PC-TIME: Primary Care Treatment Integrating Motivation and Exposure
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
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.
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| Active Comparator: 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. |
Behavioral: 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.
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Outcome Measures
Primary Outcome Measures
- 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).
- Change in daily drinking over past 30 days. [Baseline, 8 weeks, 14 weeks, and 20 weeks]
The Timeline Follow-back instrument is presented as a 30-day calendar and it is used to obtain count estimates of daily drinking.
Secondary Outcome Measures
- 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.
- Change in Depressive Symptom Severity [Baseline, 8 weeks, 14 weeks, and 20 weeks]
The Patient Health Questionnaire (PHQ-9) is a 9-item self-report measure used to assess depressive symptoms at each time point to evaluate change in severity. The PHQ-9 is a standard VA instrument with good psychometric properties. Scores range 0-27 with higher scores representing higher depressive symptom severity (worse outcome).
- Change in Quality of Life perceptions [Baseline, 8 weeks, 14 weeks, and 20 weeks]
The World Health Organization Quality of Life (WHO QOL) instrument is a 26-item self-report measure used to assess individual's perception of quality of life in quality of life in physical, psychological, social relationships, and environment domains. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life) for each domain - physical (range 7-35); psychological (range 6-30); social relationship (range 3-15); environment (range 8-40).
Eligibility Criteria
Criteria
Inclusion Criteria:
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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)
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Score ≥30 on the PTSD Checklist-5 (PCL-5) and report a traumatic event on the Criterion A screener
Exclusion Criteria:
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Score of a 26 or higher on the AUDIT
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gross cognitive impairment as assessed by the Mini Mental Status Exam
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current symptoms of mania or psychosis
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currently in need of detox services
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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)
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Are currently receiving psychotherapy for heavy drinking or PTSD outside of PC within the last 2 months
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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
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Have a preference to be directly referred to VA specialty care for heavy drinking or PTSD.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Buffalo VA Medical Center | Buffalo | New York | United States | 14215 |
| 2 | Syracuse Veterans Affairs Medical Center | Syracuse | New York | United States | 13210 |
Sponsors and Collaborators
- Syracuse VA Medical Center
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
- Principal Investigator: Kyle Possemato, PhD, Syracuse VA Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 1250312
- 1R34AA026745-01