Skip to main content
OpenTrials
Completed

NCT Number: NCT03812146

Primary Care Treatment Integrating Motivation and Exposure

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stress Disorders, Post-Traumatic Alcohol-Related Disorders Chemically-Induced Disorders Mental Disorders Stress Disorders, Traumatic Substance-Related Disorders Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Buffalo VA Medical Center, Buffalo, New York, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PC-TIME

Behavioral

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

Behavioral

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 outcomes

  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. Average Number of Drinks Per Drinking Day

    Time frame: 8 weeks

    The Timeline Follow-back instrument is presented as a 30-day calendar and it is used to obtain count estimates of daily drinking.

  3. PTSD Checklist-5

    Time frame: 8 weeks

    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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Syracuse VA Medical Center

Fed

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

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

Acronym: PC-TIME

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 22, 2019
Registry last updated
Nov 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.