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

May 8, 2023 updated by: University of South Dakota
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Bay Pines, Florida, United States, 33744
        • Not yet recruiting
        • Bay Pines VA Health care System
        • Contact:
        • Sub-Investigator:
          • Jessica Keith, PhD
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Recruiting
        • Sioux Falls VA Health Care System
        • Contact:
        • Sub-Investigator:
          • Patrick J Ronan, PhD
      • Vermillion, South Dakota, United States, 57069
        • Recruiting
        • The University of South Dakota
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jeffrey S Simons, PhD
        • Principal Investigator:
          • Raluca M Simons, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alcohol Cognitive Bias Modification (CBM) + PTSD CBM
Behavioral: Alcohol CBM
Trains approach or avoidance responses to alcohol cues.
Behavioral: PTSD CBM
Trains approach or avoidance responses to trauma cues.
Experimental: Alcohol CBM + PTSD Sham
Behavioral: Alcohol CBM
Trains approach or avoidance responses to alcohol cues.
Behavioral: PTSD Sham
Will not train approach or avoidance responses.
Experimental: Alcohol Sham + PTSD CBM
Behavioral: PTSD CBM
Trains approach or avoidance responses to trauma cues.
Behavioral: Alcohol Sham
Will not train approach or avoidance responses.
Sham Comparator: Alcohol Sham + PTSD Sham
Behavioral: PTSD Sham
Will not train approach or avoidance responses.
Behavioral: Alcohol Sham
Will not train approach or avoidance responses.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Dakota

Collaborators

National Institute of Mental Health (NIMH)
Bay Pines VA Healthcare System
Sioux Falls VA Health Care System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2020

Primary Completion (Anticipated)

April 30, 2025

Study Completion (Anticipated)

April 30, 2025

Study Registration Dates

First Submitted

September 10, 2020

First Submitted That Met QC Criteria

September 10, 2020

First Posted (Actual)

September 17, 2020

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01MH122954 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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