Anxiety Lowering and Deprescribing Through Emotion Regulation: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Anxiety Lowering and Deprescribing Through Emotion Regulation (NCT06359314), a na na study. The primary outcome is Feasibility of Intervention.

2. Clinical Question

The study addresses whether an online self-guided program can be taken up and completed by older adult BZRA users being considered for deprescribing. Its registered primary outcome is feasibility rather than a between-group estimate of treatment effect. Enrollment is defined using the number who consented relative to the number eligible. Retention is defined using the number with a complete post-intervention assessment relative to the number who consented.

The registry reports that 49 people were eligible, 33 consented, and 16 were retained at post-intervention. These counts describe recruitment and follow-up in the enrolled group. They do not establish whether changes in anxiety, sleep, positive affect, or medication use were caused by ALDER. The study description says participants completed surveys before and after the intervention, but outcome-specific measurements and results are not reported in the registry record.

3. Trial Design

ALDER is registered as a completed, single-group behavioral intervention study. The registry lists an enrollment of 33 and no randomized allocation. Masking is listed as none, and the study has no control arm for a like-for-like comparison. The intervention is an online, self-guided positive emotion skills course lasting 5 weeks.

The registry lists a study start date of 2024-05-16 and a primary completion date of 2024-09-05. The status is completed. Participants were described as older than 65 and as candidates for BZRA deprescribing. The study description says participants completed two survey assessments: one before the intervention and one after. The primary outcome timeframe is described as post-intervention (7-weeks).

The registry record distinguishes feasibility from the intervention’s broader aims. The primary outcome is feasibility, measured through enrollment and retention counts. Other stated aims concern relevance and satisfaction, and whether the intervention is associated with changes in positive emotions, anxiety, trouble sleeping, and BZRA use. Secondary outcome topics also include patient-reported stress, depression, positive affect, and meaning and purpose. Outcome-specific numerical findings for these topics are not reported in the registry record.

Because this is a single-group study, any before-and-after observations would describe change over time within participants, not a contrast against an untreated or alternative-treatment group. Changes could not be separated from other influences using a concurrent randomized control comparison. The registry record does not report a statistical analysis plan, detailed eligibility criteria, the recruitment setting, or further procedural details. Phase is listed as not applicable.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Before assignment: Participants who met all eligibility requirements and provided informed consent were given access to the web-based intervention.

Overall Study

Analysis population for the primary outcome, as defined in the registry: n=49 were eligible; n=33 consented; n=16 were retained at post-intervention

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 Feasibility of Intervention, measured over Measured post-intervention (7-weeks)..

The primary endpoint is titled feasibility of intervention and is expressed as a percentage of participants. It uses two operational measures: enrollment, defined as the number who consented divided by the number eligible, and retention, defined as the number with a complete post-intervention assessment divided by the number who consented. The registry gives the corresponding counts: 49 eligible, 33 consented, and 16 retained at post-intervention. It does not report the calculated percentages in the registry record.

These measures are used to describe whether eligible people enroll and whether enrolled participants provide the planned post-intervention assessment. They address practical aspects of conducting the intervention and collecting follow-up data. They do not directly measure whether anxiety, sleep disturbance, or BZRA use improved, nor do they estimate a causal effect of ALDER.

General statistical context: a percentage is interpretable only alongside its denominator and the rule used to define the event. Here, enrollment and retention have different denominators, so they answer different questions. A complete post-intervention assessment is the registry’s retention criterion; the record does not specify how incomplete or partially completed assessments were handled. The listed post-intervention timeframe is 7-weeks, while the intervention itself is described as 5 weeks. Further detail about the timing and calculation of the endpoint is not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies feasibility as the primary outcome and defines it through enrollment and retention. Enrollment uses the eligible group as its denominator; retention uses consenting participants as its denominator. The posted counts are 49 eligible, 33 consented, and 16 retained at post-intervention. The record does not provide the calculated percentages, uncertainty intervals, or a more detailed analysis specification for either measure.

What does a denominator contribute?

General statistical explanation: a denominator defines the group to which a proportion refers. The enrollment measure asks what share of eligible people consented. The retention measure asks what share of consenting participants completed the post-intervention assessment. Because the denominators differ, the two measures should not be combined or interpreted as though they represent the same stage of participation. Clear denominators also help readers distinguish recruitment from follow-up.

What can a single-group design estimate?

The registry lists a single-group model and no randomized allocation. In general, a single-group pre-intervention and post-intervention design can describe observations at each assessment and changes within participants if those results are reported. It does not, by itself, provide a concurrent control comparison. Without such a comparison, differences over time cannot be attributed uniquely to the intervention; other influences may also contribute. In this record, numerical results for the secondary patient-reported outcomes are not reported in the registry record, so no such change estimate can be described.

