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Imiquimod (IMQ; brand name Aldara®) is a registered topical agent that has been proven to induce local inflammation via the Toll-like receptor (TLR)7 pathway. The purpose of this study was to characterize TLR7-mediated inflammation following 7 days (168 h) of topical IMQ exposure in healthy volunteers, and to compare the effects of short exposure (48 h-72 h) with prolonged exposure (120 h-168 h). IMQ (100mg) was applied under occlusion to 5 different tape-stripped treatment sites on the back of 10 healthy participants for a maximum of 7 consecutive days. Erythema and skin perfusion were measured daily up to 168h. Biopsies for immunohistochemical staining and RNA sequencing were collected at 0h, 48h, 72h, 120h and 168h post IMQ application. IMQ triggered an inflammatory response starting at 48h after application, including erythema and perfusion of the skin. At the transcriptomic level, IMQ induced TLR7 signalling, IRF involvement and activation of TNF signalling via NF-κB. Furthermore, an enhanced inflammatory response at the cellular level was observed after prolonged IMQ exposure, with cellular infiltration of dendritic cells, macrophages and T cells which was also corroborated by transcriptomic profiles. No difference was found in the erythema and perfusion response after 168h of IMQ exposure compared to 72h. Prolonged IMQ exposure revealed enhanced cellular responses and additional pathways with modulated activity compared to short exposure and can therefore be of interest as a model for investigational compounds targeting innate and adaptive immune responses.

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BACKGROUND AND OBJECTIVES: Inhibitory Learning Theory (ILT) framework implies that in-session distress variability may promote extinction learning and thereby enhance exposure therapy efficacy. Thus far, research has mainly focused on in-session distress reduction. The aim of the current study was to assess whether in-session distress variability predicts next session PTSD symptom decline in PTSD patients receiving prolonged exposure (PE). METHODS: Eighty-six patients with PTSD received 14 to 16 sessions of PE. Using dynamic panel models, we assessed the temporal relation (i.e., within-persons) between in-session distress variability and PTSD symptom decline. Moreover, we assessed the averaged relation (i.e., between-persons) between in-session distress variability and PTSD symptom decline. RESULTS: Temporal analyses showed that in-session distress variability did not precede PTSD symptom improvement. Averaged analyses showed that distress variability was related to PTSD symptom improvement. LIMITATION: The operationalization of distress variability appeared to deviate from its theoretical conceptualization. CONCLUSIONS: In absence of distress reduction, distress variability can vary. However, our findings suggest that in-session distress variability does not drive symptom reduction during PE. In contrast, averaged over participants, distress variability was related to symptom improvement, suggesting that those with a more variable distress pattern across sessions show better treatment response. More empirical work is needed to shed light on the effect of distress variability during exposure sessions on treatment outcome and to offer grounds for clinical recommendations.

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BACKGROUND: Trauma is a significant risk factor for developing psychosis. Nevertheless, psychosis is often considered grounds for not receiving trauma-focused therapy due to concerns of exacerbating psychotic symptoms. Prolonged exposure (PE) is a recognized and effective evidence-based therapy modality for the treatment of severe trauma. OBJECTIVE: To assess the available empirical evidence for PE as a feasible treatment programme for posttraumatic stress disorder (PTSD) in patients with psychotic symptoms. METHOD: A systematic literature search was conducted using the databases Scopus, PsycINFO (OVID) and PubMed MEDLINE in December 2023 with a priori defined eligibility criteria. The literature search identified 1226 articles, of which eight met the eligibility criteria. Five studies exploring the effects of PE treatment on patients diagnosed with PTSD and suffering from comorbid psychotic experiences were included. Three studies containing follow-up data or secondary analysis on PTSD and psychotic symptoms from original studies fulfilling the inclusion and exclusion criteria were included. Each study was assessed for quality to estimate the risk of bias. RESULTS: Acknowledging the scarcity of available evidence, the results of the scoping review indicate that PE may be an effective treatment approach for reducing PTSD symptoms in patients with PTSD and comorbid psychotic symptoms. The reviewed studies found no iatrogenic effects, including no increase in psychotic symptoms. CONCLUSION: PE appears to be a possibly effective PTSD treatment for patients suffering from PTSD and comorbid psychotic symptoms or disorders. However, the evidence is scarce, and larger confirmative trials are required for more conclusive evidence.

