This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Augmenting Buried in Treasures Workshop (BIT) With In-home Decluttering Practice for Individuals With Hoarding Disorder (NCT02377986), a na na study. The primary outcome is Savings Inventory Revised.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02377986 |
| Phase | NA |
| Condition | Hoarding Disorder |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 5 |
| Arms in the primary outcome | n/a |
| Lead sponsor | New York State Psychiatric Institute |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns individuals with hoarding disorder. The registry record reports enrollment of 5 participants. It does not provide further eligibility details or a description of the enrolled participants, so characteristics such as their baseline symptom levels are not reported in the registry record.
Intervention
The intervention combines the Buried in Treasures Workshop (BIT) with in-home decluttering practice. The registry describes participants who had not received BIT through the investigators’ previous study, IRB 6681, as receiving BIT plus in-home decluttering practice. The record also lists In-Home Decluttering as a behavioral intervention.
Comparator
No separate comparison group is described. The study is listed as single-group, with allocation recorded as not applicable. There is therefore no concurrent control arm in the registry record against which to compare changes in symptoms. The design does not support a like-for-like treatment comparison.
Primary question
The primary outcome is the Savings Inventory Revised (SI-R), a questionnaire measuring symptoms associated with hoarding disorder. The stated timeframe is change from baseline at 0, 12 weeks and 18 weeks after treatment start. The clinical question is whether symptom scores are described over those time points among participants receiving BIT with in-home practice. The registry record does not report the resulting scores or an analysis of change.
3. Trial Design
NCT02377986 is listed as a completed, single-group behavioral study sponsored by New York State Psychiatric Institute. The registry lists enrollment of 5 participants, with a start date of 2015-02 and primary completion in 2015-08. The phase is recorded as not applicable. Allocation is also recorded as not applicable, and masking is listed as none.
The experimental group is described as receiving BIT plus in-home decluttering practice. The description says that patients who had not received the BIT workshop through the investigators’ previous study, IRB 6681, would receive the combined intervention. The registry also lists In-Home Decluttering as a behavioral intervention. No separate control group is described, so the design is not a randomized comparison and does not provide a concurrent control condition.
The primary outcome is the Savings Inventory Revised. Its stated timeframe is change from baseline at 0, 12 weeks and 18 weeks after treatment start. The record lists 2 outcome measures, but numerical results for the primary outcome are not reported in the registry record. It lists no analyses. The intervention’s completion status does not establish what happened to each participant or whether follow-up measurements were obtained.
With a single group, observed changes over time could describe participants’ scores during the study, but cannot by themselves separate intervention-associated change from other explanations. Without a control arm, the registry record does not establish how scores would have changed over the same period without the intervention. Details such as the recruitment process, treatment adherence, and reasons for any missing assessments are not reported in the registry record.
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: Not applicable. Participants did not have a wash out or run-in.
Overall Study
| Stage | Experimental: BIT+In-home Decluttering |
|---|---|
| STARTED | 5 |
| COMPLETED | 5 |
| NOT COMPLETED | 0 |
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.
| Characteristic | Unit | Experimental: BIT+In-home Decluttering |
|---|---|---|
| Participants analysed | 5 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 4 |
| Age, Categorical: >=65 years | Participants | 1 |
| Sex: Female, Male: Female | Participants | 5 |
| Sex: Female, Male: Male | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 |
| Race (NIH/OMB): White | Participants | 4 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Savings Inventory Revised, measured over Change from baseline at 0, 12 weeks and 18 weeks after treatment start.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Full Range |
| Unit | units on a scale |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the Savings Inventory Revised (SI-R), a questionnaire intended to measure symptoms associated with hoarding disorder. It has 23 items and three subscales: difficulty discarding, excessive clutter, and compulsive acquisition. The total score is the sum of the items and ranges from 0 to 92. The record states that a total score greater than 41 shows significant difficulty with clutter.
The acquisition subscale ranges from 0 to 28, with a score greater than 13 indicating difficulty with excessive acquisition. The difficulty-discarding subscale also ranges from 0 to 28, with a score greater than 13 indicating difficulty with discarding. The clutter subscale ranges from 0 to 36, with a score greater than 15 indicating difficulty with accumulated clutter. These are the score descriptions and thresholds recorded for the measure.
