Emotion Regulation, Suicide and Self-harm
Conditions
Keywords
suicidal ideation, suicide attempts
Brief 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. 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
Interventions
BEHAVIORALUnified Protocol
Unified Protocol based treatment, modified for use in brief treatment on inpatient units
Sponsors
Rutgers, The State University of New Jersey
Massachusetts General Hospital
National Institute of Mental Health (NIMH)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
\- 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Momentary Suicidal Thinking | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Negative Emotion | 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. | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREvan Kleiman
Rutgers, The State University of New Jersey
Participant flow
Recruitment details
Patients were recruited from an inpatient unit in an open-label study, in which all participants received the same treatment.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 27.8 Years STANDARD_DEVIATION 11.9 |
| Race/Ethnicity, Customized Hispanic/Latine | 20 Participants |
| Race/Ethnicity, Customized Not Hispanic/Latine | 39 Participants |
| Race/Ethnicity, Customized Unknown | 1 Participants |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 60 |
| other Total, other adverse events | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 |
Outcome results
None listed