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BACKGROUND: Religion/spirituality (R/S) is an important and commonly used resource for coping with difficult experiences and has been shown to reduce the development of posttraumatic stress disorder (PTSD) symptoms following a trauma. However, it is not clear how R/S affects response to treatment of PTSD. OBJECTIVE: The aim of this paper was to understand how Veterans' R/S and sense of purpose were related to clinical outcomes when engaging in Cognitive Processing Therapy (CPT) or Prolonged Exposure (PE). It was predicted that Veterans identifying as R/S would have a higher sense of purpose, be more likely to complete treatment, and have greater symptom change during treatment. METHOD: The study included 91 military Veterans from a VA Medical Center outpatient PTSD Clinical Team who initiated CPT or PE and responded to a question about the importance of R/S in their lives at intake. RESULTS: Forty nine percent of the Veterans in this sample reported R/S were important to them and had mixed feelings about whether their life had a clear sense of purpose. Neither R/S nor sense of purpose were associated with treatment completion or response to PTSD treatment. CONCLUSION: These findings suggest that once PTSD has developed, R/S or sense of purpose may not play a significant role in completion of or response to evidence-based psychotherapies (EBPs) for PTSD. EBPs for PTSD are equally effective for Veterans identifying as R/S and those who do not, which may be reflective of administering EBPs in a culturally responsive manner.

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BACKGROUND: Prolonged exposure (PE) therapy is widely recognized as an effective treatment for post-traumatic stress disorder (PTSD) and is often considered one of the primary options for addressing this condition. Nevertheless, a significant proportion of patients (30-51%) fail to demonstrate clinically significant symptom changes. One of the reasons is that a high proportion of patients drop out from treatment, which often lasts for a minimum of 3-4 months. Hence, there is an urgent need for PTSD treatments that can be delivered to decrease dropout rates. A more intensive PE treatment approach has been suggested to decrease dropout rates and in addition achieve faster recovery rates and has shown promising effects on reducing PTSD symptoms but needs to be tested against firsthand treatment. METHODS: This single-blind, randomized controlled trial (N = 140) will compare an intensive delivery format of prolonged exposure (iPE) against standard weekly delivered sessions of PE. The primary outcome is change on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Secondary outcomes include self-rated measures of symptoms of PTSD and complex PTSD, depression and quality of life, speed of recovery, cost effectiveness, dropout rates, and adverse events. DISCUSSION: This study will be the first to compare iPE with first-line treatment in a psychiatric outpatient setting. One of the key strengths of this study lies in its implementation within a clinical setting and the broad eligibility criteria. Additionally, the utilization of gold-standard assessment measures ensures the accuracy and reliability of the outcomes. However, several potential challenges may arise during the study's execution. These challenges may include difficulties in participant recruitment, ensuring adequate participant retention, adherence to the treatment protocol, and maintaining therapist retention mostly due to recruitment taking place at one single clinic. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov NCT05934175. Registered on June 6, 2023. Open Science Framework (OSF) https://osf.io/7qsb3 . Registered on September 2, 2023.

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BACKGROUND: The 2023 VA/DoD Clinical Practice Guideline for the Management of PTSD recommends individual, manualized trauma-focused such as Prolonged Exposure (PE) over pharmacologic interventions for the primary treatment of PTSD. Unfortunately, clinical trials of trauma-based therapies in the military and veteran population showed that 30% to 50% of patients did not demonstrate clinically meaningful symptom change. Ketamine, an FDA-approved anesthetic with potent non-competitive glutamatergic N-methyl-d-aspartate antagonistic properties, has demonstrated to enhance the recall of extinction learning and decrease fear renewal without interference of extinction training in preclinical studies. METHODS: We plan to conduct a single site RCT comparing three ketamine treatment vs. active placebo (midazolam) adjunct to PE therapy among Veterans with PTSD. Pharmacological phase will start simultaneously with PE session 1. Infusions will be administered 24 h. prior to PE session for the first 3 weeks. After PE is completed (session 10), patients will be assessed during a 3-month follow-up period at various time points. We estimate that out of 100 veterans, 80 will reach time point for primary outcome measure and will be considered for primary analysis. Secondary outcomes include severity of depression and anxiety scores, safety and tolerability of ketamine-enhanced PE therapy, cognitive performance during treatment and early improvement during PE related to the rate of dropouts during PE therapy. DISCUSSION: Results of the proposed RCT could provide scientific foundation to distinguish the essential components of this approach, enhance the methodology, elucidate the mechanisms involved, and identify sub-PTSD populations that most likely benefit from this intervention.

