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

Not Applicable

Completed

• Conditions: Suicide; Impulsivity
• Interventions: Device: Active Transcranial Direct Current Stimulation (tDCS); Device: Sham Transcranial Direct Current Stimulation (tDCS)

• Registration Number: NCT05231213
• Lead Sponsor: VA Office of Research and Development

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-28
• Study First Submitted QC: 2022-01-28
• Study First Posted: 2022-02-09
• Study Start: 2022-07-01
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active tDCS	Active Transcranial Direct Current Stimulation (tDCS)	Participants will receive 10 sessions of cognitive training concurrent with transcranial direct current stimulation (anode over left frontal cortex, cathode over right frontal cortex; 2 mAmps for 20 minutes).
Sham tDCS	Sham Transcranial Direct Current Stimulation (tDCS)	Participants will receive 10 sessions of cognitive training concurrent with sham tDCS. For sham tDCS, electrodes are placed at the same locations as for active tDCS, but current is ramped up for the initial 30 secs, then immediately ramped back down. This method mimics the initial physical sensation of stimulation, but there is no active current for the remainder of the session.

Primary Outcome Measures

Name	Time	Method
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 70% of subjects tolerating the intervention (able to complete 2/3 of the twice-daily EMA surveys).

Secondary Outcome Measures

Name	Time	Method
NIH Quality of Life questionnaire	Change between baseline and 1 week follow-up; 1 and 2 months following intervention	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. Higher scores indicate better QOL.
Groton Maze Task	Change between baseline and 1 week follow-up; 1 and 2 months following intervention	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.
UPPS-P Impulsive Behavior scale	Change between baseline and 1 week follow-up; 1 and 2 months following intervention	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. Higher scores indicate more impulsive behavior.

Trial Locations

Locations (1)

Minneapolis VA Health Care System, Minneapolis, MN; 🇺🇸 Minneapolis, Minnesota, United States