How should planning assumptions be read?

The registry describes planning illustrations using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect. It further notes that time-to-event calculations would use total events, while other calculations would use participants per arm. These are general design assumptions for illustrations. They do not establish that the ALDER study had two randomized arms; its registered design is single-group. Numerical planning outputs and the observed effect used for any such illustration are not reported in the registry record.

General statistical explanation: a sample-size calculation asks how much information a proposed design might need to detect a chosen effect under specified assumptions. It depends on the endpoint, the target effect, variability or event frequency, the chosen error rate, and the analysis approach. A planning illustration is conditional on those assumptions. It is not an estimate of what the study actually found, and it is not observed power. The registry record does not report a protocol sample-size justification or enough outcome-specific information to assess the assumptions against observed results.

What does uncertainty reporting add?

General statistical explanation: point estimates give a single summary of observed data, while confidence intervals communicate uncertainty around an estimate under a statistical model. For a proportion, the interval’s width depends in part on the number of observations and the observed proportion, as well as the interval method. A p-value, when used, evaluates how compatible data are with a specified null model; it does not measure the size or importance of an effect. The registry record does not report confidence intervals, p-values, or an analysis method for the primary feasibility outcome.

The primary outcome is described as a percentage of participants, but it is based on two distinct process measures. The record does not say whether intervals or hypothesis tests were planned for those measures, how missing assessments were treated, or whether any adjustments were made. No inferential conclusions should be inferred from the counts alone.

Why can over-dispersion matter?

General statistical explanation: over-dispersion occurs when observed variation in count data exceeds what a statistical model assumes. If a model underestimates variation, standard errors can be too small and intervals can appear more precise than warranted. This matters for some count outcomes, but the primary endpoint in this record is a pair of proportions, and the registry does not report a count-model analysis. Whether over-dispersion is relevant to any unreported secondary analysis cannot be determined; such methods are not reported in the registry record.

For the patient-reported outcomes, the registry lists topic areas but does not provide scale names, scoring rules, analysis models, or numerical estimates. Those details are needed to assess measurement properties, distributional assumptions, and the precision of any change estimate. The registry also lists 10 outcome measures and zero analyses. That combination indicates that outcome topics are registered, while analyzed results are not present in the registry record. It does not justify filling in missing effect estimates or methods from assumptions.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 10 outcome measures and zero analyses. It identifies several secondary topics: BZRA use, sleep disturbance, anxiety, stress, depression, positive affect, and meaning and purpose. The registry also describes broader questions about relevance and satisfaction. Numerical results and analysis details for these topics are not reported in the registry record.

When a study examines multiple outcomes, the chance of at least one apparently notable finding can increase if each outcome is tested separately without a plan for multiplicity. General statistical practice may address this through prespecified outcome hierarchies, adjusted inference, or a primarily descriptive approach. Which approach was planned or used is not reported in the registry record, so no multiplicity adjustment should be assumed.

The endpoint definitions identify the denominators for enrollment and retention, and the record reports 49 eligible people, 33 who consented, and 16 retained at post-intervention. The registry does not report how incomplete assessments were handled, whether partial responses counted as missing, or whether any imputation or sensitivity analysis was performed. The difference between the number who consented and the number retained establishes that not all consented participants were retained under the stated criterion; reasons for this are not reported in the registry record.

The analysis population is not described beyond the primary outcome’s stated counts. The registry record does not report whether analyses used all consented participants, only those with complete post-intervention assessments, or another population definition. It also does not report a prespecified statistical analysis plan or the timing of any analyses. These omissions limit assessment of how missing data, multiple outcomes, or population definitions may have influenced results.

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 reports safety counts for the intervention group, with 33 participants at risk in the serious-adverse-event category and 33 at risk in the other-adverse-event category. It records zero serious adverse events, zero other adverse events, and zero deaths. No top serious event terms are listed.

These are recorded counts in the single intervention group. They should not be read as a comparison with another treatment or with no intervention, because the study has no control group. A zero count in this cohort means no events in that category were recorded in the posted results; it does not establish that the underlying risk is absent. The registry record does not report detailed event definitions, the safety observation period, or further information about how events were collected and classified.

General statistical context: rare events can be difficult to characterize precisely when the number observed is small. A count of zero is therefore a description of the posted observations, not a guarantee about what could occur in another group or setting. No additional safety-rate calculation or comparative estimate is reported in the registry record.

