequate power for its planned analyses. The record’s statement that the pre-specified analysis was not scientifically appropriate due to insufficient enrollment should be kept distinct from the separate illustration based on the observed effect.

11. Confidence Intervals and Precision

The primary mean difference is -13.84, and its 95% confidence interval runs from -22.19 to -5.489. The interval does not include zero and lies entirely in the direction of a lower mean change in the MoodRing arm relative to usual care. Because lower change corresponds to improvement on this scale, the full interval points in that same direction under the reported comparison.

Precision is not the same as direction. An interval can lie on one side of zero while still covering a wide range of possible effect sizes. This interval spans values that differ meaningfully in magnitude, so the exact size of the contrast remains uncertain. In general, a confidence interval describes uncertainty under the method used; it does not account for every possible limitation in the trial or registry record.

The primary arm counts were 26.0 for usual care and 25.0 for MoodRing, and the standard deviations were 14.3 and 16.04. Variation in observed changes contributes to uncertainty around a group contrast. The registry says the pre-specified statistical analysis was not scientifically appropriate because of insufficient enrollment, but it does not explain the interval method or identify an alternative analysis plan. The posted interval should therefore be read as a summary of the recorded comparison, not as a resolution of the design and analysis concerns.

Secondary confidence intervals are also relevant to precision. Some span zero, reflecting uncertainty about the direction or presence of a difference on the interval’s scale; one posted secondary comparison has a more directional interval. Those results involve multiple outcomes and are unadjusted. Without a reported multiplicity plan, they do not have the same interpretive weight as a single pre-specified primary comparison would ordinarily have. More generally, intervals describe statistical uncertainty, not clinical importance, and a threshold for meaningful change is not reported in the registry record.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The sample-size figures are participants per arm. The planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The assumed effect to detect is the stated fraction of the observed effect: 100%, 75%, or 50%. The registry record’s sample-size assumptions specify total events only for time-to-event outcomes; the displayed planning comparisons concern continuous and binary outcomes, so their figures refer to participants per arm.

The 80% power column represents a planning target for the chance of detecting the specified effect under the stated assumptions, if that effect and the assumptions were correct. The 90% column uses a higher target chance of detection under the same general framework. Neither column describes the probability that the trial result is correct, nor the probability that a treatment has an effect. These are prospective planning quantities, not summaries of what happened in the trial.

The rows that use smaller fractions of the observed effect require larger participant counts. That pattern is expected in general because a smaller difference is harder to distinguish from random variation when other assumptions remain the same. The illustrations are based on the observed effect and do not reproduce the original trial’s design calculation. The original sample-size justification and design assumptions are not reported in the registry record. These figures are not observed power.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -13.840; pooled standard deviation σ = 15.177.
2. n = 2 × (1.96 + 0.842)² × 15.177² / -13.840² = 18.9, rounded up to 19 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- -13.84                      # observed difference in means
sigma <- 15.177190458187                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(5376358)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 19 (80% power), 26 (90% power)
 75% of observed effect: n per arm = 34 (80% power), 45 (90% power)
 50% of observed effect: n per arm = 76 (80% power), 102 (90% power)
power.t.test: 19.9 
Simulated power at n = 19 per arm: 0.779 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The registry lists 40 outcome measures and 21 posted secondary outcomes. It does not report a multiplicity adjustment, a hierarchy for testing outcomes, or a rule for interpreting multiple secondary comparisons together. This matters because, as a general statistical principle, examining many outcomes can increase the chance that at least one result appears notable by chance. The unadjusted p-values for secondary outcomes should be interpreted cautiously and should not be treated as if they arose from isolated tests.

The record states that the pre-specified statistical analysis for the primary outcome was not scientifically appropriate due to insufficient enrollment. Further information about the planned analysis, a revised analysis, or the reason for termination is not reported in the registry record. The type of analysis population—such as all randomized participants or only participants with observed endpoint data—is also not reported in the registry record. The masked parties and any procedures for preserving masking are not reported in the registry record.

Outcome counts vary across arms and measures. For the primary endpoint, the reported arm counts are 26.0 and 25.0, while overall enrollment is 73. The record does not explain the difference between enrollment and the endpoint counts. It also does not describe whether missing outcomes were handled by imputation, complete-case analysis, or another approach. Those methods can affect estimates if the availability of outcome data is related to participant characteristics or outcomes.

Interim analyses, stopping rules, and a fuller statistical analysis plan are not reported in the registry record. It is therefore not possible to assess from the posted information whether the termination followed a planned decision process or whether the analysis choices were made before or after outcome data were reviewed. These are reporting limitations, not evidence that any particular procedure was or was not used.

15. 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 reports serious adverse event counts for 62 participants at risk in usual care and 64 participants at risk in MoodRing. Serious adverse events affected 0 participants in each arm, and deaths were also reported as 0 in each arm. The record also lists 0 other adverse events in both arms, with the same respective at-risk counts of 62 and 64.

These figures describe the events recorded in the registry for the stated groups. A count of zero does not establish that an intervention has no risk, particularly when the number of participants at risk is limited and the record does not provide further information about observation time, event definitions, collection procedures, or completeness of reporting. The registry does not list serious adverse event terms. The figures should therefore be read as a summary of reported events, not as a comprehensive assessment of safety or a basis for an individual treatment decision.