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Introduction: Short and intensive trauma treatment programs seem promising in treating post-traumatic stress disorder (PTSD). However, little is known about the effects performing these types of intensive treatment programs online. Method: At the Altrecht Academic Anxiety Centre, an in person intensive trauma focused treatment of six days (three consecutive days in two weeks) was altered into a fully online treatment. A treatment day consisted of 90 minutes of prolonged exposure, 60 minutes of exercise, 90 minutes of Eye Movement Desensitization and Reprocessing (EMDR) 2.0 and 60 minutes of psychoeducation. Mary, a patient diagnosed with chronic and severe PTSD, chronic depressive disorder (single episode, moderate to severe), a panic disorder, and an other specified personality disorder was the first patient to take part in this intensive online trauma treatment. Results: Mary reached full remission of PTSD. The PTSD symptoms (measured on both the clinician-administered PTSD scale for DSM-5, CAPS-5 and The PTSD Checklist for DSM-5, PCL-5) showed maximum improvement and were completely absent during one month and six month follow-up. Moreover, she no longer suffered from severe depressive symptoms and did not report any general psychiatric symptoms (measured with the Beck Depression Inventory version 2, BDI-II and the Brief Symptom Inventory, BSI). Conclusion: In conclusion, the case-report demonstrates that intensive trauma treatment online was successful in this specific case, thereby being a 'proof of concept' that intensive trauma treatment online is feasible. It might be promising for patients with severe and chronic PTSD and comorbid psychiatric disorders. However, further research must show if the results of this specific case can be translated to other patients with severe and chronic PTSD and comorbid psychiatric disorders.

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Background: Individuals suffering from PTSD following childhood abuse represent a large subgroup of patients attending mental health services. The aim of phase-based treatment is to tailor treatment to the specific needs to childhood abuse survivors with PTSD with a Skills Training in Affective and Interpersonal Regulation (STAIR) phase, in which emotion dysregulation and interpersonal problems are targeted, and a trauma-focused phase.Objective: The purpose of this study was to compare STAIR + Eye Movement Desensitization and Reprocessing (EMDR) vs. STAIR + Narrative Therapy (NT) as treatments for PTSD following childhood-onset trauma in a routine clinical setting.Method: Sixty-eight adults were randomly assigned to STAIR/EMDR (8 STAIR-sessions followed by 12 EMDR-sessions) or STAIR/NT (8 STAIR-sessions followed by 12 NT-sessions). Assessments took place at pre-treatment, after each treatment phase and at 3 and 12 months post-intervention follow-up. Primary outcomes were interviewer-rated and self-reported symptom levels of PTSD. Secondary outcomes included symptom levels of depression and disturbances in emotion regulation and interpersonal skills.Results: Multilevel analyses in the intent-to-treat sample indicated that patients in both treatments improved substantially on PTSD symptom severity (CAPS: d = 0.81 to 1.29; PDS: d = 1.68 to 2.15), as well as on symptom levels of depression, anxiety, emotion regulation, dissociation and interpersonal skills. Effects increased or were maintained until 12-month follow-up. At mid-treatment, after STAIR, patients in both treatments improved moderately on PTSD symptom severity (PDS: d = 1.68 to 2.15), as well as on symptom levels of depression (BDI: d = .32 to .31). Symptoms of anxiety, emotion dysregulation, interpersonal problems and dissociation were not decreased after STAIR. There were no significant differences between the two conditions on any outcome.Conclusion: PTSD in adult survivors of childhood interpersonal trauma can effectively be treated by phase-based interventions using either EMDR or NT in the trauma-processing phase.Trial registration: ClinicalTrials.gov identifier: NCT01443182..

