Trial Of Psychotherapy Research Articles

Moving psychedelic-assisted therapies from promising research into routine clinical practice: Lessons from the field of implementation science.

Psychedelics (e.g., 3,4-Methylenedioxymethamphetamine [MDMA], lysergic acid diethylamide [LSD], psilocybin) are molecules that have the potential to produce rapid therapeutic effects when paired with psychotherapy. Randomized clinical trials of psychedelic-assisted psychotherapy (PAT) have shown promising results for post-traumatic stress disorder (PTSD), depression, and substance use disorders. The U.S. Food and Drug Administration has acknowledged the promise of PAT, signaling potential approval of psilocybin-assisted therapy for depression by 2026. Given this timeline, implementation scientists must engage with PAT researchers, policymakers, and practitioners to think critically about bringing these promising new treatments into routine practice settings while maintaining quality and safety. This commentary aims to initiate a dialogue between implementation scientists and PAT researchers and practitioners on addressing these questions with a lens toward equity. Specifically, we discuss how the field of implementation science can support PAT stakeholders to accelerate the translational process from research into practice, focusing specifically on safety-net settings (i.e., Federally Qualified Health Centers and Veterans Affairs health systems) that serve historically marginalized populations. We use the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) Framework to illustrate five critical areas where implementation science can help move PAT from research into real-world practice. For each RE-AIM dimension, we highlight ways the field of implementation science can contribute tools (e.g., implementation strategies), methodologies (e.g., pragmatic hybrid implementation-effectiveness trials), and approaches (community-based participatory research) for establishing the safety, effectiveness, and accessibility of PAT for historically underserved communities.

Suicidal Ideation and Suicide Attempts After Direct or Indirect Psychotherapy

Suicidal ideation and suicide attempts are debilitating mental health problems that are often treated with indirect psychotherapy (ie, psychotherapy that focuses on other mental health problems, such as depression or personality disorders). The effects of direct and indirect psychotherapy on suicidal ideation have not yet been examined in a meta-analysis, and several trials have been published since a previous meta-analysis examined the effect size of direct and indirect psychotherapy on suicide attempts. To investigate the effect sizes of direct and indirect psychotherapy on suicidal ideation and the incidence of suicide attempts. PubMed, Embase, PsycInfo, Web of Science, Scopus, and the Cochrane Central Register of Controlled Trials were searched for articles published up until April 1, 2023. Randomized clinical trials of psychotherapy for any mental health problem, delivered in any setting, compared with any control group, and reporting suicidal ideation or suicide attempts were included. Studies measuring suicidal ideation with 1 item were excluded. PRISMA guidelines were followed. Summary data were extracted by 2 independent researchers and pooled using 3-level meta-analyses. Hedges g was pooled for suicidal ideation and relative risk (RR) was pooled for suicide attempts. Of 15 006 studies identified, 147 comprising 193 comparisons and 11 001 participants were included. Direct and indirect psychotherapy conditions were associated with reduced suicidal ideation (direct: g, -0.39; 95% CI, -0.53 to -0.24; I2, 83.2; indirect: g, -0.30; 95% CI, -0.42 to -0.18; I2, 52.2). Direct and indirect psychotherapy conditions were also associated with reduced suicide attempts (direct: RR, 0.72; 95% CI, 0.62 to 0.84; I2, 40.5; indirect: RR, 0.68; 95% CI, 0.48 to 0.95; I2, 0). Sensitivity analyses largely confirmed these results. Direct and indirect interventions had similar effect sizes for reducing suicidal ideation and suicide attempts. Suicide prevention strategies could make greater use of indirect treatments to provide effective interventions for people who would not likely seek treatment for suicidal ideation or self-harm.

