Hyperthermic Yoga for Depressive Symptoms: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Hyperthermic Yoga for Depressive Symptoms (NCT02607514), a randomized na study. The primary outcome is Depressive Symptoms as Measured by the Inventory of Depressive Symptomatology - Clinician Rated (IDS-CR).

2. Clinical Question

3. Trial Design

The registry describes a randomized, single-masked, parallel-group trial. It lists an enrollment of 80 and a completed status. The study began on 2017-02-20, and the primary completion date is 2019-12-19. Massachusetts General Hospital is the listed sponsor. The registry does not identify who was masked, so the meaning of single masking for participants, clinicians, or outcome assessors is not reported in the registry record.

The immediate yoga arm was scheduled to start hyperthermic yoga immediately and receive the intervention over 8 weeks. The delayed yoga arm waited 8-weeks to start its 8-week intervention. This makes the primary endpoint an early comparison of immediate participation with waiting, rather than a comparison of two different yoga regimens. The record’s brief summary describes feasibility, acceptability, efficacy, and mechanisms as aims, with acceptability and feasibility identified as the primary aim and effect size or efficacy as a secondary aim.

The primary outcome summary describes an a priori Modified Intent-to-Treat analysis and states that the number of baseline participants reported is the sample analyzed for that primary analysis. The posted arm summaries give 33.0 for immediate yoga and 32.0 for delayed yoga. The reason these arm counts differ from the registry enrollment listing is not reported in the registry record; the figures alone do not establish why participants are not represented in the endpoint summaries.

Random allocation supports a comparison between assigned groups, but the registry record does not describe the allocation procedure in detail, the exact masking arrangements, or the statistical plan used for the primary comparison. The record also does not report whether participants in the delayed arm received other support during the waiting period. Such details matter when interpreting what the contrast represents and how it may differ from a comparison with an active control.

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

Analysis population for the primary outcome, as defined in the registry: The number of baseline participants reported is the sample that we analyzed in our a priori Modified Intent-to-Treat (MITT) primary analysis.

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: The number of baseline participants reported is the sample that we analyzed in our a priori Modified Intent-to-Treat (MITT) primary analysis. A modified intent-to-treat (MITT) approach was used. Analyses only included participants who completed at least one assessment following their initial baseline visit; yoga participants were only included if they completed at least one heated yoga class and subsequent assessment.

6. Primary Endpoint

The registry lists the primary outcome as Depressive Symptoms as Measured by the Inventory of Depressive Symptomatology - Clinician Rated (IDS-CR), measured over 8-week primary endpoint.

The primary endpoint is depressive symptom severity measured with the Inventory of Depressive Symptomatology - Clinician Rated (IDS-CR). It is a continuous scale ranging from 0-84, with higher scores indicating greater depressive symptoms. The registry reports the endpoint as a mean with a standard deviation for each arm at the 8-week primary endpoint.

A continuous score retains information about the degree of symptoms rather than classifying participants only by whether they cross a threshold. Comparing group means gives a concise estimate of the average difference in scores between the randomized arms. The standard deviations describe how spread out scores were within each arm; they do not describe uncertainty in the mean difference itself.

Clinician-rated measures are used to quantify symptoms through a structured assessment. The registry record does not report the assessment procedures, the identity or masking of the raters, or a threshold for a clinically important difference. Those omissions limit what can be inferred about measurement consistency and the practical importance of a numerical difference. The reported group means and their interval estimate describe the endpoint comparison, not the experience or response of every participant.

7. Results Posted in the Registry

• Delayed Yoga Arm: mean 29.63 versus 17.93 on control; difference 11.70 (95% CI 6.24 to 17.16), standardized effect d = 1.04; 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 Life as Measured by the Quality of Life Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) Over 8 Weeks.

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Delayed Yoga Arm: mean 41.34 versus 51.33 on control; difference -9.99 (95% CI -13.92 to -6.06), standardized effect d = -1.24; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for Delayed Yoga Arm than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

General Health as Measured by the Medical Outcomes Study 36-item Short-form Survey (SF-36)

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Delayed Yoga Arm: mean 53.50 versus 61.67 on control; difference -8.17 (95% CI -18.39 to 2.05), standardized effect d = -0.39; z-test p = 0.117.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Delayed Yoga Arm and the control. The interval gives the range of effects that remain compatible with the data.

