Suicidal IdeasPhase 1NCT01355848
Improving Care Provided to Patients Treated in a Level 1 Trauma Center Post-suicide Attempt
A Phase 1 study testing Brief Intervention for Suicidality in people with Suicidal Ideas, run by University of Washington at 1 site in United States.
Trial summary
The aim of the study is to refine, elaborate, and pilot a brief intervention for adult patients following a suicide attempt provided during hospitalization in an acute medical setting. 40 participants will be randomized to receive the brief intervention + care as usual or only care as usual. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Suicidal Ideas
- What is being tested?
- Brief Intervention for Suicidality
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Apr 2012
- Phase
- Phase 1
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- at least 15 years of age
- Inpatient on medical/surgical unit
- Admitted following a suicide attempt
- Sufficient English to benefit from psychotherapy in English
- Consents to be a research participant
Who cannot join
- Lack of sufficient English to participate in psychotherapy in English
- Prisoner/inmate at time of admission
- Too cognitively impaired, delirious, or psychotic to respond to psychotherapeutic intervention before end of stay on medical/surgical unit. Determination of cognitive impairment, delirium, agitation, and psychosis will be determined through the referral phone call between the PI and the referring care provider, as well as the PI's own clinical assessment of the patient at the outset of the brief intervention.
Trial locations and contacts
1 site in 1 country.
United States1 site
Harborview Medical Center
Seattle, Washington, 98104
About this study
The aim of the study is to refine, elaborate, and pilot a brief intervention for adult patients following a suicide attempt provided during hospitalization in an acute medical setting. 40 participants will be randomized to receive the brief intervention + care as usual or only care as usual. It is hypothesized that the intervention will be acceptable and feasible to both patients and intervention clinicians.
Read the detailed description
The aim of the study is to refine, elaborate, and pilot a brief intervention for adult patients following a suicide attempt provided during hospitalization in an acute medical setting, and will be addressed with a sample of cases (N = 40) from Harborview. The participants will be randomized into one of two groups: those that receive the intervention and those that do not. All participants will complete a battery of assessments The intervention is based on the theory of teachable moments, wherein timing in proximity to injury and appropriate treatment setting provide a unique opportunity to create patient behavioral change. The brief intervention consists of engaging the patient in conversation regarding suicidal ambivalence (desire to live vs. desire to die), collaborative discovery of primary and secondary drivers of suicidality, and safety planning. A guide to delivering the intervention has been completed and may undergo changes throughout the study. Adherence measures will be developed in order to assess the degree to which the clinician accurately provided the brief intervention without including additional therapeutic elements or leaving out elements required in the intervention guide. Best methods for integrating the brief intervention into services provided on medical and surgical units will be determined, as well.
- Conditions
- Suicidal Ideas
- Being tested
- Brief Intervention for Suicidality
- Keywords
- Suicide, Brief Intervention, Youth, Acute Medical Setting, Readiness to Change, Suicidality
- Medical subject headings
- Suicide, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Intervention for SuicidalityBehavioural
Focuses on behavioral elements of care, including building rapport, functional analysis, and crisis planning
| Study group | Role | What they receive |
|---|---|---|
| Brief Intervention | Experimental | The brief intervention consists of stepped care protocol, including building rapport, functional analysis of suicidal behavior, and crisis planning Receives: Behavioral: Brief Intervention for Suicidality |
| care as usual | No intervention | Patients randomized to the care as usual arm will not receive the brief intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction Questionnaire
The Patient Satisfaction Questionnaire will be used to determine the acceptability of the intervention by the patient.
Measured: (baseline) Assessment taking place immediately after completion of intervention
Secondary outcomes (1)
Scale for Suicide Ideation
The Scale for Suicide Ideation will be used to determine the severity of current suicidality in all participants at the one-month follow-up as compared to the baseline assessment.
