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

• Sponsor: University of South Dakota (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04552782
• Collaborator: National Institute of Mental Health (NIMH) (NIH), Sioux Falls VA Health Care System (U.S. Fed), Bay Pines VA Healthcare System (U.S. Fed)
• Enrollment: 250
• Locations: 3
• Arms: 4
• Anticipated Duration (Months): 52.8
• Patients Per Site: 83.3
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stress Disorders, Post-Traumatic; Alcoholism	Behavioral: Alcohol CBM; Behavioral: PTSD CBM; Behavioral: Alcohol Sham; Behavioral: PTSD Sham	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 250 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: PTSD, AUD, and Interpersonal Conflict: Within-person Associations
• Actual Study Start Date: Dec 4, 2020
• Anticipated Primary Completion Date: Apr 30, 2025
• Anticipated Study Completion Date: Apr 30, 2025

Arms and Interventions

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: Alcohol Sham; Will not train approach or avoidance responses.; Behavioral: PTSD Sham; Will not train approach or avoidance responses.

Outcome Measures

Primary Outcome Measures

1. Rate of Alcohol Use Disorder Symptoms [2 years]

   These are experience sampling items derived from Diagnostic and Statistical Manual of Mental Disorders (DSM-5).

2. Rate of PTSD Symptoms [2 years]

   These are experience sampling items derived from the PTSD Checklist from DSM-5 (PCL-5).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

• Severe risk for sleep apnea (a positive score in three categories of the Berlin Questionnaire), or reported treatment for sleep apnea

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bay Pines VA Health Care System	Bay Pines	Florida	United States	33744
2	Sioux Falls VA Health Care System	Sioux Falls	South Dakota	United States	57105
3	The University of South Dakota	Vermillion	South Dakota	United States	57069

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of South Dakota
• ClinicalTrials.gov Identifier: NCT04552782
• Other Study ID Numbers: 1R01MH122954
• First Posted: Sep 17, 2020
• Last Update Posted: May 24, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Alcoholism; Stress Disorders, Post-Traumatic; Ethanol

Study Results

No Results Posted as of May 24, 2022