Recruiting

Observational Study

Sponsor:

University of South Dakota

Code:

NCT04552782

Conditions

Stress Disorders, Post-Traumatic

Alcoholism

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Alcohol CBM

PTSD CBM

Alcohol Sham

PTSD Sham

Study Details

Brief summary:

The present study seeks to increase understanding of Alcohol Use Disorder (AUD) and Posttraumatic Stress Disorder (PTSD) among veterans, an important public health concern. We will study the effects of regulatory deficits and sleep disturbance on the dynamic course of PTSD and AUD. The study will investigate whether a short, computerized training in the laboratory will alter maladaptive response biases and reduce associations between sleep disturbance, affect and behavioral dysregulation, AUD symptoms, and PTSD symptoms in the real world.

Conditions

Stress Disorders, Post-Traumatic

Alcoholism

Study ID

NCT04552782

Start date

Dec 4, 2020

Status verified date

May, 2023

Completion date

Apr 30, 2025

Anticipated

Primary completion date

Apr 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • OIF/OEF/OND veterans
  • At risk for PTSD (i.e., PCL-5 ≥33) and/or AUD (i.e., AUDIT ≥ 7 (women) ≥ 8 (men))

Exclusion Criteria:

  • Psychosis or severe Alcohol Use Disorder that contraindicates participation (based on interview)
  • Active suicidal or homicidal ideation that contraindicates participation (based on interview)
  • \[exclusion criteria removed 6/2022\] - Severe risk for sleep apnea (a positive score in three categories of the Berlin Questionnaire), or reported treatment for sleep apnea

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Alcohol Cognitive Bias Modification (CBM) + PTSD CBM

experimental: Alcohol CBM + PTSD Sham

experimental: Alcohol Sham + PTSD CBM

sham comparator: Alcohol Sham + PTSD Sham

Interventions

Alcohol CBM

Trains approach or avoidance responses to alcohol cues.

PTSD CBM

Trains approach or avoidance responses to trauma cues.

Alcohol Sham

Will not train approach or avoidance responses.

PTSD Sham

Will not train approach or avoidance responses.

Primary outcome measure

  • Rate of Alcohol Use Disorder Symptoms [ Time Frame: 2 years ]
  • Rate of PTSD Symptoms [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Jeffrey S Simons, PhD

605-658-3710jeffrey.simons@usd.edu

Raluca M Simons, PhD

605-658-3710raluca.simons@usd.edu

Locations

Sioux Falls VA Health Care System

Recruiting

Sioux Falls, South Dakota, United States, 57105

Contacts

Patrick J Ronan, PhD

605-336-3230patrick.ronan@usd.edu

The University of South Dakota

Recruiting

Vermillion, South Dakota, United States, 57069

Contacts

Jeffrey S Simons, PhD

605-658-3710jeffrey.simons@usd.edu

Raluca M Simons, PhD

605-658-3710raluca.simons@usd.edu

Principal Investigator:

Jeffrey S Simons, PhD

More Information

Sponsor

University of South Dakota

Last update posted

May 9, 2023

Last verified

May, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of South Dakota on 2023-05-09.