Repeated measurement can describe symptom scores at different times and whether they change from baseline. The registry specifies a median and full range as the summary approach and gives the assessment timeframe as baseline, 12 weeks and 18 weeks after treatment start. The actual median scores and ranges at these time points are not reported in the registry record. Consequently, the direction, size, and precision of any observed score change cannot be assessed from the posted results.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a small, single-group study of BIT with in-home decluttering practice. It reports enrollment of 5 participants and names the SI-R as the primary outcome. However, it does not report the outcome values at baseline or follow-up, a change estimate, or a statistical analysis. The record therefore does not allow readers to quantify symptom change or determine how variable the observed scores were.
The registered summary measure is the median with the full range. A median describes the middle of the observed values and is less influenced by unusually high or low observations than a mean. The full range communicates the lowest and highest observed values, but does not show how values are distributed between those extremes. With a small group, individual observations can have substantial influence on the descriptive summary. In this record, the actual medians and ranges are not reported in the registry record.
The stated timeframe includes baseline and assessments at 12 weeks and 18 weeks after treatment start. These time points could be used to describe the course of scores during follow-up, if results were available. The record does not report whether all enrolled participants completed each assessment, so the number contributing to any time point is not reported in the registry record. It also does not state how missing assessments were handled.
There is no concurrent comparison group. Any change observed within participants would be a description of change over time, not a controlled estimate of the intervention’s effect relative to an alternative. General statistical interpretation: a before-and-after change can reflect multiple influences, including the intervention and changes in circumstances over time; a single-group design cannot isolate these explanations by comparison with an untreated or otherwise treated group.
The registry lists no analysis entries. It is therefore not possible to assess a reported estimate, its uncertainty, or the method used to analyze scores. No confidence interval or p-value for the primary outcome is reported in the registry record. The enrollment count alone does not establish whether an effect was present, absent, or estimated precisely. In particular, no conclusion about symptom outcomes follows from the study’s completed status or from the absence of numerical results.
The adverse-event entries list 5 participants at risk for serious adverse events and 0 affected, as well as 5 at risk for other adverse events and 0 affected; deaths are listed as 0. Those entries describe what the registry reports, but they do not replace the missing symptom outcome results. A zero count in a small study is not proof that an event cannot occur, and the record does not give detailed adverse-event terms.
9. Statistical Methods Explained
The registry record identifies a median and full range for the primary measure, the SI-R, and lists no analyses. The discussion below explains general statistical concepts relevant to interpreting a study with this structure; it does not describe analyses reported by the investigators.
What does a median describe?
General explanation: the median is the middle value when observations are ordered. It can be useful when data are skewed or when a few extreme observations might pull the mean away from where most observations lie. A full range reports the smallest and largest observed values, giving a sense of the span of the data. The range alone does not show how observations are distributed within that span, and it can be sensitive to individual extreme values.
The registry specifies median and full range for the SI-R but provides no numerical summaries. Thus, readers cannot use the posted results to see the central score or the spread of observed scores at the registered time points. Nor can the summaries be compared across time, since the values themselves are not reported.
What would change from baseline mean?
General explanation: a change-from-baseline analysis compares a participant’s later measurement with that participant’s starting measurement. It is a way to describe within-person movement over time. It differs from comparing separate groups, where the contrast is between participants assigned or exposed to different conditions. The registry names baseline, 12 weeks and 18 weeks after treatment start as time points, but provides neither participant-level changes nor group summaries for those assessments.
In a single-group study, a change from baseline does not by itself show what would have happened without the intervention. The absence of a concurrent comparator means that time trends and other influences cannot be distinguished from intervention-associated change using a between-group contrast. This is a general design limitation, not a finding about the direction or size of any change in this study.
How should uncertainty be considered?
General explanation: an estimate describes an observed quantity, while an uncertainty interval conveys a range of values compatible with the data under the chosen statistical model. Wider intervals indicate less precision; narrower intervals indicate greater precision, subject to the assumptions behind the analysis. The registry does not report a change estimate or confidence interval for the SI-R. Therefore, its precision cannot be evaluated from the posted results.
The enrollment of 5 participants makes careful attention to individual observations and uncertainty especially important. This statement is about the amount of information in the reported enrollment, not an estimate of statistical power. No sample-size justification is reported in the registry record, and there is no reported analysis from which to evaluate the precision of an outcome estimate.
What do the sample-size assumptions describe?
The registry’s planning assumptions describe an illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is described as a stated fraction of the observed effect. For time-to-event calculations, the assumption description refers to the total number of events using the Schoenfeld method; other calculations are expressed as participants per arm.
