PTSD, AUD, and Interpersonal Conflict: Within-person Associations

Alcoholism Clinical Trial

Official title:

PTSD, AUD, and Interpersonal Conflict: Within-person Associations

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04552782
• Other study ID #: 1R01MH122954
• Status: Recruiting
• Phase: N/A
• Start date: December 4, 2020
• Est. completion date: April 30, 2025

Study information

• Verified date: May 2023
• Source: University of South Dakota
• Contact: Jeffrey S Simons, PhD
• Phone: 605-658-3710
• Email: jeffrey.simons[@]usd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcoholism
• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Bay Pines VA Health Care System	Bay Pines	Florida
United States	Sioux Falls VA Health Care System	Sioux Falls	South Dakota
United States	The University of South Dakota	Vermillion	South Dakota

Sponsors (4)

Lead Sponsor	Collaborator
University of South Dakota	Bay Pines VA Healthcare System, National Institute of Mental Health (NIMH), Sioux Falls VA Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Alcohol Use Disorder Symptoms	These are experience sampling items derived from Diagnostic and Statistical Manual of Mental Disorders (DSM-5).	2 years
Primary	Rate of PTSD Symptoms	These are experience sampling items derived from the PTSD Checklist from DSM-5 (PCL-5).	2 years