The alliance–outcome relationship in individual psychotherapy for early psychosis: a secondary analysis of a randomized clinical trial

ABSTRACT Background Studies of the alliance–outcome relationship in psychosocial treatments for early psychosis are limited both in number and design, with few utilizing subjective measures as outcomes, multiple alliance timepoints or existing benchmarks to distinguish high or low levels of the alliance. We addressed these gaps in the context of a pilot randomized controlled psychotherapy trial for early psychosis. Methods Twenty-eight clients with early psychosis completed alliance ratings at mid-treatment (4.5 months) and post-treatment (9 months). We tested the alliance–outcome relationship through change scores between mid- and post-treatment and the use of a pre-defined benchmark to distinguish high versus low mid-treatment alliance. We also examined baseline differences between levels of the alliance. Outcomes included objective and subjective targets. Results Change in the alliance did not predict any outcomes at post-treatment. Clients with high mid-treatment alliance had lower perceived stress and higher psychological well-being at post-treatment. At baseline, clients with high alliance had lower negative symptoms and loneliness as well as higher community functioning and well-being. Discussion Use of an empirical alliance benchmark may help identify early psychosis clients who need additional support in alliance formation as well as facilitate positive psychotherapy outcomes

A Systematic Review of Antidepressants and Psychotherapy Commonly Used in the Treatment of Late Life Depression for Their Effects on Cognition

Cognitive dysfunction is common in late life depression (LLD) and is a major risk factor for dementia. Recent studies show limited improvement in cognition with commonly employed treatments for LLD, contradicting the notion that cognition "returns to normal" with treatment. However, findings differ with the treatments used. The aim of this study is to perform a systematic review of studies of antidepressants and psychotherapies commonly employed in LLD to determine their effects on cognition, particularly processing speed, memory, and executive function. We searched for trials of acute phase treatment, in nondemented individuals 60 years and older with unipolar nonpsychotic Major Depressive Disorder, that assessed cognitive performance with neuropsychological tests before and after treatment. We compared the magnitude of change in cognition by examining within group effect sizes. Six antidepressant trials and two psychotherapy trials (both using Problem Solving Therapy)(PST) provided relatively comparable data that allowed for quantitative comparison. Nine other antidepressant trials provided descriptive findings. Sertraline and vortioxetine had significant positive effects on processing speed and memory. Duloxetine had significant effects on memory. The most selective SRIs-citalopram and escitalopram-had minimal effects on cognition and citalopram had adverse effects in depression nonresponders. PST had modest effects on processing speed and no effect on memory. Effects of practice and improvement in depression on cognition are examined. In all but one study, cognition was a secondary outcome and various quality indicators (e.g. blinding cognitive assessment to treatment) were often not reported. As a consequence, these findings must be considered preliminary.

Prolonged exposure for posttraumatic stress disorder following spinal cord injury: A randomized controlled trial.

Individuals with a spinal cord injury (SCI) may experience posttraumatic stress disorder (PTSD) at a higher rate, which is associated with worse psychiatric comorbidity, decreased quality of life, and greater disability. Yet, effective PTSD interventions remain understudied for individuals with SCI. We conducted the first randomized controlled trial (RCT) of an evidence-based psychotherapy (prolonged exposure [PE]) with survivors of SCI during acute rehabilitation. We examined the efficacy, feasibility, and secondary outcomes. Participants (n = 29) were adults recruited from 2018 to 2021 1-month postinjury with PTSD randomized into either PE therapy or treatment as usual. The primary outcome was PTSD assessed at baseline, 6, 10, and 32 weeks postenrollment. An overall group-by-time interaction was not statistically significant (p = .102), but effect sizes demonstrated moderate and large improvements in PTSD for the PE group at 6 (-19.4 vs. -9.7) and 10 (-25.8 vs. -5.7), respectively. Similarly, moderate to large effect sizes were observed for depression, maladaptive posttraumatic cognitions, disruptive nocturnal behaviors, SCI-related quality of life, and risky alcohol consumption. Low rates of enrollment (50%) and treatment completion (25%) suggest feasibility challenges; however, treatment completers did report high satisfaction (100%). Results suggest that individuals who received PE had a quicker and clinically meaningful reduction in PTSD symptoms, but delivery during acute rehabilitation is not feasible for many individuals. Future research should examine abbreviated versions of PE for PTSD to enhance the feasibility of treatment in this setting. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Including Sexually and Gender Diverse Populations in 3,4-Methylenedioxymethamphetamine-Assisted Psychotherapy Trial Research.

