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 Persistence Targeted Smoking Cessation in Serious Mental Illness (SMI) (NCT03873337), a na na study. The primary outcome is Acceptability 1: Participant Rating of Usefulness of Intervention.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03873337 |
| Phase | NA |
| Condition | Tobacco Use, Tobacco Smoking, Tobacco Use Cessation |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 34 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Rutgers, The State University of New Jersey |
| Results posted | Yes |
2. Clinical Question
Population
People with serious mental illness, with the listed conditions including schizophrenia and schizoaffective disorder, who took part in a smoking-cessation study. The record describes the primary endpoint population as participants who attended at least one counseling session. It reports 34 enrolled participants and says 33 participants provided post-session ratings.
Intervention
Participants received nicotine patches for 10 weeks and task-persistence-focused smoking-cessation counseling for 8 weeks. The counseling was delivered by telehealth. The study focused on the feasibility and acceptability of delivering this intervention in that format.
Comparator
There was no separate comparison group in the completed study. The record describes a single-group, within-subjects design and lists allocation as not applicable. The intervention components were delivered together, so their separate contributions cannot be compared using this design.
Primary question
How did participants rate the usefulness of the intervention after counseling sessions? Ratings covered how easy the intervention was to understand and how helpful it was. Each item used a 1-7 scale, with higher ratings representing greater ease or helpfulness. Numerical ratings and their variability are not reported in the registry record, so the primary question cannot be answered from the posted results.
3. Trial Design
The study, titled Persistence Targeted Smoking Cessation in Serious Mental Illness, was sponsored by Rutgers, The State University of New Jersey. Its official title refers to schizophrenia. The registry lists tobacco use and tobacco smoking, along with schizophrenia and schizoaffective disorder, among the conditions studied. The study started on 2019-04-22, had a primary completion date of 2022-01-10, and is listed as completed. Its phase is recorded as not applicable.
The study plan changed during the pandemic. The registry summary says it was modified from a randomized clinical trial intended to examine feasibility, initial efficacy, and mechanisms of action into a feasibility and acceptability test of telehealth delivery. The completed design is described as a single group with within-subjects assessments. Allocation is not applicable, masking is listed as none, and no control group is described. The completed study therefore does not support a randomized comparison between the intervention and a control condition.
The intervention combined nicotine replacement therapy with behavioral counseling. Participants were to receive nicotine patches for 10 weeks and 8 weeks of counseling focused on task persistence, delivered by telehealth. Since both components were offered together, the study cannot separate the effect of the patch from the effect of counseling.
The primary endpoint concerned participant ratings of intervention usefulness at the registry-listed timeframe of 3-months post quit date, approximately 4-months after baseline assessment. The description says participants rated the intervention after each session. The record does not explain how session-level ratings were combined into a participant-level endpoint. It also does not report a protocol-level statistical analysis plan, a sample-size justification, or details of interim analyses.
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
| Stage | NRT + Persistence Targeted Smoking Cessation in Serious Mental Illness (SMI) |
|---|---|
| STARTED | 34 |
| COMPLETED | 22 |
| NOT COMPLETED | 12 |
Analysis population for the primary outcome, as defined in the registry: Participants who attended at least 1 counseling session.
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 | NRT + Persistence Targeted Smoking Cessation in SMI |
|---|---|---|
| Participants analysed | 34 | |
| Age, Continuous | years | 42.65 (SD 11.96) |
| Sex/Gender, Customized: Male | Participants | 16 |
| Sex/Gender, Customized: Female | Participants | 17 |
| Sex/Gender, Customized: Gender Nonconforming | Participants | 1 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 4 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 30 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 3 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 6 |
| Race (NIH/OMB): White | Participants | 22 |
| Race (NIH/OMB): More than one race | Participants | 2 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 |
| Region of Enrollment: United States | participants | 34 |
| relight: Yes | Participants | 24 |
| relight: No | Participants | 10 |
6. Primary Endpoint
The registry lists the primary outcome as Acceptability 1: Participant Rating of Usefulness of Intervention, measured over 3-months post quit date (approximately 4-months after baseline assessment).
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is labeled “Acceptability 1: Participant Rating of Usefulness of Intervention.” It concerns participants’ judgments of two practical aspects of the counseling: whether it was easy to understand and whether it was helpful. After each session, participants rated each aspect on a 1-7 scale. The registry says that higher numbers represent greater ease and greater helpfulness, respectively. It also says the scale was developed for the study and has no official scale title.
Acceptability ratings can describe how participants experience an intervention, which is relevant when assessing whether a program can be delivered in a particular format. In this study, that question concerns telehealth counseling for people with serious mental illness. This is a general explanation of the role of acceptability measures, not evidence about the ratings in this trial.
