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
|Condition or disease||Intervention/treatment||Phase|
|Stress Disorders, Post-Traumatic Alcohol-Related Disorders||Behavioral: PC-TIME Behavioral: PC-TAU||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Open clinical trial|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
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.
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.
- 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).
- 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.
- 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.
- 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).
- 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).
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
|Contact: Kyle Possemato, PhD||315-425-4400 ext 53551||kyle.Possemato@va.gov|
|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 email@example.com|
|Principal Investigator:||Kyle Possemato, PhD||Syracuse VA Medical Center|