Suicidal IdeationNCT05816317
Randomized Controlled Trial of a Single-session Mechanism-focused Intervention for Suicidal Thoughts and Behaviors
A study testing Single-Session Mechanism-Focused Intervention (SSMFI) and Distress Tolerance Skills Review in people with Suicidal Ideation and Hopelessness, run by Shannon E. Sauer-Zavala at 1 site in United States.
Trial summary
Across multiple models of suicide risk, hopelessness and perceptions of social relatedness (i.e., lack of social connection/thwarted belongingness, perceived burdensomeness) have emerged as candidate mechanisms that maintain STBs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicidal Ideation, Hopelessness, Wish to Live
- What is being tested?
- Single-Session Mechanism-Focused Intervention (SSMFI) and Distress Tolerance Skills Review
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2024to 20 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- admitted for care to the Adult Inpatient Unit at Good Samaritan Hospital
- endorse suicidal ideation and/or a recent suicide attempt (i.e., "a potentially self-injurious act committed with at least some wish to die") upon intake to the unit
- 18 years of age; (4) English speaking
- able to provide two methods for follow-up contact (i.e., phone number, email address) in order to complete study follow-up assessment.
Who cannot join
- current manic episode
- acutely psychotic
- actively detoxicating from substances
- the inability to comprehend the intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-session Intervention for Suicidal Thoughts and Behaviors
Across multiple models of suicide risk, hopelessness and perceptions of social relatedness (i.e., lack of social connection/thwarted belongingness, perceived burdensomeness) have emerged as candidate mechanisms that maintain STBs. Although these mechanisms have garnered strong empirical support in predicting STBs, there has been virtually no integration with interventions aimed for individuals at acute risk for suicide. Thus, the overarching goal of the present proposal is to evaluate a mechanism-focused intervention that explicitly targets two core mechanisms implicated in the maintenance of STBs: hopelessness and negative perceptions of social relatedness. Given that the period immediately following hospital discharge presents the highest risk for suicide attempts and up to 70% of patients admitted for a suicide attempt do not attend their first outpatient appointment, the intervention will be evaluated on an inpatient unit. Additionally, most of the extant interventions for STBs are administered across multiple sessions (i.e., 4 sessions and up to one year); however treatments of this length are unlikely to be feasible in acute care settings. Fortunately, very brief suicide prevention interventions, are effective in reducing future suicide attempts and increasing the likelihood of attending follow-up treatments. Additionally, single-session interventions (not suicide specific) have been shown to reduce hopelessness immediately and at a one-month follow-up.
The present study is an RCT comparing a novel Single Session Mechanism Focused Intervention (SSMFI) for STBs to treatment-as-usual (TAU) on a psychiatric inpatient unit for patients admitted for suicidal ideation or attempt. The engagement of the putative processes (hopelessness and negative perceptions of social relatedness) that maintain STBs will be assessed, along with the feasibility and acceptability of SSMFI for STBs on an inpatient psychiatric unit.
- Conditions
- Suicidal Ideation, Hopelessness, Wish to Live, Wish to Die
- Being tested
- Single-Session Mechanism-Focused Intervention (SSMFI), Distress Tolerance Skills Review
- Medical subject headings
- Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-Session Mechanism-Focused Intervention (SSMFI)Behavioural
A brief intervention for patients hospitalized for suicide risk that directly targets hopelessness and perceptions of social relatedness.
Distress Tolerance Skills ReviewBehavioural
Treatment as usual at the inpatient setting for this study.
| Study group | Role | What they receive |
|---|---|---|
| Single-Session Mechanism Focused Intervention (SSMFI) | Experimental | Not described Receives: Behavioral: Single-Session Mechanism-Focused Intervention (SSMFI) |
| Treatment as Usual | Active comparator | Not described Receives: Behavioral: Distress Tolerance Skills Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in intensity of suicidal ideation
RATE OVERALL INTENSITY OF YOUR SUICIDAL IDEATION RIGHT NOW: (scale from "1" Extremely low intensity to "5" Extremely high intensity)
Measured: Pre-intervention and directly after the intervention (i.e., 1 hour later)
Change in hopelessness
How much are you feeling hopeless right now? (scale from "1" Not at all to "5" A lot)
Measured: Pre-intervention and directly after the intervention (i.e., 1 hour later)
Change in wish to live
I wish to live this much: (scale from "0" Not at all to "8" Very much)
Measured: Pre-intervention and directly after the intervention (i.e., 1 hour later)
Change in wish to die
I wish to die this much: (scale from "0" Not at all to "8" Very much)
Measured: Pre-intervention and directly after the intervention (i.e., 1 hour later)
Change in Beck Hopelessness Scale
Hopelessness will be measured with the Beck Hopelessness Scale. Scores range from 0-20 and higher scores indicate greater levels of hopelessness.
Measured: pre-intervention, 1 week after the intervention is completed, 1 month after the intervention is completed
Change in Interpersonal Needs Questionnaire
Perceptions of social connectedness will be assessed with the Interpersonal Needs Questionnaire. Scores range from 0 to 107 with higher scores indicating less connection with others.
Measured: pre-intervention, 1 week after the intervention is completed, 1 month after the intervention is completed
Secondary outcomes (2)
Change in Columbia Suicide Severity Rating Scale
The self-report version of the Columbia Suicide Severity Rating Scale will be used to assess the presence of suicidal behaviors thoughts and behaviors. Participants are asked to respond Yes/No to 6 items that refer to various suicide related phenomena (thoughts, planning, intent, and behaviors). There is no total score for this measure.
Measured: pre-intervention, 1 week after the intervention is completed, 1 month after the intervention is completed
Change in Adult Suicidal Ideation Questionnaire
Intensity of suicidal ideation will be measured with the Adult Suicidal Ideation Questionnaire. Scores range from 0-150 and higher scores indicate greater intensity of suicidal ideation.