The registry identifies the endpoint as a mean with standard deviation and names a timeframe of 3-months post quit date, approximately 4-months after baseline assessment. Its description also states that ratings were collected after each counseling session. The numerical mean and standard deviation are not reported in the registry record, nor is the method for combining repeated session ratings described. Consequently, the endpoint’s magnitude and precision cannot be assessed from the posted results.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The completed study is described as a single-group feasibility and acceptability test of a telehealth smoking-cessation intervention. The registry reports the intervention components, the intended assessment, enrollment, and some safety figures. It does not report numerical results for the primary acceptability endpoint. Although the endpoint is specified as a mean with standard deviation, neither statistic is available in the registry record. There are also no reported confidence intervals or hypothesis-test results for this endpoint. The primary result therefore cannot be quantified from the posted information.
The record states that 34 participants were enrolled and that participants who attended at least one counseling session were the primary endpoint population. It says 33 participants provided ratings after each session. These descriptions identify the rating population, but the record does not explain whether ratings were averaged across sessions, how incomplete session ratings were handled, or how the stated endpoint timeframe relates to ratings made after each session. Those details matter when interpreting a mean based on repeated observations.
The design change is important to interpretation. The study was modified from a randomized clinical trial into a single-group, within-subjects study. There is no separate control group in the completed design. As a result, these data cannot establish how the intervention compares with another treatment, usual care, or no intervention. Because nicotine patches and counseling were delivered together, the design also cannot identify the contribution of either component separately.
The registry lists secondary outcomes concerning abstinence at the end of counseling and at follow-up, task persistence scores, and cigarettes per day. It does not report numerical results for those outcomes in the information available for this analysis. Listing an outcome is not the same as reporting its estimate; no conclusion about the size, direction, or precision of those outcomes can be drawn.
Safety information is reported for the single intervention group, including serious adverse events, other adverse events, and deaths. Those figures describe what was recorded among participants, but without a comparison group they do not estimate whether the intervention changed the risk of an event. The record does not state whether any event was judged related to nicotine replacement or counseling. Overall, the posted information characterizes the study’s design and selected safety counts, but leaves the primary endpoint result and the efficacy outcomes unquantified.
9. Statistical Methods Explained
The registry describes the completed study as a single-group, within-subjects design. In general, a within-subjects design measures participants within the same group rather than assigning separate groups to different conditions. This can describe how participants’ observations vary across measurement occasions, but it does not create a concurrent control group. In this trial, the registry does not report a randomized comparison after the design was modified.
What does the primary endpoint summarize?
The primary endpoint is identified as a mean on a continuous rating scale, with standard deviation as its measure of dispersion. In general, a mean gives a central summary of observed scores, while a standard deviation describes how spread out the scores are around that mean. The endpoint uses ratings of ease of understanding and helpfulness, each on a 1-7 scale. The numerical mean and standard deviation are not reported in the registry record. Therefore, the typical rating and the amount of participant-to-participant variation cannot be assessed from the posted results.
The description says ratings were collected after each session, whereas the endpoint timeframe is stated as 3-months post quit date, approximately 4-months after baseline assessment. A statistical analysis of repeated ratings needs to specify which observations contribute to the summary and how multiple ratings from the same participant are handled. The registry does not report those details. It also does not describe whether the two rating items were summarized separately or combined; the description names both questions but does not specify a combined score.
Why does the single-group design matter?
In general, a treatment comparison requires a suitable contrast between groups or conditions. A single-group study can describe acceptability and observed outcomes among participants who receive the intervention, but it cannot by itself distinguish an intervention effect from other explanations for changes over time. The registry indicates that the original randomized design was modified during the pandemic. It does not report a control condition for the completed study, so comparative efficacy cannot be estimated from this design. The bundled delivery of nicotine patches and counseling also means their separate effects are not identified.
How should planning illustrations be read?
Any sample-size illustrations based on the observed effect are planning exercises rather than observed power. The stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the target effect is expressed as a fraction of the observed effect. Those assumptions do not describe the completed single-group design, which has no two-arm allocation. Such illustrations should be read only as hypothetical planning scenarios, not as evidence that the study had a particular probability of detecting an effect. The registry does not report the trial’s own sample-size justification.
For time-to-event planning, the record says the illustrations use the total number of events under the Schoenfeld approach; other illustrations express participants per arm. These are general planning conventions, not observed trial findings. No numerical planning results are stated in the registry record, and no values should be interpreted as the number of participants actually enrolled or analyzed.
What statistical procedures are not described?
