New Beginnings Following Trauma
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- PTSD Checklist for DSM-5
研究概览
简要总结
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.
详细描述
Individuals interested in participating in this study will complete a phone screening or online screening based on individual preference to determine if they are likely to be eligible and can be scheduled for a telehealth or in-person diagnostic intake to take place at the Stress Trauma and Recovery Research Collaborative (STARRC) within the UK Clinic for Emotional Health. All participants will be provided with details regarding the screening questions and will be required to provide verbal consent over the phone or review a cover letter consent form (similar to the phone screening) online before proceeding with the screening. Once scheduled for an intake, participants will be sent a link to complete the intake questionnaires online prior to the start of the intake appointment. A cover letter consent form is attached for these questionnaires, as they will be administered before the in-person intake session. During the intake session, the participant will first be given a written and verbal description of the study and informed consent. The consent form will be presented to the participant on a tablet through REDCap, or via HIPAA-Compliant Zoom if telehealth, in which they will be asked to provide a digital signature. If consent is provided, they will be provided a copy. The PI or designated staff will discuss the informed consent form with the participant volunteer. The consent process will take place in a quiet and private room in our office or via HIPAA-Compliant Zoom. Participants may take as much time as needed to make a decision about their trial participation and may take the document home if desired. The person obtaining consent will thoroughly explain each element of the document and outline the risks and benefits, alternative treatment(s), and requirements of the study. Participants will be informed that they can withdraw from the research at any time.
Procedures and consent forms will comply with the requirements of the UK-IRB and ORI's Best Practices for Remote Informed Consent. The experimenter will then complete a consent post-test with participants. If a participant screens out of the study due to a consent capacity issue, any data from that participant that may have been previously collected during the phone screening and/or online surveys will not be used for research purposes and will be destroyed. Participants will also agree to the study's intoxication policy before signing the consent form. Participant privacy will be maintained and questions regarding participation will be answered. No coercion or undue influence will be used in the consent process. No research-related procedures will be performed prior to obtaining informed consent. All signatures and dates will be obtained. A copy of the signed consent will be given to the participant. Signed electronic consents will be maintained and stored through REDCap and will be separated from participant data.
After completing and signing the consent form at the intake appointment, eligible participants will be required to sign a release of information from the research team granting the research team permission to contact their methadone or buprenorphine program to coordinate care for the participant. Any additional release of information required from individual methadone or buprenorphine treatment facilities will be obtained for each participant as needed.
Initial Screening
Upon referral to the study, participants will complete a brief phone or internet screening based on participant preference to determine eligibility for an intake appointment. Screening forms for individuals who are deemed ineligible for the study for reasons other than consent capacity issues will be retained for study records and future research purposes that may be developed in the lab or by lab collaborators for which data may be useful.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of trauma meeting past-month diagnostic criteria for posttraumatic stress disorder (PTSD; meeting diagnostic status on the DIAMOND PTSD Module and score greater than or equal to 36 on the PCL-5) and current or past diagnostic criteria for opioid use disorder (OUD).
- •Enrolled in a methadone or buprenorphine treatment program in the state of Kentucky.
- •18 years of age or older and fluent in English (including being able to read and write in English).
- •Participants on psychotropic medications and medications for opioid use disorder (methadone or buprenorphine) will be included if they have been maintained on a stable dose for at least 4 weeks prior to beginning the study and are willing to maintain a stable dosage throughout the study period; this procedure allows for a broader range of participants and avoids having outcomes assessment confounded by the initiation of medication during treatment.
- •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.
- •Willing to refrain from additional trauma-focused psychological treatment for the duration of the study.
排除标准
- •Individuals diagnosed with psychological conditions that may be better addressed by alternative treatments. These conditions may include any history of psychotic disorders or dissociative identity disorder, manic episodes endorsed in the past year, current anorexia nervosa, and high risk of suicide.
- •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.
研究组 & 干预措施
3-Week Baseline
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.
干预措施: Written Exposure Therapy - Integrated (Behavioral)
5-Week Baseline
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.
干预措施: Written Exposure Therapy - Integrated (Behavioral)
结局指标
主要结局
PTSD Checklist for DSM-5
时间窗: Change in PCL-5 scores will be assessed up to 14 weeks with self-report checklist from 3 or 5 weeks prior to beginning treatment, compared to weekly during treatment, and compared weekly to 4 weeks after completing treatment
Change in Posttraumatic Stress Disorder Severity
次要结局
未报告次要终点
研究者
Jesse McCann
Doctoral Student
University of Kentucky
