Suicidal Ideation
Conditions
Keywords
Psychotherapy, Crisis Response Planning, Intramuscular ketamine, Emergency department
Brief summary
Participants are asked to take part in this research study after coming to the Emergency Department with thoughts or behaviors of seriously hurting themselves. There are very few resources to treat acute suicidal thoughts or behaviors in an emergency department. The purpose of this study is to evaluate the effectiveness of combining an intramuscular (IM) injection of ketamine and Crisis Response Planning (CRP), a single, 45-60 minute psychological intervention with a therapist, to quickly reduce suicidal thoughts in patients treated in an emergency department (ED) prior to being admitted to the hospital.
Detailed description
Adult men and women between the ages of 18 and 70 presenting to the Emergency Department with acute suicidal ideation requiring and anticipated to be for admitted as an inpatient to UH or CRDAMC based on the ED and admitting providers determination that the patient warrants hospitalization for suicidality and the capacity of the institution to admit the patient will be identified by an ED staff member. Following consent, participants will complete the baseline assessment at the hospital in the patient's assigned room. Once confirmed eligible, the participant will be randomly assigned into one of the four study arms. The study injection (either the ketamine (1 mg/kg) or saline placebo (volume matched to the equivalent dose of ketamine) for injection) will be administered in the ED by Nursing staff and the CRP will be administered by a trained member of the research team. Participants randomized to the safety plan control condition will receive their plan from hospital staff at discharge from the hospital as standard of care. Following the study injection, the ED clinical staff are responsible for monitoring participants for one hour for common side effects of ketamine including symptoms of dizziness, nausea, vomiting, confusion, or dissociative episodes. Patients' vital signs and pulse oximetry will also be monitored in accordance with the facility ED protocol for sub-dissociative administration of ketamine (e.g. frequent vital signs for 45 minutes). Follow-up assessments will be completed at 24-hours, 48-hours, 72-hours, 7-days, 28-days, and 56-days after study treatment in the STRONG STAR offices, or by phone.
Interventions
1 mg.kg IM ketamine is administered after enrollment and randomization
OTHERPlacebo Injection
Placebo is administered after enrollment and randomization
BEHAVIORALCrisis Response Plan
Crisis Response Planning is a collaborative, patient-centered psychosocial intervention that begins with a narrative assessment and concludes with the development of a personalized plan that outlines a series of self-regulatory strategies for managing acute emotional distress
OTHERSafety Planning
The Safety Planning intervention (provided as standard of care at discharge) includes a brief review of current suicide risk, provides patients with a suite of cognitive tools for avoiding future acute crises, and allows for a discussion and teach-back period to ensure patients' understanding of and willingness to use the plan
Sponsors
The University of Texas Health Science Center at San Antonio
United States Department of Defense
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The investigators, study staff, hospital staff administering the medication, and participants will be blind to the administration of ketamine or the normal saline control. Pharmacy staff will prepare the drug per the physician order set and so will not be blinded to the treatment condition. However, because participants, interventionalists, and study staff cannot be blind to the behavioral therapies being delivered, only the independent evaluators will be blind to the behavioral treatment condition.
Intervention model description
The study design is a four-arm 2x2 factorial design randomized clinical trial (RCT)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Adult men and women between the ages of 18 and 70 presenting to the Emergency Department with acute suicidal ideation anticipated to be admitted as an inpatient at University Health (UH) or Carl R Darnall Army Medical Center (CRDAMC) based on the ED and admitting providers determination that the patient warrants hospitalization for suicidality and the capacity of the institution to admit the patient. * Able to read and write English.
Exclusion criteria
* Serious mental illness with active and significant signs of psychosis, mania, hallucinations, paranoia, agitation, and drug-induced or other toxidromic symptoms determined to be the priority of treatment relative to treatment of the suicidal thoughts and behaviors. * Acute intoxication with clinically significant symptoms as determined by the ED provider to significantly increase the risk of participation (e.g., potential interaction with ketamine) or render the patient unable to consent. * The patient is not capable of understanding the research procedures and providing informed consent for themselves as determined by the research staff obtaining informed consent in consultation with the patient's ED provider. * Admittance to and treatment in an ED for acute suicidality within the past 30 days as determined by self-report, or if available, hospital records. * Lack of reliable means to be available for follow-up assessments (e. g, working mobile phone) as determined by self-report. * Persistent resting blood pressure lower than 90/60 or higher than 180/110, or persistent resting heart rate lower than 45 beats/minute or higher than 120 beats/minute. * Injuries requiring procedural sedation with ketamine as determined by the patient's ED provider. * Pregnancy as determined by pregnancy testing, or self-report of breast feeding. * Known hypersensitivity to ketamine as determined by self-report. * Legal or illegal use of ketamine in the previous 90 days as determined by self-report. * End-stage or severe cardiovascular (e.g., acute coronary syndrome (ACS) or decompensated heart failure), end-stage or severe liver, or kidney disease as determined by the ED chart history and ED provider's exam. * Patient is a prisoner as determined by prisoner escort. * Patient is physically restrained or actively under custody of law enforcement.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depressive Symptoms Index - Suicidality Subscale (DSI-SS) | Baseline, 24 hours and 28 days | A 4 item scale scored from 0-3 for each item and summed to give a total between 0-12 with a higher score indication greater suicidal ideation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Suicide Visual Analogue Scale (S-VAS) | Baseline to 56 days | A scale scored from 0=none to 100=extreme urge to commit suicide |
| Beck Scale for Suicidal Ideation (SSI) | Baseline to 72 hours | A scale with 19 possible items scored from 0-2 to give a possible score between 0-38 with a higher score indicating greater suicidal ideation. If the participant scores 0 (no indication of suicidal ideation) on questions 4 and 5, the survey is stopped at that point, otherwise the survey is continued. |
Countries
United States
Contacts
CONTACTRobert DeLorenzo, MD
CONTACTStephanie Perez, MHA
PRINCIPAL_INVESTIGATORRobert DeLorenzo, MD
The University of Texas Health Science Center at San Antonio
Outcome results
None listed