Trial Outcomes & Findings for Adapting and Piloting Behavioral Activation for Veterans With Alcohol Use Disorder and Posttraumatic Stress Disorder (NCT NCT06249386)
NCT ID: NCT06249386
Last Updated: 2026-05-18
Results Overview
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.
COMPLETED
NA
10 participants
Through study completion, an average of 3 months
2026-05-18
Participant Flow
Participant milestones
| Measure |
Behavioral Activation (BA)
Individual BA psychotherapy for alcohol use disorder and co-occurring posttraumatic stress disorder
|
Relapse Prevention (RP)
Individual RP psychotherapy for alcohol use disorder and co-occurring posttraumatic stress disorder
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
Attended at least 6 sessions
|
4
|
2
|
|
Overall Study
COMPLETED
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Adapting and Piloting Behavioral Activation for Veterans With Alcohol Use Disorder and Posttraumatic Stress Disorder
Baseline characteristics by cohort
| Measure |
Behavioral Activation (BA)
n=5 Participants
Individual BA psychotherapy for alcohol use disorder and co-occurring posttraumatic stress disorder
|
Relapse Prevention (RP)
n=5 Participants
Individual RP psychotherapy for alcohol use disorder and co-occurring posttraumatic stress disorder
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.42 Years
STANDARD_DEVIATION 6.44 • n=11 Participants
|
52.53 Years
STANDARD_DEVIATION 16.84 • n=9 Participants
|
50.98 Years
STANDARD_DEVIATION 12.13 • n=20 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=11 Participants
|
1 Participants
n=9 Participants
|
2 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=11 Participants
|
4 Participants
n=9 Participants
|
8 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=11 Participants
|
3 Participants
n=9 Participants
|
4 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=11 Participants
|
2 Participants
n=9 Participants
|
6 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=11 Participants
|
5 Participants
n=9 Participants
|
10 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
|
Timeline Follow-Back (percent of past 30 days with any alcohol use)
|
84.67 Percentage
STANDARD_DEVIATION 34.29 • n=11 Participants
|
82.67 Percentage
STANDARD_DEVIATION 33.28 • n=9 Participants
|
83.67 Percentage
STANDARD_DEVIATION 31.87 • n=20 Participants
|
|
Timeline Follow-Back (percent of past 30 days with heavy alcohol use)
|
16.00 Percentage
STANDARD_DEVIATION 8.63 • n=11 Participants
|
22.67 Percentage
STANDARD_DEVIATION 18.32 • n=9 Participants
|
19.33 Percentage
STANDARD_DEVIATION 13.95 • n=20 Participants
|
|
Timeline Follow-Back (average drinks per drinking day in the past 30 days)
|
4.36 Drinks per day
STANDARD_DEVIATION 1.59 • n=11 Participants
|
3.90 Drinks per day
STANDARD_DEVIATION 0.85 • n=9 Participants
|
4.13 Drinks per day
STANDARD_DEVIATION 1.22 • n=20 Participants
|
|
Clinician-Administered PTSD Scale for DSM-5 (PTSD severity)
|
36.60 Total symptom severity score
STANDARD_DEVIATION 9.37 • n=11 Participants
|
38.20 Total symptom severity score
STANDARD_DEVIATION 10.64 • n=9 Participants
|
37.40 Total symptom severity score
STANDARD_DEVIATION 9.49 • n=20 Participants
|
|
Brief Inventory of Psychosocial Functioning (psychosocial functioning difficulties)
|
70.95 Percentage impairment
STANDARD_DEVIATION 15.74 • n=11 Participants
|
50.74 Percentage impairment
STANDARD_DEVIATION 18.49 • n=9 Participants
|
64.52 Percentage impairment
STANDARD_DEVIATION 17.55 • n=20 Participants
|
|
PTSD Checklist for DSM-5 (PCL-5)
|
42.20 Total symptom severity score
STANDARD_DEVIATION 17.77 • n=11 Participants
|
36.40 Total symptom severity score
STANDARD_DEVIATION 9.56 • n=9 Participants
|
39.30 Total symptom severity score
STANDARD_DEVIATION 13.79 • n=20 Participants
|
|
Generalized Anxiety Disorder-7 (GAD-7)
