PTSD, AUD, and Interpersonal Conflict: Within-person Associations
1 other identifier
interventional
250
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2020
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2020
CompletedFirst Posted
Study publicly available on registry
September 17, 2020
CompletedStudy Start
First participant enrolled
December 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2025
CompletedMay 9, 2023
May 1, 2023
4.4 years
September 10, 2020
May 8, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Rate of Alcohol Use Disorder Symptoms
These are experience sampling items derived from Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
2 years
Rate of PTSD Symptoms
These are experience sampling items derived from the PTSD Checklist from DSM-5 (PCL-5).
2 years
Study Arms (4)
Alcohol Cognitive Bias Modification (CBM) + PTSD CBM
EXPERIMENTALAlcohol CBM + PTSD Sham
EXPERIMENTALAlcohol Sham + PTSD CBM
EXPERIMENTALAlcohol Sham + PTSD Sham
SHAM COMPARATORInterventions
Trains approach or avoidance responses to alcohol cues.
Trains approach or avoidance responses to trauma cues.
Will not train approach or avoidance responses.
Will not train approach or avoidance responses.
Eligibility Criteria
You may qualify if:
- OIF/OEF/OND veterans
- At risk for PTSD (i.e., PCL-5 ≥33) and/or AUD (i.e., AUDIT ≥ 7 (women) ≥ 8 (men))
You may not qualify if:
- Psychosis or severe Alcohol Use Disorder that contraindicates participation (based on interview)
- Active suicidal or homicidal ideation that contraindicates participation (based on interview)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of South Dakotalead
- National Institute of Mental Health (NIMH)collaborator
- Sioux Falls VA Health Care Systemcollaborator
- Bay Pines VA Healthcare Systemcollaborator
Study Sites (3)
Bay Pines VA Health Care System
Bay Pines, Florida, 33744, United States
Sioux Falls VA Health Care System
Sioux Falls, South Dakota, 57105, United States
The University of South Dakota
Vermillion, South Dakota, 57069, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2020
First Posted
September 17, 2020
Study Start
December 4, 2020
Primary Completion
April 30, 2025
Study Completion
April 30, 2025
Last Updated
May 9, 2023
Record last verified: 2023-05