The registry lists the primary endpoint’s summary type but does not report a full statistical analysis plan. The particular inferential test, any adjustment for baseline values or other variables, and any confidence-interval procedure are not reported in the registry record. A confidence interval, in general, expresses uncertainty around an estimate under the assumptions of a specified method; without an estimate and interval, the precision of the primary result cannot be evaluated.
The registry lists 12 outcome measures and 4 analyses, but it does not describe how the analyses relate to those outcomes or how multiple comparisons were handled. Over-dispersion is a general concern when count outcomes vary more than a chosen statistical model assumes; the record does not report whether such a model was used for any outcome. Likewise, no model for repeated ratings is specified. These are methodological details that would be needed to assess the analysis fully, not procedures that can be assumed from the endpoint descriptions.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 12 outcome measures and 4 analyses. It names one primary acceptability endpoint and several secondary outcomes, including abstinence measures, task persistence scores, and cigarettes per day. However, the registry record does not report how the analyses were mapped to the outcomes, whether all listed outcomes were analyzed, or whether any outcomes were added or changed. It does not report a multiplicity adjustment or a hierarchy for interpreting multiple tests. In general, examining several outcomes can increase the chance of a seemingly notable finding arising by chance; methods for addressing this depend on the analysis plan. No such plan is described in the record.
Missing-data methods are also not reported in the registry record. The record says 34 participants were enrolled and that 33 participants provided ratings, but it does not explain the missing rating for the remaining enrolled participant, whether session-level ratings were incomplete, or how incomplete observations were handled. It does not report imputation, exclusion rules, or sensitivity analyses. These omissions limit assessment of whether the reported rating population could differ from the enrolled group.
The primary endpoint population is defined as participants who attended at least one counseling session. The record does not describe an intention-to-treat analysis population or another complete analysis-set definition. It also does not state how participants who discontinued, missed sessions, or lacked follow-up information were treated for secondary outcomes. The listed sample and endpoint descriptions should not be read as confirmation that all enrolled participants contributed to every analysis.
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 |
|---|---|---|---|
| NRT + Persistence Targeted Smoking Cessation in SMI | 3 | 34 | 8.8% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| NRT + Persistence Targeted Smoking Cessation in SMI | 2 of 34 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| NRT + Persistence Targeted Smoking Cessation in SMI | 19 of 34 |
Most frequent serious adverse event terms
| Event term | Organ system | NRT + Persistence Targeted Smoking Cessation in SMI |
|---|---|---|
| Psychiatric hospitalization | Psychiatric disorders | 2 of 34 |
| Fractured nose | Injury, poisoning and procedural complications | 1 of 34 |
Most frequent non-serious adverse event terms
| Event term | Organ system | NRT + Persistence Targeted Smoking Cessation in SMI |
|---|---|---|
| Depression | Psychiatric disorders | 10 of 34 |
| Anxiety | Psychiatric disorders | 6 of 34 |
| Increased psychiatric symptoms | Psychiatric disorders | 6 of 34 |
| skin irritation at the patch site | Skin and subcutaneous tissue disorders | 4 of 34 |
| Headache | Nervous system disorders | 4 of 34 |
| Nausea / Upset stomach | Gastrointestinal disorders | 3 of 34 |
| Cold symptoms | Infections and infestations | 3 of 34 |
| Vivid dreams | Nervous system disorders | 2 of 34 |
Serious events with the highest arm-level rate: psychiatric hospitalization (5.9%), fractured nose (2.9%).
For the intervention group, the registry reports 34 participants at risk for serious adverse events, 3 participants affected by serious adverse events, 34 at risk for other adverse events, and 19 affected by other adverse events. It separately reports 2 deaths. The record lists psychiatric hospitalization at 5.9% and fractured nose at 2.9% among the leading serious adverse event terms.
These figures describe events recorded in the single intervention group. They are not a comparison of risks between treatment groups, because the completed study has no separate control group. The event counts also do not establish that an event was caused by the nicotine patch, counseling, or study participation. Whether an event was judged related to the intervention is not reported in the registry record. The relationship, if any, between the reported deaths and the adverse-event categories is also not reported.
In general, adverse-event counts are descriptive safety information. They do not, by themselves, show whether an intervention increased or decreased risk. The posted figures should therefore be read as counts and listed event terms for this group, not as causal estimates or comparative safety results.
12. What the Result Does, and Does Not, Mean
The registry record supports a limited description of the completed study: a single group received nicotine patches and telehealth counseling, and the study was reframed as an assessment of feasibility and acceptability. Participants rated ease of understanding and helpfulness after sessions, using a 1-7 scale. The record also reports the number enrolled, the number said to have provided ratings, and selected adverse-event information.