These are planning assumptions, not evidence that this single-group study used a two-arm design. They are not the trial’s own design justification, and the registry record does not report a sample-size justification. The assumptions alone do not provide a numerical planning estimate or establish the study’s power. Any planning illustration based on an observed effect should be understood as a planning scenario, not as observed power. The registry record reports no numerical sample-size estimates for these scenarios.
What analysis can be assessed?
The record lists 2 outcome measures and no analyses. It names the SI-R as the primary outcome, but does not report a statistical model, a test, an estimate, or a measure of uncertainty. General explanation: evaluating an analysis requires knowing what outcome was analyzed, how repeated observations were handled, what assumptions were made, and how missing observations were treated. Those analysis details are not reported in the registry record, so readers cannot assess whether an inferential method was appropriate or reproduce an analysis.
Statistical significance, if it had been reported, would not by itself describe the magnitude or precision of a change. A p-value addresses compatibility between data and a specified null model under assumptions; it does not give the probability that a hypothesis is true. Here, no p-value for the primary outcome is reported, so there is no inferential result to interpret. The absence of such a result should not be read as evidence for either no change or a particular effect.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 2 outcome measures and identifies the SI-R as the primary outcome. It does not provide numerical results or analysis entries. The other outcome measure is not described in the available registry entries, and the record does not report how it was analyzed. A multiplicity strategy is not reported in the registry record.
General explanation: when several outcomes, time points, or statistical comparisons are examined, the chance of finding an apparently unusual result can increase if each is treated as an independent primary test. Prespecifying a primary outcome and analysis can help distinguish confirmatory questions from exploratory ones. Adjustments or other strategies may be used to address multiple testing, but the appropriate approach depends on the study’s aims and analysis plan. No such plan or adjustment is reported in this record.
Missing-data procedures and analysis populations are also not reported in the registry record. The enrollment is 5, but the record does not state how many participants contributed data at each SI-R assessment, whether any participants discontinued, or how missing measurements were handled. It does not identify an intention-to-treat, per-protocol, or other analysis population. These omissions prevent assessment of whether the reported summaries, if available, would represent all enrolled participants or only participants with observed measurements.
General explanation: missingness can affect interpretation when the chance of an observation being absent is related to its value or to participants’ circumstances. Statistical methods for missing data rely on assumptions, and the assumptions should be described alongside the analysis. Because neither missingness details nor a missing-data method are reported, the potential influence of missing observations cannot be evaluated from the posted results.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Experimental: BIT+In-home Decluttering | 0 | 5 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Experimental: BIT+In-home Decluttering | 0 of 5 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 1% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Experimental: BIT+In-home Decluttering | 0 of 5 |
The registry lists 5 participants at risk for serious adverse events and 0 affected. It also lists 5 at risk for other adverse events and 0 affected, with 0 deaths. No serious adverse-event terms are listed. These are registry counts, not estimates of comparative risk, because the study has no separate control group.
A count of zero affected participants means that the registry reports no events in that category for the participants counted. It does not establish that the intervention has no risks or that such events could not occur. General explanation: safety counts are interpreted in light of the number of people observed, the length and completeness of follow-up, and how events were collected and classified. The registry record does not provide detailed event definitions, collection procedures, or follow-up completeness for safety reporting.
The enrollment was 5, and the record does not give a comparison with another group. The absence of reported events should therefore be read narrowly as the recorded count, not as proof of safety or as a finding that can be generalized to other participants. The registry’s serious and other adverse-event entries do not provide information about SI-R symptom changes.
12. What the Result Does, and Does Not, Mean
This record documents a completed, single-group study of BIT combined with in-home decluttering practice for individuals with hoarding disorder. It identifies the SI-R as the primary measure and states that change from baseline was to be assessed at 0, 12 weeks and 18 weeks after treatment start. It also reports enrollment of 5 participants. These details describe the study’s focus and design, not its clinical outcome.
The registry record does not report numerical SI-R results, a change estimate, a confidence interval, or a p-value. As a result, the posted results do not show the direction or magnitude of symptom-score change, how variable the scores were, or how precisely any change was estimated. They also do not establish whether all participants completed the planned assessments.
The absence of a comparator matters for causal interpretation. Even if within-person score changes had been reported, a single-group design could describe change over time but would not provide a concurrent estimate of what would have happened without the intervention. The registry record therefore does not establish that the intervention caused a change. Equally, because numerical outcome results are not reported, the record does not establish that there was no change.
