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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04552782
Recruitment Status : Recruiting
First Posted : September 17, 2020
Last Update Posted : May 24, 2022
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Sioux Falls VA Health Care System
Bay Pines VA Healthcare System
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Stress Disorders, Post-Traumatic Alcoholism Behavioral: Alcohol CBM Behavioral: PTSD CBM Behavioral: Alcohol Sham Behavioral: PTSD Sham Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 4, 2020
Estimated Primary Completion Date : April 30, 2025
Estimated Study Completion Date : April 30, 2025

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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. Rate of PTSD Symptoms [ Time Frame: 2 years ]
    These are experience sampling items derived from the PTSD Checklist from DSM-5 (PCL-5).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04552782


Contacts
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Contact: Jeffrey S Simons, PhD 605-658-3710 jeffrey.simons@usd.edu
Contact: Raluca M Simons, PhD 605-658-3710 raluca.simons@usd.edu

Locations
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United States, Florida
Bay Pines VA Health Care System Not yet recruiting
Bay Pines, Florida, United States, 33744
Contact: Jessica Keith, PhD       jessica.keith@va.gov   
Sub-Investigator: Jessica Keith, PhD         
United States, South Dakota
Sioux Falls VA Health Care System Recruiting
Sioux Falls, South Dakota, United States, 57105
Contact: Patrick J Ronan, PhD    605-336-3230 ext 6508    patrick.ronan@usd.edu   
Sub-Investigator: Patrick J Ronan, PhD         
The University of South Dakota Recruiting
Vermillion, South Dakota, United States, 57069
Contact: Jeffrey S Simons, PhD    605-658-3710    jeffrey.simons@usd.edu   
Contact: Raluca M Simons, PhD    605-658-3710    raluca.simons@usd.edu   
Principal Investigator: Jeffrey S Simons, PhD         
Principal Investigator: Raluca M Simons, PhD         
Sponsors and Collaborators
University of South Dakota
National Institute of Mental Health (NIMH)
Sioux Falls VA Health Care System
Bay Pines VA Healthcare System
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Responsible Party: University of South Dakota
ClinicalTrials.gov Identifier: NCT04552782    
Other Study ID Numbers: 1R01MH122954 ( U.S. NIH Grant/Contract )
First Posted: September 17, 2020    Key Record Dates
Last Update Posted: May 24, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alcoholism
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs