Alcohol Use DisorderNCT04463225
The Network Study: Soldiers Connecting for Work and Health
A study testing Internet-Delivered Brief Intervention in people with Alcohol Use Disorder and Depression, run by Cornell University at 1 site in United States.
Trial summary
This study will examine the efficacy of an internet-based brief intervention designed to reduce risky behavior in Soldiers as they transition from Active Duty into the civilian workforce as a Veteran. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2021to 31 Mar 2024
- 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 solider intending to separate from active duty during the study enrollment period
- Intends to seek civilian employment
- Plans to live in US
Who cannot join
- Plans to retire and not seek civilian employment
- Plans to live outside of the US
- Is separating or retiring from the National Guard or Reserves
Trial locations and contacts
1 site in 1 country.
Paul D Bliese, Ph.D. contact
United States1 site, 1 recruiting
- Recruiting
Joint Base Lewis-McChord
Tacoma, Washington, 98433
Sherry Matheney, 253-477-4744, sherry.k.matheney.civ@army.mil
About this study
Official title: Patterns of Alcohol Use and Suicide-related Thoughts Among Recently Discharged Veterans: Risk Factors Associated With the Military-to-Veteran Transition
This study will examine the efficacy of an internet-based brief intervention designed to reduce risky behavior in Soldiers as they transition from Active Duty into the civilian workforce as a Veteran. Up to 700 soldiers intending to separate from the Army will be recruited, with the intention of drawing a final sample of 450 participants. Study participants will be randomly assigned to either the intervention or the control group, stratified by age and gender.
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 soldiers undergo the transition from Active Duty to Veteran 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 over the transition; 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 transitioning Veteran population.
- Conditions
- Alcohol Use Disorder, Depression
- Being tested
- Internet-Delivered Brief Intervention
- Keywords
- Negative Emotional States, Anxiety, Alcohol norms, Trauma, PTSD, Stress, Self-medication
- Medical subject headings
- Alcoholism, Depression, Anxiety Disorders, Wounds and Injuries, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-Delivered Brief InterventionOther
The internet-delivered brief intervention developed for the study can be accessed via computers and mobile devices.. The intervention will employ assessment data to give study participants feedback on their drinking behavior and offer strategies to avoid risky behavior.
| Study group | Role | What they receive |
|---|---|---|
| Intervention condition | Other | Participants assigned to the intervention condition will be invited to engage with an internet-based intervention three times during the course of the study. Receives: Other: Internet-Delivered Brief Intervention |
| Control | No intervention | The control group will not be offered the internet-based intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Heavy Episodic Drinking
Description Single Alcohol Screening Question (SASQ) (Williams and Vinson, 2001)
Measured: Through study completion, an average of monthly over 15 months
Change in Modal alcohol consumption
Daily Drinking Questionnaire (DDQ) (Collins, Parks, \& Marlatt, 1985)
Measured: Through study completion, an average of monthly over 15 months
Change in Negative Emotional State -- Depression
The Patient Health Questionnaire (PHQ)-9
Measured: Through study completion, an average of monthly over 15 months
Secondary outcomes (2)
Change in Alcohol-related problems
Short Rutgers Alcohol Problems Index (S-RAPI) (Earleywine, LaBrie \& Pedersen)
Measured: Through study completion, an average of monthly over 15 months
Change in Suicidal ideation
Measure developed by Nock et al., 2007
Measured: Through study completion, an average of monthly over 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start30 Mar 2021
- Primary completion28 Feb 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (73)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 three opportunities to engage with a personalized internet-delivered brief intervention over the course of seven months and the second group will not be granted access.
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, University of South Carolina
- Responsible party
- Sponsor
- Investigators
- Samuel Bacharach, Ph.D., Principal investigator, Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04463225
- Sponsor's protocol ID
- IRB0009650
- Other IDs
- W81XWH1920001;CDMRP-BA160401
- Status last verified
- May 2023
- First submitted
- 24 Jun 2020
- Last updated
- 26 May 2023
- 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 11300981Collins 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 3998247Kroenke 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 11556941Earleywine M, LaBrie JW, Pedersen ER. A brief Rutgers Alcohol Problem Index with less potential for bias. Addict Behav. 2008 Sep;33(9):1249-53. doi: 10.1016/j.addbeh.2008.05.006. Epub 2008 May 13.
