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Introduction: Children and adolescents, after natural and man-made disasters, often exhibit various psychological, emotional, and behavioral issues, showing a range of clinical symptoms related to post-traumatic stress disorder (PTSD) and depression. This review used a network meta-analysis (NMA) approach to compare and rank psychological interventions for PTSD and depression in children and adolescents after exposure to natural and man-made disasters. Methods: Randomized studies of psychosocial interventions for PTSD and depression in children and adolescents exposed to natural and man-made disasters were identified. PTSD and depression symptoms at postintervention and 1–12 month follow-up are the outcomes. The standardized mean differences (SMDs) between pairs of interventions at postintervention and follow-up were pooled. Mean effect sizes with 95% credible intervals (CI) were calculated, and the ranking probabilities for all interventions were estimated using the surface under the cumulative ranking curve. Study quality was assessed with version 2 of the Cochrane risk-of-bias tool for randomized trials (RoB 2). Results: In total, 26 studies with 4331 participants were included in this NMA. Eye movement desensitization and reprocessing therapy (EMDR) (SMD = − 0.67; 95% CI − 1.17 to − 0.17), exposure therapy (ET) (SMD = − 0.66; 95% CI − 1.11 to − 0.22), and cognitive behavioral therapy (CBT) (SMD = − 0.62; 95% CI − 0.90 to − 0.34) were significantly more effective for PTSD at postintervention than inactive intervention. EMDR (SMD = − 0.72; 95% CI − 1.11 to − 0.33) and ET (SMD = − 0.62; 95% CI − 0.97 to − 0.27) were associated with a higher reduction in PTSD symptoms at follow-up than inactive intervention. EMDR (SMD = − 0.40; 95% CI − 0.78 to − 0.03) and play therapy (PT) (SMD = − 0.37; 95% CI − 0.62 to − 0.12) were significantly more effective for depression at postintervention than inactive intervention. For all psychological interventions in reducing depression symptoms at follow-up compared with inactive intervention, the differences were not significant. Conclusion: EMDR appears to be most effective in reducing PTSD and depression in children and adolescents exposed to natural and man-made disasters. In addition, ET and CBT are potentially effective in reducing PTSD symptoms at postintervention, while PT is beneficial in managing depression symptoms at the treatment endpoint. [ABSTRACT FROM AUTHOR]

Background: Preliminary evidence shows promising treatment outcomes at short-term follow-up for intensive posttraumatic stress disorder (PTSD) treatment, but long-term follow-up studies are sparse. This study is a sequel to a previous pilot study and open trial, set out to investigate treatment outcomes at 12-month follow-up for outpatients completing an 8-day intensive treatment for PTSD. Methods: All patients were diagnosed with PTSD and had multiple previous psychotherapy attempts (M = 3.1). Patients were assessed at pre-treatment, post-treatment, 3- and 12-month follow-up. Of 35 treated patients, 32 (91.4%) attended the long-term follow-up assessment. The treatment programme combined prolonged exposure therapy, eye movement desensitization and reprocessing, and physical activity. Results: The effect sizes indicated large reductions in symptoms of PTSD, depression, anxiety, interpersonal problems, and well-being. Changes in functioning showed a small-medium effect. Results were stable across the follow-up period. The treatment response rates showed that 46–60% of patients achieved recovery with respect to PTSD symptoms, and that 44–48% no longer met diagnostic criteria for PTSD. Conclusions: Time-limited and concentrated outpatient treatment for PTSD can yield large and enduring positive outcomes. Controlled trials are needed to establish relative efficacy. Trial registration: The study was registered in Current Research Information System In Norway (Cristin). Cristin-project-ID: 654,790. Date of registration: 18.03.2019. [ABSTRACT FROM AUTHOR]

