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Primary Care Treatment Integrating Motivation and Exposure (PC-TIME)

Primary Purpose

Stress Disorders, Post-Traumatic, Alcohol-Related Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PC-TIME
PC-TAU
Sponsored by
Syracuse VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorders, Post-Traumatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Buffalo VA Medical Center
  • Syracuse Veterans Affairs Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PC-TIME

PC-TAU

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 18, 2019
Last Updated
October 26, 2022
Sponsor
Syracuse VA Medical Center
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT03812146
Brief Title
Primary Care Treatment Integrating Motivation and Exposure
Acronym
PC-TIME
Official Title
An Integrated Brief Alcohol and PTSD Intervention for Veterans in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
July 15, 2021 (Actual)
Study Completion Date
November 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Syracuse VA Medical Center
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic, Alcohol-Related Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Open clinical trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PC-TIME
Arm Type
Experimental
Arm Description
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.
Arm Title
PC-TAU
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
PC-TIME
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
PC-TAU
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Clinician Administered PTSD Scale (CAPS)-5 Severity Rating
Description
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
Title
Average Number of Drinks Per Drinking Day
Description
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
Title
PTSD Checklist-5
Description
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
Secondary Outcome Measure Information:
Title
Post-intervention Treatment Engagement
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyle Possemato, PhD
Organizational Affiliation
Syracuse VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Buffalo VA Medical Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Syracuse Veterans Affairs Medical Center
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
The data will be available once the database is finalized and will remain available in the future.
IPD Sharing Access Criteria
Access to the data can be obtained by emailing the PIs and describing the reason the data is needed.
Citations:
PubMed Identifier
16582040
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. doi: 10.1097/01.JGP.0000199382.96115.86.
Results Reference
background
PubMed Identifier
26727007
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.
Results Reference
background
PubMed Identifier
26985726
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.
Results Reference
background
PubMed Identifier
26519833
Citation
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.
Results Reference
background
PubMed Identifier
29283612
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.
Results Reference
background
PubMed Identifier
22893166
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.
Results Reference
background
PubMed Identifier
28585777
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.
Results Reference
background
PubMed Identifier
24766758
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. doi: 10.15288/jsad.2014.75.458.
Results Reference
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Primary Care Treatment Integrating Motivation and Exposure

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