Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05231213
Other study ID # D4104-P
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1, 2022
Est. completion date June 30, 2024

Study information

Verified date June 2023
Source VA Office of Research and Development
Contact Casey S Gilmore, PhD
Phone (612) 725-2000
Email Casey.Gilmore2@va.gov
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 38
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
Active Transcranial Direct Current Stimulation (tDCS)
Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the left frontal cortex for 20 minutes.
Sham 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).

Locations

Country Name City State
United States Minneapolis VA Health Care System, Minneapolis, MN Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Recruitment Feasibility Recruitment feasibility will be demonstrated by successful recruitment of 15 participants per year into the study. 2 years
Primary Intervention Acceptability 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). 2 months
Secondary Groton Maze Task 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 between baseline and 1 week follow-up; 1 and 2 months following intervention
Secondary NIH Quality of Life questionnaire 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. Change between baseline and 1 week follow-up; 1 and 2 months following intervention
Secondary UPPS-P Impulsive Behavior scale 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. Change between baseline and 1 week follow-up; 1 and 2 months following intervention
See also
  Status Clinical Trial Phase
Completed NCT04127292 - Impact of Clinician Virtual Human Interaction Training in Emotional Self-Awareness on Patients Suicidal Ideation and Suicide Crisis Syndrome N/A
Recruiting NCT06079853 - Nurse Suicide: Physiologic Sleep Health Promotion Trial N/A
Recruiting NCT05423483 - Developing an Intervention to Promote Lethal Means Safety in Suicidal Adolescents Phase 2
Completed NCT03272048 - Identifying Effective Approaches to Counseling on Firearm Safety N/A
Completed NCT05514587 - Meaning of Life Questionnaire (MLQ) in Patients Admitted to the Crisis Centre (MSVCAC)
Enrolling by invitation NCT05639426 - Preventing Youth Violence Through Building Equitable Communities N/A
Completed NCT03703128 - Suicide in People Aged 45-60: A Case-control Psychological Autopsy Study
Completed NCT03646903 - Reducing Help-Seeking Stigma in Young Adults at Elevated Suicide Risk N/A
Not yet recruiting NCT05558332 - Youth Nominated Support Team N/A
Not yet recruiting NCT06349915 - A Pilot Evaluation of a Digital Peer Support Intervention for Suicidal Adolescents N/A
Completed NCT02718248 - Ottawa Suicide Prevention in Men Pilot Study N/A
Completed NCT02094898 - Ketamine for Depression and Suicide Risk Phase 2
Completed NCT01594138 - Linguistic Characteristics of Suicidal Patients in the Emergency Department N/A
Completed NCT01360736 - A Brief Intervention to Reduce Suicide Risk in Military Service Members and Veterans - Study 2 (SAFEMIL) N/A
Completed NCT02228044 - Alcohol, Suicide and HIV Prevention for Teens in Mental Health Treatment N/A
Completed NCT00604097 - Preventing Youth Suicide in Primary Care: A Family Model Phase 3
Completed NCT00387855 - An Evaluation of the SOS (Suicide Prevention) Program N/A
Recruiting NCT03519802 - Evaluation of Cognitive Function in a Suicidal Crisis
Completed NCT05580757 - Pharmacists as Gate Keepers in Suicide Prevention: Needs of Pharmacists
Recruiting NCT03030924 - Wearable Suicidal Early Warning System for Adolescents