Background: There is ongoing debate regarding the treatment of severe and multiple traumatized children and adolescents with post-traumatic stress disorder (PTSD). Many clinicians favor a phase-based treatment approach (i.e., a stabilization phase prior to trauma-focused therapy) over immediate trauma-focused psychological treatment, despite the lack of scientific evidence. Research on the effects of different treatment approaches is needed for children and adolescents with (symptoms of complex) PTSD resulting from repeated sexual and/or physical abuse during childhood. Objective: This paper describes the rationale, study design, and methods of the MARS-study, a two-arm randomized controlled trial (RCT) that aims to compare the results of phase-based treatment with those of immediate trauma-focused treatment and determine whether immediate trauma-focused treatment is not worse than phase-based treatment in reducing PTSD symptoms. Methods: Participants are individuals between 12 and 18 years who meet the diagnostic criteria for PTSD due to repeated sexual abuse, physical abuse, or domestic violence during childhood. Participants will be blindly allocated to either the phase-based or immediate trauma-focused treatment condition. In the phase-based treatment condition, participants receive 12 sessions of the Dutch version of Skill Training in Affective and Interpersonal Regulation (STAIR-A), followed by 12 sessions of EMDR therapy. In the immediate trauma-focused condition, the participants receive 12 sessions of EMDR therapy. The two groups are compared for several outcome variables before treatment, mid-treatment (only in the phase-based treatment condition), after 12 trauma-focused treatment sessions (post-treatment), and six months post-treatment (follow-up). The main parameter is the presence and severity of PTSD symptoms (Clinician-Administered PTSD Scale for Children and Adolescents, CAPS-CA). The secondary outcome variables are the severity of complex PTSD symptoms (Interpersonal Problems as measured by the Experiences in Close Relationship-Revised, ECR-RC; Emotion Regulation as measured by the Difficulties in Emotion Regulation Scale, DERS; Self Esteem as measured by the Rosenberg Self Esteem Scale, RSES), changes in anxiety and mood symptoms (Revised Anxiety and Depression Scale; RCADS), changes in posttraumatic cognitions (Child Posttraumatic Cognitions Inventory, CPTCI), changes in general psychopathology symptoms (Child Behavior Checklist, CBCL), and Quality of Life (Youth Outcome Questionnaire, Y-OQ-30). Furthermore, parental stress (Opvoedingsvragenlijst, OBVL) and patient-therapist relationship (Feedback Informed Treatment, FIT) will be measured, whereas PTSD symptoms will be monitored in each session during both treatment conditions (Children's Revised Impact of Event Scale, CRIES-13). Discussion: Treating (symptoms of complex) PTSD in children and adolescents with a history of repeated sexual and/or physical abuse during childhood is of great importance. However, there is a lack of consensus among trauma experts regarding the optimal treatment approach. The results of the current study may have important implications for selecting effective treatment options for clinicians working with children and adolescents who experience the effects of exposure to multiple interpersonal traumatic events during childhood. Trial registrations: The study was registered on the "National Trial Register (NTR)" with the number NTR7024. This registry was obtained from the International Clinical Trial Registry Platform (ICTRP) and can be accessed through the ICTRP Search Portal (https://trialsearch.who.int/). [ABSTRACT FROM AUTHOR]

Background: Exposure-based therapy is the treatment of choice for anxiety disorders, but many patients do not benefit sufficiently from it. Distressing images of threat related to the future or past may maintain the anxiety symptomatology or impede exposure therapy. An intervention that targets threat-related imagery is eye movement desensitization and reprocessing (EMDR) therapy. The main goal of this multicenter randomized controlled trial is to investigate whether EMDR therapy plus exposure therapy, relative to supportive counseling plus exposure therapy, improves treatment efficacy, tolerability, and adherence in patients with panic disorder. In addition, we will examine potential predictors of optimal treatment allocation, mechanisms of change as well as the long term effects of treatment. Finally, we will assess cost-effectiveness. Methods: A multicenter randomized controlled trial mixed design will be conducted. Participants will be 50 patients, aged ≥ 18, diagnosed with a panic disorder. They will be randomly assigned to one of two conditions: EMDR therapy (i.e., flashforward strategy) or supportive counseling (each consisting of four weekly sessions of 90 min each) prior to exposure therapy (consisting of eight weekly sessions of 90 min each). Assessments will be made pre-treatment (T1), between-treatments (T2), post-treatment (T3), one month post-treatment (FU1) and six months post-treatment (FU2) by an assessor blind to treatment condition. The primary outcome measure is severity of panic-related symptoms. Secondary outcome measures are: tolerability of exposure therapy (initial avoidance, willingness to start exposure therapy, considered drop-out; no-show and drop-out), related symptomatology (generalized anxiety, depression), and functional impairment. Discussion: The primary goals of this research are to compare the efficacy, tolerability, and adherence of EMDR therapy plus exposure therapy and supportive counseling plus exposure therapy and to identify predictors, moderators, and mediators for treatment success. This multi-center research aims to make a significant contribution to our understanding as to how treatment for patients with anxiety disorders can be optimized, and elucidate who can benefit most from this novel approach. Trial registration: ISRCTN—ISRCTN29668369: Improving anxiety treatment by modifying emotional memories before real-life exposure. Registered 27 June 2022—retrospectively registered. ISRCTN—ISRCTN29668369. [ABSTRACT FROM AUTHOR]

