Written Exposure Therapy for PTSD

Overseen By Christal Badour, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jesse McCann

Must be taking: Methadone, Buprenorphine

Disqualifiers: Psychotic disorders, Dissociative identity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

3 Participants Needed

Trial Summary

What is the purpose of this trial?

Posttraumatic stress disorder (PTSD) is associated with increased rates of prescription opioid misuse, high-risk opioid use, illicit use of substances, and overdose (Meshberg-Cohen et al., 2021) Some research has demonstrated that among individuals with opioid use disorder (OUD), 92% report exposure to a traumatic event (Mills et al., 2005). Approximately 41% of those with OUD have a lifetime history of PTSD and 33.2% of individuals with OUD meet current diagnostic criteria for PTSD, indicating very high rates of PTSD among people with co-occurring OUD (Mills et al., 2006, 2007). PTSD also prospectively increases risk for OUD after exposure to opioids (Hassan et al., 2017). Medications for opioid use disorder (MOUD) are evidence-based pharmacological interventions for OUD (methadone, buprenorphine, naltrexone) to manage pain and withdrawal (Leshner \& Mancher, 2019). Though effective, dropout from MOUD programs is high (Mokri et al., 2016; O'Connor et al., 2020). It is also common in substance use disorder (SUD) treatment settings not to treat PTSD (Norman \& Hien, 2020), though concurrent PTSD and MOUD treatment is associated with higher continuation in MOUD programs compared to no PTSD treatment (Meshberg-Cohen et al., 2019; Schacht et al., 2017). Despite this, there is little data regarding efficacy or effectiveness of specific trauma-focused PTSD treatments among patients in MOUD programs. Combined with effective cognitive-behavioral techniques for substance use disorder (SUD), evaluation of brief, trauma-focused interventions for PTSD has substantial potential to improve care for individuals with PTSD receiving MOUD. The present study will begin to address this need by evaluating the feasibility, acceptability, and initial efficacy of Written Exposure Therapy (WET) for PTSD integrated with harm reduction skills for managing SUD symptoms among a sample of patients receiving MOUD \[Written Exposure Therapy-Integrated (WET-I)\]. WET is a five-session treatment for PTSD requiring limited therapist training and minimal patient burden (Sloan \& Marx, 2019). WET has shown comparable outcomes to gold-standard interventions for PTSD, with improved retention rates (Sloan et al., 2018). WET has marked potential within this population, especially given that many clinicians in SUD programs do not have specialized training in PTSD treatments (Killeen et al., 2015). Using a multiple baseline single case experimental design (SCED), 6 participants with current PTSD and current or past OUD will be recruited from MOUD treatment programs to engage in 5 weekly sessions of WET-I. Participants will complete an intake assessment to establish PTSD and OUD diagnoses and will be randomized to a 3- or 5-week baseline assessment period. Weekly assessments of symptoms (i.e., PTSD, anxiety, depression), substance craving and use, quality of life, and compliance with MOUD treatment will be completed during the baseline, treatment, and one-month follow-up phase. During the treatment phase, participants will also complete weekly measures of therapeutic alliance and will provide feedback on treatment credibility and treatment satisfaction. Aim 1: To examine feasibility and acceptability of WET-I among participants in MOUD treatment with co-occurring PTSD/OUD. Feasibility of WET-I will be demonstrated via treatment retention and completion. Acceptability of engaging in WET-I in tandem with MOUD treatment will be demonstrated via high patient credibility ratings of WET-I and high treatment satisfaction ratings. Aim 2: To determine if WET-I can significantly reduce symptoms of PTSD, anxiety, and depression in participants with comorbid PTSD and OUD and to monitor changes in drug use behaviors and craving over the treatment period. Participants will report reliable clinical improvement in symptoms (PTSD, anxiety, depression) and quality of life during the treatment phase and post-assessment without corresponding increases in substance use behavior or craving, and these improvements will be maintained at follow-up.

Research Team

Christal Badour, PhD

Principal Investigator

University of Kentucky

Jesse McCann, MS

Principal Investigator

University of Kentucky

Eligibility Criteria

This trial is for adults over 18 who have experienced trauma, are diagnosed with PTSD and opioid use disorder (OUD), can read and write in English, and are currently enrolled in a methadone or buprenorphine program in Kentucky. They must not be undergoing other trauma-focused treatments and should maintain stable doses of any psychotropic or OUD medications.

Inclusion Criteria

Participants in this study will also be required to sign a release of medical information for their methadone or buprenorphine clinic so that study staff can coordinate care with their methadone or buprenorphine provider

History of trauma meeting past-month diagnostic criteria for posttraumatic stress disorder (PTSD) and current or past diagnostic criteria for opioid use disorder (OUD)

I am enrolled in a methadone or buprenorphine program in Kentucky.

Exclusion Criteria

Individuals who endorse factors for which the treatment being studied (WET-I) may be contraindicated. These factors may include having no or limited memory of the trauma that would prevent the individual from engaging in written exposures

I have a psychological condition that might need different treatment.

Treatment Details

Interventions

• Written Exposure Therapy - Integrated

Trial Overview The study tests Written Exposure Therapy-Integrated (WET-I) combined with harm reduction skills among patients receiving medication for OUD. It aims to see if this five-session treatment can reduce PTSD symptoms without increasing substance cravings or use, using weekly sessions over a one-month follow-up period.

Participant Groups

Group I: 5-Week Baseline Experimental Treatment 1 Intervention

Participants in this arm are randomized to a 5-week baseline period with repeated weekly assessment after the initial intake. Following the 5-week baseline, participants receive 5 weekly sessions of Written Exposure Therapy - Integrated (WET-I) followed by a 4-week follow-up phase with repeated weekly assessments.

Group II: 3-Week Baseline Experimental Treatment 1 Intervention

Participants in this arm are randomized to a 3-week baseline period with repeated weekly assessment after the initial intake. Following the 3-week baseline, participants receive 5 weekly sessions of Written Exposure Therapy - Integrated (WET-I) followed by a 4-week follow-up phase with repeated weekly assessments.

Who Is Running the Clinical Trial?

Jesse McCann

Lead Sponsor

Trials

2

Recruited

20+