Clinical trial NCT05231213: Effects of Neuromodulation and Cognitive Training for Suicide in Veterans (ENACTS)
Official title: Effects of Neuromodulation and Cognitive Training for Suicide in Veterans (ENACTS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Impulsivity
Keywords: Suicide
Impulsive Behavior
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2022-02-09
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Recruitment Feasibility
timeFrame: 2 years
measure: Intervention Acceptability
timeFrame: 2 months
Secondary outcomes:
measure: Groton Maze Task
timeFrame: Change between baseline and 1 week follow-up; 1 and 2 months following intervention
measure: NIH Quality of Life questionnaire
timeFrame: Change between baseline and 1 week follow-up; 1 and 2 months following intervention
measure: UPPS-P Impulsive Behavior scale
timeFrame: Change between baseline and 1 week follow-up; 1 and 2 months following intervention
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System, Minneapolis, MN
state: Minnesota
Study officials:
affiliation: Minneapolis VA Health Care System, Minneapolis, MN
name: Casey S Gilmore, PhD
role: PRINCIPAL_INVESTIGATOR
References: