Alcohol-Related Disorders, Stress Disorders, Post-Traumatic
Conditions
Brief summary
This project aims to develop and test an integrated brief intervention to reduce heavy alcohol use and PTSD severity in veterans receiving Veterans Affairs Primary Care. Standard brief alcohol interventions have been unsuccessful in reducing heavy drinking in traumatized individuals and current integrated treatment for alcohol use disorder and PTSD are too long to be delivered in Primary Care. Therefore, this application addresses this gap by developing an intervention tailored to the specific needs of heavy drinking veterans who have co- occurring PTSD. This study aims to incorporate two evidenced-based interventions: Brief Motivational Interviewing (BMI) with Prolonged Exposure for Primary Care (PE-PC). This newly developed brief intervention will be piloted in an open trial to gather veteran participant feedback and develop clinician training and fidelity procedures.
Interventions
BEHAVIORALPC-TIME
PC-TIME consists of five, 30-minute sessions delivered over 8 weeks. Intervention will be delivered by a behavioral health provider and will consist of brief Prolonged Exposure for PTSD integrated with aspects of the Motivational Interviewing counseling approach.
BEHAVIORALPC-TAU
PC-TAU consists of Brief Advice intervention from their PC medical provider that is built into the electronic medical record as a mandatory response to a positive screen. In addition, patients who score positive on the AUDIT-C or PC-PTSD are offered a referral to the PCMHI provider within the PC clinic. PCMHI in VA consists of licensed, independent providers (typically psychologists or clinical social workers) providing brief assessment and interventions to veterans and consultation to other members of the PC team. PCMHI sessions are typically focused on assessment, psycho-education, and supportive counseling.
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Syracuse VA Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Open clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A score of 8-25 for men, 6-25 for women on the AUDIT and have past month drinking (i.e., have not quit drinking over the last month) * Score ≥30 on the PTSD Checklist-5 (PCL-5) and report a traumatic event on the Criterion A screener
Exclusion criteria
* Score of a 26 or higher on the AUDIT * gross cognitive impairment as assessed by the Mini Mental Status Exam * current symptoms of mania or psychosis * currently in need of detox services * Have had a suicide attempt in the last two months or a current intent to commit suicide as assessed on the P4 Screener. (Patients with recent suicide attempts or intent may be enrolled following receipt of suicide prevention services) * Are currently receiving psychotherapy for heavy drinking or PTSD outside of PC within the last 2 months * Have started or changed the dose of a psychotropic medication for heavy drinking or PTSD in the last two months that was prescribed outside of VA PC * Have a preference to be directly referred to VA specialty care for heavy drinking or PTSD.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinician Administered PTSD Scale (CAPS)-5 Severity Rating | Baseline and 8 weeks | This 30-item structured interview assesses DSM-5 symptoms of Posttraumatic stress disorder. It includes assessment of traumatic events and symptom severity ratings are based on symptom frequency and intensity. CAPS-5 total symptom severity score ranges 0-80, with higher scores representing higher severity (worse outcome). |
| Average Number of Drinks Per Drinking Day | 8 weeks | The Timeline Follow-back instrument is presented as a 30-day calendar and it is used to obtain count estimates of daily drinking. |
| PTSD Checklist-5 | 8 weeks | This 21-item self-report measure asks respondents to rate how much they have been bothered by DSM-5 PTSD symptoms in the past month on a 0-4 Likert-type scale. The scale ranges from 0-84 with 84 being the most severe PTSD. The total score was used to indicate PTSD severity at post-treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-intervention Treatment Engagement | 20 weeks | With HIPAA authorization, information from participants' VA administrative data will be extracted to assess if treatment condition relates to engagement in specialty treatment. Number of mental health or substance use visits attended between enrollment and 20 week follow-up will be extracted for each participant. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PC-TIME PC-TIME consists of meeting with a behavioral health provider for 5, 30-minute sessions that will be delivered over the course of 8 weeks (spaced about 1-2 weeks apart). PC-TIME sessions integrate two effective treatments: motivational enhancement therapy approaches and brief Prolonged Exposure.
PC-TIME: PC-TIME consists of five, 30-minute sessions delivered over 8 weeks. Intervention will be delivered by a behavioral health provider and will consist of brief Prolonged Exposure for PTSD integrated with aspects of the Motivational Interviewing counseling approach. | 33 |
| PC-TAU Primary Care - treatment as usual. Participants in PC-TAU will be referred to the PCMHI mental health provider within their primary care team, and will receive whichever care or intervention is typically provided. PCMHI in VA consists of licensed, independent providers (typically psychologists or clinical social workers) providing brief assessment and interventions to veterans and consultation to other members of the PC team.
