Alcohol Use DisorderNCT06095817

Project VALOR: Veteran Stress and Wellbeing

A study testing Internet Delivered Brief Intervention (IDBI) in people with Alcohol Use Disorder and Depression, run by Cornell University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This study will examine the efficacy of an internet-based brief intervention designed to reduce risky behavior veterans as the move into their second year post-Army. Up to 350 veterans drawn from The Network Study (Dept of Defense; Award number: W81XWH1920001) will be recruited with the intention of drawing a final… Read more about this study

Who is it for?: Ages 18 to 62 yearsHealthy volunteers can take part
Conditions the study is for: Alcohol Use Disorder, Depression
What is being tested?: Internet Delivered Brief Intervention (IDBI)
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 140 participants
Where: 1 siteUnited States
Study dates: 1 Jun 2023to 6 Oct 2023
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 62 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Is US Army veteran who participated in The Network Study (Dept of Defense; Award number: W81XWH1920001)
Seeks/engages in civilian employment
Lives in US

Who cannot join

Retired with no plans to seek civilian employment
Living outside of the US
Separated from the National Guard or Reserves

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Washington
Seattle, Washington, 98105

Other trials in United States

About this study

Official title: Continuity of Military Transition Study: Project VALOR

Read the detailed description

The combination of alcohol use and negative emotional states is a particularly toxic combination for suicide risk. The current study examines changes in alcohol/drug use/misuse and depression as veterans transition further into their post-Army environment and offers a personalized internet-based brief intervention intended to prevent/reduce alcohol misuse and depression in this population.

The study's objectives are to empirically quantify the form of changes that occur with respect to alcohol use and depression as veterans move into their second year post-Army; to identify stable individual risk factors (e.g., personality, military experiences) and dynamic risk factors (e.g., changes in stressors and normative contexts over time) that may be associated with differential temporal patterns of suicide-related behavior (i.e., alcohol use/misuse) and cognition (i.e., depression); and lastly, to determine whether a simple, internet-delivered brief intervention shown can reduce risky behavior in the veteran population.

Conditions: Alcohol Use Disorder, Depression
Being tested: Internet Delivered Brief Intervention (IDBI)
Keywords: Alcohol-Related Disorders, Anxiety, Alcoholism, Self Medication, Stress Disorders, Post-Traumatic, Depression, Psychological Distress, Drinking Behavior, Substance-Related Disorders
Medical subject headings: Alcoholism, Depression, Alcohol-Related Disorders, Anxiety Disorders, Stress Disorders, Post-Traumatic, Drinking Behavior, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Internet Delivered Brief Intervention (IDBI)Behavioural
The intervention is an online module that can be accessed through smartphone, tablet, computer or other device. Participants will receive information about alcohol expectancies, alcohol use and norms, identity (service member, veteran, civilian), sleep, stress, and strategies for coping on the job.

Study groups in NCT06095817
Study group	Role	What they receive
Intervention Condition	Experimental	Participants assigned to the intervention condition will be invited to engage with an internet-based intervention at the start of the study (12 months following their separation) * Half of those in the intervention condition will have already received two prior IDBIs (as part of the DoD funded study) within the first 6 months of separation. * The other half of those in the intervention condition will have received no prior IDBIs. Receives: Behavioral: Internet Delivered Brief Intervention (IDBI)
Control	No intervention	The control group will not be offered this month-12 internet-based intervention. * Half of those in the control condition will have received two earlier IDBIs (as part of the DoD funded study) within the first 6 months of their separation. * The other half of those in the control condition will have received no prior IDBIs.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Heavy Episodic Drinking
Single Alcohol Screening Question (SASQ) (Williams and Vinson, 2001)
Measured: Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army
Change in Modal alcohol consumption
Daily Drinking Questionnaire (DDQ) (Collins, Parks, \& Marlatt, 1985)
Measured: Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army
Change in Negative Emotional State -- Depression
The Patient Health Questionnaire (PHQ)-9
Measured: Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army

