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

Primary Purpose

Stress Disorders, Post-Traumatic, Alcoholism

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alcohol CBM
PTSD CBM
Alcohol Sham
PTSD Sham
Sponsored by
University of South Dakota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Stress Disorders, Post-Traumatic

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bay Pines VA Health Care System
  • Sioux Falls VA Health Care SystemRecruiting
  • The University of South DakotaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Sham Comparator

Arm Label

Alcohol Cognitive Bias Modification (CBM) + PTSD CBM

Alcohol CBM + PTSD Sham

Alcohol Sham + PTSD CBM

Alcohol Sham + PTSD Sham

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 10, 2020
Last Updated
May 8, 2023
Sponsor
University of South Dakota
Collaborators
National Institute of Mental Health (NIMH), Sioux Falls VA Health Care System, Bay Pines VA Healthcare System
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1. Study Identification

Unique Protocol Identification Number
NCT04552782
Brief Title
PTSD, AUD, and Interpersonal Conflict: Within-person Associations
Official Title
PTSD, AUD, and Interpersonal Conflict: Within-person Associations
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 4, 2020 (Actual)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Dakota
Collaborators
National Institute of Mental Health (NIMH), Sioux Falls VA Health Care System, Bay Pines VA Healthcare System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic, Alcoholism

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Alcohol Cognitive Bias Modification (CBM) + PTSD CBM
Arm Type
Experimental
Arm Title
Alcohol CBM + PTSD Sham
Arm Type
Experimental
Arm Title
Alcohol Sham + PTSD CBM
Arm Type
Experimental
Arm Title
Alcohol Sham + PTSD Sham
Arm Type
Sham Comparator
Intervention Type
Behavioral
Intervention Name(s)
Alcohol CBM
Intervention Description
Trains approach or avoidance responses to alcohol cues.
Intervention Type
Behavioral
Intervention Name(s)
PTSD CBM
Intervention Description
Trains approach or avoidance responses to trauma cues.
Intervention Type
Behavioral
Intervention Name(s)
Alcohol Sham
Intervention Description
Will not train approach or avoidance responses.
Intervention Type
Behavioral
Intervention Name(s)
PTSD Sham
Intervention Description
Will not train approach or avoidance responses.
Primary Outcome Measure Information:
Title
Rate of Alcohol Use Disorder Symptoms
Description
These are experience sampling items derived from Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
Time Frame
2 years
Title
Rate of PTSD Symptoms
Description
These are experience sampling items derived from the PTSD Checklist from DSM-5 (PCL-5).
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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) [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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeffrey S Simons, PhD
Phone
605-658-3710
Email
jeffrey.simons@usd.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Raluca M Simons, PhD
Phone
605-658-3710
Email
raluca.simons@usd.edu
Facility Information:
Facility Name
Bay Pines VA Health Care System
City
Bay Pines
State/Province
Florida
ZIP/Postal Code
33744
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Keith, PhD
Email
jessica.keith@va.gov
First Name & Middle Initial & Last Name & Degree
Jessica Keith, PhD
Facility Name
Sioux Falls VA Health Care System
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick J Ronan, PhD
Phone
605-336-3230
Ext
6508
Email
patrick.ronan@usd.edu
First Name & Middle Initial & Last Name & Degree
Patrick J Ronan, PhD
Facility Name
The University of South Dakota
City
Vermillion
State/Province
South Dakota
ZIP/Postal Code
57069
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey S Simons, PhD
Phone
605-658-3710
Email
jeffrey.simons@usd.edu
First Name & Middle Initial & Last Name & Degree
Raluca M Simons, PhD
Phone
605-658-3710
Email
raluca.simons@usd.edu
First Name & Middle Initial & Last Name & Degree
Jeffrey S Simons, PhD
First Name & Middle Initial & Last Name & Degree
Raluca M Simons, PhD

12. IPD Sharing Statement

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

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