Physical Functioning as Measured by the Physical Component Scale (PCS) of the Medical Outcomes Study 36-item Short-form Survey (SF-36) Over 8 Weeks.

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Delayed Yoga Arm: mean 53.33 versus 47.62 on control; difference 5.71 (95% CI -0.80 to 12.22), standardized effect d = 0.43; z-test p = 0.086.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Delayed Yoga Arm and the control. The interval gives the range of effects that remain compatible with the data.

The recorded secondary outcomes span quality of life, general health, physical functioning, perceived stress, anxiety, sleep, and longer-term measures. The available numerical comparisons cover quality of life, general health, and physical functioning at the 8-week endpoint. Across those three comparisons, the directions are not uniform: the immediate arm has the higher mean for quality of life and general health, while the delayed arm has the higher mean for physical functioning. The uncertainty also differs by outcome; some posted intervals exclude zero and others include it. These broad patterns should be read from each measure’s own scale and interval, not collapsed into a single overall result.

The secondary findings relate to the primary result by describing other dimensions that may be relevant to participants, but they are not substitutes for the prespecified primary endpoint. A difference in one scale does not imply a similar difference in another, and the scales do not share a common unit or necessarily the same meaning. The record lists additional outcomes, including perceived stress, anxiety, sleep, and long-term measures, but a full numerical account of every listed outcome is not present in the registry record.

Unadjusted secondary comparisons carry less weight when several outcomes are examined. In general, the chance of obtaining at least one apparently notable result can increase as the number of statistical comparisons grows. A prespecified hierarchy or multiplicity adjustment can address this issue, but the details of any such strategy are not reported in the registry record. The posted secondary p-values and intervals should therefore be treated as exploratory evidence unless the original analysis plan establishes otherwise. They provide context and may motivate further study; they do not independently confirm the primary finding or demonstrate a mechanism.

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

• Quality of Life as Measured by the Quality of Life Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) Over 8 Weeks.
• General Health as Measured by the Medical Outcomes Study 36-item Short-form Survey (SF-36)
• Physical Functioning as Measured by the Physical Component Scale (PCS) of the Medical Outcomes Study 36-item Short-form Survey (SF-36) Over 8 Weeks.
• Perceived Stress as Measured by the Perceived Stress Scale (PSS) Over 8 Weeks.
• Anxiety as Measured by the Spielberger State-Trait Anxiety Inventory (STAI), State, Over 8 Weeks.
• Sleep as Measured by the Pittsburg Sleep Quality Index (PSQI): A Commonly Used and Well-validated Self-rated Measure of Sleep-quality and Disturbance Over 8-weeks.
• Long Term Effects of Heated Yoga Intervention -- IDS-CR
• Long Term Effects of Heated Yoga Intervention -- PSQI

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous, and the registry reports an arm-specific mean and standard deviation. A mean is the arithmetic average of the recorded scores in a group. A standard deviation describes the spread of individual scores around that group’s mean. It is not the same as a confidence interval: the standard deviation concerns variation among observations, while a confidence interval describes uncertainty around an estimated quantity such as a difference between means.

What does the mean difference represent?

The reported primary mean difference is 11.7 units, with the delayed yoga arm as the comparison group and the immediate yoga arm as the reference. The arm means are 29.63 and 17.93, respectively. Since the scale assigns higher scores to greater depressive symptoms, a positive difference in this orientation corresponds to a higher average score in the delayed arm. The estimate is in the scale’s units, which makes its direction interpretable against the IDS-CR score meaning. It remains a group-level contrast, not a description of a typical individual’s change.

The record also gives a standardized effect estimate, d = 1.038, based on a pooled standard deviation of 11.27. In general, standardization expresses a mean difference relative to the spread of scores, which can help compare effects measured on different scales. It does not replace the scale-specific mean difference, and its interpretation depends on the variability in these particular groups. No new standardized estimate is needed to understand the reported result.

How should the p-value be read?

The primary comparison has an unadjusted p-value of < 0.001. In general, a p-value describes how compatible the observed data are with a specified no-difference model, under the assumptions of the statistical test. A small p-value is not the probability that the no-difference model is true, and it does not measure the size or clinical importance of an effect. The registry record does not report enough detail to identify the exact test or all assumptions used for the primary p-value. The term unadjusted indicates that the posted value is not presented as corrected for multiple comparisons.