Secondary outcomes (2)

Change in Alcohol-related problems
Short Rutgers Alcohol Problems Index (S-RAPI) (Earleywine, LaBrie \& Pedersen)
Measured: Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army
Change in Suicidal ideation
Suicide ideation measure developed by Nock, 2007
Measured: Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 20236 Oct 2023

First posted23 Oct 2023
Study start1 Jun 2023
Primary completion6 Oct 2023
Study completion6 Oct 2023

Why it stopped: Lack of funding to continue

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (55)Papers the sponsor has linked to this study.
Other trials for Alcohol Use DisorderStudies 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: One group will receive an opportunity to engage with a personalized internet-delivered brief intervention (IDBI) and the second group will not be granted access. This IDBI will serve as a second booster intervention for half o those randomized into the treatment condition. For the other half randomized into the treatment condition, this IDBI will serve as an initial intervention coming 12 months after separation from the military.
Masking: None (open label)
Enrolment: 140 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06095817
Sponsor's protocol ID: Smithers2023
Status last verified: Jan 2025
First submitted: 18 Oct 2023
Last updated: 15 Jan 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Williams R, Vinson DC. Validation of a single screening question for problem drinking. J Fam Pract. 2001 Apr;50(4):307-12.
PubMed 11300981
Collins RL, Parks GA, Marlatt GA. Social determinants of alcohol consumption: the effects of social interaction and model status on the self-administration of alcohol. J Consult Clin Psychol. 1985 Apr;53(2):189-200. doi: 10.1037//0022-006x.53.2.189. No abstract available.
PubMed 3998247
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941
Nock MK, Banaji MR. Prediction of suicide ideation and attempts among adolescents using a brief performance-based test. J Consult Clin Psychol. 2007 Oct;75(5):707-15. doi: 10.1037/0022-006X.75.5.707.
PubMed 17907852
Saunders JB, Aasland OG, Babor TF, de la Fuente JR, Grant M. Development of the Alcohol Use Disorders Identification Test (AUDIT): WHO Collaborative Project on Early Detection of Persons with Harmful Alcohol Consumption--II. Addiction. 1993 Jun;88(6):791-804. doi: 10.1111/j.1360-0443.1993.tb02093.x.
PubMed 8329970
Forbes D, Alkemade N, Mitchell D, Elhai JD, McHugh T, Bates G, Novaco RW, Bryant R, Lewis V. Utility of the Dimensions of Anger Reactions-5 (DAR-5) scale as a brief anger measure. Depress Anxiety. 2014 Feb;31(2):166-73. doi: 10.1002/da.22148. Epub 2013 Jun 25.
PubMed 23801571
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171
Britt TW, Adler AB, Sawhney G, Bliese PD. Coping Strategies as Moderators of the Association Between Combat Exposure and Posttraumatic Stress Disorder Symptoms. J Trauma Stress. 2017 Oct;30(5):491-501. doi: 10.1002/jts.22221.
PubMed 29078001
Carver CS. You want to measure coping but your protocol's too long: consider the brief COPE. Int J Behav Med. 1997;4(1):92-100. doi: 10.1207/s15327558ijbm0401_6.
PubMed 16250744
Sayer NA, Frazier P, Orazem RJ, Murdoch M, Gravely A, Carlson KF, Hintz S, Noorbaloochi S. Military to civilian questionnaire: a measure of postdeployment community reintegration difficulty among veterans using Department of Veterans Affairs medical care. J Trauma Stress. 2011 Dec;24(6):660-70. doi: 10.1002/jts.20706. Epub 2011 Dec 7.
PubMed 22162082
Lindgren KP, Neighbors C, Teachman BA, Wiers RW, Westgate E, Greenwald AG. I drink therefore I am: validating alcohol-related implicit association tests. Psychol Addict Behav. 2013 Mar;27(1):1-13. doi: 10.1037/a0027640. Epub 2012 Mar 19.
PubMed 22428863
Grant VV, Stewart SH, O'Connor RM, Blackwell E, Conrod PJ. Psychometric evaluation of the five-factor Modified Drinking Motives Questionnaire--Revised in undergraduates. Addict Behav. 2007 Nov;32(11):2611-32. doi: 10.1016/j.addbeh.2007.07.004. Epub 2007 Jul 13.
PubMed 17716823
Ames GM, Grube JW. Alcohol availability and workplace drinking: mixed method analyses. J Stud Alcohol. 1999 May;60(3):383-93. doi: 10.15288/jsa.1999.60.383.
PubMed 10371267
Ames GM, Grube JW, Moore RS. Social control and workplace drinking norms: a comparison of two organizational cultures. J Stud Alcohol. 2000 Mar;61(2):203-19. doi: 10.15288/jsa.2000.61.203.
PubMed 10757130
Baer JS, Stacy A, Larimer M. Biases in the perception of drinking norms among college students. J Stud Alcohol. 1991 Nov;52(6):580-6. doi: 10.15288/jsa.1991.52.580.
PubMed 1758185

