Alcohol Use DisorderNCT06249386
Adapting and Piloting Behavioral Activation for Veterans With Alcohol Use Disorder and Posttraumatic Stress Disorder
A study testing Behavioral Activation (BA) and Relapse Prevention (RP) in people with Alcohol Use Disorder and Posttraumatic Stress Disorder, run by RTI International at 1 site in United States.
Trial summary
The goal of this clinical trial is to compare an adaptation of Behavioral Activation, a behavioral intervention, to Relapse Prevention treatment, another behavioral intervention, in a sample of U.S. military veterans with co-occurring alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder, Posttraumatic Stress Disorder
- What is being tested?
- Behavioral Activation (BA) and Relapse Prevention (RP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2025to 6 Oct 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be a U.S. veteran,
- Be at least 18 years old,
- Meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for current AUD,
- Report 3+ heavy drinking days (5+ drinks for men/4+ drinks for women) or 1+ heavy drinking week (15+ drinks men/8+ drinks women) in the past 30 days,
- Meet DSM-5 criteria for current PTSD or satisfy the definition of current subthreshold PTSD (i.e., up to one of symptom clusters B-E may fall below diagnostic threshold),
- Be fluent and literate in English, and
- Be able to provide voluntary, informed consent to participate.
Who cannot join
- Current mania/hypomania or current psychosis,
- Lifetime alcohol withdrawal-related seizures, delirium, or hallucinations,
- Prior inpatient alcohol withdrawal management,
- Current DSM-5 severe drug use disorder (DUD) except for severe tobacco use disorder,
- Psychotropic (including alcohol abstinence) medication changes within 30 days of study enrollment or plans to change medications during the study,
- Current/planned non-study BA for any disorder during the study, or
- Current/planned evidence-based psychotherapy for AUD, PTSD, or DUD during the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University School of Medicine
Durham, North Carolina, 27710
About this study
Official title: Adapting and Piloting Behavioral Activation for Veterans With Co-Occurring AUD and Posttraumatic Stress Disorder
The goal of this clinical trial is to compare an adaptation of Behavioral Activation, a behavioral intervention, to Relapse Prevention treatment, another behavioral intervention, in a sample of U.S. military veterans with co-occurring alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD).
The primary aims of this study are to:
Read more
- Adapt Behavioral Activation to treat veterans with AUD/PTSD,
- Evaluate the feasibility, acceptability, and preliminary effects of Behavioral Activation for AUD/PTSD, and
- Explore geospatial analysis as a new method for measuring AUD/PTSD recovery.
Participants will complete self-report and interview measures immediately before and immediately after treatment. Participants will also be asked to participate in passive geospatial assessment for 14-day periods immediately before and immediately after treatment. Participants will be randomized to treatment condition, which involves 8 sessions of either Behavioral Activation or Relapse Prevention, delivered individually by a trained study therapist.
Read the detailed description
Alcohol use disorder (AUD) frequently co-occurs with posttraumatic stress disorder (PTSD) among U.S. military veterans. Compared to veterans with AUD only, veterans with AUD/PTSD have greater symptom severity, more psychosocial functioning difficulties, and higher risk of suicide. Many people with AUD/PTSD perform behaviors aimed at avoiding unpleasant emotions (e.g., drinking to avoid trauma-related nightmares, skipping social events to avoid anxiety-provoking crowds). These "avoidance behaviors" provide temporary relief from unpleasant emotions, but they maintain AUD/PTSD and interfere with long-term functioning. Although treatments for AUD/PTSD exist, they emphasize symptom reduction (not functional improvement) and have dropout rates as high as 50%. Originally developed to treat depression, Behavioral Activation (BA) is an intervention that increases daily participation in rewarding, alcohol-free activities relevant to patients' social, vocational, and health-related values. Randomized controlled trials (RCTs) adapting BA for other disorders have shown that BA is efficacious for adults with alcohol/drug use disorders and acceptable to veterans with PTSD, but BA has not been used to treat co-occurring AUD/PTSD. Additionally, because RCTs of AUD/PTSD treatments typically emphasize significant mean group differences in AUD/PTSD outcomes, less is known about the degree to which these treatments yield clinically significant improvements at the individual level. Individual-level improvements in AUD/PTSD should be evident not only in subjective clinical assessments, but also in objective measures of geospatial activity. Specifically, patients' daily geospatial activity is likely to change as they decrease their avoidance behaviors and increase their engagement in various social, vocational, and health-promoting activities. Advances in geospatial methods, coupled with discreet and portable global positioning system (GPS) trackers, have made it possible to objectively measure people's spatial movement within their communities. Yet although geospatial methods have been used to identify social determinants of alcohol use, they have not been used to measure response to AUD or AUD/PTSD treatment. As the long-term objectives of this work are to identify a more acceptable AUD/PTSD treatment option and improve the measurement of AUD/PTSD recovery, this R34 project will address the following specific aims: (1) adapt BA for use with veterans with AUD/PTSD; (2) evaluate the feasibility, acceptability, and preliminary effects of BA, relative to Relapse Prevention, for veterans with AUD/PTSD in a pilot RCT; and (3) explore geospatial analysis of GPS-collected data as a new approach to measuring AUD/PTSD treatment response. This study will advance research and practice by piloting a novel application of BA and a novel measure of AUD/PTSD recovery. This project aligns with the National Institute on Alcohol Abuse and Alcoholism's special interest in investigating treatments for patients with AUD and co-occurring disorders, dimensions of functioning and well-being associated with recovery, and innovative methods for evaluating AUD treatment and recovery.