The study directly compares Skills Training in Affective and Interpersonal Regulation (STAIR) followed by either EMDR or Narrative Therapy in the trauma-processing phase in routine clinical setting.The brief phase-based treatment was found to be effective in reducing both symptoms of PTSD as well as emotion regulation and interpersonal problems in survivors of childhood abuse.Posttraumatic Stress Disorder in adult survivors of childhood interpersonal trauma can effectively be treated by phase-based interventions using either EMDR or Narrative Therapy in the trauma-processing phase.

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BACKGROUND: Post-traumatic stress disorder (PTSD) is common in adults with intellectual disabilities. Often there are additional disorders such as substance use, mood and anxiety disorders. The current study focuses on the feasibility and initial efficacy of prolonged exposure (PE) for PTSD in adults with mild intellectual disabilities. The secondary effect of PE on additional mood, anxiety and substance use disorders is also examined. METHODS: A single case experimental design (N = 12) with an A (baseline)-B (intervention) phase including a follow-up measurement after 3 months was conducted. Time series and single time points measurements were performed. RESULTS: Six participants dropped-out. The results showed a significant decrease in PTSD symptoms and a significant decrease in additional symptoms (social avoidance, anxiety and stress), among participants who completed treatment. CONCLUSION: PE appears to be a feasible and effective treatment for PTSD in some adults with mild intellectual disabilities. Suggestions emerge from this study to make standard PE treatment more appropriate for adults with mild intellectual disabilities. Further research is needed to reduce drop-out in trauma treatment. Some suggestions for this are made in this study. Treatment of PTSD with PE did not appear to affect comorbid mood disorders. Further research is needed.

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Background and objective: Patients with intermediate-risk non-muscle-invasive bladder cancer (IR NMIBC) have a high risk of recurrence and need effective therapies to reduce the risk of disease recurrence or progression. This phase 1b study (NCT02720367) assessed the safety and tolerability of TAR-200, an intravesical drug delivery system, in participants with IR NMIBC. Methods: Participants with recurrent IR NMIBC were eligible. Participants received either two 7-d or two 21-d TAR-200 dosing cycles over a 4-6-wk period in a marker lesion/ablation design. TAR-200 was placed in the window between the cystoscopy showing recurrent papillary disease and the subsequent complete transurethral resection of the bladder tumour. The primary endpoint was TAR-200 safety. The secondary endpoints included TAR-200 tolerability, pharmacokinetics, and preliminary efficacy. Key findings and limitations: Twelve participants received TAR-200 treatment. No TAR-200-related serious or grade ≥ 3 treatment-emergent adverse events (TEAEs) occurred. Nine participants had grade ≤ 2 TAR-200-related TEAEs, with urgency, dysuria, and haematuria being most common. Two participants refused a second dosing cycle due to urinary urgency and frequency. Insertion and removal of TAR-200 was successful in all cases. Plasma gemcitabine concentrations remained below the lower limit of detection. Five participants (42%) had complete response (CR): four had pathological CR and one had CR based on visual assessment. Conclusions and clinical implications: TAR-200 appears to be safe and well tolerated, with encouraging preliminary efficacy in participants with IR NMIBC. This study lays the groundwork for the multiple phase 2 and 3 global studies that are currently on-going for TAR-200. Patient summary: In this study, researchers evaluated the safety of the novel drug delivery system TAR-200 in participants with intermediate-risk non-muscle-invasive bladder cancer. They concluded that TAR-200 was safe and well tolerated with promising antitumour activity.