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Alcohol Use Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Continuity of Military Transition Study: Project VALOR
ClinicalTrials.gov ID: NCT06095817
Acronym / sponsor ID: Smithers2023
Conditions: Alcohol Use Disorder, Depression
Keywords: Alcohol-Related Disorders, Anxiety, Alcoholism, Self Medication, Stress Disorders, Post-Traumatic, Depression, Psychological Distress, Drinking Behavior
Study type: Interventional
Recruitment status: TerminatedReason stopped: Lack of funding to continue
Enrolment: 140 participants (actual)
Lead sponsor: Cornell UniversityUniversity, hospital or other
Collaborators: University of Washington
Study start: 1 Jun 2023 (actual)
Primary completion: 6 Oct 2023 (actual)
Study completion: 6 Oct 2023 (actual)
First posted: 23 Oct 2023 (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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: One group will receive an opportunity to engage with a personalized internet-delivered brief intervention (IDBI) and the second group will not be granted access. This IDBI will serve as a second booster intervention for half o those randomized into the treatment condition. For the other half randomized into the treatment condition, this IDBI will serve as an initial intervention coming 12 months after separation from the military.

Arm	Type	Receives
Intervention Condition	Experimental	Behavioral: Internet Delivered Brief Intervention (IDBI)Participants assigned to the intervention condition will be invited to engage with an internet-based intervention at the start of the study (12 months following their separation) * Half of those in the intervention condition will have already received two prior IDBIs (as part of the DoD funded study) within the first 6 months of separation. * The other half of those in the intervention condition will have received no prior IDBIs.
Control	No intervention	–The control group will not be offered this month-12 internet-based intervention. * Half of those in the control condition will have received two earlier IDBIs (as part of the DoD funded study) within the first 6 months of their separation. * The other half of those in the control condition will have received no prior IDBIs.

Who may qualify

Ages: 18 to 62 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Is US Army veteran who participated in The Network Study (Dept of Defense; Award number: W81XWH1920001)
Seeks/engages in civilian employment
Lives in US

Key exclusion criteria (3 listed)

Retired with no plans to seek civilian employment
Living outside of the US
Separated from the National Guard or Reserves

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
Internet Delivered Brief Intervention (IDBI)The intervention is an online module that can be accessed through smartphone, tablet, computer or other device. Participants will receive information about alcohol expectancies, alcohol use and norms, identity (service member, veteran, civilian), sleep, stress, and strategies for coping on the job.	Behavioural	Intervention Condition

Primary outcome

Change in Heavy Episodic Drinking
Time frame: Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army
Single Alcohol Screening Question (SASQ) (Williams and Vinson, 2001)
Change in Modal alcohol consumption
Time frame: Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army
Daily Drinking Questionnaire (DDQ) (Collins, Parks, \& Marlatt, 1985)
Change in Negative Emotional State -- Depression
Time frame: Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army
The Patient Health Questionnaire (PHQ)-9