- Being tested
- Behavioral Activation (BA), Relapse Prevention (RP)
- Medical subject headings
- Alcoholism, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Activation (BA)Behavioural
BA reduces alcohol use and posttraumatic stress symptoms and increases psychosocial functioning via psychoeducation, activity monitoring, values clarification, and activity scheduling.
Relapse Prevention (RP)Behavioural
RP reduces alcohol use via increasing awareness and avoidance of high-risk situations, enhancing drink refusal skills, improving assertiveness, and other strategies.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Activation (BA) | Experimental | Individual psychotherapy Receives: Behavioral: Behavioral Activation (BA) |
| Relapse Prevention (RP) | Active comparator | Individual psychotherapy Receives: Behavioral: Relapse Prevention (RP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timeline Follow-Back (Alcohol Use)
Changes in past-30-day alcohol consumption from baseline to immediately post-treatment. One standard drink is defined in the United States as any beverage containing 0.6 fl oz or 14 grams. A drinking day refers to a day with any alcohol use. Higher values on this outcome reflect greater alcohol consumption.
Measured: Through study completion, an average of 3 months
Clinician-Administered PTSD Scale for DSM-5 (PTSD Severity)
Changes in past-month PTSD severity from baseline to immediately post-treatment. Total scores on this measure range 0 to 80, with higher scores reflecting more severe PTSD symptoms.
Measured: Through study completion, an average of 3 months
Secondary outcomes (6)
Brief Inventory of Psychosocial Functioning (Psychosocial Functioning)
Changes in past-30-day psychosocial functioning from baseline to immediately post-treatment. The percentage measurement scale has a minimum value of 0 and a maximum value of 100, where higher values reflect greater functioning difficulties (worse functioning).
Measured: Through study completion, an average of 3 months
Geospatial Activity
Changes in past-14-day geospatial activity metrics (e.g., activity space) from baseline to immediately post-treatment. This outcome is measured in square kilometers (km2). The 14-day period began on the date of the baseline or post-treatment assessment at which all other outcome data were collected. Reported values represent the average activity space per day.
Measured: Through study completion, an average of 3 months
PTSD Checklist for DSM-5 (PCL-5)
Changes in past-month PTSD severity from baseline through mid-treatment (an average of 1.5 months) to immediately post-treatment (an average of 3 months). Total scores on this measure range 0 to 80, with higher scores reflecting more severe PTSD symptoms.
Measured: Through study completion, an average of 1.5 months (mid-treatment) and 3 months (post-treatment)
Generalized Anxiety Disorder-7 (GAD-7)
Changes in past-2-week anxiety severity from baseline to immediately post-treatment. Total scores on this measure range 0 to 21, with higher scores reflecting more severe anxiety symptoms.
Measured: Through study completion, an average of 3 months
Patient Health Questionnaire-9 (PHQ-9)
Changes in past-2-week depressive symptom severity from baseline to immediately posttreatment. Total scores on this measure range 0 to 27, with higher scores reflecting more severe depressive symptoms.
Measured: Through study completion, an average of 3 months
Insomnia Severity Index
Changes in past-2-week sleep disturbance from baseline to immediately post-treatment. Total scores on this measure range 0 to 28, with higher scores reflecting more severe insomnia symptoms.
Measured: Through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start17 Jan 2025
- Primary completion6 Oct 2025
- Study completion6 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be block randomized to either Behavioral Activation treatment (n=23) or Relapse Prevention treatment (n=23).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Duke University
- Responsible party
- Principal investigator, Shannon Blakey, RTI International
- Investigators
- Shannon M Blakey, PhD, Principal investigator, RTI InternationalEric B Elbogen, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06249386
- Sponsor's protocol ID
- 0219135
- Other IDs
- R34AA030820, Pro00113641, STUDY00022679
- Status last verified
- Jan 2026
- First submitted
- 30 Jan 2024
- Last updated
- 9 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data from consenting participants will be submitted to the National Institute on Alcohol Abuse and Alcoholism Data Archive.