Sexually and gender diverse (SGD) populations experience an increased prevalence and severity of posttraumatic stress disorder (PTSD) compared with the general population. Minority stress theory contextualizes this increased disease burden by outlining how stigma and discrimination (e.g., homophobia and transphobia) contribute to worse mental health outcomes. The standard-of-care pharmacotherapy for PTSD is associated with significant treatment resistance. 3,4-Methylenedioxymethamphetamine (MDMA)-assisted psychotherapy (MDMA-AP) has emerged as an investigational treatment for PTSD but has lacked consideration for SGD populations. This article explores next steps in clinical trial design and implementation for the study of MDMA-AP with SGD populations who have PTSD.

Halifax somatic symptom disorder trial: A pilot randomized controlled trial of intensive short-term dynamic psychotherapy in the emergency department

BackgroundPatients commonly present at hospital Emergency Departments (ED) with distress that meet criteria for a Somatic Symptom and Related Disorder (SSRD). Without access to effective treatment, risk of ongoing patient disability and further ED visits is high. MethodThis pilot trial used a randomized parallel group design to test the efficacy of Intensive Short-Term Dynamic Psychotherapy (ISTDP). ED patients who met criteria for SSRD were recruited. The effects of ISTDP plus medical care as usual (MCAU) were judged through comparison against 8 weeks of MCAU plus wait-list symptom monitoring (WL-SM). The primary outcome was somatic symptom at 8 weeks. Patients allocated to WL-SM could cross-over to receive ISTDP and 6-month follow-up data was collected. Baseline measures of patient attachment style and alexithymia were collected to examine vulnerabilities to somatic symptoms. ClinicalTrials.gov: NCT02076867. ResultsThirty-seven patients were randomized to 2 groups (ISTDP = 19 and WL-SM = 18). Multi-level modelling showed that change over time on somatic symptoms was significantly greater in the ISTDP group. Between-group differences were large at 8 weeks (Cohen's d = 0.94) and increased by end of treatment (Cohen's d = 1.54). Observed differences in symptoms of depression and illness anxiety were also large, favoring ISTDP, and effects were maintained at follow-up. Patients receiving ISTDP had reduced ED service utilization at 2-year follow-up. ConclusionsISTDP appears an efficacious treatment for SSRD and a larger randomized trial is justified.

Childhood trauma and differential response to long-term psychoanalytic versus cognitive-behavioural therapy for chronic depression in adults.

Childhood trauma is a major risk factor for chronic depression. It has been suggested that adults with chronic depression who have experienced childhood trauma may require long-term treatment owing to a breakdown of basic trust and related difficulties in developing a productive therapeutic relationship. As empirical studies have been preliminary and scarce, we studied the effects of psychoanalytic therapy (PAT) versus cognitive-behavioural therapy (CBT) for chronic depression in adults with a history of childhood trauma. In this subgroup, we expected a greater symptom reduction in PAT compared with CBT. In a large trial of long-term psychotherapies for chronic depression (LAC-Study; Clinical Trial Register ISRCTN91956346), 210 adults received open-ended CBT or PAT in an out-patient setting and were examined yearly over 5 years on the Beck Depression Inventory - II (BDI-II). Based on a linear mixed model approach, we tested participant-reported childhood trauma based on the Childhood Trauma Questionnaire (CTQ) as a predictor and moderator of treatment outcome. CTQ subscales were examined exploratively. Depressive symptoms decreased over time (b = -4.55, s.e. = 0.90, 95% CI -6.32 to -2.81, T = -5.08; P < 0.001). A significant three-way interaction between childhood trauma, time and therapy group (b = -0.05, s.e. = 0.02, 95% CI -0.09 to -0.01, T = -2.42; P = 0.016) indicated that participants with childhood trauma profited especially well from PATs. Our results indicate differential benefits from PAT compared with CBT among adults with chronic depression and a history of childhood trauma. The results have important implications for differential indication and policy.

A framework for assessment of adverse events occurring in psychedelic-assisted therapies.

