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Clinical Trials/NCT05231213
NCT05231213
Completed
N/A

Effects of Neuromodulation and Cognitive Training for Suicide in Veterans (ENACTS)

VA Office of Research and Development1 site in 1 country14 target enrollmentJuly 1, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Suicide
Sponsor
VA Office of Research and Development
Enrollment
14
Locations
1
Primary Endpoint
Recruitment Feasibility
Status
Completed
Last Updated
12 months ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
July 1, 2022
End Date
March 31, 2025
Last Updated
12 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Recruitment Feasibility

Time Frame: 2 years

Recruitment feasibility will be demonstrated by successful recruitment of 15 participants per year into the study.

Intervention Acceptability

Time Frame: 2 months

Acceptability of the intervention will be demonstrated by a retention rate of 80% at the 2 month follow-up assessment, and 70% of subjects tolerating the intervention (able to complete 2/3 of the twice-daily EMA surveys).

Secondary Outcomes

  • NIH Quality of Life questionnaire(Change between baseline and 1 week follow-up; 1 and 2 months following intervention)
  • Groton Maze Task(Change between baseline and 1 week follow-up; 1 and 2 months following intervention)
  • UPPS-P Impulsive Behavior scale(Change between baseline and 1 week follow-up; 1 and 2 months following intervention)

Study Sites (1)

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