Background: Major depressive disorder (MDD) is a common, recurrent mental disorder and a leading cause of disability worldwide. A large part of adult MDD patients report a history of childhood trauma (CT). Patients with MDD and CT are assumed to represent a clinically and neurobiologically distinct MDD subtype with an earlier onset, unfavorable disease course, stress systems' dysregulations and brain alterations. Currently, there is no evidence-based treatment strategy for MDD that specifically targets CT. Given the central role of trauma in MDD patients with CT, trauma-focused therapy (TFT), adjunctive to treatment as usual (TAU), may be efficacious to alleviate depressive symptoms in this patient population. Methods: The RESET-psychotherapy study is a 12-week, single-blind, randomized controlled trial testing the efficacy of TFT in 158 adults with moderate to severe MDD, as a 'stand-alone' depression diagnosis or superimposed on a persistent depressive disorder (PDD), and CT. TFT (6–10 sessions of Eye Movement Desensitization and Reprocessing and/or imagery rescripting) + TAU is compared to TAU only. Assessments, including a wide range of psychological/psychiatric and biological characteristics, take place before randomization (T0), during treatment (T1), at post-treatment (T2) and at 6-month follow-up (T3). Pre-post treatment stress-related biomarkers in hair (cortisol) and blood (epigenetics and inflammation) will be assessed to better understand working mechanisms of TFT. A subgroup of 60 participants will undergo structural and functional Magnetic Resonance Imaging (MRI) assessments to determine pre-post treatment brain activity. The primary outcome is self-reported depression symptom severity at post-treatment, measured with the 30-item Inventory of Depressive Symptomatology – Self Report (IDS-SR). Discussion: If adjunctive TFT efficaciously alleviates depressive symptoms in MDD patients with CT, this novel treatment strategy could pave the way for a more personalized and targeted MDD treatment. Trial registration: ClinicalTrials.gov, registered at 08–12-2021, number of identification: NCT05149352. [ABSTRACT FROM AUTHOR]

Background: Emotion regulation (ER) is a key process underlying posttraumatic stress disorder (PTSD), yet, little is known about how ER changes with PTSD treatment. Understanding these effects may shed light on treatment processes. Methods: We recently completed a non-inferiority design randomised controlled trial demonstrating that a breathing-based yoga practice (Sudarshan kriya yoga; SKY) was not clinically inferior to cognitive processing therapy (CPT) across symptoms of PTSD, depression, or negative affect. Here, in secondary exploratory analyses (intent-to-treat N = 85; per protocol N = 59), we examined whether self-reported ER (Difficulties in Emotion Regulation Scale; DERS) and physiological ER (heart rate variability; HRV) improved with treatment for clinically significant PTSD symptoms among US Veterans. Results: DERS-Total and all six subscales improved with small-to-moderate effect sizes (d =.24–.66) following CPT or SKY, with no differences between treatment groups. Following SKY (but not CPT), HR max–min (average difference between maximum and minimum beats per minute), LF/HF (low-to-high frequency) ratio, and normalised HF-HRV (high frequency power) improved (moved towards a healthier profile; d =.42–.55). Conclusions: To our knowledge, this is the first study to demonstrate that a breathing-based yoga (SKY) improved both voluntary/intentional and automatic/physiological ER. In contrast, trauma-focused therapy (CPT) only reliably improved self-reported ER. Findings have implications for PTSD treatment and interventions for emotional disorders more broadly. Trial registration: Secondary analyses of ClinicalTrials.gov NCT02366403. [ABSTRACT FROM AUTHOR]