Despite considerable research examining the efficacy of psychedelic-assisted therapies (PATs) for treating psychiatric disorders, assessment of adverse events (AEs) in PAT research has lagged. Current AE reporting standards in PAT trials are poorly calibrated to features of PAT that distinguish it from other treatments, leaving many potential AEs unassessed. A multidisciplinary working group of experts involved in PAT pooled formally and informally documented AEs observed through research experience and published literature. This information was integrated with (a) current standards and practices for AE reporting in pharmacotherapy and psychotherapy trials and (b) published findings documenting post-acute dosing impacts of psychedelics on subjective states, meaning, and psychosocial health variables, to produce a set of AE constructs important to evaluate in PAT as well as recommended methods and time frames for their assessment and monitoring. Correspondence between identified potential AEs and current standards for AE assessment was examined, including the extent of coverage of identified AE constructs by 25 existing measures used in relevant research. Fifty-four potential AE terms warranting systematized assessment in PAT were identified, defined, and categorized. Existing measures demonstrated substantial gaps in their coverage of identified AE constructs. Recommendations were developed for how to assess PAT AEs (including patient, clinician, and informant reports), and when to assess over preparation, dosing session, integration, and follow-up. Application of this framework is demonstrated in a preliminary assessment protocol (available in the supplement). This assessment framework addresses the need to capture post-acute dosing AEs in PAT, accounting for its pharmacotherapy and psychotherapy components, as well as documented impacts of psychedelics on worldviews and spirituality.

Meta-analysis of Psychotherapy for Autistic Youth.

In order to provide more individualized support, it is imperative to further understand the effectiveness of different types of psychotherapy on the clinical areas of need common in autistic youth (Wood et al. in Behav Ther 46:83-95, 2015). Randomized controlled trials of psychotherapy for autistic youth were included if published in English, included random assignment to treatment or control group, required a previous diagnosis of autism, had a mean age of 6-17years, and provided outcome measure data from both intervention and control groups. A total of 133 measures were coded across 29 studies and included 1464 participants with a mean age of 10.39years (1.89). A small mean effect size (0.38,95% CI [0.26, 0.47]) was found overall, with the largest effects for cognitive behavioral therapies on autism-related clinical needs (0.81) and overall mental health (0.78). The results show the significant impact of psychotherapy interventions for autistic youth. Additional research should further assess the details of the most effective psychotherapies for each area of clinical need.

The psychedelic call: analysis of Australian Poisons Information Centre calls associated with classic psychedelics

Introduction The global use of certain classical psychedelics has increased in recent years, but little is known about their spectrum of toxicity within Australia. We aim to describe calls to New South Wales Poisons Information Centre relating to exposures to classical psychedelics including lysergic acid diethylamide, psilocybin, N,N-dimethyltryptamine, ayahuasca, mescaline and ibogaine. Methods This is a retrospective observational study of calls to New South Wales Poisons Information Centre between January 2014 and December 2022. We identified exposures to classical psychedelics within New South Wales Poisons Information Centre database and measured the annual number of exposures, source of call (hospital, health care worker, member of the public), co-ingested substances, clinical features and advice given. Results There were 737 calls related to relevant psychedelic exposures; 352 (47.8 per cent) to lysergic acid diethylamide, 347 (47.0 per cent) to psilocybin, 28 (3.8 per cent) to N,N-dimethyltryptamine, 4 (0.5 per cent) to ayahuasca, 4 (0.5 per cent) to mescaline and 2 (0.3 per cent) to ibogaine. Cases were predominantly male (77.2 per cent) and aged between 20 and 74 years (65.6 per cent). Psychedelic calls more than doubled from 45 in 2014 to 105 in 2022 and 625 (85 per cent) of all calls were either from or referred to hospital. Co-ingestion of psychedelics with another substance occurred in 249 (33.8 per cent) of calls and the most frequent clinical features related to single substance psychedelic exposures were hallucinations (27.6 per cent), gastrointestinal symptoms (21.7 per cent) and tachycardia (18.1 per cent). Seizures occurred in 2.9 per cent of single substance psychedelic exposures. Discussion Increasing incidence of psychedelic exposure calls, including those reporting significant toxicity, likely reflects increasing community use. This may in part be driven by increasing interest in psychedelic assisted psychotherapy trials subsequently increasing public awareness. Conclusion Relatively high poisoning severity contrasts with safety within clinical trials of psychedelic assisted psychotherapy that may relate to the uncontrolled nature of community use which is mitigated within clinical trial environments. Education about safe use may be useful.