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Introduction: Research has shown that combining different evidence-based PTSD treatments for patients with PTSD in an intensive inpatient format seems to be a promising approach to enhance efficiency and reduce generally high dropout rates.Objective: To assess the effectiveness of an intensive six-day outpatient trauma-focused treatment for patients with PTSD.Method: Data from 146 patients (89.7% female, mean age = 36.79, SD = 11.31) with PTSD due to multiple traumatization were included in the analyses. The treatment programme consisted of six days of treatment within two weeks, with two daily individual 90-minute trauma-focused sessions (prolonged exposure and eye movement desensitization and reprocessing), one hour of exercise, and one hour of psychoeducation. All participants experienced multiple traumas, and 85.6% reported one or more comorbid psychiatric disorders. PTSD symptoms and diagnoses were assessed with the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), and self-reported symptoms were assessed with the PTSD Checklist for DSM-5 (PCL-5).Results: A significant decline in PTSD symptoms (CAPS-5 and PCL-5) from pretreatment to one-month follow-up (Cohen's d = 1.13 and 1.59) was observed and retained at six-month follow-up (Cohen's d = 1.47 and 1.63). After one month, 52.4% of the patients no longer met the diagnostic criteria for PTSD (CAPS-5). The Reliable Change Index (RCI) shows that 73.9% of patients showed improvement on the CAPS-5 and 77.61% on the PCL-5. Additionally, 21.77% (CAPS-5) and 20.0% (PCL-5) showed no change, while 4.84% (CAPS-5) and 2.96% (PCL-5) showed symptom worsening.Discussion: The results show that an intensive outpatient trauma treatment programme, including two evidence-based trauma-focused treatments, exercise, and psychoeducation, is effective for patients suffering from PTSD as a result of multiple traumatization. Subsequent research should focus on more controlled studies comparing the treatment programme with other intensive trauma treatments and less frequent routine treatment.

Intensive outpatient trauma treatment is effective in treating PTSD.Six days of combining prolonged exposure, EMDR, exercise and psycho-education seems feasible and effective in treating PTSD.73.9% of the patients show improvement on the CAPS-5 and 77.61% show improvement on the PCL-5, symptom worsening was there in 4,84, respectively 2.96%.

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Military personnel and veterans are at heightened risk for exposure to traumatic events and posttraumatic stress disorder (PTSD), as well as intimate relationship problems associated with PTSD.The purpose of this study was to evaluate the relative efficacy of CBCT and PE in improving intimate relationship functioning in active duty military personnel or veterans and their intimate partners; both conditions were hypothesized to significantly improve PTSD. Method: In this study, 32 military service members or veterans with PTSD and their intimate partners were randomized to receive either Cognitive-Behavioral Conjoint Therapy for PTSD (n = 15; CBCT; [Monson, C. M., & Fredman, S. J. (2012). Cognitive-behavioral conjoint therapy for posttraumatic stress disorder: Harnessing the healing power of relationships. Guilford]), a trauma-focused couple therapy, or Prolonged Exposure (n = 17; PE; [Foa, E. B., Hembree, E. A., Dancu, C. V., Peterson, A. L., Cigrang, J. A., & Riggs, D. S. (2008). Prolonged exposure treatment for combat-related stress disorders - provider's treatment manual [unpublished]. Department of Psychiatry, University of Pennsylvania]), a front-line evidence-based individual treatment for PTSD.There were significant challenges with recruitment and a significant difference in dropout from treatment for the two therapies (65% for PE; 27% for CBCT). Treatment dropout was differentially related to pre-treatment relationship functioning; those with below average relationship functioning had higher dropout in PE compared with CBCT, whereas those with above average relationship functioning did not show differential dropout. In general, CBCT led to relational improvements, but this was not consistently found in PE. Clinician- and self-reported PTSD symptoms improved with both treatments.This study is the first to test a couple or family therapy against a well-established, front-line recommended treatment for PTSD, with expected superiority of CBCT over PE on relationship outcomes. Lessons learned in trial design, including considerations of equipoise, and the effects of differential dropout on trial analyses are discussed. This trial provides further support for the efficacy of CBCT in the treatment of PTSD and enhancement of intimate relationships.

Differential dropout from trial of couple versus individual therapy for PTSD.General pattern of improvements in relationship outcomes in couple therapy for PTSD.PTSD symptoms improved in the individual and couple therapy for PTSD.Lessons learned in trial design, including considerations of equipoise, and the effects of differential dropout by condition on trial analyses are discussed.