Background: Trauma-focused psychotherapies for combat-related posttraumatic stress disorder (PTSD) in military veterans are efficacious, but there are many barriers to receiving treatment. The objective of this study was to determine if cognitive processing therapy (CPT) for PTSD among active duty military personnel and veterans would result in increased acceptability, fewer dropouts, and better outcomes when delivered In-Home or by Telehealth as compared to In-Office treatment. Methods: The trial used an equipoise-stratified randomization design in which participants (N = 120) could decline none or any 1 arm of the study and were then randomized equally to 1 of the remaining arms. Therapists delivered CPT in 12 sessions lasting 60-min each. Self-reported PTSD symptoms on the PTSD Checklist for DSM-5 (PCL-5) served as the primary outcome. Results: Over half of the participants (57%) declined 1 treatment arm. Telehealth was the most acceptable and least often refused delivery format (17%), followed by In-Office (29%), and In-Home (54%); these differences were significant (p = 0.0008). Significant reductions in PTSD symptoms occurred with all treatment formats (p <.0001). Improvement on the PCL-5 was about twice as large in the In-Home (d = 2.1) and Telehealth (d = 2.0) formats than In-Office (d = 1.3); those differences were statistically large and significant (d = 0.8, 0.7 and p = 0.009, 0.014, respectively). There were no significant differences between In-Home and Telehealth outcomes (p = 0.77, d = −.08). Dropout from treatment was numerically lowest when therapy was delivered In-Home (25%) compared to Telehealth (34%) and In-Office (43%), but these differences were not statistically significant. Conclusions: CPT delivered by telehealth is an efficient and effective treatment modality for PTSD, especially considering in-person restrictions resulting from COVID-19. Trial registration: ClinicalTrials.gov ID NCT02290847 (Registered 13/08/2014; First Posted Date 14/11/2014). [ABSTRACT FROM AUTHOR]

Background: Mass outbreaks such as pandemics are associated with mental health problems requiring effective psychological interventions. Although several forms of psychological interventions may be advocated or used, some may lack strong evidence of efficacy and some may not have been evaluated in mass infectious disease outbreaks. This paper reports a systematic review of published studies (PROSPERO CRD:42020182094. Registered: 24.04.2020) examining the types and effectiveness of psychological support interventions for the general population and healthcare workers exposed to mass infectious disease outbreaks. Methods: A systematic review was conducted. Randomised Controlled Trials (RCT) were identified through searches of electronic databases: Medline (Ovid), Embase (Ovid), PsycINFO (EBSCO) and the Cochrane Library Database from inception to 06.05.2021 using an agreed search strategy. Studies were included if they assessed the effectiveness of interventions providing psychological support to the general population and / or healthcare workers exposed to mass infectious disease outbreaks. Studies were excluded if they focused on man-made or natural disasters or if they included armed forces, police, fire-fighters or coastguards. Results: Twenty-two RCTs were included after screening. Various psychological interventions have been used: therapist-guided therapy (n = 1); online counselling (n = 1); 'Emotional Freedom Techniques' (n = 1); mobile phone apps (n = 2); brief crisis intervention (n = 1); psychological-behavioural intervention (n = 1); Cognitive Behavioural Therapy (n = 3); progressive muscle relaxation (n = 2); emotional-based directed drawing (n = 1); psycho-educational debriefing (n = 1); guided imagery (n = 1); Eye Movement Desensitization and Reprocessing (EMDR) (n = 1); expressive writing (n = 2); tailored intervention for patients with a chronic medical conditions (n = 1); community health workers (n = 1); self-guided psychological intervention (n = 1), and a digital behaviour change intervention (n = 1). Meta-analyses showed that psychological interventions had a statistically significant benefit in managing depression (Standardised Mean Difference [SMD]: -0.40; 95% Confidence Interval [CI]: − 0.76 to − 0.03), and anxiety (SMD: -0.72; 95% CI: − 1.03 to − 0.40). The effect on stress was equivocal (SMD: 0.16; 95% CI: − 0.19 to 0.51). The heterogeneity of studies, studies' high risk of bias, and the lack of available evidence means uncertainty remains. Conclusions: Further RCTs and intervention studies involving representative study populations are needed to inform the development of targeted and tailored psychological interventions for those exposed to mass infectious disease outbreaks. [ABSTRACT FROM AUTHOR]