PC-TAU: PC-TAU consists of Brief Advice intervention from their PC medical provider that is built into the electronic medical record as a mandatory response to a positive screen. In addition, patients who score positive on the AUDIT-C or PC-PTSD are offered a referral to the PCMHI provider within the PC clinic. PCMHI in VA consists of licensed, independent providers (typically psychologists or clinical social workers) providing brief assessment and interventions to veterans and consultation to other members of the PC team. PCMHI sessions are typically focused on assessment, psycho-education, and supportive counseling. | 30 |
| Total | 63 |
Baseline characteristics
| Characteristic | PC-TIME | PC-TAU | Total |
|---|---|---|---|
| Age, Continuous | 45.48 years STANDARD_DEVIATION 12.62 | 50.13 years STANDARD_DEVIATION 12.8 | 47.70 years STANDARD_DEVIATION 12.82 |
| average drinks per drinking day | 3.83 drinks per day STANDARD_DEVIATION 2.02 | 3.72 drinks per day STANDARD_DEVIATION 2.89 | 3.76 drinks per day STANDARD_DEVIATION 2.5 |
| CAPS-5 PTSD Severity | 34.30 score on a scale STANDARD_DEVIATION 10.91 | 34.03 score on a scale STANDARD_DEVIATION 8.39 | 34.17 score on a scale STANDARD_DEVIATION 9.72 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 2 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 27 Participants | 54 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 3 Participants |
| Posttraumatic Stress Disorder (PTSD) Checklist-5 | 46.45 score on a scale STANDARD_DEVIATION 12.29 | 46.17 score on a scale STANDARD_DEVIATION 13.01 | 46.32 score on a scale STANDARD_DEVIATION 12.53 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 6 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 24 Participants | 23 Participants | 47 Participants |
| Region of Enrollment United States | 33 participants | 30 participants | 63 participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 8 Participants |
| Sex: Female, Male Male | 29 Participants | 26 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 30 |
| other Total, other adverse events | 0 / 33 | 0 / 30 |
| serious Total, serious adverse events | 0 / 33 | 0 / 30 |
Outcome results
Primary
Average Number of Drinks Per Drinking Day
The Timeline Follow-back instrument is presented as a 30-day calendar and it is used to obtain count estimates of daily drinking.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PC-TIME | Average Number of Drinks Per Drinking Day | 2.34 drinks per day | Standard Deviation 2.05 |
| PC-TAU | Average Number of Drinks Per Drinking Day | 3.72 drinks per day | Standard Deviation 2.73 |
Primary
Change in Clinician Administered PTSD Scale (CAPS)-5 Severity Rating
This 30-item structured interview assesses DSM-5 symptoms of Posttraumatic stress disorder. It includes assessment of traumatic events and symptom severity ratings are based on symptom frequency and intensity. CAPS-5 total symptom severity score ranges 0-80, with higher scores representing higher severity (worse outcome).
Time frame: Baseline and 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PC-TIME | Change in Clinician Administered PTSD Scale (CAPS)-5 Severity Rating | 28.46 score on a scale | Standard Deviation 13.35 |
| PC-TAU | Change in Clinician Administered PTSD Scale (CAPS)-5 Severity Rating | 33.45 score on a scale | Standard Deviation 11.41 |
Primary
PTSD Checklist-5
This 21-item self-report measure asks respondents to rate how much they have been bothered by DSM-5 PTSD symptoms in the past month on a 0-4 Likert-type scale. The scale ranges from 0-84 with 84 being the most severe PTSD. The total score was used to indicate PTSD severity at post-treatment.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PC-TIME | PTSD Checklist-5 | 34.17 score on a scale | Standard Deviation 15.89 |
| PC-TAU | PTSD Checklist-5 | 43.40 score on a scale | Standard Deviation 11.92 |
Secondary
Post-intervention Treatment Engagement
With HIPAA authorization, information from participants' VA administrative data will be extracted to assess if treatment condition relates to engagement in specialty treatment. Number of mental health or substance use visits attended between enrollment and 20 week follow-up will be extracted for each participant.
Time frame: 20 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PC-TIME | Post-intervention Treatment Engagement | 5.61 number of visits | Standard Deviation 4.14 |
| PC-TAU | Post-intervention Treatment Engagement | 5.73 number of visits | Standard Deviation 5.73 |