The zero adverse-event counts are limited to the registry entries and the participants counted. They are not proof that adverse events cannot occur, and they do not resolve the missing efficacy results. The record also does not report a statistical analysis plan, missing-data procedures, or analysis populations, so important aspects of how outcomes were intended to be interpreted are unavailable.
In short, the available record supports a description of a small, completed single-group study and its planned symptom measure. It does not support a quantitative conclusion about symptom outcomes, a comparison with an alternative, or a causal claim. Those boundaries reflect what is and is not reported in the registry record.
13. Why This Trial Matters Statistically
This study is statistically notable because its design and the scope of its available results need to be kept distinct. The registry identifies a single-group behavioral intervention and a repeated symptom measure, but does not report numerical outcome analyses. A completed status is not a substitute for an effect estimate, and enrollment alone cannot establish whether a change occurred.
The design also illustrates why a within-group trajectory and a comparative treatment effect are different statistical questions. Repeated SI-R measurements could describe participant scores over time. Without a concurrent control group, however, such a trajectory would not provide a direct contrast with what happened under another condition. This limits causal interpretation independently of the size or direction of any observed change.
The registry specifies a median and full range, which are descriptive summaries rather than a complete account of uncertainty. For a study enrolling 5 participants, individual observations can be important to the summaries. Without the actual values, readers cannot judge the spread, whether scores shifted consistently, or how precisely a typical change was estimated.
The record’s planning assumptions also offer a useful distinction: sample-size calculations are planning illustrations, not observed results or evidence of power. The listed assumptions describe a hypothetical two-arm calculation, while the registered study is single-group. No numerical planning estimates or trial-specific sample-size justification are reported in the registry record.
Finally, the absence of analysis entries, missing-data details, and a multiplicity strategy limits statistical appraisal. These are not merely technical details: they determine which observations and questions underlie an estimate. The record’s value is therefore in documenting the study’s stated design, intervention, and outcome measure, while its statistical conclusions remain unavailable from the posted results.
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 most important limitation specific to this trial is that the registry record does not report numerical results for the primary SI-R outcome. The stated assessments at baseline, 12 weeks and 18 weeks cannot be evaluated without score summaries or an analysis. The record also lists no analyses, so there is no reported estimate or uncertainty measure to interpret.
The design is single-group and has no like-for-like control comparison. This means that any change over time, if reported, could not be distinguished from other changes over the same period using a concurrent comparison. The record does not describe a randomized allocation or a separate comparator arm.
Enrollment was 5. The registry does not report participant characteristics, baseline SI-R values, adherence to the intervention, completion of follow-up, or reasons for missing observations. The number contributing to each outcome assessment and the method for handling missing data are not reported in the registry record. These omissions constrain assessment of the representativeness and completeness of any outcome summaries.
The record lists 2 outcome measures but does not describe the second measure in the details available for this analysis. It does not report an analysis plan, multiplicity approach, or analysis population. A sample-size justification is not reported in the registry record; the listed planning assumptions are not a substitute for one and do not provide numerical estimates.
Safety information is limited to the reported counts, with no serious-event terms listed. Detailed event definitions, collection methods, and follow-up completeness are not reported. Taken together, these limitations mean the registry supports a description of the study’s stated design and measures, but not a quantitative assessment of clinical outcomes or comparative effects.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Augmenting Buried in Treasures Workshop (BIT) With In-home Decluttering Practice for Individuals With Hoarding Disorder — NCT02377986.
- Registry record last updated 2020-02-11; status last verified 2020-02.
- Results first posted 2020-02-11.
- 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.
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18. Record Summary
NCT02377986 is a completed, single-group behavioral study sponsored by New York State Psychiatric Institute. It enrolled 5 participants and evaluated BIT with in-home decluttering practice for individuals with hoarding disorder. The registry lists no masking and no applicable allocation.
The primary outcome is the Savings Inventory Revised, with change from baseline specified at 0, 12 weeks and 18 weeks after treatment start. The registry describes the measure’s total and subscale scores and identifies a median and full range as the summary approach. Numerical outcome results and analyses are not reported in the registry record.
The record lists 2 outcome measures and no analyses. It reports 0 participants affected by serious adverse events, 0 affected by other adverse events, and 0 deaths among 5 participants at risk in each adverse-event category. The study has no concurrent comparator, and analysis populations, missing-data procedures, and a trial-specific sample-size justification are not reported in the registry record.