Background: In addition to having a negative impact on the physical and emotional health of the population, the global Covid–19 pandemic has necessitated psychotherapists moving their practice to online environments. This service evaluation examines the efficacy of Eye Movement Desensitization and Reprocessing (EMDR) Therapy delivered via the internet. Methods: A real–world service evaluation was conducted from a self–selecting group of EMDR therapists that subscribe to either a JISCMail discussion list or either the UK or All Ireland National EMDR Associations. Author designed questionnaires were used to gather information on the efficacy of EMDR delivered online as well as client and therapist characteristics. Results: Thirty-three therapists provided efficacy data on a total of 93 patients. Statistically significant and clinically meaningful reductions were found in all four-psychometrics used both in adult and children and young people populations. Client outcome was not related to therapist experience. Conclusions: EMDR delivered via the internet can be an effective treatment for clients experiencing mental health issues. [ABSTRACT FROM AUTHOR]

Background: Posttraumatic stress disorder (PTSD) and substance use disorder (SUD) have high comorbidity. Although prior research indicated that PTSD can effectively be treated with Prolonged Exposure (PE) in these patients, reported effects are small and treatment dropout rates high. Eye Movement Desensitization and Reprocessing (EMDR) and Imagery Rescripting (ImRs) are other promising treatment options for PTSD, that have not yet been examined in this patient group. Furthermore, it is unclear whether PTSD treatment is most effective when offered simultaneous to or after SUD treatment. Methods: In this article, the Treatment Of PTSD and Addiction (TOPA) study is described: a Dutch randomized controlled trial (RCT) that studies the effectiveness of PTSD treatment as an add-on to regular SUD treatment in patients with SUD and co-occurring PTSD. Effects of PE, EMDR, ImRs, and a 3-month SUD treatment only condition will be compared, as well as simultaneous SUD/PTSD treatment to sequential SUD/PTSD treatment. The primary outcome measure is PTSD symptoms. Secondary outcomes are: treatment completion, psychological distress, substance use, interpersonal problems, emotion dysregulation, and trauma-related emotions guilt, shame, and anger. Discussion: This study is the first to compare effects of PE, EMDR, and ImRs in one study and to compare simultaneous SUD/PTSD treatment to sequential SUD/PTSD treatment as well. This RCT will provide more knowledge about the effectiveness of different treatment strategies for PTSD in patients with co-occurring SUD and will ultimately improve treatment outcomes for patients with this common co-morbidity worldwide. Trial registration: Netherlands Trial Register (NTR), Identifier: NL7885. Registered 22 July 2019. [ABSTRACT FROM AUTHOR]

