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

Not Applicable

Recruiting

• Conditions: Stress Disorders, Post-Traumatic; Alcoholism
• Interventions: Behavioral: PTSD CBM; Behavioral: Alcohol Sham; Behavioral: Alcohol CBM; Behavioral: PTSD Sham

• Registration Number: NCT04552782
• Lead Sponsor: University of South Dakota

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-10
• Study First Submitted QC: 2020-09-10
• Study First Posted: 2020-09-17
• Study Start: 2020-12-04
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-09
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Alcohol Sham + PTSD CBM	PTSD CBM	-
Alcohol Sham + PTSD Sham	Alcohol Sham	-
Alcohol Sham + PTSD Sham	PTSD Sham	-
Alcohol Cognitive Bias Modification (CBM) + PTSD CBM	PTSD CBM	-
Alcohol Cognitive Bias Modification (CBM) + PTSD CBM	Alcohol CBM	-
Alcohol Sham + PTSD CBM	Alcohol Sham	-
Alcohol CBM + PTSD Sham	Alcohol CBM	-
Alcohol CBM + PTSD Sham	PTSD Sham	-

Primary Outcome Measures

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

Trial Locations

Locations (3)

The University of South Dakota; 🇺🇸 Vermillion, South Dakota, United States

Sioux Falls VA Health Care System; 🇺🇸 Sioux Falls, South Dakota, United States

Bay Pines VA Health Care System; 🇺🇸 Bay Pines, Florida, United States