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Individuals with posttraumatic stress disorder (PTSD) often engage in harmful alcohol use. These co-occurring conditions are associated with negative health consequences and disability. PTSD and harmful drinking are typically experienced as closely related-thus treatments that target both simultaneously are preferred by patients. Many individuals with PTSD and harmful alcohol use receive primary care services but encounter treatment barriers in engaging in specialty mental health and substance use services. A pilot randomized controlled trial of a brief integrated treatment for PTSD and harmful drinking versus primary care treatment as usual (PC-TAU) took place in three U.S. Department of Veterans Affairs (VA) primary care clinics. The intervention (primary care treatment integrating motivation and exposure [PC-TIME]) combines motivational interviewing to reduce alcohol use and brief prolonged exposure for PTSD delivered over five brief sessions. Participants (N = 63) were veterans with PTSD and harmful drinking. Multilevel growth curve modeling examined changes in drinking (average number of drinks per drinking day and percentage of heavy drinking days) and self-reported PTSD severity at baseline, 8, 14, and 20 weeks. Participants reported high satisfaction with PC-TIME and 70% (n = 23) completed treatment. As hypothesized, a significantly steeper decrease in self-reported PTSD severity and heavy drinking was evident for participants randomized to PC-TIME compared with PC-TAU. Contrary to expectations, no significant posttreatment differences in PTSD diagnoses were observed. PC-TIME participants were less likely to exceed National Institute for Alcoholism and Alcohol Abuse (NIAAA) guidelines for harmful alcohol use posttreatment compared with PC-TAU participants. PC-TIME is a promising brief, primary care-based treatment for individuals with co-occurring PTSD and harmful alcohol use. A full-scale randomized clinical trial is needed to fully test its effectiveness.

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Background: Trauma-focused cognitive behavioural therapy such as prolonged exposure is considered firsthand choice for treatment of posttraumatic stress disorder (PTSD) but is seldom available in regular care. Digital therapy is proposed to bridge this gap, but its effectiveness for severe and complex PTSD is uncertain. The primary objective of the current study was to examine the feasibility, acceptability, and preliminary effects of digital therapist-guided prolonged exposure (Huddinge Online Prolonged Exposure; HOPE).Method: Thirty participants with moderate to severe PTSD, with the majority self-reporting complex PTSD symptoms, received HOPE over a ten-week period. Eighty percent of participants had been diagnosed with other psychiatric comorbidity by a mental health professional. Primary outcome was the feasibility and acceptability of treatment. Participants were repeatedly assessed using clinician- and self-rated outcome measures at baseline, during the treatment period, post-treatment, and at 1-month and 6-month follow-ups to estimate preliminary treatment effects. The Clinician Administered PTSD Scale version 5 (CAPS-5), administered by independent assessors, evaluated PTSD symptom severity.Results: HOPE proved feasible and effective, delivering evidence-based treatment content in a psychiatric outpatient setting with reduced therapist time. The treatment was well-tolerated, with no severe adverse events and a 17% dropout rate. Sixty-four percent completed the exposure-based portion of the treatment, and overall satisfaction measured by the Client Satisfaction Questionnaire was moderate. Furthermore, significant reductions in PTSD symptoms as assessed with the CAPS-5 (Cohen's d = 1.30 [95% CI -1.79 to -0.82]) at the primary endpoint 1 month which were sustained at the 6-month follow up.Conclusion: Altogether, this study indicate feasibility of treating severe and complex PTSD through a digital PE intervention, thereby building upon and extending previous research findings. Large-scale controlled trials are needed to further validate the specific effect and long-term benefits of HOPE.Trial registration: ClinicalTrials.gov identifier: NCT05560854.

HOPE, a digital therapist-guided prolonged exposure programme, demonstrated feasibility and preliminary effects for severe and complex PTSD in a psychiatric outpatient setting, while requiring less therapist time.HOPE was well-tolerated by participants, with a relatively low dropout rate and average overall satisfaction.Significant reductions in PTSD symptoms were observed, and these benefits were sustained at the 6-month follow-up.

