Trauma and Trauma-Focused Therapy in the University of Kentucky SMART Clinic

All patients served by the SMART clinic in UK Psychiatry will be invited to complete an online survey to assess for lifetime history of trauma, current PTSD symptoms perceptions of how patients' trauma history and PTSD symptoms are related to their substance use (e.g., do they perceive there to be a connection) and other mental health problems, whether patients have received treatment directly focused on trauma and/or PTSD symptoms and if so how helpful they perceived this treatment to be, and patient interest in receiving additional individual trauma-focused treatment as part of their care within the SMART program.

Patients indicating interest in trauma-focused treatment will be provided with additional details regarding the purpose of the pilot trial to obtain patient feedback regarding their impressions of the 12-session COPE intervention, and feedback regarding how the treatment could be modified to better meet the needs of patients in the UK Psychiatry SMART Program and other MAT programs. Information regarding patient recovery is collected and retained within an internal database within the SMART program to track patient recovery services week-to-week as part of routine clinical services. This database is retained on secured computer systems within the clinic. The investigators will seek permission from participants to draw the following historical information from this database and link it to the survey responses they provide as part of this research study to allow us to examine whether the following clinical factors differ as a function of trauma history or PTSD symptoms:

• Dates of scheduled and attended visits (length and frequency of care)
• Results of urine drug screens
• Weekly report of substance use, mental health, physical pain, and recovery activities (See attached Recovery Update Form)
• Medications patients are taking
• Emergency department visits or hospitalizations since beginning treatment In addition, patients with probable PTSD on the PCL-5 who express interest in participating in the pilot trial will be invited to complete clinical interviews at baseline to assess for PTSD diagnosis/severity and co-occurring conditions that would contraindicate participation in the treatment portion of the study (i.e., schizophrenia or other psychotic disorders, current manic episode, acute suicidal ideation with intent). A total of 6 patients with a current diagnosis of PTSD (who are deemed not at high risk for suicide, have been actively engaged in MAT for at least 4 weeks, and are determined to be medically stable) will be invited to participate in the pilot trial. Eligible patients will then complete additional baseline interviews to assess substance use frequency/quantity, SUD and depression diagnoses, and qualitative information regarding participants' beliefs regarding the role of trauma and PTSD symptoms in their recovery, satisfaction with prior treatment experience, and expectations regarding their experience with COPE.

The treatment part of the study will utilize a randomized, non-concurrent multiple baseline design across participants. This is a form of single-case experimental design that provides a time and cost-effective method of evaluating initial efficacy or effectiveness of an intervention while controlling for the passage of time and repeated assessment in small numbers of patients. Patients will be randomized to either a 4- (n=3) or 6-week (n =3) baseline assessment phase where weekly self-report measures of PTSD symptoms will be completed prior to initiating the COPE treatment. Randomizing to varying baseline periods enables assessments of whether symptoms change (only or more rapidly) when the COPE intervention is applied (i.e., each participant acts as their own control). This design allows for causal inferences and controls for many threats to internal validity. Dr. Badour (PI) will train and supervise clinical psychology doctoral student therapists in delivery of the COPE intervention. Patients will meet with an independent assessor at three points throughout the treatment (3 visits at baseline, 1 visit after session 6, and 2 visits after session 12) to assess symptoms and to provide both quantitative and qualitative feedback regarding their preferences and perspective on the treatment (e.g., treatment credibility, clarity and applicability of material, patient satisfaction, therapeutic alliance) and ways the content could be modified to better fit their needs. At the session 12 assessment, interview measures of PTSD and depression symptoms will be repeated to assess symptom change. Self-report symptoms of PTSD and depression will be administered weekly throughout treatment. MAT adherence and substance use will be monitored as part of routine clinical procedures in the SMART program using the attached Recovery Update Form. As not all patients are seen weekly at the SMART Program, the Recovery Update Form will be administered by the research team on weeks when patients do not have regular clinic visits. The addition of up to two "stressor" sessions (for 14 total possible sessions) will be offered. Content of these sessions will be allowed to deviate from the protocol to address current stressors that arise during the course of treatment. A previous psychotherapy trial found that this modification increases flexibility in PTSD treatment without sacrificing efficacy, and is more in line with a patient-centered approach to treatment. With the exception of the addition of COPE, MAT and other therapeutic programming will continue per normal (e.g., group medication management, ongoing therapy groups, case management). Clinical and demographic data collected by providers in the course of treatment will be obtained and examined for its relevance to illness course and treatment outcome.