Stress Disorders, Post-TraumaticNCT04552782
PTSD, AUD, and Interpersonal Conflict: Within-person Associations
A study testing Alcohol CBM and PTSD CBM in people with Stress Disorders, Post-Traumatic and Alcoholism, run by University of South Dakota at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Stress Disorders, Post-Traumatic, Alcoholism
- What is being tested?
- Alcohol CBM and PTSD CBM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 3 sitesUnited States
- Study dates
- 4 Dec 2020to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- OIF/OEF/OND veterans
- At risk for PTSD (i.e., PCL-5 ≥33) and/or AUD (i.e., AUDIT ≥ 7 (women) ≥ 8 (men))
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Not yet recruiting
Bay Pines VA Health Care System
Bay Pines, Florida, 33744
Jessica Keith, PhD, jessica.keith@va.gov
Jessica Keith, PhD
- Recruiting
Sioux Falls VA Health Care System
Sioux Falls, South Dakota, 57105
Patrick J Ronan, PhD, 605-336-3230 ext. 6508, patrick.ronan@usd.edu
Patrick J Ronan, PhD
- Recruiting
The University of South Dakota
Vermillion, South Dakota, 57069
Jeffrey S Simons, PhD, 605-658-3710, jeffrey.simons@usd.edu
Raluca M Simons, PhD, 605-658-3710, raluca.simons@usd.edu
About this study
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.
- Conditions
- Stress Disorders, Post-Traumatic, Alcoholism
- Being tested
- Alcohol CBM, PTSD CBM, Alcohol Sham, PTSD Sham
- Medical subject headings
- Stress Disorders, Post-Traumatic, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol CBMBehavioural
Trains approach or avoidance responses to alcohol cues.
PTSD CBMBehavioural
Trains approach or avoidance responses to trauma cues.
Alcohol ShamBehavioural
Will not train approach or avoidance responses.
PTSD ShamBehavioural
Will not train approach or avoidance responses.
| Study group | Role | What they receive |
|---|---|---|
| Alcohol Cognitive Bias Modification (CBM) + PTSD CBM | Experimental | Not described Receives: Behavioral: Alcohol CBM; Behavioral: PTSD CBM |
| Alcohol CBM + PTSD Sham | Experimental | Not described Receives: Behavioral: Alcohol CBM; Behavioral: PTSD Sham |
| Alcohol Sham + PTSD CBM | Experimental | Not described Receives: Behavioral: PTSD CBM; Behavioral: Alcohol Sham |
| Alcohol Sham + PTSD Sham | Sham comparator | Not described Receives: Behavioral: Alcohol Sham; Behavioral: PTSD Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Alcohol Use Disorder Symptoms
These are experience sampling items derived from Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
Measured: 2 years
Rate of PTSD Symptoms
These are experience sampling items derived from the PTSD Checklist from DSM-5 (PCL-5).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start4 Dec 2020
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Dakota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Sioux Falls VA Health Care System, Bay Pines VA Healthcare System
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04552782
- Sponsor's protocol ID
- 1R01MH122954
- Status last verified
- May 2023
- First submitted
- 10 Sep 2020
- Last updated
- 9 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PTSD, AUD, and Interpersonal Conflict: Within-person Associations
- ClinicalTrials.gov ID
- NCT04552782
- Acronym / sponsor ID
- 1R01MH122954
- Conditions
- Stress Disorders, Post-Traumatic, Alcoholism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of South DakotaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Sioux Falls VA Health Care System, Bay Pines VA Healthcare System
- Study start
- 4 Dec 2020 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 17 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Alcohol Cognitive Bias Modification (CBM) + PTSD CBM | Experimental | Behavioral: Alcohol CBM, Behavioral: PTSD CBM |
| Alcohol CBM + PTSD Sham | Experimental | Behavioral: Alcohol CBM, Behavioral: PTSD Sham |
| Alcohol Sham + PTSD CBM | Experimental | Behavioral: PTSD CBM, Behavioral: Alcohol Sham |
| Alcohol Sham + PTSD Sham | Sham comparator | Behavioral: Alcohol Sham, Behavioral: PTSD Sham |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- OIF/OEF/OND veterans
- At risk for PTSD (i.e., PCL-5 ≥33) and/or AUD (i.e., AUDIT ≥ 7 (women) ≥ 8 (men))
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcohol CBMTrains approach or avoidance responses to alcohol cues. | Behavioural | Alcohol CBM + PTSD Sham, Alcohol Cognitive Bias Modification (CBM) + PTSD CBM |
| PTSD CBMTrains approach or avoidance responses to trauma cues. | Behavioural | Alcohol Cognitive Bias Modification (CBM) + PTSD CBM, Alcohol Sham + PTSD CBM |
| Alcohol ShamWill not train approach or avoidance responses. | Behavioural | Alcohol Sham + PTSD CBM, Alcohol Sham + PTSD Sham |
| PTSD ShamWill not train approach or avoidance responses. | Behavioural | Alcohol CBM + PTSD Sham, Alcohol Sham + PTSD Sham |
Primary outcome
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).
Rate of PTSD Symptoms
Time frame: 2 years
These are experience sampling items derived from the PTSD Checklist from DSM-5 (PCL-5).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol CBM and PTSD CBM in people with Stress Disorders, Post-Traumatic and Alcoholism, run by University of South Dakota at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeffrey S Simons, PhD (605-658-3710, jeffrey.simons@usd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Alcohol Use Disorder Symptoms (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.