2 secondary outcomes

Change in Alcohol-related problems
Time frame: Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army
Change in Suicidal ideation
Time frame: Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army

Results and safety

The study was stopped early (reason given: Lack of funding to continue). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
Background: PubMed 11300981Williams R, Vinson DC. Validation of a single screening question for problem drinking. J Fam Pract. 2001 Apr;50(4):307-12.
Background: PubMed 3998247Collins RL, Parks GA, Marlatt GA. Social determinants of alcohol consumption: the effects of social interaction and model status on the self-administration of alcohol. J Consult Clin Psychol. 1985 Apr;53(2):189-200. doi: 10.1037//0022-006x.53.2.189. No abstract available.
Background: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
Background: PubMed 17907852Nock MK, Banaji MR. Prediction of suicide ideation and attempts among adolescents using a brief performance-based test. J Consult Clin Psychol. 2007 Oct;75(5):707-15. doi: 10.1037/0022-006X.75.5.707.
Background: PubMed 8329970Saunders JB, Aasland OG, Babor TF, de la Fuente JR, Grant M. Development of the Alcohol Use Disorders Identification Test (AUDIT): WHO Collaborative Project on Early Detection of Persons with Harmful Alcohol Consumption--II. Addiction. 1993 Jun;88(6):791-804. doi: 10.1111/j.1360-0443.1993.tb02093.x.
Background: PubMed 23801571Forbes D, Alkemade N, Mitchell D, Elhai JD, McHugh T, Bates G, Novaco RW, Bryant R, Lewis V. Utility of the Dimensions of Anger Reactions-5 (DAR-5) scale as a brief anger measure. Depress Anxiety. 2014 Feb;31(2):166-73. doi: 10.1002/da.22148. Epub 2013 Jun 25.
Background: PubMed 16717171Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
Background: PubMed 29078001Britt TW, Adler AB, Sawhney G, Bliese PD. Coping Strategies as Moderators of the Association Between Combat Exposure and Posttraumatic Stress Disorder Symptoms. J Trauma Stress. 2017 Oct;30(5):491-501. doi: 10.1002/jts.22221.
Background: PubMed 16250744Carver CS. You want to measure coping but your protocol's too long: consider the brief COPE. Int J Behav Med. 1997;4(1):92-100. doi: 10.1207/s15327558ijbm0401_6.
Background: PubMed 22162082Sayer NA, Frazier P, Orazem RJ, Murdoch M, Gravely A, Carlson KF, Hintz S, Noorbaloochi S. Military to civilian questionnaire: a measure of postdeployment community reintegration difficulty among veterans using Department of Veterans Affairs medical care. J Trauma Stress. 2011 Dec;24(6):660-70. doi: 10.1002/jts.20706. Epub 2011 Dec 7.
Background: PubMed 22428863Lindgren KP, Neighbors C, Teachman BA, Wiers RW, Westgate E, Greenwald AG. I drink therefore I am: validating alcohol-related implicit association tests. Psychol Addict Behav. 2013 Mar;27(1):1-13. doi: 10.1037/a0027640. Epub 2012 Mar 19.
Background: PubMed 17716823Grant VV, Stewart SH, O'Connor RM, Blackwell E, Conrod PJ. Psychometric evaluation of the five-factor Modified Drinking Motives Questionnaire--Revised in undergraduates. Addict Behav. 2007 Nov;32(11):2611-32. doi: 10.1016/j.addbeh.2007.07.004. Epub 2007 Jul 13.
Individual participant dataSharing planned: No

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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.

Samuel Bacharach, PhD principal investigator

Cornell University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Internet Delivered Brief Intervention (IDBI) in people with Alcohol Use Disorder and Depression, run by Cornell University at 1 site 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 3 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: stopped early, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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?

The study was stopped early (reason given: Lack of funding to continue). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Heavy Episodic Drinking (time frame: Through study completion, data collected quarterly from 15 to up to 24 months post-separation from the Army). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06095817, which also lists 55 linked publications.

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 15 Jan 2025.