Randomization concerns how participants were assigned; it does not guarantee that every measured feature will be balanced in a finite sample. Nor does randomization alone resolve missing outcome data, adherence, masking, or the suitability of a particular analysis. The registry describes the primary analysis as a priori Modified Intent-to-Treat, but its operational definition and any adjustment variables are not reported in the registry record.

Why do standard deviations and uncertainty both matter?

The standard deviations for the primary outcome are 12.7 in the immediate arm and 9.58 in the delayed arm. They show that individual scores varied within each group. The confidence interval for the mean difference, from 6.242 to 17.16, instead expresses uncertainty about the estimated group contrast. A confidence interval is generally a range of values compatible with the data and the method used to construct it. It should not be read as containing a specified proportion of individual scores or as assigning a probability to each possible true difference.

General statistical practice also distinguishes the analysis sample from the enrollment target or count. The registry lists enrollment as 80, while the primary arm summaries report 33.0 and 32.0 participants. The primary outcome description says these counts refer to baseline participants in the a priori analysis. The record does not explain how participants were handled after baseline or why the analysis counts differ from the enrollment listing. No conclusions about withdrawal, missingness, or exclusions should be inferred from the counts alone.

What do the planning calculations assume?

The sample-size illustrations are planning calculations based on the observed effect, not a report of the trial’s original design assumptions. They use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is set to the stated fraction of the observed effect. For continuous outcomes, the displayed quantities are participants per arm. The original design assumptions, including any sample-size justification prepared before the trial, are not reported in the registry record.

General power calculations ask how often a specified statistical procedure would reject a null hypothesis under a particular assumed effect and model. Their results depend on assumptions about the effect, variability, allocation, significance threshold, and analysis. If the assumed effect is smaller while the other planning assumptions are held fixed, more participants are needed to achieve the same target power. These calculations are illustrations and should not be confused with the evidence observed in the trial or with a retrospective measure of whether the trial was adequately powered.

11. Confidence Intervals and Precision

The primary mean difference is 11.7 IDS-CR units, with a 95% confidence interval from 6.242 to 17.16. The interval gives a range of values compatible with the data under the method used to calculate it. In this case, both limits are positive, and the interval does not include zero. The posted unadjusted p-value is < 0.001, which accords with evidence against a zero mean difference under the corresponding test assumptions.

The interval’s width conveys uncertainty: the data do not identify a single exact value for the population mean difference. The interval should not be interpreted as a range containing 95% of participant scores, nor as a 95% probability that the true effect lies within it. Its meaning depends on the sampling and analysis assumptions, which are not fully described in the registry record.

The endpoint standard deviations—12.7 for immediate yoga and 9.58 for delayed yoga—describe variation in individual scores, not the precision of the difference directly. The interval for the group difference is the relevant posted measure of precision for the primary comparison. It does not address uncertainty about clinical importance, measurement quality, the consequences of missing data, or generalizability beyond the studied population.

For the secondary outcomes, posted intervals vary in whether they include zero. Such intervals indicate differing levels of statistical uncertainty around the corresponding mean differences; they do not establish that one endpoint is more important than another. The record does not report a multiplicity adjustment, and the listed intervals should be read as outcome-specific rather than as simultaneous confidence intervals covering all outcomes together.

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 table and curve are planning illustrations, not a report of the trial’s original design assumptions. For continuous outcomes such as the IDS-CR, the values are participants per arm, not a total across arms. The illustrations assume two-sided significance level 0.05, equal allocation between the two arms, and a normal approximation. They use the observed effect as a starting point and consider the stated fractions of that effect. The registry record does not report the assumptions used for the original trial design.

For the primary endpoint, planning for 100% of the observed effect gives 15 participants per arm for 80% power and 20 participants per arm for 90% power. Planning for 75% of the observed effect gives 26 participants per arm for 80% power and 35 participants per arm for 90% power. Planning for 50% of the observed effect gives 59 participants per arm for 80% power and 79 participants per arm for 90% power.

