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Completed

NCT Number: NCT05231213

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

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).

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Key information

Conditions

Suicide Behavior Behavioral Symptoms Impulsive Behavior Impulsivity Self-Injurious Behavior

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417-2309, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active Transcranial Direct Current Stimulation (tDCS)

Device

Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the left frontal cortex for 20 minutes.

Sham Transcranial Direct Current Stimulation (tDCS)

Device

Cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning and end of session).

Primary outcomes

  1. Recruitment Feasibility

    Time frame: 2 years

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

  2. 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 by 70% of participants being able to complete ⅔ of treatment sessions.

Secondary outcomes

  1. Change in Completion Time of the Groton Maze Task

    Time frame: 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.

  2. Change in NIH Quality of Life Questionnaire

    Time frame: 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.

  3. Change in UPPS-P Impulsive Behavior Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Acronym: ENACTS

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 9, 2022
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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