Publications
Blakey SM, Alsobrooks AK, Morgan-Lopez AA, Kruskamp N, Simpson TL, Daughters SB, DuBois CM, Huang JS, Evans J, Serrano BN, Calhoun PS, Beckham JC, Elbogen EB. Behavioral activation for veterans with co-occurring alcohol use disorder and posttraumatic stress disorder: Basis and methodology for a pilot randomized controlled trial. Contemp Clin Trials. 2024 Nov;146:107670. doi: 10.1016/j.cct.2024.107670. Epub 2024 Aug 24.
PubMed 39186971
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting and Piloting Behavioral Activation for Veterans With Co-Occurring AUD and Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT06249386
- Acronym / sponsor ID
- 0219135
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Duke University
- Study start
- 17 Jan 2025 (actual)
- Primary completion
- 6 Oct 2025 (actual)
- Study completion
- 6 Oct 2025 (actual)
- First posted
- 8 Feb 2024 (actual)
- Results
- Posted 28 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare an adaptation of Behavioral Activation, a behavioral intervention, to Relapse Prevention treatment, another behavioral intervention, in a sample of U.S. military veterans with co-occurring alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD).
The primary aims of this study are to:
- Adapt Behavioral Activation to treat veterans with AUD/PTSD,
- Evaluate the feasibility, acceptability, and preliminary effects of Behavioral Activation for AUD/PTSD, and
- Explore geospatial analysis as a new method for measuring AUD/PTSD recovery.
Participants will complete self-report and interview measures immediately before and immediately after treatment. Participants will also be asked to participate in passive geospatial assessment for 14-day periods immediately before and immediately after treatment. Participants will be randomized to treatment condition, which involves 8 sessions of either Behavioral Activation or Relapse Prevention, delivered individually by a trained study therapist.
Detailed description
Alcohol use disorder (AUD) frequently co-occurs with posttraumatic stress disorder (PTSD) among U.S. military veterans. Compared to veterans with AUD only, veterans with AUD/PTSD have greater symptom severity, more psychosocial functioning difficulties, and higher risk of suicide. Many people with AUD/PTSD perform behaviors aimed at avoiding unpleasant emotions (e.g., drinking to avoid trauma-related nightmares, skipping social events to avoid anxiety-provoking crowds). These "avoidance behaviors" provide temporary relief from unpleasant emotions, but they maintain AUD/PTSD and interfere with long-term functioning. Although treatments for AUD/PTSD exist, they emphasize symptom reduction (not functional improvement) and have dropout rates as high as 50%. Originally developed to treat depression, Behavioral Activation (BA) is an intervention that increases daily participation in rewarding, alcohol-free activities relevant to patients' social, vocational, and health-related values. Randomized controlled trials (RCTs) adapting BA for other disorders have shown that BA is efficacious for adults with alcohol/drug use disorders and acceptable to veterans with PTSD, but BA has not been used to treat co-occurring AUD/PTSD. Additionally, because RCTs of AUD/PTSD treatments typically emphasize significant mean group differences in AUD/PTSD outcomes, less is known about the degree to which these treatments yield clinically significant improvements at the individual level. Individual-level improvements in AUD/PTSD should be evident not only in subjective clinical assessments, but also in objective measures of geospatial activity. Specifically, patients' daily geospatial activity is likely to change as they decrease their avoidance behaviors and increase their engagement in various social, vocational, and health-promoting activities. Advances in geospatial methods, coupled with discreet and portable global positioning system (GPS) trackers, have made it possible to objectively measure people's spatial movement within their communities. Yet although geospatial methods have been used to identify social determinants of alcohol use, they have not been used to measure response to AUD or AUD/PTSD treatment. As the long-term objectives of this work are to identify a more acceptable AUD/PTSD treatment option and improve the measurement of AUD/PTSD recovery, this R34 project will address the following specific aims: (1) adapt BA for use with veterans with AUD/PTSD; (2) evaluate the feasibility, acceptability, and preliminary effects of BA, relative to Relapse Prevention, for veterans with AUD/PTSD in a pilot RCT; and (3) explore geospatial analysis of GPS-collected data as a new approach to measuring AUD/PTSD treatment response. This study will advance research and practice by piloting a novel application of BA and a novel measure of AUD/PTSD recovery. This project aligns with the National Institute on Alcohol Abuse and Alcoholism's special interest in investigating treatments for patients with AUD and co-occurring disorders, dimensions of functioning and well-being associated with recovery, and innovative methods for evaluating AUD treatment and recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be block randomized to either Behavioral Activation treatment (n=23) or Relapse Prevention treatment (n=23).