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

The primary posted comparison describes a difference in mean change in self-management score between the randomized groups. The observed arm means and the mean difference are in the direction of greater improvement for MoodRing according to the scale’s stated scoring direction. The confidence interval is entirely negative, while its width leaves uncertainty about the precise size of the difference. These results are a statistical description of the posted data, not a determination that the intervention works or does not work.

The endpoint measures self-management, not depression symptoms alone. The trial also listed other outcomes related to depression management, adherence, healthcare utilization, sleep, and self-efficacy. These measures address different constructs and should not be collapsed into a single claim about depression management without a reported analysis plan supporting that interpretation. The secondary findings are unadjusted and mixed in direction and precision.

Several limits affect how far the result can be taken. The registry says the pre-specified primary analysis was not scientifically appropriate because of insufficient enrollment. It reports enrollment of 73 but smaller counts for the primary endpoint, without describing the reasons or missing-data approach. The trial status is terminated, and the reason is not reported in the registry record. The record also does not provide a sample-size justification for the original trial, interim-analysis details, or a complete account of analysis populations.

Random allocation supports a comparison between groups, but the posted information does not resolve the limitations in analysis and reporting. The results do not establish how the estimate would change under another analysis, how representative the enrolled participants are of other adolescents, or whether the observed score difference is meaningful to participants. No clinical threshold for meaningful change is reported in the registry record. Conclusions should stay close to the recorded outcome, comparison, and uncertainty.

17. Why This Trial Matters Statistically

This trial illustrates why a numerical estimate should be read alongside the analysis plan and the amount of information available. The primary comparison has a directionally clear confidence interval, yet the registry explicitly says the pre-specified statistical analysis was not scientifically appropriate because of insufficient enrollment. A numerical contrast and a design-level caution can both be true; neither should be ignored when interpreting the result.

It also demonstrates the distinction between total enrollment and outcome-specific counts. Enrollment is 73, while fewer participants contribute to the posted primary endpoint summaries. The record does not explain this difference or describe missing-data handling. Without that context, readers cannot determine whether the observed endpoint group counts represent all eligible participants, participants with available measurements, or another analysis population.

The secondary outcomes raise a separate statistical issue. A broad set of measures can illuminate different aspects of a research question, but unadjusted comparisons across many outcomes can generate chance findings. The registry lists 40 outcome measures and 21 posted secondary outcomes, with no reported multiplicity strategy. Considering the overall pattern and uncertainty is more informative than focusing on a single secondary p-value.

Finally, the trial’s terminated status and absent explanation show why registry status alone does not explain the context behind results. The reason for termination and the original sample-size rationale are not reported. These gaps do not erase the recorded estimates, but they constrain claims about the intended design, planned analyses, and completeness of the evidence. Transparent reporting of analysis populations, missing-data methods, and multiplicity plans would make the statistical meaning of the results easier to assess.

18. 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 record identifies insufficient enrollment as the reason the pre-specified statistical analysis was not scientifically appropriate, but it does not describe a replacement analysis or the statistical method used to obtain the posted primary comparison. The trial is listed as terminated, and the reason for termination is not reported in the registry record. The original sample-size justification and design assumptions are also not reported, so the planning illustrations based on observed effects cannot explain the intended enrollment target.

The primary endpoint counts are smaller than total enrollment, and outcome-specific sample sizes differ across secondary measures. Reasons for these differences, the extent and pattern of missing data, and the handling of missing observations are not reported in the registry record. The record does not identify the analysis populations or explain whether all randomized participants were included in the posted summaries.

Although the trial is described as single-masked, the masked parties and masking procedures are not reported. Further details about allocation procedures, the usual-care services received, and the completeness of intervention use are not included in the reported information. The MoodRing arm description is limited, so details beyond its stated monitoring and application features should not be assumed.

The registry lists many outcome measures and secondary outcomes, but it does not report a multiplicity plan or a hierarchy for outcome interpretation. No interim analyses or stopping rules are reported. The adverse-event summary includes zero events, but details about observation time, event definitions, and ascertainment are not reported. These limitations concern the information available in the registry record and do not establish that an unreported procedure was not performed.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Evaluation of MoodRing on Improving the Quality of Depression Management in Adolescents — NCT05376358.
• Registry record last updated 2025-08-14; status last verified 2025-07.
• Results first posted 2025-08-14.
• 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.

22. Record Summary

NCT05376358 is a randomized, single-masked, parallel-group trial of MoodRing compared with usual care for adolescent depression management. Enrollment was 73, and the registry lists the study status as terminated. MoodRing involved a mobile application and a web-based clinician portal, with passive smartphone data collection; the usual-care arm continued care through mental health services and used a non-interactive data-collection application.

The primary outcome was change from baseline in self-management score at 3 months, measured with the revised Partners in Health Scale. The posted mean difference was -13.84, with a 95% confidence interval from -22.19 to -5.489 and an unadjusted p-value of 0.001. The registry states that the pre-specified analysis was not scientifically appropriate due to insufficient enrollment. The reason for termination, the original sample-size justification, missing-data methods, and multiplicity procedures are not reported in the registry record.