Suicide and Self-harmNCT05867316
Supplementing Brief Psychotherapy With a Mobile App
A study testing Unified Protocol in people with Suicide and Self-harm and Emotion Regulation, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
Suicide is among the leading causes of death worldwide, and the risk of suicide is highest in the period immediately following discharge from inpatient psychiatric care.1Importantly, despite the enormously elevated risk during this period, nearly 50% of patients do not attend scheduled therapy after discharge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide and Self-harm, Emotion Regulation
- What is being tested?
- Unified Protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2023to 6 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adult status (18+ years)
- Admission to eligible units in our partner hospital with a reason for admission having to do with suicide risk
- The ability to speak and write English fluently,
- Ownership of and consistent access to an internet-capable smartphone (e.g., an iPhone or Android phone)
Who cannot join
- The presence of any factor that impairs an individual's ability to provide informed consent and comprehend and effectively participate in the study including: an inability to speak or write English fluently, the presence of gross cognitive impairment due to florid psychosis, intellectual disability, dementia, acute intoxication, or the presence of extremely agitated or violent behavior.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers University Behavioral Healthcare
Piscataway, New Jersey, 08854
About this study
Suicide is among the leading causes of death worldwide, and the risk of suicide is highest in the period immediately following discharge from inpatient psychiatric care.1Importantly, despite the enormously elevated risk during this period, nearly 50% of patients do not attend scheduled therapy after discharge. Even among those who do attend therapy, however, the skills learned in treatment may be difficult to use during the highly distressing time leading up to and during a suicide crisis. Most traditional treatments are not designed to be effective during a suicide crisis. In order to reduce the risk of suicidal thoughts and behaviors in general and specifically during the post-discharge period, interventions are needed that: (1) are easily adhered to and (2) are accessible and effective during a suicide crisis. As such, the purpose of this research study is to test an innovative, new intervention in order to develop an effective and accessible intervention for those at high risk for suicide
- Conditions
- Suicide and Self-harm, Emotion Regulation
- Being tested
- Unified Protocol
- Keywords
- suicidal ideation, suicide attempts
- Medical subject headings
- Suicide, Self-Injurious Behavior, Emotional Regulation, Suicidal Ideation, Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unified ProtocolBehavioural
Unified Protocol based treatment, modified for use in brief treatment on inpatient units
| Study group | Role | What they receive |
|---|---|---|
| Unified Protocol | Experimental | Unified Protocol-based treatment, with three sessions Receives: Behavioral: Unified Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Momentary Suicidal Thinking
This is an 11-point scale regarding momentary self-reported intensity of suicidal urges ("Right now, how strongly do you want to kill yourself?". A score of 0 is equivalent to no suicidal thinking at all ("not at all"), a score of 10 is a score of very extreme suicidal thinking ("Extremely). Lower scores equal less severe suicidal thinking (i.e., a better outcome). Scores are averaged across all participants and all instances of survey completion.
Measured: Assessed immediately before and immediately after each in-app skills-practice exercise, across the 28-day (4-week) post-discharge monitoring period; averaged across exercises within participant.
Self-efficacy for Managing Negative Emotion
Measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) self-efficacy for managing negative emotions scale. The scale is measured with four five-point scale items, summed to a score ranging from 4 to 20 where higher scores are better.
Measured: Beginning of study and end-of-study, approximately four weeks post discharge
Secondary outcomes (1)
Negative Emotion
Negative emotion ("How negative do you feel right now?") on a 0 to 10 scale, where 0 is not at all negative (i.e., better) and 10 is extremely negative. Slopes were extracted for each participant and then those values were averaged over the whole sample.