Measured: One month follow-up assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2011 (estimated)
- Study startMay 2011
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Suicidal IdeasStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen O'Connor, University of Washington
- Investigators
- Stephen O'Connor, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01355848
- Sponsor's protocol ID
- 39417-C
- Other IDs
- T32HS013835_1
- Status last verified
- Mar 2015
- First submitted
- 10 May 2011
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
PubMed 33884617
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Care Provided to Patients Treated in a Level 1 Trauma Center Post-suicide Attempt
- ClinicalTrials.gov ID
- NCT01355848
- Acronym / sponsor ID
- 39417-C
- Conditions
- Suicidal Ideas
- Keywords
- Suicide, Brief Intervention, Youth, Acute Medical Setting, Readiness to Change, Suicidality
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 18 May 2011 (estimated)
- 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.
The aim of the study is to refine, elaborate, and pilot a brief intervention for adult patients following a suicide attempt provided during hospitalization in an acute medical setting. 40 participants will be randomized to receive the brief intervention + care as usual or only care as usual. It is hypothesized that the intervention will be acceptable and feasible to both patients and intervention clinicians.
Detailed description
The aim of the study is to refine, elaborate, and pilot a brief intervention for adult patients following a suicide attempt provided during hospitalization in an acute medical setting, and will be addressed with a sample of cases (N = 40) from Harborview. The participants will be randomized into one of two groups: those that receive the intervention and those that do not. All participants will complete a battery of assessments The intervention is based on the theory of teachable moments, wherein timing in proximity to injury and appropriate treatment setting provide a unique opportunity to create patient behavioral change. The brief intervention consists of engaging the patient in conversation regarding suicidal ambivalence (desire to live vs. desire to die), collaborative discovery of primary and secondary drivers of suicidality, and safety planning. A guide to delivering the intervention has been completed and may undergo changes throughout the study. Adherence measures will be developed in order to assess the degree to which the clinician accurately provided the brief intervention without including additional therapeutic elements or leaving out elements required in the intervention guide. Best methods for integrating the brief intervention into services provided on medical and surgical units will be determined, as well.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Intervention | Experimental | Behavioral: Brief Intervention for SuicidalityThe brief intervention consists of stepped care protocol, including building rapport, functional analysis of suicidal behavior, and crisis planning |
| care as usual | No intervention | –Patients randomized to the care as usual arm will not receive the brief intervention. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- at least 15 years of age
- Inpatient on medical/surgical unit
- Admitted following a suicide attempt
- Sufficient English to benefit from psychotherapy in English
- Consents to be a research participant
Key exclusion criteria (3 listed)
- Lack of sufficient English to participate in psychotherapy in English
- Prisoner/inmate at time of admission
- Too cognitively impaired, delirious, or psychotic to respond to psychotherapeutic intervention before end of stay on medical/surgical unit. Determination of cognitive impairment, delirium, agitation, and psychosis will be determined through the referral phone call between the PI and the referring care provider, as well as the PI's own clinical assessment of the patient at the outset of the brief 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 |
|---|---|---|
| Brief Intervention for SuicidalityFocuses on behavioral elements of care, including building rapport, functional analysis, and crisis planning | Behavioural | Brief Intervention |
Primary outcome
Patient Satisfaction Questionnaire
Time frame: (baseline) Assessment taking place immediately after completion of intervention
The Patient Satisfaction Questionnaire will be used to determine the acceptability of the intervention by the patient.
1 secondary outcome
Scale for Suicide Ideation
Time frame: One month follow-up assessment
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 10 Mar 2015.
- Derived from this study: PubMed 33884617Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
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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.
Stephen O'Connor, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Brief Intervention for Suicidality in people with Suicidal Ideas, run by University of Washington 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 5 inclusion and 3 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 10 Mar 2015. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Patient Satisfaction Questionnaire (time frame: (baseline) Assessment taking place immediately after completion of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01355848, which also lists 1 linked publication.
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 10 Mar 2015; AzTrials last refreshed its copy on 1 Nov 2026.