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

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ClinicalTrials.gov Identifier: NCT03812146
Recruitment Status : Recruiting
First Posted : January 21, 2019
Last Update Posted : July 11, 2019
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Syracuse VA Medical Center

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
Stress Disorders, Post-Traumatic Alcohol-Related Disorders Behavioral: PC-TIME Behavioral: PC-TAU Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open clinical trial
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Integrated Brief Alcohol and PTSD Intervention for Veterans in Primary Care
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : October 2021

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.

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.




Primary Outcome Measures :
  1. Change in Clinician Administered PTSD Scale (CAPS)-5 severity rating [ Time Frame: 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).

  2. Change in daily drinking over past 30 days. [ Time Frame: 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 :
  1. Post-intervention Treatment Engagement [ Time Frame: 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.

  2. Change in Depressive Symptom Severity [ Time Frame: 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).

  3. Change in Quality of Life perceptions [ Time Frame: 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03812146


Contacts
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Contact: Kyle Possemato, PhD 315-425-4400 ext 53551 kyle.Possemato@va.gov

Locations
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United States, New York
Buffalo VA Medical Center Not yet recruiting
Buffalo, New York, United States, 14215
Contact: Paul King, Ph.D.    716-862-6038      
Syracuse Veterans Affairs Medical Center Recruiting
Syracuse, New York, United States, 13210
Contact: Kyle Possemato, Ph.D.    315-425-4400 ext 53551    kyle.possemato@va.gov   
Sponsors and Collaborators
Syracuse VA Medical Center
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Kyle Possemato, PhD Syracuse VA Medical Center

Publications:

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Responsible Party: Syracuse VA Medical Center
ClinicalTrials.gov Identifier: NCT03812146     History of Changes
Other Study ID Numbers: 1250312
1R34AA026745-01 ( U.S. NIH Grant/Contract )
First Posted: January 21, 2019    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: The data will be available once the database is finalized and will remain available in the future.
Access Criteria: Access to the data can be obtained by emailing the PIs and describing the reason the data is needed.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Disease
Stress Disorders, Post-Traumatic
Alcohol-Related Disorders
Pathologic Processes
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders