Suicide AttemptPhase 1NCT02414763
Pilot Study of a Brief Intervention for Medically Hospitalized Suicide Attempt Survivors
A Phase 1 study testing Teachable Moment Brief Intervention in people with Suicide Attempt, run by Western Kentucky University at 1 site in United States.
Trial summary
The current study proposes to study the feasibility and acceptability of a brief psychosocial intervention delivered to suicide attempt survivors hospitalized on a medical/surgical floor or inpatient psychiatry unit at Vanderbilt University Medical Center. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide Attempt
- What is being tested?
- Teachable Moment Brief Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to 14 Jun 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age and above
- Inpatient on medical/surgical unit either currently or prior to transfer to inpatient psychiatric 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 in the medical center. Determination of cognitive impairment, delirium, agitation, and psychosis will be determined through the referral phone call between discussions with research team members and the Adult Psychiatry Consultation Service Physician providing care to the patient, as well as the interventionist'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
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
The current study proposes to study the feasibility and acceptability of a brief psychosocial intervention delivered to suicide attempt survivors hospitalized on a medical/surgical floor or inpatient psychiatry unit at Vanderbilt University Medical Center. The proposed study will involve training of care providers affiliated with Vanderbilt University Medical Center to deliver the brief intervention. Additionally, the participants will complete baseline, 1, 3, and 12-month assessments on outcomes of interest, including readiness to change problematic behaviors, engagement in outpatient mental health services, suicidal ideation, self-harming behavior, and reasons for living.
Read the detailed description
One-hundred participants will be recruited from a medical/surgical floor or inpatient psychiatry unit at Vanderbilt University Medical Center. The PI, other Attending Psychiatrists, Psychiatry Resident Physicians, Clinical Psychology Trainees, Psychiatric Nurse Practitioners, Psychiatric Social Workers, and Psychiatric Nurse Case Managers will serve as study therapists. A member from the Vanderbilt University research team will obtain informed consent for the participants and then administer the baseline assessment battery. Patients will then be randomized to either (1) a group receiving care as usual plus an experimental intervention targeting suicidal thoughts and behaviors or to (2) a group receiving care as usual. Patients randomized to the experimental group will receive the intervention prior to discharge from the medical center, most likely on the same day as the baseline assessment battery. Patients receiving the experimental intervention will then be asked to complete a brief post-intervention client satisfaction survey. All study participants will then complete telephone follow-up assessments at 1, 3, and 12 months. The intervention will consist of no more than 90 minutes of 1:1 interaction with a study clinician. The baseline assessment battery will take approximately 30 minutes, the post-intervention measures will take approximately 10 minutes, and the 1-, 3-, and 12-month assessment batteries will take approximately 30 minutes. Maximum length of time in the study is approximately 3.75 hours.
- Conditions
- Suicide Attempt
- Being tested
- Teachable Moment Brief Intervention
- Medical subject headings
- Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teachable Moment Brief InterventionBehavioural
functional analysis, collaborative interpersonal style
| Study group | Role | What they receive |
|---|---|---|
| Care as Usual | No intervention | Participants will receive usual care services provided to suicide attempt survivors, including inpatient psychiatry, outpatient psychotherapy, and case management. |
| Teachable Moment Brief Intervention | Experimental | 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, functional analysis of the suicidal ideation and behaviors, and crisis response planning. Participants will also receive usual care services provided to suicide attempt survivors, including inpatient psychiatry, outpatient psychotherapy, and case management. Receives: Behavioral: Teachable Moment Brief Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Client Satisfaction Questionnaire
The 8-item Client Satisfaction Questionnaire is a general measure of individual satisfaction with health and human services that takes 3-8 minutes to complete.
Measured: Immediately following Brief Intervention
Secondary outcomes (6)
Change in Stages of Change Questionnaire
The Stages of Change Questionnaire is an 18-item measure based on the original, 32- item scale created by McConnaughy, Prochaska, and Verlicer. The measure has shown acceptable levels of internal consistency in an adult sample (α = .75 to .87) and predictive validity of response to treatment.