Psychotherapies for generalized anxiety disorder in adults: systematic review and network meta-analysis of randomized-controlled trials

IntroductionGeneralized anxiety disorder (GAD) is one of the most common mental disorders in adults. Psychotherapies are among the most recommended treatment choices for GAD, but which should be considered as first-line treatment still needs to be clarified.ObjectivesTo examine the most effective and accepted psychotherapy for GAD both in the short and long-term, via a network meta-analysis.MethodsWe searched MEDLINE, Embase, PsycINFO, and the Cochrane Register of Controlled Trials – CENTRAL, from database inception to January 1st, 2023, to find randomized controlled trials (RCTs) of psychotherapies for GAD. Eight psychotherapies (behaviour therapy, cognitive-behaviour therapy, cognitive restructuring, psychoeducation, psychodynamic therapy, relaxation therapy, supportive psychotherapy, and third-wave CBTs) were compared with each other and two control conditions (treatment as usual, waiting list). We followed Cochrane standards when extracting data and assessing data quality and used PRISMA guidelines for the reporting. We conducted random-effects model pairwise and network meta-analyses. We assessed risk of bias of individual studies through the second version of the Cochrane’s Risk of Bias tool and used the Confidence in Network Meta-Analysis (CINeMA) to rate certainty of evidence for meta-analytical results. Severity of GAD symptoms and acceptability of the psychotherapies were our outcomes of interest.ResultsWe analysed data from 66 RCTs. Effect size estimates on data from 5,597 participants suggest third wave cognitive-behavioural therapies (standardized mean differences [SMDs] =-0.78; 95%CI=-1.19 to -0.37; certainty=moderate), cognitive-behavioural therapy (CBT) (SMD=-0.68; 95%CI=-1.05 to -0.32 certainty=moderate), and relaxation therapy (SMD=-0.54; 95%CI=-1.04 to -0.05; certainty=low) reduced generalized anxiety symptoms more than treatment as usual (TAU). Relative risks for all-cause discontinuation signalled no differences compared with TAU for all psychotherapies. When excluding studies at high risk of bias, relaxation therapy lost its superiority over TAU. When considering anxiety severity at three to twelve months after completion of the intervention only CBT remained significantly more efficacious than TAU (SMD=-0.58; 95%CI=-0.93 to -0.23).Image:ConclusionsGiven the evidence for both acute and long-term efficacy, CBT may represent the reasonable first-line psychological treatment for GAD. Third-wave CBT and relaxation therapy have short-term efficacy and may also be offered. Results from this investigation should inform patients, clinicians, and guidelines. This project is funded by the European Union’s HORIZON EUROPE research programme under grant agreement No 101061648.Disclosure of InterestNone Declared

Project harmony: A systematic review and network meta-analysis of psychotherapy and pharmacologic trials for comorbid posttraumatic stress, alcohol, and other drug use disorders.

We conducted a systematic review and network meta-analyses (NMA) of psychotherapy and pharmacologic treatments for individuals with co-occurring posttraumatic stress disorder (PTSD) and alcohol or other drug use disorder (AOD). A comprehensive search spanning 1995-2019 yielded a pool of 39 studies for systematic review, including 24 randomized controlled trials for the NMA. Study interventions were grouped by target of treatment (PTSD + AOD, PTSD-only, and AOD-only) and approach (psychotherapy or medication). Standardized mean differences (SMD) from the NMA yielded evidence that at the end of treatment, integrated, trauma-focused therapy for PTSD + AOD was more effective at reducing PTSD symptoms than integrated, non-trauma-focused therapy (SMD = -0.30), AOD-focused psychotherapy (SMD = -0.29), and other control psychotherapies (SMD = -0.43). End-of-treatment alcohol use severity was less for AOD medication compared to placebo medication (SMD = -0.36) and trauma-focused therapy for PTSD + placebo medication (SMD = -0.67), and less for trauma-focused psychotherapy + AOD medication compared to PTSD medication (SMD = -0.53), placebo medication (SMD = -0.50), and trauma-focused psychotherapy + placebo medication (SMD = -0.81). Key limitations include the small number of studies in the NMA for pharmacologic treatments and the lack of demographic diversity apparent in the existing literature. Findings suggest room for new studies that can address limitations in study sample composition, sample sizes, retention, and apply new techniques for conducting comparative effectiveness in PTSD + AOD treatment. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Assessment of suicidality in trials of psychological interventions for depression: a meta-analysis