| Arm | Type | Receives |
|---|---|---|
| Behavioral Activation (BA) | Experimental | Behavioral: Behavioral Activation (BA)Individual psychotherapy |
| Relapse Prevention (RP) | Active comparator | Behavioral: Relapse Prevention (RP)Individual psychotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Be a U.S. veteran,
- Be at least 18 years old,
- Meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for current AUD,
- Report 3+ heavy drinking days (5+ drinks for men/4+ drinks for women) or 1+ heavy drinking week (15+ drinks men/8+ drinks women) in the past 30 days,
- Meet DSM-5 criteria for current PTSD or satisfy the definition of current subthreshold PTSD (i.e., up to one of symptom clusters B-E may fall below diagnostic threshold),
Key exclusion criteria (7 listed)
- Current mania/hypomania or current psychosis,
- Lifetime alcohol withdrawal-related seizures, delirium, or hallucinations,
- Prior inpatient alcohol withdrawal management,
- Current DSM-5 severe drug use disorder (DUD) except for severe tobacco use disorder,
- Psychotropic (including alcohol abstinence) medication changes within 30 days of study enrollment or plans to change medications during the study,
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 |
|---|---|---|
| Behavioral Activation (BA)BA reduces alcohol use and posttraumatic stress symptoms and increases psychosocial functioning via psychoeducation, activity monitoring, values clarification, and activity scheduling. | Behavioural | Behavioral Activation (BA) |
| Relapse Prevention (RP)RP reduces alcohol use via increasing awareness and avoidance of high-risk situations, enhancing drink refusal skills, improving assertiveness, and other strategies. | Behavioural | Relapse Prevention (RP) |
Primary outcome
Timeline Follow-Back (Alcohol Use)
Time frame: Through study completion, an average of 3 months
Changes in past-30-day alcohol consumption from baseline to immediately post-treatment. One standard drink is defined in the United States as any beverage containing 0.6 fl oz or 14 grams. A drinking day refers to a day with any alcohol use. Higher values on this outcome reflect greater alcohol consumption.
Clinician-Administered PTSD Scale for DSM-5 (PTSD Severity)
Time frame: Through study completion, an average of 3 months
Changes in past-month PTSD severity from baseline to immediately post-treatment. Total scores on this measure range 0 to 80, with higher scores reflecting more severe PTSD symptoms.
6 secondary outcomes
Brief Inventory of Psychosocial Functioning (Psychosocial Functioning)
Time frame: Through study completion, an average of 3 months
Geospatial Activity
Time frame: Through study completion, an average of 3 months
PTSD Checklist for DSM-5 (PCL-5)
Time frame: Through study completion, an average of 1.5 months (mid-treatment) and 3 months (post-treatment)
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Through study completion, an average of 3 months
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Through study completion, an average of 3 months
Insomnia Severity Index
Time frame: Through study completion, an average of 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39186971Blakey SM, Alsobrooks AK, Morgan-Lopez AA, Kruskamp N, Simpson TL, Daughters SB, DuBois CM, Huang JS, Evans J, Serrano BN, Calhoun PS, Beckham JC, Elbogen EB. Behavioral activation for veterans with co-occurring alcohol use disorder and posttraumatic stress disorder: Basis and methodology for a pilot randomized controlled trial. Contemp Clin Trials. 2024 Nov;146:107670. doi: 10.1016/j.cct.2024.107670. Epub 2024 Aug 24.
- Individual participant dataSharing planned: Yes. De-identified data from consenting participants will be submitted to the National Institute on Alcohol Abuse and Alcoholism Data Archive.
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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.
Shannon M Blakey, PhD principal investigator
RTI International
Eric B Elbogen, PhD principal investigator
Duke 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 Behavioral Activation (BA) and Relapse Prevention (RP) in people with Alcohol Use Disorder and Posttraumatic Stress Disorder, run by RTI International 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 7 inclusion and 7 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: finished, as of the sponsor's last update on 9 Jun 2026. 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?
Yes. Results are posted in the registry (first posted 28 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Timeline Follow-Back (Alcohol Use) (time frame: Through study completion, an average of 3 months). 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?
On the ClinicalTrials.gov record for NCT06249386, which also lists 1 linked publication.
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 Jun 2026.