Journeys to Wellness: A Transplant Candidate Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Journeys to Wellness: A Transplant Candidate Study (NCT01254214), a randomized phase 3 study. The primary outcome is State-Trait Anxiety Inventory.

2. Clinical Question

The study description also identifies depression, sleep and quality of life as areas of interest. Participants were to complete questionnaires at 3 timepoints over 6 months, with additional questionnaires if they received a transplant. Sleep diaries, Actiwatches and saliva samples were described as additional measurements. The registry record does not report results for these measures.

3. Trial Design

This was a Phase 3, randomized, open-label, parallel-group study sponsored by the University of Minnesota. The registry lists the study as completed, with a start date of 2010-02 and primary completion in 2014-06. Enrollment was 63. The record does not report the number of participants assigned to each group or how many completed follow-up.

The two interventions were behavioral programs delivered over 8 weeks. The tMBSR program involved mindfulness meditation and gentle Hatha yoga, with two in-person group meetings and 6 conference calls led by a trained meditation teacher. The support group was led by a trained facilitator and designed to match tMBSR for time, attention and social support. The study description says both programs included an initial and concluding in-person meeting and 6 weekly teleconference calls.

Because masking was recorded as none, the trial was open-label: participants and study personnel were not described as masked to group assignment. The registry record does not explain whether outcome assessors or analysts were masked. Random allocation helps make treatment groups comparable on average, but does not guarantee balance in a study of this size; the allocation sequence and concealment procedures are not reported in the registry record.

The primary outcome was the STAI, measured at baseline, 8 weeks and 26 weeks. Secondary outcomes included the Short Form -12 MCS, SF-12 PCS, Pittsburgh Sleep Quality Index and Center for Epidemiologic Studies Depression Scale. The registry describes additional sleep and cortisol measurements in the study summary. The record does not report the timing, analysis populations or results for these secondary measures beyond the descriptions listed.

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: 66 people were screened, 3 were ineligible, and of the 63 who consented only 55 actually participated in the trial.

Overall Study

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 State-Trait Anxiety Inventory, measured over Baseline, 8 weeks, 26 weeks.

The primary outcome was the State-Trait Anxiety Inventory (STAI), a 20 item scale described in the registry as measuring current anxiety symptoms. Its scores range from 20 to 80, with higher scores indicating greater levels of anxiety. The registry also gives a norm for working adults of 34. This reference provides context for interpreting a score, but the record does not report trial scores or establish how the norm should be used for comparing the study groups.

The STAI was measured at baseline, 8 weeks and 26 weeks. Repeated measurement can describe anxiety at the start of the program and at later follow-up, and can help distinguish an early measurement from a later one. A change in score within a group is not, by itself, evidence of a difference between groups: the relevant comparison depends on the analysis and the contrast specified for the research question.

The registry identifies the outcome as a mean of a continuous measure, with standard deviation as its dispersion measure. A mean summarizes the group’s average score, while a standard deviation describes how spread out individual scores are around that average. The registry record does not report group means, standard deviations, confidence intervals or a primary treatment-effect estimate. It also does not identify one of the listed timepoints as the sole primary comparison.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes the primary outcome as the mean of a continuous measure, with standard deviation as its dispersion. The STAI produces scores on a numerical scale, so means can summarize average anxiety scores within a group or at a measurement time. A standard deviation describes variability among individual scores; it is not the same as the uncertainty around a group mean or treatment-effect estimate.

What would a group comparison estimate?

In general, a comparison between randomized groups estimates how their outcome distributions differ under the study conditions. For a continuous outcome, an analysis might compare mean scores at a specified timepoint, compare change from baseline, or model scores across repeated measurements. These approaches answer related but not identical questions. The registry record does not report which approach was used, the adjustment variables, or the exact primary contrast.

Baseline measurement can describe the groups before the program and can be used in some analyses to improve precision. Follow-up measurement can then be interpreted relative to baseline or compared directly between groups, depending on the prespecified method. Randomization supports a treatment-group comparison, but it does not determine which statistical model is appropriate or how missing measurements should be handled. Those details are not reported in the registry record.

How should uncertainty be read?

In general, a confidence interval expresses statistical uncertainty around an estimate. It is useful to consider both its width and the range of effect sizes it includes, rather than relying only on a thresholded p-value. A p-value, when reported, describes how compatible the data are with a specified null hypothesis under the assumptions of the analysis; it does not measure the probability that the null hypothesis is true. The registry record does not report a confidence interval, p-value or estimated group difference for the primary outcome.