Background: Traumatic stress is a global mental health problem requiring novel, easily implemented treatment solutions. We compared the effectiveness and efficiency of Reconsolidation Therapy (RT) to the well-established antidepressant paroxetine, in reducing symptoms of traumatic stress among patients from Nepal, a low-income country. Methods: Forty-six adults with posttraumatic stress disorder (PTSD) were randomized to one of two groups. The reconsolidation blocker propranolol was administered 90 min before briefly recalling a traumatic memory with a therapist, weekly for six consecutive weeks. This was compared to daily paroxetine for 26 weeks. Self-reported PTSD symptoms were assessed blindly at the 7th, 13th, and 26th weeks. Results: An intent-to-treat analysis revealed a robust pre- to post-treatment main effect (β1 = − 4.83, 95% CI = [− 5.66, − 4.01], p <.001), whereby both groups improved, with Cohen's effect sizes of d = 2.34 (95% CI = [1.57, 3.12]) for paroxetine, and of 2.82 (95% CI = [1.98, 3.66]) for RT after 7 weeks, suggesting treatment effectiveness for both groups in a real-world setting. Three and six-month follow-up yielded further significant improvement in both groups, which did not differ from each other. Conclusion: RT also displayed promising efficiency, considering that it had been discontinued weeks earlier while the paroxetine treatment was continued, as recommended. RT could be taught in low-income countries as part of the local therapeutic resources to treat the core symptoms of PTSD, provided that such results are replicated on a broader scale. Trial registration: ISRCTN34308454 (11/10/2017). [ABSTRACT FROM AUTHOR]

Background: Comorbidity between Posttraumatic Stress Disorder (PTSD) and Borderline Personality Disorder (BPD) is high. There is growing motivation among clinicians to offer PTSD treatments – such as Eye Movement Desensitization and Reprocessing (EMDR) - to patients with PTSD and comorbid BPD. However, a large subgroup with comorbid BPD does not sufficiently respond to PTSD treatment and is more likely to be excluded or to dropout from treatment. Dialectical Behaviour Therapy (DBT) for BPD is well established and although there is some evidence that DBT combined with DBT Prolonged Exposure (DBT + DBT PE) is twice as effective in reducing PTSD symptoms than DBT alone, the comparative efficacy of integrated PTSD-DBT and PTSD-only treatment has not been investigated yet. The current study will therefore evaluate the comparative clinical efficacy and cost-effectiveness of EMDR-DBT and EMDR-only in patients with PTSD and comorbid (sub)clinical BPD. Moreover, it is not clear yet what treatment works best for which individual patient. The current study will therefore evaluate neurobiological predictors and mediators of the individual response to treatment. Method: A randomized controlled trial comparing the clinical efficacy and cost-effectiveness of integrated EMDR-DBT (n = 63) and EMDR-only (n = 63) in treatment-seeking adult patients with PTSD and comorbid (sub)clinical BPD. In addition, neurobiological predictors and mediators of treatment outcome, such as hair cortisol, FKBP5 and BDNF protein levels and FKBP5 and BDNF methylation status, are measured through hair and blood samples. Discussion: This is the first study to compare the clinical efficacy and cost-effectiveness of integrated EMDR-DBT and EMDR-only in patients with PTSD and comorbid (sub)clinical BPD, while simultaneously identifying individual predictors and mediators of treatment response. Results will reveal which treatment works best for which individual patient, thereby guiding individual treatment choices and personalizing psychiatry. Trial registration: Clinical Trials, NCT03833453. Retrospectively registered, 15 March 2019. [ABSTRACT FROM AUTHOR]

Background: Most patients with Posttraumatic Stress Disorder (PTSD) suffer residual symptoms following first-line treatment. Oxidative stress has been implicated in the pathophysiology of PTSD. N-acetylcysteine (NAC) is a precursor of the brain's primary antioxidant, glutathione, and may diminish oxidative cellular damage. An 8-week pilot study of NAC in veterans with PTSD found that symptoms were significantly reduced in the NAC group compared to placebo. This study aims to confirm these findings with a larger sample in a double-blind, placebo-controlled trial to further explore the efficacy of NAC as an adjunctive therapy in treatment-resistant PTSD. Methods: A multicentre, randomised, double-blind, placebo-controlled trial for adult patients who still meet criteria for PTSD following first-line treatment. The intervention comprises either NAC as a fixed dose regime of 2.7 g/day (900 mg three times daily) administered orally for 12 weeks, or placebo. Standard care for PTSD will continue in addition, including other pharmacotherapies. Detailed clinical data will be collected at randomisation and weeks 4, 8, 12, 16, and 64 post-randomisation, with self-report measures completed weekly from baseline to 16 weeks and at 64 weeks post-randomisation. Blood-based biomarkers will be collected at baseline and 12 weeks to assess the mechanism of effect. The primary outcome measure will be change in Clinician-Administered PTSD Scale for DSM-5 at 12 weeks compared with baseline. Secondary outcomes will be change in quality of life, depression, anxiety, substance use and craving, and somatic symptoms. With 126 completed participants (63 per arm), the study is powered at 80% to detect a true difference in the primary outcome measure using a two-tailed analysis with alpha = 0.05, beta = 0.2. Discussion: This is the first multicentre, double blind, randomised, placebo-controlled trial of adjunctive NAC for treatment-resistant PTSD. NAC has an established safety profile, is readily available and easy to administer, and has a favourable tolerability profile, therefore making it an attractive adjunctive therapy. Inclusion of blood analyses to assess potential target engagement biomarkers of oxidative stress and neuroinflammation may help gauge the biological mechanisms of effect of NAC. Trial registration: ACTRN12618001784202, retrospectively registered 31/10/2018, URL: http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376004. [ABSTRACT FROM AUTHOR]