In plain language, a power target describes the chance of detecting an assumed effect under the specified model and planning conditions if that effect is present. The 80% and 90% columns represent different targets: the higher target generally requires more participants for the same assumed effect. The rows also illustrate that smaller effects need more participants to reach a given power target. The curve expresses this planning relationship rather than showing observed participant outcomes. These calculations 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 = 11.700; pooled standard deviation σ = 11.273.
2. n = 2 × (1.96 + 0.842)² × 11.273² / 11.700² = 14.6, rounded up to 15 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 <- 11.7                      # observed difference in means
sigma <- 11.2731936574378                     # 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(2607514)
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 = 15 (80% power), 20 (90% power)
 75% of observed effect: n per arm = 26 (80% power), 35 (90% power)
 50% of observed effect: n per arm = 59 (80% power), 79 (90% power)
power.t.test: 15.6 
Simulated power at n = 15 per arm: 0.781 (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 record reports one primary analysis and several secondary outcomes, but it does not describe a multiplicity adjustment, a hierarchy for testing outcomes, or rules governing which comparisons would be treated as confirmatory. The reported p-values are labeled unadjusted. When multiple outcomes are examined, unadjusted testing can make isolated small p-values less persuasive because each test contributes an opportunity for a result to appear unusual by chance. This general concern does not change the numerical estimates; it affects how confidently a collection of findings can be interpreted.

The record describes the primary analysis population as an a priori Modified Intent-to-Treat sample of baseline participants. However, the exact inclusion rules, treatment of participants without an endpoint measurement, and handling of missing data are not reported in the registry record. No imputation approach, sensitivity analysis, or missing-data assumption is described. The arm counts in the primary summaries are 33.0 and 32.0, and the registry enrollment listing is 80, but the record does not explain the difference. It would be inappropriate to infer a particular pattern of attrition or exclusions from those figures alone.

Information about interim analyses, stopping rules, covariate adjustment, and the precise statistical test is also not reported in the registry record. These details can affect interpretation of uncertainty and the analysis population, so their absence limits independent assessment of the analysis. This does not show that such procedures were or were not used; it means their use cannot be established from the registry record.

The primary outcome is described as a priori, which distinguishes its stated role from the secondary outcomes, but the registry entry does not supply a complete protocol or statistical analysis plan. Conclusions should keep the primary comparison separate from the broader set of secondary findings and recognize that the available registry information does not resolve all questions about multiplicity or missingness.

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 5% reporting threshold.

Most frequent non-serious adverse event terms

The serious adverse event figures show zero participants affected in the immediate yoga arm and zero in the delayed yoga arm. The death counts are also zero in both arms. These are counts for the participants reported at risk in each arm: 33 in the immediate arm and 32 in the delayed arm. The registry record lists no serious adverse event terms.

The record also reports other adverse events affecting 3 participants in the immediate arm and 1 in the delayed arm. These figures should not be confused with serious adverse events. Counts alone do not describe event type, timing, severity beyond the registry categories, relatedness to the intervention, or whether one participant experienced multiple events. The record does not provide those details in the safety figures.

Zero reported serious events in these groups does not establish that serious events are impossible or that the intervention is safe in other populations or settings. The observed counts describe what was recorded during this trial, not a guarantee about future experience. The safety summary also does not replace a full account of adverse event definitions, monitoring, or follow-up, which is not reported in the registry record.

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

The posted primary result is a difference in mean clinician-rated depressive symptom scores at the 8-week endpoint. The immediate yoga arm’s mean score is lower than the delayed yoga arm’s mean, and the reported mean difference is 11.7 units with a 95% confidence interval from 6.242 to 17.16. Because higher IDS-CR scores indicate greater depressive symptoms, the direction of this group contrast is toward lower scores in the immediate arm. The interval and unadjusted p-value describe statistical evidence and precision, not clinical importance by themselves.

The result does not establish how much any particular participant’s score changed, how many participants improved, or whether an individual experienced a meaningful change. The registry does not report a threshold for clinical importance, responder definitions, or the distribution of individual changes. It also does not provide enough detail to assess adherence, missing outcomes, or the exact analysis procedures.

The randomized waitlist comparison addresses assignment to immediate yoga versus waiting during the primary endpoint period. It does not isolate which component of the intervention or study experience might account for the group contrast. The record does not describe an active comparison condition, and it does not report masking details beyond the designation of single masking. These features constrain causal interpretation of the specific mechanisms involved.