Psychological interventions that are efficacious as treatments for depression could indirectly affect suicide-related outcomes. We examined suicidal thoughts and behaviours as eligibility criteria, outcomes, and adverse events across trials of psychotherapy for depression. We used a publicly available meta-analytic database developed through systematic searches (updated as of May 1, 2023) to identify randomised controlled trials in which a psychological intervention for depression was compared with an inactive or non-specific control condition in adults with depression and in which any suicide-related outcomes were reported. We also identified studies in which suicide risk was an exclusion criterion. We excluded inpatient studies and trials of unguided digital interventions or collaborative care that included a psychological component. Pairs of reviewers worked independently to select studies and extract data. In a random-effects meta-analysis with robust variance estimation, we assessed the effect of the psychological intervention on suicide outcomes in trials in which suicide was explicitly assessed as an outcome with clinical scales with established psychometric properties. Risk of bias was assessed with the Cochrane risk-of-bias tool (version 2). Of the 469 randomised trials we identified in which a psychological intervention was compared with an inactive control in people with depression, 251 excluded people judged at risk of suicide. Any assessment of suicide was included in only 45 trials, 12 of which assessed suicidal ideation or risk as an outcome. These 12 trials included 3930 participants, 2795 (71%) of whom were female and 1135 (29%) of whom were male; data for age and ethnicity were not consistently reported. Psychological interventions for depression were associated with a small reduction in suicidal ideation and risk in 11 trials (one trial reported only follow-up data) after the intervention (standardised mean difference -0·31 [95% CI -0·60 to -0·03]) but not at follow-up (-0·49 [-1·31 to 0·32]). Suicide-related adverse events were reported in 25 trials, and suicide-related serious adverse events (eg, suicide attempts, deaths by suicide) were reported in 13 trials. Heterogeneity was substantial across all analyses, and prediction intervals crossed zero. Trials of psychological interventions for depression rarely report assessments of suicide. Psychological interventions might reduce suicidal ideation in patients with depression, but more randomised controlled trials are required to clarify this effect. Monitoring and reporting of suicide-related adverse events should be improved in trials of psychological interventions for depression, and future trials should incorporate outcomes related to suicidal thoughts or behaviours. None. For the Spanish translation of the abstract see Supplementary Materials section.

Negative effects in randomized controlled trials of psychotherapies and psychological interventions: A systematic review

Background: Psychotherapy is a key evidence-based method for the treatment of mental disorders. However, little research has been published on the negative effects of psychotherapies. Aims: We examined this issue through a systematic literature review of previous systematic reviews on randomized controlled trials (RCTs). Methods: We focused on previous reviews and meta-analyses on 1) RCTs examining the effectiveness of psychotherapies and 2) previous reviews and meta-analyses specifically focusing on the negative effects of psychotherapy. We included publications published in PubMed and the Cochrane Databases from the year 2000 or later. Results: Of the 1,430 relevant publications, only a small proportion (30%) mentioned negative outcomes, mostly withdrawal. Only 57 of the extracted original studies monitored potential negative effects, and only three small-scale studies indicated negative effects. Conclusions: The systematic monitoring of negative effects in psychotherapy has not been given the same attention as has been given to the benefits of therapy.