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OBJECTIVES: Limited research exists that outlines the predictive relevance of the treatment components of prolonged exposure (PE) for post-traumatic stress disorder (PTSD) on PTSD and depression symptom outcomes. The goal of the present study was to investigate relations between participant completion of breathing retraining, in vivo exposure, and imaginal exposure exercises and symptom outcomes. METHODS: A total of 58 participants completed a trial of PE as part of a larger trial on peer involvement and treatment adherence. Diagnostic and self-report measures were completed throughout treatment. Participants also recorded weekly completion of breathing retraining, in vivo exposure, and imaginal exposure exercises. Pearson correlations and hierarchical regression analyses were used to investigate relations between average weekly treatment component completion and treatment outcomes, controlling for relevant variables. RESULTS: Although breathing retraining and in vivo exposures were associated with PTSD outcomes in the correlational findings, use of breathing retraining, in vivo exposures, and imaginal exposures were not reliably associated with PTSD symptom outcomes when controlling for other variables in the regression analysis. However, when investigating changes in comorbid symptoms of depression, greater use of breathing retraining was associated with decreased symptoms of depression at posttreatment. CONCLUSIONS: Present findings demonstrate the differential relations between participation in various PE treatment components and posttreatment symptom outcomes. The importance of breathing retraining in addressing comorbid depressive symptoms is discussed, with emphasis on potentially increasing relaxation and positive activities more broadly to encourage further treatment benefits.

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Recent studies indicated that Prolonged Exposure (PE) is safe and effective for posttraumatic stress disorder (PTSD). It is unclear whether PE also leads to a reduction in comorbid diagnoses. Data from a large randomized controlled trial (N = 149) on the effects of three variants of PE for PTSD were used. We examined the treatment effects on co-morbid diagnoses of depressive, anxiety, obsessive compulsive, substance abuse, psychotic, eating and personality disorders in a sample of patients with PTSD related to childhood abuse. Outcomes were assessed with clinical interviews at baseline, post-treatment and at 6- and 12-month follow-up. All variants of PE led to a decrease from baseline to post-treatment in diagnoses of depressive, anxiety, substance use and personality disorders. Improvements were sustained during follow-up. We found an additional decrease in the number of patients that fulfilled the diagnostic criteria of a depressive disorder between 6- and 12-month follow-up. No significant changes were observed for the presence of OCD, psychotic and eating disorders. Findings suggest that it is effective to treat PTSD related to childhood abuse with trauma-focused treatments since our 14-to-16 weeks PE for PTSD resulted in reductions in comorbid diagnoses of depressive, anxiety, substance use and personality disorders.

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Background: The impact of posttraumatic stress disorder (PTSD) is substantial and often results in pervasive functional impairments. Although evidence-based treatments for PTSD are established, there remains room for improvement as many individuals continue to meet diagnostic criteria even after successful treatment completion. Cannabidiol (CBD) has attracted considerable attention based on its potential to treat a myriad of health conditions. CBD may decrease anxiety and facilitate extinction learning processes, two critical targets of trauma-focused psychotherapies. We present the design and methods for a pilot randomized clinical trial to examine the combination of CBD and prolonged exposure for PTSD. Methods: Participants (n = 24) will be randomized to CBD or placebo for 18 days delivered in combination with ten daily prolonged exposure sessions over two weeks. The study medication will be Epidiolex® (250 mg BID). The PTSD Checklist for DSM-5 will be the primary outcome to assess PTSD severity at baseline, during treatment, and at 1-month follow-up. Blood, saliva, and heart rate will be collected during treatment to assess intervention effects on biological outcomes related to PTSD and the endocannabinoid system. Results: Consistent with the purpose of a pilot, our goals are to evaluate the feasibility of study procedures, safety of the intervention, and the preliminary effect of CBD to inform a larger trial. Descriptive and inferential statistics will be used to address study aims. Conclusion: Findings will inform decision making on combining CBD with behavioral interventions for PTSD to enhance outcomes and mitigate the morbidity of this debilitating condition.