The findings should not be taken as medical advice or as a universal conclusion about hyperthermic yoga. They pertain to the reported study population, endpoint, analysis, and time frame. The study’s stated aims included feasibility, acceptability, and exploration of physiological and psychological mechanisms, but the numerical primary comparison alone cannot answer all of those questions. The registry record also does not establish longer-term effects from the 8-week primary endpoint.

17. Why This Trial Matters Statistically

This trial illustrates why statistical interpretation needs more than a p-value. The primary endpoint is a continuous clinician-rated scale, and the registry reports the arm means, within-arm standard deviations, mean difference, confidence interval, and unadjusted p-value. Together, these quantities describe the direction and size of the endpoint contrast, the observed variability, and uncertainty around the group difference. They answer related but distinct questions.

The design also makes the comparator’s timing important. The study compares immediate yoga with a waitlist and delayed yoga, so the primary endpoint contrast is about immediate assignment versus waiting over the stated period. It should not be described as a comparison against another active treatment or as a test of one isolated component of yoga. A clear account of the comparator helps keep the statistical estimate aligned with the question the design can address.

The entry provides a useful example of limits in registry-based interpretation. It identifies a primary analysis population and reports endpoint counts, yet does not explain the relationship between those counts and the listed enrollment. Details of missing-data handling, multiplicity, and the analysis plan are not reported in the registry record. These omissions do not invalidate the posted numbers, but they constrain how fully an independent reader can assess the analysis.

Finally, the planning illustrations show how assumptions about the effect to detect and target power change the number of participants needed in a future design. They are separate from evidence about what was observed in this completed trial. Keeping observed estimates, uncertainty, and forward-looking planning calculations distinct is central to sound statistical communication.

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 primary endpoint is measured at an 8-week endpoint, while the registry also lists longer-term outcomes. The numerical primary comparison alone cannot establish persistence of the endpoint pattern. The detailed long-term results are not reported in the registry record among the numerical summaries described for this comparison.

The comparator is a waitlist with delayed yoga, not an active control. Accordingly, the estimate does not isolate yoga-specific effects from possible differences associated with expectations, attention, or other aspects of being assigned to immediate participation. The registry record does not report enough information about contact, adherence, or experiences during the waiting period to assess these factors.

Although the record labels the design single-masked, it does not identify who was masked or explain how masking was maintained. This matters for an intervention that may be apparent to participants, and for an outcome assessed by a clinician, but the record does not permit a judgment about whether or how masking affected measurement.

The registry lists enrollment as 80, whereas the primary endpoint summaries report 33.0 and 32.0 participants in the two arms. The primary analysis description identifies the counts as baseline participants in the a priori Modified Intent-to-Treat analysis; the reason for the difference from enrollment is not reported in the registry record. Missing-data methods and sensitivity analyses are also not reported, so the effect of unavailable endpoint measurements cannot be assessed from this entry.

Finally, the study has multiple secondary outcomes, and the registry does not report a multiplicity strategy or complete statistical analysis plan. The secondary comparisons should be interpreted cautiously, particularly when considered together. The registry record also does not provide a clinically important difference threshold for the primary scale, limiting interpretation of practical significance.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Hyperthermic Yoga for Depressive Symptoms — NCT02607514.
• Registry record last updated 2026-09-10; status last verified 2026-09.
• Results first posted 2024-08-27.
• 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

The registry describes a completed randomized, single-masked, parallel-group trial of hyperthermic yoga versus a waitlist with delayed yoga. Enrollment is listed as 80, and the primary endpoint is clinician-rated depressive symptoms on the IDS-CR at 8 weeks. The primary analysis is described as an a priori Modified Intent-to-Treat analysis.

The reported mean IDS-CR score is 17.93 in the immediate yoga arm and 29.63 in the delayed yoga arm. The posted mean difference is 11.7, with a 95% confidence interval from 6.242 to 17.16 and unadjusted p < 0.001. Higher IDS-CR scores indicate greater depressive symptoms. The registry also lists secondary quality-of-life, health, physical-functioning, stress, anxiety, sleep, and longer-term outcomes. Safety figures report zero serious adverse events and zero deaths in both arms. Details about the original sample-size justification, missing-data handling, multiplicity, and several analysis procedures are not reported in the registry record.