An interventional study of PC-TIME and PC-TAU in Stress Disorders, Post-Traumatic and Alcohol-Related Disorders, sponsored by Syracuse VA Medical Center. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-16.
Sponsored by Syracuse VA Medical Center · Not applicable, Interventional, and Treatment
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.
143 studies on the registry are indexed under Alcohol-Related Disorders; 22 are open to participants now.
This study's enrollment of 63 is below the median of 113 across 120 interventional studies indexed under Alcohol-Related Disorders.
Browse Alcohol-Related Disorders studies →Syracuse VA Medical Center is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: PC-TIME
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.
Behavioral: PC-TAU
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.
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.
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
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
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
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
| Milestone | PC-TIME | PC-TAU |
|---|---|---|
| Started | 33 | 30 |
| Completed | 26 | 29 |
| Not completed | 7 | 1 |
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).
| score on a scale | PC-TIME | PC-TAU |
|---|---|---|
| Change in Clinician Administered PTSD Scale (CAPS)-5 Severity Rating | 28.46 ± 13.35 | 33.45 ± 11.41 |
The Timeline Follow-back instrument is presented as a 30-day calendar and it is used to obtain count estimates of daily drinking.
| drinks per day | PC-TIME | PC-TAU |
|---|---|---|
| Average Number of Drinks Per Drinking Day | 2.34 ± 2.05 | 3.72 ± 2.73 |
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.
| score on a scale | PC-TIME | PC-TAU |
|---|---|---|
| PTSD Checklist-5 | 34.17 ± 15.89 | 43.40 ± 11.92 |
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.
| number of visits | PC-TIME | PC-TAU |
|---|---|---|
| Post-intervention Treatment Engagement | 5.61 ± 4.14 | 5.73 ± 5.73 |
Collected over 20 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PC-TIME | 0/33 (0%) | 0/33 (0%) | 0/33 (0%) |
| PC-TAU | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Age, Continuous(years) | PC-TIME | PC-TAU | Total |
|---|---|---|---|
| Mean | 45.48 ± 12.62 | 50.13 ± 12.80 | 47.70 ± 12.82 |
| Sex: Female, Male(Participants) | PC-TIME | PC-TAU | Total |
|---|---|---|---|
| Female | 4 | 4 | 8 |
| Male | 29 | 26 | 55 |
| Ethnicity (NIH/OMB)(Participants) | PC-TIME | PC-TAU | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 2 | 6 |
| Not Hispanic or Latino | 27 | 27 | 54 |
| Unknown or Not Reported | 2 | 1 | 3 |
| Race (NIH/OMB)(Participants) | PC-TIME | PC-TAU | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 6 | 6 | 12 |
| White | 24 | 23 | 47 |
| More than one race | 3 | 0 | 3 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | PC-TIME | PC-TAU | Total |
|---|---|---|---|
| United States | 33 | 30 | 63 |
| CAPS-5 PTSD Severity(score on a scale) | PC-TIME | PC-TAU | Total |
|---|---|---|---|
| Mean | 34.30 ± 10.91 | 34.03 ± 8.39 | 34.17 ± 9.72 |
| Posttraumatic Stress Disorder (PTSD) Checklist-5(score on a scale) | PC-TIME | PC-TAU | Total |
|---|---|---|---|
| Mean | 46.45 ± 12.29 | 46.17 ± 13.01 | 46.32 ± 12.53 |
| average drinks per drinking day(drinks per day) | PC-TIME | PC-TAU | Total |
|---|---|---|---|
| Mean | 3.83 ± 2.02 | 3.72 ± 2.89 | 3.76 ± 2.50 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Once all data collection is complete and the coded database is finalized, IPD will be shared according to PI discretion. For instance, IPD may be shared to be used in meta-analyses or other review papers. No identifiable participant information will be shared.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Syracuse VA Medical Center