Impulsivity, Suicide
Conditions
Keywords
Suicide, Impulsive Behavior
Brief summary
Impaired executive function, such as impaired decision making and impulsivity, has been identified as an important contributor to the transition from suicidal ideation to suicide attempt. To address the epidemic of Veteran suicide in the United States, this study tests the feasibility, acceptability, and preliminary effectiveness of a five day transcranial direct current stimulation (tDCS) augmented executive functioning training intervention. This intervention is delivered to high suicide risk inpatients. The ultimate goal is to reduce future suicide events (ideation, attempts, deaths) and improve quality of life (e.g. social relationships, health resource utilization).
Interventions
DEVICEActive Transcranial Direct Current Stimulation (tDCS)
Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the left frontal cortex for 20 minutes.
DEVICESham Transcranial Direct Current Stimulation (tDCS)
Cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning and end of session).
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
This study will be a double-blind, randomized, placebo (sham) controlled feasibility study. Thirty-eight Veteran inpatients in the Minneapolis VA Psychiatric unit will be recruited. Each participant will be randomly assigned to receive either active or sham tDCS, both paired with executive function cognitive training tasks. Training/tDCS sessions will occur twice a day for five days, for a total of 10 sessions. tDCS (2mA current), with anode over left prefrontal cortex and cathode over right prefrontal cortex, will be applied concurrently with cognitive training. Training/tDCS sessions last approx. 45 min, with tDCS applied during the first 20 min of training.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* currently admitted into the MVAHCS Inpatient Psychiatric Unit * at a heightened risk for suicide (defined as a positive screen on the VA Comprehensive Suicide Risk Evaluation (CSRE) at intake and/or a suicide attempt within the previous 12 months) * able to complete procedures and tasks
Exclusion criteria
* are unable to provide informed consent as determined by the Modified Dysken Tool * have moderate/severe cognitive impairment as determined by the Mini-Mental State Examination (score 27) * have contraindications for tDCS (history of seizures, metallic cranial plates/screws or implanted device, history of eczema on scalp) * do not have a smartphone or device running Android or Apple iOS with which to download the mPRO EMA app * have been involuntarily committed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Feasibility | 2 years | Recruitment feasibility will be demonstrated by successful recruitment of 15 participants per year into the study. |
| Intervention Acceptability | 2 months | Acceptability of the intervention will be demonstrated by a retention rate of 80% at the 2 month follow-up assessment, and by 70% of participants being able to complete ⅔ of treatment sessions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Completion Time of the Groton Maze Task | Change over time from the baseline session through post-intervention, 1 month follow-up, and 2 month follow-up sessions. | Differences in magnitude of change in performance on the Groton Maze Task between active and sham tDCS groups from baseline to follow-up sessions. Outcome score is time to complete task, with longer time indicating worse performance. |
| Change in NIH Quality of Life Questionnaire | Change over time from the baseline session through post-intervention, 1 month follow-up, and 2 month follow-up sessions. | Differences in magnitude of change in scores on the NIH Quality of Life (QoL) battery in the domains of cognitive, social, emotional, and behavioral abilities between active and sham tDCS groups from baseline to follow-up sessions. Responses are on a 0-5 Likert scale. The primary outcome measure is the mean Total score across these domains. Higher scores indicate better QoL. |
| Change in UPPS-P Impulsive Behavior Scale | Change over time from the baseline session through post-intervention, 1 month follow-up, and 2 month follow-up sessions. | The UPPS-P assesses impulsive behavior in five domains: Positive Urgency, Negative Urgency, (lack of) Premeditation, (lack of) Perseverance, and Sensation Seeking. The scale uses a 1 (agree strongly) to 4 (disagree strongly) response format. The primary outcome measure is the Total score across these domains, calculated as the average of all items in the questionnaire. Higher scores indicate more impulsive behavior. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCasey S Gilmore, PhD
Minneapolis VA Health Care System, Minneapolis, MN
Participant flow
Recruitment details
Participants were Veterans recruited based on being admitted to the Minneapolis VA Inpatient Psychiatric unit at heightened risk for suicide. The first participant was enrolled on November 2, 2022, and the last participant was enrolled on November 6, 2024.
Pre-assignment details
All 14 participants enrolled in the study were randomized to a treatment arm.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 45.3 years STANDARD_DEVIATION 10.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 7 |
| other Total, other adverse events | 0 / 7 | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 | 0 / 7 |
Outcome results
None listed