A randomized control clinical trial of brief supportive psychotherapy in acute coronary syndrome patients: focus on neutrophil-lymphocyte ratio and psychological symptoms

Background Neutrophil-lymphocyte ratio (NLR) may predict prognosis in acute coronary syndrome (ACS) patients. Psychological conditions play a role before, during and after infarction that can be treated with brief supportive psychotherapy (BSP). This study aimed to analyze effect of BSP on NLR and psychological symptoms (PS) in ACS patients. Methods This double opened clinical randomized study included ACS patients who were treated in Intensive Cardiac Care Unit (ICCU) Cipto Mangunkusumo Hospital, Jakarta in April to July 2019. The BSP was planned for 5 sessions as long as the patients were in ICCU. NLR and PS that was evaluated using hospital anxiety depression scale were measured at baseline and after last BSP or right before discharged from ICCU. Data were analyzed with independent t-test or Mann-Whitney test. Results We recruited 32 patients in BSP and 35 patients in control group. The median age was 55 (32 – 86) years old and mostly were men (75%). The median length of stay in ICCU was 5 (2-13) days. NLR was similar in BSP and control group (3.35 [2.26] vs 3.63 [1.79], p=0.346). ΔNLR was higher in BSP than control group in patients without CHF (3.87 [5.48] vs 0.33 [2.54], p=0.007) and without CAD (3.88 [4.55] vs 0.84 [2.51], p=0.014). Meanwhile, Δ depression score was higher in BSP than control group in patients with CHF (1.73 [3.58] vs -1.27 [2.8], p=0.041) and with CAD (2.08 [3.4] vs -0.8 [3.3], p=0.035). Conclusions There was influence of BSP on NLR in ACS patients without CHF or CAD, and psychological symptoms in ACS ones with CHF or CAD. This trial had registered in ClinicalTrial.gov.id with code number NCT04274205.

Is cognitive behavioral therapy more effective than pharmacotherapy for binge spectrum disorders? A systematic review and meta-analysis.

Binge spectrum disorders are prevalent worldwide. Psychiatric and medical comorbidities are common, and societal costs are significant. Evidence-based treatment remains underutilized. Cognitive behavioral therapy is the recommended first-line treatment, but pharmacotherapy may be easier to access. Meta-analytic evidence directly comparing cognitive behavioral therapy with pharmacotherapy is lacking. We aimed to compare the effects of cognitive behavioral therapy interventions with any pharmacological treatment for binge spectrum disorders. We searched PubMed, Embase, CENTRAL, ClinicalTrials.gov and reference lists for randomized controlled trials comparing cognitive behavioral therapy with any pharmacotherapy for bulimia nervosa/binge eating disorder and performed pairwise meta-analytic evaluations. Primary outcomes are remission and frequency of binges. Secondary outcomes are frequency of purges, response, eating disorder psychopathology, weight/body mass index, depression, anxiety, quality of life and dropouts. Eleven randomized controlled trials comparing cognitive behavioral therapy with fluoxetine/imipramine/desipramine/methylphenidate/sibutramine were identified (N = 531). Cognitive behavioral therapy was superior to antidepressants in terms of remission, frequency of binges and eating disorder psychopathology. There were no statistically significant differences for any of the individual cognitive behavioral therapy vs drug comparisons in terms of response/depression/anxiety/weight/quality of life/dropouts. Cognitive behavioral therapy was not superior to sibutramine/methylphenidate for the primary outcomes. Data are scarce, comparisons underpowered and, considering the inherent methodological limitations of psychotherapy trials, questions arise regarding the presumed superiority of cognitive behavioral therapy. Further research is needed.

Open Trial of a Brief Imagery-Based Stabilization Psychotherapy for Adults with Acute Posttraumatic Stress Disorder.

Early intervention after trauma is needed for reduction in clinical distress and prevention of chronic posttraumatic stress disorder (PTSD). This study describes findings from an open pilot trial of a brief stabilization psychotherapy based on imagery techniques for adults with acute PTSD (i.e., within 3 months of onset). Four sessions of 60-minute individual psychotherapy were conducted on 18 participants with PTSD within 3 months after accidents, 15 of whom completed the treatment. The clinician-administered PTSD scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), the Hamilton Depression and Anxiety Rating Scales, and self-questionnaires were administered at pre-treatment, post-treatment, and 6-month follow-up. Eight (53.3%) of the 15 patients at post-treatment and 8 of the 9 patients at 6-month follow-up did not meet the DSM-5 criteria for PTSD. Reliable change of PTSD symptoms after treatment was observed in 6 of 15 (45.0%) patients at post-treatment and in 4 of 9 (45.0%) patients after 6 months. There was a significant decrease in PTSD, depression, anxiety, and impaired quality of life scores after treatment, and these gains were maintained after 6 months. No cases of exacerbated PTSD symptoms were observed among completers and non-completers. Our findings suggest that brief stabilization sessions are safe treatment options for acute PTSD (KCT0001918).

