Alcohol Use Disorder, Posttraumatic Stress Disorder
Conditions
Brief 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). The primary aims of this study are to: 1. Adapt Behavioral Activation to treat veterans with AUD/PTSD, 2. Evaluate the feasibility, acceptability, and preliminary effects of Behavioral Activation for AUD/PTSD, and 3. 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.
Interventions
BEHAVIORALBehavioral Activation (BA)
BA reduces alcohol use and posttraumatic stress symptoms and increases psychosocial functioning via psychoeducation, activity monitoring, values clarification, and activity scheduling.
BEHAVIORALRelapse Prevention (RP)
RP reduces alcohol use via increasing awareness and avoidance of high-risk situations, enhancing drink refusal skills, improving assertiveness, and other strategies.
Sponsors
RTI International
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
Participants will be block randomized to either Behavioral Activation treatment (n=23) or Relapse Prevention treatment (n=23).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Be a U.S. veteran, 2. Be at least 18 years old, 3. Meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for current AUD, 4. 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, 5. 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), 6. Be fluent and literate in English, and 7. Be able to provide voluntary, informed consent to participate.
Exclusion criteria
1. Current mania/hypomania or current psychosis, 2. Lifetime alcohol withdrawal-related seizures, delirium, or hallucinations, 3. Prior inpatient alcohol withdrawal management, 4. Current DSM-5 severe drug use disorder (DUD) except for severe tobacco use disorder, 5. Psychotropic (including alcohol abstinence) medication changes within 30 days of study enrollment or plans to change medications during the study, 6. Current/planned non-study BA for any disorder during the study, or 7. Current/planned evidence-based psychotherapy for AUD, PTSD, or DUD during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Timeline Follow-Back (Alcohol Use) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brief Inventory of Psychosocial Functioning (Psychosocial Functioning) | Through study completion, an average of 3 months | 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). |
| Geospatial Activity | Through study completion, an average of 3 months | 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. |
| PTSD Checklist for DSM-5 (PCL-5) | Through study completion, an average of 1.5 months (mid-treatment) and 3 months (post-treatment) | 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. |
| Generalized Anxiety Disorder-7 (GAD-7) | Through study completion, an average of 3 months | 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. |
| Patient Health Questionnaire-9 (PHQ-9) | Through study completion, an average of 3 months | 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. |
| Insomnia Severity Index | Through study completion, an average of 3 months | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORShannon M Blakey, PhD
RTI International
PRINCIPAL_INVESTIGATOREric B Elbogen, PhD
Duke University
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 49.42 Years STANDARD_DEVIATION 6.44 |
| Brief Inventory of Psychosocial Functioning (psychosocial functioning difficulties) | 64.52 Percentage impairment STANDARD_DEVIATION 17.55 |
| Clinician-Administered PTSD Scale for DSM-5 (PTSD severity) | 36.60 Total symptom severity score STANDARD_DEVIATION 9.37 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Generalized Anxiety Disorder-7 (GAD-7) | 12.60 Total symptom severity score STANDARD_DEVIATION 8.2 |
| Geospatial Activity | 247.52 Square kilometers (km2) STANDARD_DEVIATION 1254.03 |
| Insomnia Severity Index | 17.80 Total symptom severity score STANDARD_DEVIATION 6.22 |
| Patient Health Questionnaire-9 (PHQ-9) | 13.80 Total symptom severity score STANDARD_DEVIATION 7.79 |
| PTSD Checklist for DSM-5 (PCL-5) | 42.20 Total symptom severity score STANDARD_DEVIATION 17.77 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 4 Participants |
| Timeline Follow-Back (average drinks per drinking day in the past 30 days) | 3.90 Drinks per day STANDARD_DEVIATION 0.85 |
| Timeline Follow-Back (percent of past 30 days with any alcohol use) | 83.67 Percentage STANDARD_DEVIATION 31.87 |
| Timeline Follow-Back (percent of past 30 days with heavy alcohol use) | 22.67 Percentage STANDARD_DEVIATION 18.32 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 |
Outcome results
None listed