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Background: Recent practice guidelines strongly recommend evidence-based psychotherapies (EBPs) as the first-line treatment for post-traumatic stress disorder (PTSD). However, previous studies found barriers to the implementation of EBPs and a relatively high dropout rate in clinical settings. After proving the efficacy of prolonged exposure (PE) in Japan [Asukai, N., Saito, A., Tsuruta, N., Kishimoto, J., & Nishikawa, T. (2010). Efficacy of exposure therapy for Japanese patients with posttraumatic stress disorder due to mixed traumatic events: A randomized controlled study. Journal of Traumatic Stress, 23(6), 744-750. https://doi.org/10.1002/jts.20589], we began implementing PE in a real-world clinical setting at the Victim Support Center of Tokyo (VSCT).Objective: We aimed to investigate the effectiveness and benefit of PE for crime-induced PTSD among VSCT clients and what causes dropout from treatment.Method: Of 311 adult clients who received counselling from clinical psychologists at VSCT due to violent or physical crime victimization from April 2008 through December 2019, 100 individuals received PE and participated in this study. Their PTSD symptoms were evaluated before and after treatment using the Impact of Event Scale-Revised and the Clinician-Administered PTSD Scale for DSM-IV.Results: A total of 93 participants completed PE and seven dropped out after six sessions or less. The completers group improved in PTSD symptoms with significant score differences between pre- and post-treatment in IES-R and CAPS-IV. Participants' symptoms did not exacerbate after treatment. Forty of 49 completers who left their workplace or college/school after victimization returned to work or study shortly after treatment. Compared to the completers, all dropout participants were women and younger. The majority were rape survivors, with significantly shorter intervals between victimization and treatment. The reasons for dropout were difficulty scheduling treatment between work/study schedules and manifestation of bipolar disorder or physical illness.Conclusions: PE can be implemented with significant effectiveness and a low dropout rate in a real-world clinical setting if advantages in the system and policies, local organizational context, fidelity support and patient engagement are fortified.

We conducted prolonged exposure (PE) with a low dropout rate for crime-induced PTSD in a non-Western real-world practice setting.Patient outcomes and low dropout rate of PE for PTSD in this study may be due to advantages in the following areas: system and policies, local organizational context, fidelity support and patient engagement.When introducing PE for PTSD, it is important to confirm that patients can be reasonably engaged with PE, and to carefully assess the status of other psychiatric and physical illnesses.

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OBJECTIVE: Changes in trauma-related beliefs and therapeutic alliance have been found to temporally precede symptom reduction; however, it is likely these processes do not act in isolation but rather in interactive ways. METHODS: The present study examined the temporal relationships between negative posttraumatic cognitions (PTCI) and therapeutic alliance (WAI) in 142 patients who were part of a randomized trial comparing prolonged exposure (PE) to sertraline for chronic PTSD. RESULTS: Using time-lagged mixed regression models, improvements in the therapeutic alliance predicted subsequent improvements in trauma-related beliefs (d = 0.59), an effect accounted for by between-patient variability (d = 0.64) compared to within-patient variability (d = .04) giving weaker support to the causal role of alliance on outcome. Belief change did not predict improvements in alliance and neither model was moderated by treatment type. CONCLUSION: Findings suggest alliance may not be an independent driver of cognition change and point to the need for additional study of the impact of patient characteristics on treatment processes.

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OBJECTIVE: Substance use disorders (SUDs) and posttraumatic stress disorder (PTSD) are costly and highly co-occurring diagnoses, particularly among veterans, suggesting a need to understand this comorbidity and effectively treat both disorders among this population. METHODS: The current study aimed to examine substance use outcomes among post-9/11 veterans and service members (N = 48) who completed a two-week intensive outpatient program with concurrent treatment for and PTSD using Prolonged Exposure and substance use. Substance use was assessed at two weeks and three months posttreatment. RESULTS: The intensive program had high completion rates and demonstrated decreases in substance use at two weeks and three months posttreatment. Additionally, lower PTSD symptoms at treatment completion were related to less substance use posttreatment. CONCLUSIONS: Concurrent intensive treatment of PTSD and SUDs can lead to symptom improvement in a short period of time. Findings support the self-medication model, such that PTSD symptoms at treatment completion were related to substance use at follow-up.

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