|
12.60 Total symptom severity score
STANDARD_DEVIATION 8.20 • n=11 Participants
|
9.40 Total symptom severity score
STANDARD_DEVIATION 1.52 • n=9 Participants
|
11.00 Total symptom severity score
STANDARD_DEVIATION 5.81 • n=20 Participants
|
|
Patient Health Questionnaire-9 (PHQ-9)
|
13.80 Total symptom severity score
STANDARD_DEVIATION 7.79 • n=11 Participants
|
12.80 Total symptom severity score
STANDARD_DEVIATION 2.39 • n=9 Participants
|
13.30 Total symptom severity score
STANDARD_DEVIATION 5.46 • n=20 Participants
|
|
Insomnia Severity Index
|
20.00 Total symptom severity score
STANDARD_DEVIATION 6.75 • n=11 Participants
|
17.80 Total symptom severity score
STANDARD_DEVIATION 6.22 • n=9 Participants
|
18.90 Total symptom severity score
STANDARD_DEVIATION 6.23 • n=20 Participants
|
|
Geospatial Activity
|
426.5 Square kilometers (km2)
STANDARD_DEVIATION 1664.32 • n=11 Participants
|
23.8 Square kilometers (km2)
STANDARD_DEVIATION 76.43 • n=9 Participants
|
247.52 Square kilometers (km2)
STANDARD_DEVIATION 1254.03 • n=20 Participants
|
PRIMARY outcome
Timeframe: Through study completion, an average of 3 monthsPopulation: 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.
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 measures
| Measure |
Relapse Prevention (RP)
n=5 Participants
Individual RP psychotherapy for alcohol use disorder and co-occurring posttraumatic stress disorder
|
Behavioral Activation (BA)
n=5 Participants
Individual BA psychotherapy for alcohol use disorder and co-occurring posttraumatic stress disorder
|
|---|---|---|
|
Timeline Follow-Back (Alcohol Use)
Baseline
|
3.90 Drinks per day
Standard Deviation 0.85
|
4.36 Drinks per day
Standard Deviation 1.59
|
|
Timeline Follow-Back (Alcohol Use)
Post-treatment
|
3.31 Drinks per day
Standard Deviation 2.70
|
1.82 Drinks per day
Standard Deviation 0.00
|
PRIMARY outcome
Timeframe: Through study completion, an average of 3 monthsPopulation: 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.
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 measures
| Measure |
Relapse Prevention (RP)
n=5 Participants
Individual RP psychotherapy for alcohol use disorder and co-occurring posttraumatic stress disorder
|
Behavioral Activation (BA)
n=5 Participants
Individual BA psychotherapy for alcohol use disorder and co-occurring posttraumatic stress disorder
|
|---|---|---|
|
Clinician-Administered PTSD Scale for DSM-5 (PTSD Severity)
Baseline
|
38.20 Symptom severity score
Standard Deviation 10.64
|
36.60 Symptom severity score
Standard Deviation 9.37
|
|
Clinician-Administered PTSD Scale for DSM-5 (PTSD Severity)
Post-treatment
|
20.00 Symptom severity score
Standard Deviation 14.00
|
15.67 Symptom severity score
Standard Deviation 10.60
|
SECONDARY outcome
Timeframe: Through study completion, an average of 3 monthsPopulation: 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.
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 measures
| Measure |
Relapse Prevention (RP)
n=5 Participants
Individual RP psychotherapy for alcohol use disorder and co-occurring posttraumatic stress disorder
|
Behavioral Activation (BA)
n=5 Participants
Individual BA psychotherapy for alcohol use disorder and co-occurring posttraumatic stress disorder
|
|---|---|---|
|
Brief Inventory of Psychosocial Functioning (Psychosocial Functioning)
Baseline
|
50.74 Percentage impairment
Standard Deviation 18.49
|
70.95 Percentage impairment
Standard Deviation 15.74
|
|
Brief Inventory of Psychosocial Functioning (Psychosocial Functioning)
Post-treatment
|
29.37 Percentage impairment
Standard Deviation 9.91
|
26.19 Percentage impairment
Standard Deviation 28.87
|
SECONDARY outcome
Timeframe: Through study completion, an average of 3 monthsPopulation: 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.