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

The result in the registry is primarily a feasibility description. It records 49 eligible people, 33 who consented, and 16 retained at post-intervention. These counts show that recruitment and follow-up were recorded for a completed single-group study. The registry does not report the calculated enrollment or retention percentages, so the counts do not support a claim about a particular percentage reaching either stage.

The record does not report numerical pre-intervention or post-intervention results for anxiety, sleep disturbance, positive affect, BZRA use, or the other listed patient-reported outcomes. It therefore does not establish the magnitude, direction, or precision of change in those outcomes. Questions about relevance and satisfaction are described as study aims, but results for them are not reported in the registry record.

The design also limits interpretation of any within-participant change that might be available elsewhere. There is no randomized control group in this record, so a change over time would not by itself distinguish an intervention effect from other changes occurring over the same period. The posted counts should not be treated as evidence that the intervention caused a change in symptoms or medication use.

The serious adverse event counts are zero, as are the displayed other adverse event and death counts. These figures describe recorded events among the intervention group; they are not comparative evidence and do not establish that risks are absent.

General statistical context: feasibility and effectiveness are different questions. Feasibility measures whether people can be recruited and retained under the study procedures. Effectiveness requires outcome results and an appropriate design and analysis to estimate how outcomes differ under the intervention relative to a relevant alternative. The registry record gives feasibility counts but does not report comparative effect estimates or the analyses needed to answer the broader outcome questions.

13. Why This Trial Matters Statistically

Feasibility studies address practical questions that can matter before a larger evaluation is undertaken: whether eligible people consent and whether participants complete follow-up. ALDER’s registered primary outcome focuses on those steps, using enrollment and post-intervention retention. Reporting the underlying counts—49 eligible, 33 consented, and 16 retained—makes the flow of participants visible without conflating recruitment with outcome change.

The distinction is statistically important. A program may be of interest as an intervention, while the available endpoint evaluates whether participation and assessment occurred. These are different estimands: one concerns study process, while another would concern change in clinical or behavioral outcomes. The registry describes both feasibility and broader questions about anxiety, sleep, positive emotions, and BZRA use, but outcome analyses for those broader questions are not reported in the registry record.

The single-group design makes the boundaries of inference especially important. The study can document its own recruitment and retention experience, but without a randomized comparator it cannot estimate a controlled between-group difference. The record’s planning assumptions referring to equal allocation between two arms are assumptions for planning illustrations, not a description of the registered design.

These features make careful separation of aims, observed counts, and effect estimates essential. The posted information is useful for understanding how the feasibility endpoint was defined and how many people reached each recorded stage. It does not provide the outcome estimates or uncertainty measures needed to judge changes in symptoms or medication use. This distinction helps readers interpret the record without treating an implementation question as an efficacy conclusion.

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 registry record gives limited information about how participants were selected, approached, and assessed. It identifies the intended population as adults over the age of 65 who were candidates for BZRA deprescribing, but detailed eligibility criteria and the recruitment setting are not reported in the registry record. Reasons eligible people did not consent and reasons participants were not retained are also not reported.

The primary outcome is defined through enrollment and retention counts, but calculated percentages and uncertainty intervals are not reported in the registry record. The record does not specify how incomplete or partially completed surveys were classified, whether any missing-data method was used, or which analysis population was intended. These omissions restrict interpretation of the follow-up count.

The intervention is described as a 5-week online self-guided course, with survey assessments before and after. More detail about adherence, intervention exposure, and the exact timing of assessments is not reported in the registry record. The post-intervention outcome timeframe is listed as 7-weeks, but further timing details are not given.

The single-group design and absence of randomization mean there is no concurrent control comparison. In addition, numerical results for the secondary outcomes and analyses are not reported in the registry record. The analysis plan, outcome scoring methods, and handling of multiple outcomes are also not reported. These limitations mean that the record supports a description of the feasibility counts and safety counts, but not a detailed estimate of intervention-associated changes or their precision.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Anxiety Lowering and Deprescribing Through Emotion Regulation — NCT06359314.
• Registry record last updated 2025-12-16; status last verified 2025-11.
• Results first posted 2025-12-16.
• 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

NCT06359314 is a completed, single-group behavioral study of ALDER, a 5-week online self-guided positive emotion skills course for older adults who were candidates for BZRA deprescribing. The registry lists an enrollment of 33, no randomized allocation, and no masking.

The primary outcome is feasibility, defined through enrollment among eligible people and retention at post-intervention. The record reports 49 eligible, 33 consented, and 16 retained. Calculated percentages and uncertainty estimates are not reported in the registry record. Results for the broader patient-reported outcome topics are also not reported.

For the intervention group, the registry records zero serious adverse events, zero other adverse events, and zero deaths. With no control group, these are descriptive cohort counts rather than comparative safety estimates.