Measured: Assessed immediately before and immediately after each in-app skills-practice exercise, across the 28-day (4-week) post-discharge monitoring period; averaged across exercises within participant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start14 Sep 2023
- Primary completion7 May 2024
- Study completion6 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Suicide and Self-harmStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Evan M. Kleiman, Ph.D., Rutgers, The State University of New Jersey
- Investigators
- Evan Kleiman, Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05867316
- Sponsor's protocol ID
- Pro2022001944
- Other IDs
- R34MH113757
- Status last verified
- May 2026
- First submitted
- 3 Apr 2023
- Last updated
- 25 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices)
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplementing Brief Psychotherapy With a Mobile App
- ClinicalTrials.gov ID
- NCT05867316
- Acronym / sponsor ID
- Pro2022001944
- Conditions
- Suicide and Self-harm, Emotion Regulation
- Keywords
- suicidal ideation, suicide attempts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, National Institute of Mental Health (NIMH)
- Study start
- 14 Sep 2023 (actual)
- Primary completion
- 7 May 2024 (actual)
- Study completion
- 6 Jun 2024 (actual)
- First posted
- 19 May 2023 (actual)
- Results
- Posted 25 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Suicide is among the leading causes of death worldwide, and the risk of suicide is highest in the period immediately following discharge from inpatient psychiatric care.1Importantly, despite the enormously elevated risk during this period, nearly 50% of patients do not attend scheduled therapy after discharge. Even among those who do attend therapy, however, the skills learned in treatment may be difficult to use during the highly distressing time leading up to and during a suicide crisis. Most traditional treatments are not designed to be effective during a suicide crisis. In order to reduce the risk of suicidal thoughts and behaviors in general and specifically during the post-discharge period, interventions are needed that: (1) are easily adhered to and (2) are accessible and effective during a suicide crisis. As such, the purpose of this research study is to test an innovative, new intervention in order to develop an effective and accessible intervention for those at high risk for suicide
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unified Protocol | Experimental | Behavioral: Unified ProtocolUnified Protocol-based treatment, with three sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult status (18+ years)
- Admission to eligible units in our partner hospital with a reason for admission having to do with suicide risk
- The ability to speak and write English fluently,
- Ownership of and consistent access to an internet-capable smartphone (e.g., an iPhone or Android phone)
Key exclusion criteria (1 listed)
- The presence of any factor that impairs an individual's ability to provide informed consent and comprehend and effectively participate in the study including: an inability to speak or write English fluently, the presence of gross cognitive impairment due to florid psychosis, intellectual disability, dementia, acute intoxication, or the presence of extremely agitated or violent behavior.
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 |
|---|---|---|
| Unified ProtocolUnified Protocol based treatment, modified for use in brief treatment on inpatient units | Behavioural | Unified Protocol |
Primary outcome
Momentary Suicidal Thinking
Time frame: Assessed immediately before and immediately after each in-app skills-practice exercise, across the 28-day (4-week) post-discharge monitoring period; averaged across exercises within participant.
This is an 11-point scale regarding momentary self-reported intensity of suicidal urges ("Right now, how strongly do you want to kill yourself?". A score of 0 is equivalent to no suicidal thinking at all ("not at all"), a score of 10 is a score of very extreme suicidal thinking ("Extremely). Lower scores equal less severe suicidal thinking (i.e., a better outcome). Scores are averaged across all participants and all instances of survey completion.
Self-efficacy for Managing Negative Emotion
Time frame: Beginning of study and end-of-study, approximately four weeks post discharge
Measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) self-efficacy for managing negative emotions scale. The scale is measured with four five-point scale items, summed to a score ranging from 4 to 20 where higher scores are better.
1 secondary outcome
Negative Emotion
Time frame: Assessed immediately before and immediately after each in-app skills-practice exercise, across the 28-day (4-week) post-discharge monitoring period; averaged across exercises within participant.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. We will share Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices)
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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.
Evan Kleiman principal investigator
Rutgers, The State University of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unified Protocol in people with Suicide and Self-harm and Emotion Regulation, run by Rutgers, The State University of New Jersey 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 1 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 25 Aug 2026. 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?
Yes. Results are posted in the registry (first posted 25 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Momentary Suicidal Thinking (time frame: Assessed immediately before and immediately after each in-app skills-practice exercise, across the 28-day (4-week) post-discharge monitoring period; averaged across exercises within participant.). The study lists 2 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 25 Aug 2026.