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| ID | Type | Description | Link |
|---|---|---|---|
| R34AA030820 | U.S. NIH Grant/Contract | View source | |
| Pro00113641 | Other Identifier | Duke University School of Medicine | |
| STUDY00022679 | Other Identifier | RTI International |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
| Duke University | OTHER |
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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral Activation (BA) | Experimental | Individual psychotherapy |
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| Relapse Prevention (RP) | Active Comparator | Individual psychotherapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Activation (BA) | Behavioral | BA reduces alcohol use and posttraumatic stress symptoms and increases psychosocial functioning via psychoeducation, activity monitoring, values clarification, and activity scheduling. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Through study completion, an average of 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Through study completion, an average of 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shannon M Blakey, PhD | RTI International | Principal Investigator |
| Eric B Elbogen, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University School of Medicine | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39186971 | Derived | 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. |
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De-identified data from consenting participants will be submitted to the National Institute on Alcohol Abuse and Alcoholism Data Archive.
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All collection data are shared automatically two years after the grant end date specified on the first Notice of Award. PI requests for exceptions will be considered for only extreme and unusual circumstances (e.g., unanticipated life event [death of family member] or other force majeure).
Data access requires sponsorship by an Institution on behalf of Recipient(s) and satisfaction of any other criteria required by the National Institute on Alcohol Abuse and Alcoholism Data Archive.
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| ID | Title | Description |
|---|---|---|
| FG000 | Behavioral Activation (BA) | Individual BA psychotherapy for alcohol use disorder and co-occurring posttraumatic stress disorder |
| FG001 | Relapse Prevention (RP) | Individual RP psychotherapy for alcohol use disorder and co-occurring posttraumatic stress disorder |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 22, 2024 |
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Participants will be block randomized to either Behavioral Activation treatment (n=23) or Relapse Prevention treatment (n=23).
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Outcomes assessors will be blind to treatment condition. The participant, study therapist, and PI (providing clinical consultation and evaluating therapist fidelity to treatment protocol) will not be blinded to participants' assigned treatment condition.
| Relapse Prevention (RP) | Behavioral | RP reduces alcohol use via increasing awareness and avoidance of high-risk situations, enhancing drink refusal skills, improving assertiveness, and other strategies. |
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| 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. | 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. | 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. | 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. | 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. | Through study completion, an average of 3 months |
| Attended at least 6 sessions |
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| ID | Title | Description |
|---|---|---|
| BG000 | Behavioral Activation (BA) | Individual BA psychotherapy for alcohol use disorder and co-occurring posttraumatic stress disorder |
| BG001 | Relapse Prevention (RP) | Individual RP psychotherapy for alcohol use disorder and co-occurring posttraumatic stress disorder |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Timeline Follow-Back (percent of past 30 days with any alcohol use) | This percentage measurement scale has a minimum value of 0 and a maximum value of 100, where higher values reflect more frequent drinking. | Mean | Standard Deviation | Percentage |
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| Timeline Follow-Back (percent of past 30 days with heavy alcohol use) | This percentage measurement scale has a minimum value of 0 and a maximum value of 100, where higher values reflect more frequent heavy drinking, defined as drinking 5 or more standard alcohol drinks per day or 15 or more standard alcohol drinks per week for males and 4 or more standard alcohol drinks per day or 8 or more standard alcohol drinks per week for females. | Mean | Standard Deviation | Percentage |
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| Timeline Follow-Back (average drinks per drinking day in the past 30 days) | 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. | Mean | Standard Deviation | Drinks per day |
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| Clinician-Administered PTSD Scale for DSM-5 (PTSD severity) | Total scores on this measure range 0 to 80, with higher scores reflecting more severe PTSD symptoms. | Mean | Standard Deviation | Total symptom severity score |
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| Brief Inventory of Psychosocial Functioning (psychosocial functioning difficulties) | This percentage measurement scale has a minimum value of 0 and a maximum value of 100, where higher values reflect greater functioning difficulties (worse functioning). | Mean | Standard Deviation | Percentage impairment |
