This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record.
1. Trial at a Glance
SAMIT is a randomized, parallel, single-masked study evaluating an early psychotherapeutic intervention for attempted suicide intervention and prevention.
| Feature | SAMIT |
|---|---|
| NCT ID | NCT06238414 |
| Lead sponsor | Hospital Universitari Vall d'Hebron Research Institute |
| Condition | Suicide, Attempted; Suicide Prevention |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Primary purpose | Treatment |
2. Clinical Question
Population
Individuals included in the SAMIT program for attempted suicide intervention and prevention.
Intervention
Early psychotherapeutic intervention.
Comparator
A randomized comparator arm within the two-arm parallel study design.
Primary question
Does the intervention reduce recurrence and affect measures of suicidal behavior severity and lethality over 1 year?
3. Trial Design
Patients are allocated randomly between two study arms.
The registry describes the study as single masked.
Active, not recruiting.
The registry reports enrollment of 75 participants.
4. Endpoints
| Endpoint | Time frame | Description |
|---|---|---|
| Number of suicide attempts (recurrence) | 1 year | Recurrence monitored through follow-up evaluations at 3, 6, and 12 months and review of hospital medical history. |
| Severity of suicide behaviour | 1 year | Evaluated using the Columbia Suicide Severity Rating Scale (C-SSRS) when applicable during follow-up. |
| Suicide behaviour | 1 year | Evaluated using the Suicidal Crisis Syndrome (SCS) scale. |
| Lethality of suicide attempt | 1 year | Evaluated using the Scale for Assessment of the Lethality of the Suicide Attempt (SALSA). |
5. Planned Analysis
The registry does not report posted statistical analyses or outcome results for SAMIT. The primary completion date is listed as 2026-04-19.
The primary endpoint measuring recurrence of suicide attempts is a binary outcome recorded as YES or NO during follow-up. A comparison between randomized groups would typically use methods appropriate for binary outcomes, such as a risk comparison, odds ratio, or regression model depending on the prespecified analysis plan.
The C-SSRS, SCS, and SALSA endpoints involve structured clinical assessments. The appropriate statistical approach depends on the final measurement strategy, including whether analyses treat scores as continuous, categorical, or repeated measurements over time.
6. Statistical Methodology
Randomized comparison
Randomization is designed to balance known and unknown factors between treatment groups, allowing differences in outcomes to be interpreted as comparisons between assigned strategies.
Binary outcomes
For recurrence of suicide attempts, the central statistical question is whether the proportion of participants experiencing recurrence differs between randomized groups.
Longitudinal follow-up
The recurrence endpoint is assessed through follow-up contacts at 3, 6, and 12 months. Repeated assessments require careful handling of timing, missing observations, and participant follow-up completeness.
7. Statistical Methods Explained
Why does randomization matter?
Randomization reduces systematic differences between groups before treatment begins, supporting an unbiased comparison of outcomes.
Why is recurrence recorded as YES or NO?
A binary endpoint directly answers whether a participant experienced a recurrence during the defined follow-up period.
How would a binary endpoint usually be analysed?
Common approaches compare event proportions between groups, with confidence intervals used to describe uncertainty around the estimated difference.
Why are repeated follow-up assessments important?
Suicide-related outcomes may change over time. Measurements at multiple follow-up points provide information about the trajectory of outcomes.
Why are scales such as C-SSRS and SALSA useful?
Structured scales provide standardized assessments of clinically meaningful characteristics that may not be captured by a simple event count alone.
8. Limitations
- No posted results: the registry does not report statistical analyses or outcomes for SAMIT.
- Sample size: enrollment is 75 participants, which may affect precision of estimates.
- Outcome complexity: suicide-related outcomes require careful interpretation because recurrence, severity, behavior, and lethality represent different constructs.
- Follow-up dependence: conclusions from longitudinal outcomes depend on complete and reliable follow-up assessments.
9. Why This Trial Matters Statistically
| Concept | How it appears in SAMIT |
|---|---|
| Randomization | Two-arm randomized parallel design. |
| Binary endpoints | Recurrence of suicide attempts recorded as YES or NO. |
| Repeated follow-up | Assessments at 3, 6, and 12 months. |
| Clinical scales | C-SSRS, SCS, and SALSA measurements. |