PubMed 18547738Nock 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 17907852Morean ME, Kong G, Camenga DR, Cavallo DA, Connell C, Krishnan-Sarin S. First drink to first drunk: age of onset and delay to intoxication are associated with adolescent alcohol use and binge drinking. Alcohol Clin Exp Res. 2014 Oct;38(10):2615-21. doi: 10.1111/acer.12526. Epub 2014 Sep 24.
PubMed 25257574Saunders 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 8329970Forbes 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 23801571Spitzer 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 16717171Britt 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 29078001Carver 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 16250744Sayer 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 22162082Lindgren 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 22428863Grant 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 17716823Ames 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
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patterns of Alcohol Use and Suicide-related Thoughts Among Recently Discharged Veterans: Risk Factors Associated With the Military-to-Veteran Transition
- ClinicalTrials.gov ID
- NCT04463225
- Acronym / sponsor ID
- IRB0009650
- Conditions
- Alcohol Use Disorder, Depression
- Keywords
- Negative Emotional States, Anxiety, Alcohol norms, Trauma, PTSD, Stress, Self-medication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Cornell UniversityUniversity, hospital or other
- Collaborators
- University of Washington, University of South Carolina
- Study start
- 30 Mar 2021 (actual)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 9 Jul 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.
This study will examine the efficacy of an internet-based brief intervention designed to reduce risky behavior in Soldiers as they transition from Active Duty into the civilian workforce as a Veteran. Up to 700 soldiers intending to separate from the Army will be recruited, with the intention of drawing a final sample of 450 participants. Study participants will be randomly assigned to either the intervention or the control group, stratified by age and gender.
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 soldiers undergo the transition from Active Duty to Veteran 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 over the transition; 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 transitioning Veteran population.
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 three opportunities to engage with a personalized internet-delivered brief intervention over the course of seven months and the second group will not be granted access.
| Arm | Type | Receives |
|---|---|---|
| Intervention condition | Other | Other: Internet-Delivered Brief InterventionParticipants assigned to the intervention condition will be invited to engage with an internet-based intervention three times during the course of the study. |
| Control | No intervention | –The control group will not be offered the internet-based intervention. |
Who may qualify
- Ages
- 18 to 62 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Is US solider intending to separate from active duty during the study enrollment period
- Intends to seek civilian employment
- Plans to live in US
Key exclusion criteria (3 listed)
- Plans to retire and not seek civilian employment
- Plans to live outside of the US
- Is separating or retiring 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 InterventionThe internet-delivered brief intervention developed for the study can be accessed via computers and mobile devices.. The intervention will employ assessment data to give study participants feedback on their drinking behavior and offer strategies to avoid risky behavior. | Other | Intervention condition |
Primary outcome
Change in Heavy Episodic Drinking
Time frame: Through study completion, an average of monthly over 15 months
Description Single Alcohol Screening Question (SASQ) (Williams and Vinson, 2001)
Change in Modal alcohol consumption
Time frame: Through study completion, an average of monthly over 15 months
Daily Drinking Questionnaire (DDQ) (Collins, Parks, \& Marlatt, 1985)
Change in Negative Emotional State -- Depression
Time frame: Through study completion, an average of monthly over 15 months
The Patient Health Questionnaire (PHQ)-9
2 secondary outcomes
Change in Alcohol-related problems
Time frame: Through study completion, an average of monthly over 15 months
Change in Suicidal ideation
Time frame: Through study completion, an average of monthly over 15 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
- 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 18547738Earleywine M, LaBrie JW, Pedersen ER. A brief Rutgers Alcohol Problem Index with less potential for bias. Addict Behav. 2008 Sep;33(9):1249-53. doi: 10.1016/j.addbeh.2008.05.006. Epub 2008 May 13.
- 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 25257574Morean ME, Kong G, Camenga DR, Cavallo DA, Connell C, Krishnan-Sarin S. First drink to first drunk: age of onset and delay to intoxication are associated with adolescent alcohol use and binge drinking. Alcohol Clin Exp Res. 2014 Oct;38(10):2615-21. doi: 10.1111/acer.12526. Epub 2014 Sep 24.
- 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.
- 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.
Paul D Bliese, Ph.D. contact
Samuel Bacharach, Ph.D. 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 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: status not confirmed, as of the sponsor's last update on 26 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samuel Bacharach, Ph.D. (212-340-2850, sb22@cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Heavy Episodic Drinking (time frame: Through study completion, an average of monthly over 15 months). 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 NCT04463225, which also lists 73 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 26 May 2023.