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| PTSD Checklist for DSM-5 (PCL-5) | Total scores on this measure range 0 to 80, with higher scores reflecting more severe PTSD symptoms. | Mean | Standard Deviation | Total symptom severity score |
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| Generalized Anxiety Disorder-7 (GAD-7) | Total scores on this measure range 0 to 21, with higher scores reflecting more severe anxiety symptoms. | Mean | Standard Deviation | Total symptom severity score |
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| Patient Health Questionnaire-9 (PHQ-9) | Total scores on this measure range 0 to 27, with higher scores reflecting more severe depressive symptoms. | Mean | Standard Deviation | Total symptom severity score |
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| Insomnia Severity Index | Total scores on this measure range 0 to 28, with higher scores reflecting more severe insomnia symptoms. | Mean | Standard Deviation | Total symptom severity score |
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| Geospatial Activity | Past-14-day activity space | Outcome data were available for 5 BA participants and 4 RP participants at baseline (1 RP participant did not consent to geospatial data collection). | Mean | Standard Deviation | Square kilometers (km2) |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | Outcome data were available for 5 BA participants and 5 RP participants at baseline. Outcome data were available for 3 BA participants and 3 RP participants at post-treatment. | Posted | Mean | Standard Deviation | Drinks per day | Through study completion, an average of 3 months |
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| Primary | 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. | Outcome data were available for 5 BA participants and 5 RP participants at baseline. Outcome data were available for 3 BA participants and 3 RP participants at post-treatment. | Posted | Mean | Standard Deviation | Symptom severity score | Through study completion, an average of 3 months |
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| Secondary | 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). | Outcome data were available for 5 BA participants and 5 RP participants at baseline. Outcome data were available for 3 BA participants and 3 RP participants at post-treatment. | Posted | Mean | Standard Deviation | Percentage impairment | Through study completion, an average of 3 months |
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| Secondary | 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. | Outcome data were available for 5 BA participants and 4 RP participants at baseline (1 RP participant did not consent to geospatial data collection). Outcome data were available for 3 BA participants and 2 RP participants at post-treatment. | Posted | Mean | Standard Deviation | Square kilometers (km2) | Through study completion, an average of 3 months |
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| Secondary | 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. | Outcome data were available for 5 BA participants and 5 RP participants at baseline. Outcome data were available for 3 BA participants and 3 RP participants at post-treatment. | Posted | Mean | Standard Deviation | Symptom severity score | Through study completion, an average of 1.5 months (mid-treatment) and 3 months (post-treatment) |
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| Secondary | 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. | Outcome data were available for 5 BA participants and 5 RP participants at baseline. Outcome data were available for 3 BA participants and 3 RP participants at post-treatment. | Posted | Mean | Standard Deviation | Symptom severity score | Through study completion, an average of 3 months |
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| Secondary | 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. | Outcome data were available for 5 BA participants and 5 RP participants at baseline. Outcome data were available for 3 BA participants and 3 RP participants at post-treatment. | Posted | Mean | Standard Deviation | Symptom severity score | Through study completion, an average of 3 months |
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| Secondary | 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. | Outcome data were available for 5 BA participants and 5 RP participants at baseline. Outcome data were available for 3 BA participants and 3 RP participants at post-treatment. | Posted | Mean | Standard Deviation | Symptom severity score | Through study completion, an average of 3 months |
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From enrollment through study completion, an average of 3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | Behavioral Activation (BA) | Individual BA psychotherapy for alcohol use disorder co-occurring with posttraumatic stress disorder | 0 | 5 | 0 | 5 | 0 | 5 |
| EG001 | Relapse Prevention (RP) | Individual RP psychotherapy for alcohol use disorder co-occurring with posttraumatic stress disorder | 0 | 5 | 0 | 5 | 0 | 5 |
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| Title | Organization | Phone | Extension | |
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| Shannon Blakey, PhD | RTI International | 919-485-5427 | sblakey@rti.org |
| Apr 3, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
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| ID | Term |
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| D055502 | Secondary Prevention |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D015980 | Public Health Practice |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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