For repeated measurements, estimates at multiple timepoints can be correlated because measurements come from the same participants. General statistical methods for repeated outcomes account for this within-participant structure in different ways. The choice can affect estimates and their uncertainty. The registry record lists baseline, 8 weeks and 26 weeks as assessment times but does not describe a repeated-measures model, covariance structure or other method for accounting for within-participant correlation.

What does the planning illustration mean?

The registry’s sample-size assumptions describe a planning illustration based on a fraction of the observed effect, using a two-sided significance level of 0.05, equal allocation between groups and a normal approximation. Such calculations ask what sample size might be needed under stated assumptions. They are planning illustrations, not observed power and not evidence that the trial had a particular probability of detecting an effect. The registry record does not report the trial’s own sample-size justification or design assumptions.

The illustration depends on the effect size used as its starting point. The registry record does not report the observed STAI effect estimate or the fraction used for a particular illustration. A planning calculation based on an observed estimate can also be uncertain because that estimate comes from data. The registry record does not report whether the trial used any such calculation to plan enrollment.

What can be inferred from the posted record?

The design information establishes that the study was randomized, parallel-group and open-label, and that the primary outcome was measured repeatedly. It does not establish a treatment effect. Statistical interpretation requires outcome estimates, measures of uncertainty and a clear analysis contrast; those results and details are not reported in the registry record. General statistical explanations of means, uncertainty and repeated measurements describe how such data may be analyzed, not which analysis was actually performed in this trial.

10. Multiplicity, Missing Data and Analysis Populations

The primary outcome was measured at baseline, 8 weeks and 26 weeks. The registry explicitly notes that the primary outcome has several categories or timepoints and was not reduced to one comparison. It does not specify which timepoint or contrast was designated as primary for statistical testing, nor does it report a multiplicity-adjustment plan. When multiple outcomes, timepoints or comparisons are examined, the chance of at least one apparently notable result can increase. General methods for addressing multiplicity include prespecifying a primary contrast, adjusting inference across comparisons, or treating some analyses as exploratory. The registry record does not say whether any such approach was used.

The study lists secondary outcomes covering mental health, sleep and quality of life, and describes sleep diary, Actiwatch and saliva measurements. The registry record does not report which secondary comparisons were prespecified for formal inference, whether the investigators adjusted for multiple testing, or which results were considered exploratory. No secondary-outcome estimates or statistical results are reported in the registry record.

Missing-data handling is also not reported in the registry record. The study description says participants were to complete questionnaires at 3 timepoints over 6 months and additional questionnaires if they received a transplant. It does not state how many observations were missing, why they were missing, or how participants with incomplete follow-up were included in analyses. The record does not identify an intention-to-treat or other analysis population, nor does it describe imputation, model-based handling of incomplete observations or sensitivity analyses. These omissions prevent assessment of how attrition and missing measurements might affect the reported estimates.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

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 serious adverse events for the tMBSR group with 27 at risk and 0 affected, and for the Support Group with 28 at risk and 0 affected. These entries indicate that the record reports no serious adverse events in either group within the listed at-risk counts. The registry also lists other adverse events with 27 at risk and 0 affected for tMBSR, and 28 at risk and 0 affected for the Support Group.

These figures should be read as registry entries, not as proof that no adverse events occurred in any setting or at any time. The record does not provide event descriptions for serious events, and no serious adverse event terms are listed. Death counts are not reported in the registry record. The at-risk counts for adverse events do not establish the number of participants included in the primary-outcome analysis or the amount of follow-up available.

In general, an observed count of zero does not establish that an event is impossible or that the underlying risk is exactly zero. How informative a zero count is depends on the amount and completeness of observation and on how events were collected and defined. Those details are not reported in the registry record, so the adverse-event entries should be interpreted narrowly as the counts recorded there.

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

The registry describes a randomized comparison of an 8-week telephone-adapted mindfulness program with a support group for people with end-stage renal disease waiting for kidney transplantation. It identifies the STAI as the primary outcome and records assessments at baseline, 8 weeks and 26 weeks. This establishes the study’s intended outcome and follow-up schedule, but it does not provide results showing how anxiety scores differed between groups.