Background: Eye Movement Desensitization and Reprocessing (EMDR) is an evidence-based treatment for PTSD. However, it is unclear whether EMDR shows the same effectiveness in patients with substance use disorders (SUD) and comorbid PTSD. In this trial, we examine the effectiveness of EMDR in reducing PTSD symptoms in patients with SUD and PTSD. Methods/Design: We conduct a single-blinded RCT among 158 patients with SUD and comorbid PTSD admitted to a German addiction rehabilitation center specialized for the treatment of patients with SUD and comorbid PTSD. Patients are randomized to receive either EMDR, added to SUD rehabilitation and non-trauma-focused PTSD treatment (TAU), or TAU alone. The primary outcome is change from baseline in PTSD symptom severity as measured by the Clinician-Administered PTSD Scale at 6-month follow-up. Secondary outcomes are change from baseline in substance use, addiction-related problems, depressive symptoms, dissociative symptoms, emotion dysregulation and quality of life. Assessments are carried out by blinded raters at admission, at end of treatment, and at 3- and 6-month follow-up. We expect that EMDR plus TAU will be more effective in reducing PTSD symptoms than TAU alone. Mixed models will be conducted using an intention-to-treat and per-protocol approach. Discussion: This study aims to expand the knowledge about the effectiveness of EMDR in patients with SUD and comorbid PTSD. The expected finding of the superiority of EMDR in reducing PTSD symptoms compared to non-trauma-focused PTSD treatment may enhance the use of trauma-focused treatment approaches for patients with SUD and co-morbid PTSD. [ABSTRACT FROM AUTHOR]

Background: Addiction constitutes a major public health problem, and despite treatment, relapse rates remain very high. Preliminary findings suggest that Eye Movement Desensitization and Reprocessing (EMDR), an evidence-based treatment for PTSD, may also reduce craving and relapse rates when applied in substance abuse. This study aims to determine the feasibility, efficacy and effectiveness of EMDR when added to treatment as usual (TAU) for addiction in alcohol dependent outpatients, compared to TAU only. Methods/Design: A single blinded study in which 100 adult patients with a primary DSM-IV-TR diagnosis of alcohol dependence or abuse receiving treatment in one of six Dutch outpatient addiction care facility sites, will be enrolled. After baseline assessment participants will be allocated to one of two treatment conditions (allocation ratio of 1:1) using a stratified (per site, per care pathway), blocked randomization procedure. The intervention consists of EMDR (seven weekly 90 minute sessions) + TAU or TAU only. Assessments are scheduled pre-treatment (t0), post-treatment (t0 + eight weeks), and one and six months post treatment. The effects of both treatment arms are compared on indices of (a) drinking behavior, (b) mediators, moderators and predictors of treatment outcome, (c) quality of life and d) safety, acceptability and feasibility of treatment. Repeated measures ANOVA's will be conducted using an intention-to-treat and per-protocol approach. Multiple imputation will be used to deal with missing values when possible. Discussion: This study adapts and extends the standard EMDR treatment for traumatized patients for use with patients with alcohol use disorders without psychological trauma. [ABSTRACT FROM AUTHOR]