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 measures
| Measure |
Relapse Prevention (RP)
n=5 Participants
Individual RP psychotherapy for alcohol use disorder and co-occurring posttraumatic stress disorder
|
Behavioral Activation (BA)
n=5 Participants
Individual BA psychotherapy for alcohol use disorder and co-occurring posttraumatic stress disorder
|
|---|---|---|
|
Geospatial Activity
Baseline
|
23.8 Square kilometers (km2)
Standard Deviation 76.43
|
426.5 Square kilometers (km2)
Standard Deviation 1664.32
|
|
Geospatial Activity
Post-Treatment
|
4.29 Square kilometers (km2)
Standard Deviation 22.32
|
1277.44 Square kilometers (km2)
Standard Deviation 8098.43
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1.5 months (mid-treatment) and 3 months (post-treatment)Population: 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.
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 measures
| Measure |
Relapse Prevention (RP)
n=5 Participants
Individual RP psychotherapy for alcohol use disorder and co-occurring posttraumatic stress disorder
|
Behavioral Activation (BA)
n=5 Participants
Individual BA psychotherapy for alcohol use disorder and co-occurring posttraumatic stress disorder
|
|---|---|---|
|
PTSD Checklist for DSM-5 (PCL-5)
Mid-Treatment
|
33.50 Symptom severity score
Standard Deviation 9.19
|
41.50 Symptom severity score
Standard Deviation 16.05
|
|
PTSD Checklist for DSM-5 (PCL-5)
Baseline
|
36.40 Symptom severity score
Standard Deviation 9.56
|
42.20 Symptom severity score
Standard Deviation 17.77
|
|
PTSD Checklist for DSM-5 (PCL-5)
Post-Treatment
|
22.33 Symptom severity score
Standard Deviation 19.60
|
23.00 Symptom severity score
Standard Deviation 17.00
|
SECONDARY outcome
Timeframe: Through study completion, an average of 3 monthsPopulation: 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.
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 measures
| Measure |
Relapse Prevention (RP)
n=5 Participants
Individual RP psychotherapy for alcohol use disorder and co-occurring posttraumatic stress disorder
|
Behavioral Activation (BA)
n=5 Participants
Individual BA psychotherapy for alcohol use disorder and co-occurring posttraumatic stress disorder
|
|---|---|---|
|
Generalized Anxiety Disorder-7 (GAD-7)
Baseline
|
9.40 Symptom severity score
Standard Deviation 1.52
|
12.60 Symptom severity score
Standard Deviation 8.20
|
|
Generalized Anxiety Disorder-7 (GAD-7)
Post-treatment
|
5.33 Symptom severity score
Standard Deviation 3.06
|
6.67 Symptom severity score
Standard Deviation 5.51
|
SECONDARY outcome
Timeframe: Through study completion, an average of 3 monthsPopulation: 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.
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 measures
| Measure |
Relapse Prevention (RP)
n=5 Participants
Individual RP psychotherapy for alcohol use disorder and co-occurring posttraumatic stress disorder
|
Behavioral Activation (BA)
n=5 Participants
Individual BA psychotherapy for alcohol use disorder and co-occurring posttraumatic stress disorder
|
|---|---|---|
|
Patient Health Questionnaire-9 (PHQ-9)
Baseline
|
12.80 Symptom severity score
Standard Deviation 2.39
|
13.80 Symptom severity score
Standard Deviation 7.79
|
|
Patient Health Questionnaire-9 (PHQ-9)
Post-treatment
|
6.00 Symptom severity score
Standard Deviation 5.57
|
6.67 Symptom severity score
Standard Deviation 6.43
|
SECONDARY outcome
Timeframe: Through study completion, an average of 3 monthsPopulation: 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.
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 measures
| Measure |
Relapse Prevention (RP)
n=5 Participants
Individual RP psychotherapy for alcohol use disorder and co-occurring posttraumatic stress disorder
|
Behavioral Activation (BA)
n=5 Participants
Individual BA psychotherapy for alcohol use disorder and co-occurring posttraumatic stress disorder
|
|---|---|---|
|
Insomnia Severity Index
Baseline
|
17.80 Symptom severity score
Standard Deviation 6.22
|
20.00 Symptom severity score
Standard Deviation 6.75
|
|
Insomnia Severity Index
Post-treatment
|
12.00 Symptom severity score
Standard Deviation 13.89
|
13.00 Symptom severity score
Standard Deviation 7.94
|
Adverse Events
Behavioral Activation (BA)
Relapse Prevention (RP)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place