Measured: Baseline, 1-, 3-, and 12-months interviews
Change in Scale for Suicide Ideation
The Scale for Suicide Ideation is a 19-item assessment used to evaluate the current intensity of the patient's specific attitudes toward, behavior, and plans to commit suicide. The measure has been the primary outcome measure in several trials targeting suicidal patients and has evidence of strong psychometrics
Measured: Baseline, 1-, 3-, and 12-months interviews
Change in Suicide Attempt Self-Injury Count
The Suicide Attempt Self-Injury Count is a brief two-page instrument determining for the first, most recent, and most severe suicide attempt or non-suicidal self-injury (SASI) the date, method of SASI attempt used in index and previous attempts according to the definitions of Linehan et al. (e.g., using definitions of self-inflicted injuries which include situations of actual tissue damage and situations where tissue damage would have occurred except for outside intervention or sheer luck [e.g., firearm jammed]), intent to die (i.e., intent to die, ambivalent, no intent to die), highest level of medical treatment received, and lethality.
Measured: Baseline, 1-, 3-, and 12-months interviews
Change in Interpersonal Needs Questionnaire
The Interpersonal Needs Questionnaire is a 25-item measure that inquires about the extent to which individuals feel connected to others (i.e., belongingness) and the extent to which they feel like a burden on the people in their lives (i.e., perceived burdensomeness). The measure has been used in previous research examining mechanisms underlying suicide attempt survivors and has demonstrated acceptable psychometric properties
Measured: Baseline, 1-, 3-, and 12-months interviews
Change in Reasons for Living Inventory
The Reasons for Living Inventory is a 48-item measure that rates the importance of different reasons why people choose not to kill themselves. It has shown strong internal consistency and test-retest reliability
Measured: Baseline, 1-, 3-, and 12-months interviews
Change in Health Services and Medication Use
The Health Services and Medication Use measure will be utilized to examine history of mental health services and medication use in lifetime, previous year, and previous month time periods. The measure was developed and utilized in the National Study of Costs and Outcomes for Trauma.
Measured: 1-, 3-, and 12-months interviews
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2015 (estimated)
- Study startJul 2014
- Primary completion14 Jun 2017
- Study completion14 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Suicide AttemptStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Kentucky University
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt University
- Responsible party
- Sponsor
- Investigators
- Stephen S O'Connor, Ph.D., Principal investigator, Western Kentucky University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02414763
- Sponsor's protocol ID
- 131757
- Status last verified
- May 2018
- First submitted
- 16 Dec 2014
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
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 33884617O'Connor SS, Mcclay MM, Choudhry S, Shields AD, Carlson R, Alonso Y, Lavin K, Venanzi L, Comtois KA, Wilson JE, Nicolson SE. Pilot randomized clinical trial of the Teachable Moment Brief Intervention for hospitalized suicide attempt survivors. Gen Hosp Psychiatry. 2020 Mar-Apr;63:111-118. doi: 10.1016/j.genhosppsych.2018.08.001. Epub 2018 Aug 10.
PubMed 30389316
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of a Brief Intervention for Medically Hospitalized Suicide Attempt Survivors
- ClinicalTrials.gov ID
- NCT02414763
- Acronym / sponsor ID
- 131757
- Conditions
- Suicide Attempt
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Western Kentucky UniversityUniversity, hospital or other
- Collaborators
- Vanderbilt University
- Study start
- Jul 2014
- Primary completion
- 14 Jun 2017 (actual)
- Study completion
- 14 Jun 2017 (actual)
- First posted
- 13 Apr 2015 (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 current study proposes to study the feasibility and acceptability of a brief psychosocial intervention delivered to suicide attempt survivors hospitalized on a medical/surgical floor or inpatient psychiatry unit at Vanderbilt University Medical Center. The proposed study will involve training of care providers affiliated with Vanderbilt University Medical Center to deliver the brief intervention. Additionally, the participants will complete baseline, 1, 3, and 12-month assessments on outcomes of interest, including readiness to change problematic behaviors, engagement in outpatient mental health services, suicidal ideation, self-harming behavior, and reasons for living.