Without group means, treatment-effect estimates and uncertainty intervals, the direction, size and precision of any difference cannot be assessed from the registry record. The record also does not identify one primary comparison across the multiple listed timepoints. It is therefore not possible to determine from the posted results whether scores changed, whether groups differed at follow-up, or whether any difference was large enough to be important to participants.

The record’s description of secondary outcomes and additional sleep and cortisol measurements shows that the study considered outcomes beyond anxiety. However, those descriptions do not constitute findings. Their results and the statistical analyses used for them are not reported in the registry record.

In general, a randomized design can support a causal comparison when allocation, follow-up and analysis are appropriately implemented, but the design label alone does not establish that the groups were comparable in every observed or unobserved respect, nor does it show what the outcome estimates were. The registry record does not provide enough analysis detail to assess all of these features.

The absence of reported results in the registry record should not be interpreted as evidence that the groups were the same, or as evidence of a benefit or lack of benefit. It means that the posted information does not quantify the outcome comparison. Any conclusion about the treatment effect would require results and methods that are not reported in the registry record.

13. Why This Trial Matters Statistically

This study raises several important statistical issues for clinical research. First, the primary outcome was assessed repeatedly, at baseline, 8 weeks and 26 weeks. A clear primary contrast is necessary to make the main question interpretable: a comparison at one follow-up timepoint differs from a comparison of changes over time. The registry record notes that the multiple timepoints were not reduced to one comparison, leaving the intended primary statistical question unspecified.

Second, the comparator was an active support group designed to match time, attention and social support. A randomized comparison between these programs addresses the contrast between the two assigned approaches, not necessarily the contrast between mindfulness training and receiving no group contact. The registry’s comparator description is therefore important context for defining what a between-group estimate would represent.

Third, open-label delivery and self-reported questionnaire outcomes are relevant design features. In general, awareness of group assignment can influence participation or reporting, although the registry record does not establish that such influence occurred. Clear outcome definitions, prespecified analyses and transparent reporting help readers evaluate these possibilities.

Finally, repeated questionnaires, secondary outcomes and additional measurements create multiple opportunities for analysis. Prespecification and transparent reporting of multiplicity and missing-data methods help readers distinguish a primary confirmatory result from exploratory findings. The registry record does not report those methods or the outcome estimates. This limits the statistical conclusions that can be drawn from the posted record, even though the trial design and measurement schedule are described.

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 main limitation for interpreting this trial from the registry record is the absence of reported statistical results for the primary outcome. No STAI group means, standard deviations, treatment-effect estimate, confidence interval or p-value are reported. The record identifies multiple assessment timepoints and explicitly does not reduce them to one comparison, so the primary contrast is also unclear.

The record reports enrollment of 63 but does not give the number assigned to each intervention, the number assessed at follow-up or the analysis population. It does not describe withdrawals, adherence, missing questionnaire data or the handling of participants who received a transplant. These details are important for understanding how much of the planned follow-up contributed to any analysis.

The open-label design is recorded, but masking of outcome assessors and analysts is not reported. Allocation concealment procedures and the method used to generate the random sequence are not reported in the registry record. Statistical analysis details, including covariate adjustment, repeated-measures methods, multiplicity handling and sensitivity analyses, are also not reported.

The registry lists secondary outcomes and describes additional sleep and saliva measurements, but does not report their results or the analyses used. Serious adverse event counts are recorded as zero affected in both groups, while death counts are not reported in the registry record. The event-collection period and other safety-monitoring details are not reported. These limitations concern what the registry record makes available; they do not establish whether further information exists elsewhere.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Journeys to Wellness: A Transplant Candidate Study — NCT01254214.
• Registry record last updated 2016-10-31; status last verified 2016-09.
• Results first posted 2016-10-31.
• 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

NCT01254214, titled Journeys to Wellness: A Transplant Candidate Study, is recorded as a completed Phase 3 randomized, open-label, parallel-group study sponsored by the University of Minnesota. The registry lists enrollment of 63, a start date of 2010-02 and primary completion in 2014-06.

The study compared an 8-week telephone-adapted Mindfulness Based Stress Reduction program with a support group. The primary outcome was the State-Trait Anxiety Inventory, assessed at baseline, 8 weeks and 26 weeks. Secondary outcomes included measures of mental health, sleep and quality of life.

The registry record does not report a single primary comparison, primary-outcome estimates or statistical results. It also does not report the analysis population, missing-data methods or multiplicity procedures. The listed adverse-event entries show zero affected for serious and other events in both groups; death counts are not reported in the registry record.