Measured: pre-intervention, 1 week after the intervention is completed, 1 month after the intervention is completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start16 Oct 2024
- Primary completion20 May 2025
- Study completion20 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shannon E. Sauer-Zavala
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shannon E. Sauer-Zavala, University of Kentucky
- Investigators
- Shannon Sauer-Zavala, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05816317
- Sponsor's protocol ID
- 343205
- Status last verified
- Jul 2025
- First submitted
- 29 Mar 2023
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-session Intervention for Suicidal Thoughts and Behaviors
- ClinicalTrials.gov ID
- NCT05816317
- Acronym / sponsor ID
- 343205
- Conditions
- Suicidal Ideation, Hopelessness, Wish to Live, Wish to Die
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Shannon E. Sauer-ZavalaUniversity, hospital or other
- Study start
- 16 Oct 2024 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Across multiple models of suicide risk, hopelessness and perceptions of social relatedness (i.e., lack of social connection/thwarted belongingness, perceived burdensomeness) have emerged as candidate mechanisms that maintain STBs. Although these mechanisms have garnered strong empirical support in predicting STBs, there has been virtually no integration with interventions aimed for individuals at acute risk for suicide. Thus, the overarching goal of the present proposal is to evaluate a mechanism-focused intervention that explicitly targets two core mechanisms implicated in the maintenance of STBs: hopelessness and negative perceptions of social relatedness. Given that the period immediately following hospital discharge presents the highest risk for suicide attempts and up to 70% of patients admitted for a suicide attempt do not attend their first outpatient appointment, the intervention will be evaluated on an inpatient unit. Additionally, most of the extant interventions for STBs are administered across multiple sessions (i.e., 4 sessions and up to one year); however treatments of this length are unlikely to be feasible in acute care settings. Fortunately, very brief suicide prevention interventions, are effective in reducing future suicide attempts and increasing the likelihood of attending follow-up treatments. Additionally, single-session interventions (not suicide specific) have been shown to reduce hopelessness immediately and at a one-month follow-up.
The present study is an RCT comparing a novel Single Session Mechanism Focused Intervention (SSMFI) for STBs to treatment-as-usual (TAU) on a psychiatric inpatient unit for patients admitted for suicidal ideation or attempt. The engagement of the putative processes (hopelessness and negative perceptions of social relatedness) that maintain STBs will be assessed, along with the feasibility and acceptability of SSMFI for STBs on an inpatient psychiatric unit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-Session Mechanism Focused Intervention (SSMFI) | Experimental | Behavioral: Single-Session Mechanism-Focused Intervention (SSMFI) |
| Treatment as Usual | Active comparator | Behavioral: Distress Tolerance Skills Review |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- admitted for care to the Adult Inpatient Unit at Good Samaritan Hospital
- endorse suicidal ideation and/or a recent suicide attempt (i.e., "a potentially self-injurious act committed with at least some wish to die") upon intake to the unit
- 18 years of age; (4) English speaking
- able to provide two methods for follow-up contact (i.e., phone number, email address) in order to complete study follow-up assessment.
Key exclusion criteria (4 listed)
- current manic episode
- acutely psychotic
- actively detoxicating from substances
- the inability to comprehend the intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single-Session Mechanism-Focused Intervention (SSMFI)A brief intervention for patients hospitalized for suicide risk that directly targets hopelessness and perceptions of social relatedness. | Behavioural | Single-Session Mechanism Focused Intervention (SSMFI) |
| Distress Tolerance Skills ReviewTreatment as usual at the inpatient setting for this study. | Behavioural | Treatment as Usual |
Primary outcome
Change in intensity of suicidal ideation
Time frame: Pre-intervention and directly after the intervention (i.e., 1 hour later)
RATE OVERALL INTENSITY OF YOUR SUICIDAL IDEATION RIGHT NOW: (scale from "1" Extremely low intensity to "5" Extremely high intensity)
Change in hopelessness
Time frame: Pre-intervention and directly after the intervention (i.e., 1 hour later)
How much are you feeling hopeless right now? (scale from "1" Not at all to "5" A lot)
Change in wish to live
Time frame: Pre-intervention and directly after the intervention (i.e., 1 hour later)
I wish to live this much: (scale from "0" Not at all to "8" Very much)
Change in wish to die
Time frame: Pre-intervention and directly after the intervention (i.e., 1 hour later)
I wish to die this much: (scale from "0" Not at all to "8" Very much)
Change in Beck Hopelessness Scale
Time frame: pre-intervention, 1 week after the intervention is completed, 1 month after the intervention is completed
Hopelessness will be measured with the Beck Hopelessness Scale. Scores range from 0-20 and higher scores indicate greater levels of hopelessness.
Change in Interpersonal Needs Questionnaire
Time frame: pre-intervention, 1 week after the intervention is completed, 1 month after the intervention is completed
Perceptions of social connectedness will be assessed with the Interpersonal Needs Questionnaire. Scores range from 0 to 107 with higher scores indicating less connection with others.
2 secondary outcomes
Change in Columbia Suicide Severity Rating Scale
Time frame: pre-intervention, 1 week after the intervention is completed, 1 month after the intervention is completed
Change in Adult Suicidal Ideation Questionnaire
Time frame: pre-intervention, 1 week after the intervention is completed, 1 month after the intervention is completed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shannon Sauer-Zavala, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-Session Mechanism-Focused Intervention (SSMFI) and Distress Tolerance Skills Review in people with Suicidal Ideation and Hopelessness, run by Shannon E. Sauer-Zavala at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in intensity of suicidal ideation (time frame: Pre-intervention and directly after the intervention (i.e., 1 hour later)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.