Detailed description
One-hundred participants will be recruited from a medical/surgical floor or inpatient psychiatry unit at Vanderbilt University Medical Center. The PI, other Attending Psychiatrists, Psychiatry Resident Physicians, Clinical Psychology Trainees, Psychiatric Nurse Practitioners, Psychiatric Social Workers, and Psychiatric Nurse Case Managers will serve as study therapists. A member from the Vanderbilt University research team will obtain informed consent for the participants and then administer the baseline assessment battery. Patients will then be randomized to either (1) a group receiving care as usual plus an experimental intervention targeting suicidal thoughts and behaviors or to (2) a group receiving care as usual. Patients randomized to the experimental group will receive the intervention prior to discharge from the medical center, most likely on the same day as the baseline assessment battery. Patients receiving the experimental intervention will then be asked to complete a brief post-intervention client satisfaction survey. All study participants will then complete telephone follow-up assessments at 1, 3, and 12 months. The intervention will consist of no more than 90 minutes of 1:1 interaction with a study clinician. The baseline assessment battery will take approximately 30 minutes, the post-intervention measures will take approximately 10 minutes, and the 1-, 3-, and 12-month assessment batteries will take approximately 30 minutes. Maximum length of time in the study is approximately 3.75 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Care as Usual | No intervention | –Participants will receive usual care services provided to suicide attempt survivors, including inpatient psychiatry, outpatient psychotherapy, and case management. |
| Teachable Moment Brief Intervention | Experimental | Behavioral: Teachable Moment Brief InterventionThe 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, functional analysis of the suicidal ideation and behaviors, and crisis response planning. Participants will also receive usual care services provided to suicide attempt survivors, including inpatient psychiatry, outpatient psychotherapy, and case management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age and above
- Inpatient on medical/surgical unit either currently or prior to transfer to inpatient psychiatric 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 in the medical center. Determination of cognitive impairment, delirium, agitation, and psychosis will be determined through the referral phone call between discussions with research team members and the Adult Psychiatry Consultation Service Physician providing care to the patient, as well as the interventionist'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 |
|---|---|---|
| Teachable Moment Brief Interventionfunctional analysis, collaborative interpersonal style | Behavioural | Teachable Moment Brief Intervention |
Primary outcome
Client Satisfaction Questionnaire
Time frame: Immediately following Brief Intervention
The 8-item Client Satisfaction Questionnaire is a general measure of individual satisfaction with health and human services that takes 3-8 minutes to complete.
6 secondary outcomes
Change in Stages of Change Questionnaire
Time frame: Baseline, 1-, 3-, and 12-months interviews
Change in Scale for Suicide Ideation
Time frame: Baseline, 1-, 3-, and 12-months interviews
Change in Suicide Attempt Self-Injury Count
Time frame: Baseline, 1-, 3-, and 12-months interviews
Change in Interpersonal Needs Questionnaire
Time frame: Baseline, 1-, 3-, and 12-months interviews
Change in Reasons for Living Inventory
Time frame: Baseline, 1-, 3-, and 12-months interviews
Change in Health Services and Medication Use
Time frame: 1-, 3-, and 12-months interviews
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 3 May 2018.
- 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.
- Derived from this study: PubMed 30389316O'Connor SS, Mcclay MM, Choudhry S, Shields AD, Carlson R, Alonso Y, Lavin K, Venanzi L, Comtois KA, Wilson JE, Nicolson SE. Pilot randomized clinical trial of the Teachable Moment Brief Intervention for hospitalized suicide attempt survivors. Gen Hosp Psychiatry. 2020 Mar-Apr;63:111-118. doi: 10.1016/j.genhosppsych.2018.08.001. Epub 2018 Aug 10.
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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 S O'Connor, Ph.D. principal investigator
Western Kentucky University
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 Teachable Moment Brief Intervention in people with Suicide Attempt, run by Western Kentucky University 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 3 May 2018. 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?
Client Satisfaction Questionnaire (time frame: Immediately following Brief 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 NCT02414763, which also lists 2 linked publications.
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 3 May 2018.