Primary Care Treatment Integrating Motivation and Exposure

Stress Disorders, Post-Traumatic Clinical Trial

— PC-TIME  

Official title:

An Integrated Brief Alcohol and PTSD Intervention for Veterans in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03812146
• Other study ID #: 1250312
• Secondary ID: 1R34AA026745-01
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: November 23, 2021

Study information

• Verified date: October 2022
• Source: Syracuse VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: November 23, 2021
• Est. primary completion date: July 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol-Related Disorders
• Disease
• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Buffalo VA Medical Center	Buffalo	New York
United States	Syracuse Veterans Affairs Medical Center	Syracuse	New York

Sponsors (2)

Lead Sponsor	Collaborator
Syracuse VA Medical Center	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

References & Publications (8)

Cigrang JA, Rauch SA, Mintz J, Brundige A, Avila LL, Bryan CJ, Goodie JL, Peterson AL; STRONG STAR Consortium. Treatment of active duty military with PTSD in primary care: A follow-up report. J Anxiety Disord. 2015 Dec;36:110-4. doi: 10.1016/j.janxdis.2015.10.003. Epub 2015 Oct 22. — View Citation

Cigrang JA, Rauch SA, Mintz J, Brundige AR, Mitchell JA, Najera E, Litz BT, Young-McCaughan S, Roache JD, Hembree EA, Goodie JL, Sonnek SM, Peterson AL; STRONG STAR Consortium. Moving effective treatment for posttraumatic stress disorder to primary care: A randomized controlled trial with active duty military. Fam Syst Health. 2017 Dec;35(4):450-462. doi: 10.1037/fsh0000315. — View Citation

Mastroleo NR, Magill M, Barnett NP, Borsari B. A pilot study of two supervision approaches for peer-led alcohol interventions with mandated college students. J Stud Alcohol Drugs. 2014 May;75(3):458-66. — View Citation

Mills KL, Teesson M, Back SE, Brady KT, Baker AL, Hopwood S, Sannibale C, Barrett EL, Merz S, Rosenfeld J, Ewer PL. Integrated exposure-based therapy for co-occurring posttraumatic stress disorder and substance dependence: a randomized controlled trial. JAMA. 2012 Aug 15;308(7):690-9. doi: 10.1001/jama.2012.9071. — View Citation

Monti PM, Mastroleo NR, Barnett NP, Colby SM, Kahler CW, Operario D. Brief motivational intervention to reduce alcohol and HIV/sexual risk behavior in emergency department patients: A randomized controlled trial. J Consult Clin Psychol. 2016 Jul;84(7):580-91. doi: 10.1037/ccp0000097. Epub 2016 Mar 17. — View Citation

Possemato K, Maisto SA, Wade M, Barrie K, Johnson EM, Ouimette PC. Natural Course of Co-Occurring PTSD and Alcohol Use Disorder Among Recent Combat Veterans. J Trauma Stress. 2017 Jun;30(3):279-287. doi: 10.1002/jts.22192. Epub 2017 Jun 6. — View Citation

Possemato K, Maisto SA, Wade M, Barrie K, McKenzie S, Lantinga LJ, Ouimette P. Ecological momentary assessment of PTSD symptoms and alcohol use in combat veterans. Psychol Addict Behav. 2015 Dec;29(4):894-905. doi: 10.1037/adb0000129. — View Citation

Rauch SA, Morales KH, Zubritsky C, Knott K, Oslin D. Posttraumatic stress, depression, and health among older adults in primary care. Am J Geriatr Psychiatry. 2006 Apr;14(4):316-24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	Baseline and 8 weeks
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.	8 weeks
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.	8 weeks
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.	20 weeks