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385 Combining Cannabidiol with Prolonged Exposure Therapy for PTSD: Design and Methodology of a Pilot Randomized Clinical Trial
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- Casey Straud, John Roache, Bret Ginsburg, Rais Baig, Van King, Stacey Young-McCaughan, Alan Peterson
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- Journal:
- Journal of Clinical and Translational Science / Volume 7 / Issue s1 / April 2023
- Published online by Cambridge University Press:
- 24 April 2023, p. 114
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OBJECTIVES/GOALS: There is increasing evidence that cannabidiol (CBD) has promising potential to treat PTSD. However, more research is warranted to fully understand the benefits of CBD for PTSD. This poster will describe the design and methodology of one of the first ever pilot RCTs examining CBD (vs. placebo) combined with prolonged exposure therapy for PTSD. METHODS/STUDY POPULATION: This study is an early Phase II double-blind, pilot RCT. Participants are 24 individuals 18-65 years old who meet DSM-5 criteria for PTSD on the CAPS-5 and were recruited from local hospitals and the community. Individuals complete a standardized baseline assessment with an independent evaluator to assess study eligibility. Participants who meet study inclusion are randomized to 18 days of CBD 250mg (BID) or placebo delivered in combination with 10-sessions Prolonged Exposure (PE) psychotherapy over 2 weeks. Individuals begin medication 3 days prior to beginning PE to ensure steady state. Participants complete self-report and biomarker outcomes at select timepoints during study participation, and are also asked to complete a 1-month follow-up assessment following treatment. RESULTS/ANTICIPATED RESULTS: This aims of this study are to: 1) examine the safety, feasibility, and PTSD symptom reductions associated with the combined intervention; 2) evaluate biomarkers associated with the endocannabinoid system and stress response; 3) determine the association between changes in biomarkers and PTSD symptoms following treatment. It is expected that CBD+PE will be safe and feasible, and that there will be a detectable signal of CBD vs. placebo in the reduction of PTSD symptoms. It is also anticipated that CBD will have higher levels of endocannabinoids and lower stress response levels compared to placebo. Lastly, we expect that greater changes in biomarkers will be associated with lower levels of PTSD severity following treatment. DISCUSSION/SIGNIFICANCE: Although there is growing interest in cannabinoids for psychiatric conditions, such as PTSD, controlled trials are limited and have yet to examine the proposed intervention for PTSD. If successful, this study will enhance the feasibility of a larger, adequately powered RCT to address immediate and long-term improvements for PTSD treatments.
4065 Preferences, Expectancies, and Stigma among Treatment Seeking Combat PTSD Patients
- John Moring, Alan Peterson, Casey Straud, Jim Mintz, Paul Nabity, Lindsay Bira, Stacey Young-McCaughan, Willie Hale, Donald McGeary, Patricia Resick
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- Journal:
- Journal of Clinical and Translational Science / Volume 4 / Issue s1 / June 2020
- Published online by Cambridge University Press:
- 29 July 2020, pp. 34-35
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OBJECTIVES/GOALS: Cognitive Processing Therapy (CPT) is a cognitive behavioral treatment for posttraumatic stress disorder (PTSD). CPT is effective in treating combat-related PTSD among Veterans and active duty service members. It is unknown whether improvement in PTSD is related to accommodation of patient preference of the modality of therapy, such as in-office, telehealth, and in-home settings. An equipoise-stratified randomization design allows for complete randomization of participants who are interested and eligible for all three treatment arms. It also allows participants to reject one treatment arm if they are not interested or eligible. Participants who elect to opt out of one arm are randomized to one of the two remaining treatment arms. The primary aim of this study was to evaluate differences in patient satisfaction, treatment stigma beliefs, and credibility beliefs based on patient treatment modality preference. The second aim of this study was to examine if baseline satisfaction, stigma beliefs, and credibility beliefs predicted PTSD treatment outcomes. METHODS/STUDY POPULATION: Active duty service members and veterans with PTSD (N = 123) were randomized to one of three arms using an equipoise stratified randomization. Participants underwent diagnostic interviews for PTSD at baseline and post-treatment and completed self-report measures of satisfaction, stigma, credibility and expectancies of therapy. RESULTS/ANTICIPATED RESULTS: A series of ANOVAs indicated that there were group differences on patient stigma beliefs regarding mental health, F = 5.61, p = .001, and therapist credibility, F = 5.11, p = .002. Post hoc analyses revealed that participants who did not opt of any treatment arm demonstrated lower levels of stigma beliefs compared to participants who opted-out of in-office, p = .001. Participants who opted out of in-home viewed the therapist as less credible compared to participants who did not opt of any arm, p = .004. Multiple regression analysis found that baseline patient satisfaction, stigma beliefs, and credibility beliefs were not predictive of PTSD treatment outcomes, p > .05. DISCUSSION/SIGNIFICANCE OF IMPACT: Combat PTSD patients may opt out of in-office therapy due to mental health stigma beliefs, and visibility in mental health clinics may be a concern. For patients who opted out of in-home therapy, lack of credibility may have decreased participants’ desire for therapists to enter their home. Despite concerns of mental health stigma and the credibility of the therapy in certain treatment arms, patients in each treatment arm significantly improved in PTSD symptomotology. Moreover, patient characteristics, including satisfaction, stigma, and credibility of the therapy, did not significantly predict treatment outcomes, which demonstrates the robustness of Cognitive Processing Therapy.