The most important limitation for interpreting the main question is that the numerical primary endpoint results are not reported in the registry record. The mean rating and standard deviation are absent, and no confidence interval or inferential result is reported. It is therefore not possible to determine from the posted results how participants rated the intervention overall, how much ratings varied, or how precisely any estimated mean was measured.
The design does not support a randomized comparison. No control group is reported for the completed study, and the intervention combined counseling with nicotine patches. Thus the study cannot show how outcomes compare with an alternative condition or separate the effects of the two intervention components. Although the registry names smoking-related secondary outcomes, their numerical results are not reported in the information available for this analysis.
These limitations do not negate the descriptive role of a feasibility and acceptability study. They do mean that conclusions must stay within what is documented: the study tested telehealth delivery in a single group, but the posted record does not quantify the primary acceptability ratings or establish comparative efficacy. The safety counts are likewise descriptive and do not establish causation or comparative risk. Missing details about repeated ratings, analysis populations, missing data, and statistical procedures further constrain assessment of the estimates.
13. Why This Trial Matters Statistically
This trial is statistically notable because its planned purpose changed. The registry summary says the study shifted from a randomized clinical trial intended to examine feasibility, initial efficacy, and mechanisms of action to a feasibility and acceptability test of telehealth delivery. The final design is single-group and within-subjects, rather than a randomized comparison. That distinction determines which questions the collected data can address.
Feasibility and acceptability questions can be important when an intervention is delivered in a particular setting or format. In general, participant ratings can describe whether an intervention is understandable and perceived as helpful. Here, however, the registry identifies the ratings but does not report their numerical results. This prevents readers from assessing the level and variability of acceptability from the posted record.
The study also illustrates why a protocol’s original aims should not be carried over automatically after a design change. A single group receiving a combined behavioral and drug intervention cannot provide the same comparative evidence as a randomized study with a control condition. The intervention components cannot be evaluated separately, and the registry does not report numerical results for the listed smoking outcomes.
Finally, a planning illustration based on observed effects should not be confused with the power of the completed study. The record’s described planning assumptions include equal allocation between two arms, which does not match the completed single-group design. This makes clear why sample-size calculations need to be interpreted in relation to the design and purpose they assume. The trial matters statistically as an example of how design, reporting, and the scope of an estimand shape the conclusions that can be drawn.
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 primary endpoint description contains repeated-session ratings, while the timeframe is stated as 3-months post quit date, approximately 4-months after baseline assessment. The registry does not explain how those session-specific observations were reduced to the endpoint summary, whether ratings were analyzed separately for ease and helpfulness, or how repeated measures within a participant were accounted for. Without these details, the meaning of a participant-level mean is not fully specified.
The completed design is single-group, and the registry says the study was modified from its randomized plan during the pandemic. The record does not describe a concurrent control group. As a result, it cannot support a randomized estimate of comparative effect. Nicotine replacement and counseling were offered together, so their individual contributions cannot be isolated.
Although the record lists secondary smoking-related outcomes, it does not report their numerical results in the information available for this analysis. The primary acceptability mean and standard deviation are also not reported. The record does not give a statistical analysis plan, sample-size justification, missing-data procedures, analysis-population rules, multiplicity handling, or details of interim analyses. These items should be regarded as not reported in the registry record rather than inferred from the outcome descriptions.
The enrollment and rating descriptions do not resolve how missing observations were handled. The record reports 34 enrolled participants and ratings from 33 participants, but does not explain the unreported rating or describe completeness across sessions. Finally, adverse-event figures are available for only the intervention group in the record, with no comparison group or reported judgment of event relatedness. This limits causal and comparative safety interpretation.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Persistence Targeted Smoking Cessation in Serious Mental Illness (SMI) — NCT03873337.
- Registry record last updated 2022-09-13; status last verified 2022-08.
- Results first posted 2022-08-16.
- 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.
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18. Record Summary
The registry describes a completed, single-group, within-subjects study of telehealth smoking-cessation counseling and nicotine patches for people with serious mental illness. It reports 34 enrolled participants. The intervention consisted of 10 weeks of nicotine patches and 8 weeks of task-persistence-focused counseling. The study was modified during the pandemic from a randomized trial plan to a feasibility and acceptability test.
The primary endpoint was participant ratings of ease of understanding and helpfulness on a 1-7 scale. The description says 33 participants provided ratings after sessions, but the numerical mean and standard deviation are not reported in the registry record. Secondary outcomes include abstinence measures, task persistence, and cigarettes per day, without numerical results in the information available for this analysis. The record also reports adverse-event counts and 2 deaths in the intervention group. It does not report comparative efficacy, missing-data methods, multiplicity handling, or a full statistical analysis plan.