4286 The Relationship Between Tinnitus-Related Distress and PTSD Symptoms Among Post 9/11 Veterans with Posttraumatic Headache
- John Moring, Casey Straud, Donald Penzien, Patricia Resick, Alan Peterson, Carlos Jaramillo, Blessen Eapen, Cindy McGeary, Jim Mintz, Willie Hale, Don McGeary
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- Journal:
- Journal of Clinical and Translational Science / Volume 4 / Issue s1 / June 2020
- Published online by Cambridge University Press:
- 29 July 2020, pp. 38-39
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OBJECTIVES/GOALS: Military personnel are at significantly greater risk for developing tinnitus, due to increased exposure to acoustic trauma. Many psychiatric disorders are common among individuals with chronic tinnitus, including posttraumatic stress disorder (PTSD). Although tinnitus and PTSD are clearly different, research supports the notion of shared mechanisms between both disorders. First, there are overlapping symptoms between tinnitus-related distress and PTSD, including irritability, distorted cognitions, persistent negative emotional states, diminished interests in activities, exaggerated startle response, sleep disturbance, concentration problems, and hypervigilance. Second, tinnitus and PTSD are highly comorbid with one another, whereas 34% of veterans with tinnitus also carry a PTSD diagnosis. Third, those with both disorders are significantly more emotionally impaired compared to those with tinnitus and any other psychiatric disorder. Lastly, neuroimaging research has shown similar regions within the auditory vigilance network are implicated among those with tinnitus, and separately, among combat PTSD patients, suggesting shared neurobiological mechanisms between both disorders. Though we are aware that tinnitus and comorbid PTSD presents as a significantly greater clinical concern, the relationship between tinnitus-related distress and PTSD symptomotology it is still unknown. Canonical correlation analyses will be conducted to examine the relationship between tinnitus-related distress and PTSD among veterans as a part of a larger clinical trial for posttraumatic headache. Results of the study will shed light on the relationship between tinnitus-related distress and PTSD, and may suggest a different phenotype for those with both disorders. Researchers and clinicians will further understand and conceptualize the relationships among the cognitive, emotional, and behavioral symptoms associated with tinnitus and PTSD, both individually and conjointly. METHODS/STUDY POPULATION: Baseline data (N = 112) from a larger clinical trial examining the effectiveness of two different psychotherapies for the alleviation of posttraumatic headache was examined. The primary aim of this project was to evaluate the relationship between tinnitus-related distress and PTSD based on the eight subscale scores of the Tinnitus Functional Index (TFI) and the four scales of the Clinician Administered PTSD Scale for the DSM-5 (CAPS-5), respectively. To address this aim, canonical correlation analysis was used where the tinnitus-related symptom subscales made up one variable set and PTSD symptom subscales made up the second variable set. First, we evaluated the overall model fit based on Wilks Lambda to determine if the two variable sets were related at the p < .05 level. Next, we evaluated the canonical correlations (comparable to an eigenvalue) for each canonical dimension to determine the required number of significant canonical dimensions (or latent constructs) that were necessary to understand the association between the two variable sets. Finally, the standardized canonical coefficients, which are analogous to regression coefficients, evaluate the magnitude of variate relationships and determine which subscales best describe significant canonical dimensions. RESULTS/ANTICIPATED RESULTS: Prior to the canonical correlation analysis, total score descriptive statistics and subscale score zero-order correlations were carried out. The CAPS-5 total score was 33.24 (SD = 9.39) and the TFI total score was 50.81 (SD = 21.88) in this sample. Interpretation of the zero-order correlations indicated that TFI Relaxation subscale was the only tinnitus-related subscale moderately associated with a PTSD subscale (i.e., Reexperiencing, r = .35). Canonical correlation omnibus model fit analysis via the Wilks Lambda overall multivariate test indicated that the tinnitus variable set was significantly associated with the PTSD variable set, F = 1.55, p = .04. Evaluation of the canonical correlations indicated that one dimension was significant in explaining the relationship between the two variable sets and accounted for 25% of the overall variance, F = 1.55, p < .04, R2 = .249. Standardized canonical coefficients indicated that the PTSD subscales Reexperiencing (b = 0.64) and Negative Alterations in Cognition and Mood (b = 0.55) were the most representative of the identified canonical dimension. In terms of the TFI, the Relaxation (b = 1.28) and Sleep (b = 0.72) subscales appeared to be most related to the canonical dimension. The TFI subscales Auditory Difficulty (b = −0.30) and Quality of Life (b = 0.30) also appeared to be related the canonical dimension to a lesser degree. DISCUSSION/SIGNIFICANCE OF IMPACT: Findings support prior research suggesting particularly deleterious functional outcomes among individuals with comorbid tinnitus and PTSD. Results of this study suggest a latent variable that can explain the unique experience of individuals with both disorders. This latent variable consists of two PTSD constructs: Reexperiencing traumatic events (i.e., flashbacks, nightmares, intrusive memories), and Negative Alterations in Cognition and Mood (i.e., self- and other-blame, strong negative feelings, loss of interest, feeling distant). This latent variable also consists of two tinnitus-related constructs: Sleep (i.e., trouble falling and staying asleep, peaceful sleep) and Relaxation (i.e., ability to relax, enjoyment of peace and quiet). Auditory Difficulty (i.e., hear clearly, understand people) and Quality of Life (i.e., social activities, relationships, difficulty performing tasks) also contributed to the latent variable, but to a lesser degree. It is suggested that the constellation of symptoms related to the latent variable is a Dysphoric Factor, unique to individuals with PTSD, tinnitus, and posttraumatic headache. It may be necessary to incorporate different techniques into existing evidence-based treatments for both tinnitus and PTSD, for optimal symptom improvement.