Analysis of implementation processes in a hybrid effectiveness-implementation trial of interpersonal psychotherapy (IPT) for major depressive disorder in prisons: Training, supervision, and recommendations.

There are 10 million admissions to U.S. prisons and jails each year. More than half of those admitted have mental health problems. The goal of this article is to inform: (1) implementation of evidence-based mental health treatments in prisons and jails, an important effort that needs more evidence to guide it; (2) psychotherapy and interpersonal psychotherapy (IPT) training efforts, especially in low-resource settings. A randomized hybrid effectiveness-implementation trial of group IPT for major depressive disorder (MDD) in state prisons found that IPT increased rates of MDD remission and lowered posttraumatic stress disorder symptoms relative to prison treatment as usual. The trial used prison counselors, only some of whom had prior psychotherapy training/experience, to deliver IPT. IPT treatment adherence was high (96%), but trial training and supervision were too costly to be scalable outside the trial. The current article reports results from a planned qualitative analysis of 460 structured implementation and supervision documents in that trial to describe training and supervision processes and lessons learned, inform training recommendations, and facilitate future work to optimize training and supervision for under-resourced settings. Themes identified in implementation and supervision process notes reflected: work on psychotherapy basics (reflective listening, focusing on emotions, open-ended questions, specific experiences), IPT case conceptualization (forming a conceptualization, what is and is not therapeutic work, structure and limit setting, structure vs. flexibility), IPT techniques (enhancing social support, role plays, communication analysis), psychotherapy processes (alliance repair, managing group processes), and managing difficult situations (avoidance, specific clients, challenging work settings). Counselors were receptive to feedback; some relied on study supervisors for support in managing stressful prison working conditions. Findings can be used to make future training and supervision more efficient. Based on our results, we recommend that initial and refresher training focus on IPT case conceptualization, steps for addressing each IPT problem area, and reflective listening. We also recommend supervision through at least counselors' first two rounds of groups. More low-cost, scalable training methods are needed to get mental health treatment to individuals who need it most, who are often served in challenging, low-resource settings such as prisons. This is a mental health access and equity issue. The trial was registered at clinicaltrials.gov (NCT01685294).

Longitudinal Clusters of Long-Term Trajectories in Patients with Early-Onset Chronic Depression: 2 Years of Naturalistic Follow-Up after Extensive Psychological Treatment

Introduction: In clinical trials, mostly group-level treatment effects of repeated cross-sectional measures are analyzed. However, substantial heterogeneity regarding individual symptom profiles and the variability of treatment effects are often neglected, especially over the long-term course. To provide effective personalized treatments, investigations of these characteristics are urgently needed. Methods: Depression severity ratings over 104 weeks of follow-up after year-long treatment with the Cognitive Behavioral Analysis System of Psychotherapy (CBASP) or Supportive Psychotherapy (SP) were analyzed. Longitudinal cluster analysis and multinomial logistic regression analysis were conducted to investigate intraindividual trajectories from one of the largest psychotherapy trials in early-onset chronic depression. Results: Two-year post-study-treatment trajectories of N = 188 patients with early-onset chronic depression were grouped into four prototypical clusters. Overall, 16.0% of patients remitted (cluster 1) and most of them did not receive any treatment during the 2-year follow-up. However, 84.0% of patients continued to experience subthreshold (37.2% cluster 2) or major depressive symptoms (46.8% clusters 3–4) and spent on average more than half of the follow-up in pharmacological and psychological treatment. Hierarchical regression analysis indicated that previous study treatment with CBASP or SP did not significantly predict cluster allocation, while baseline variables accounted for a large proportion of explained variance (R² _N = 0.64). Conclusion: While some patients experienced stable remission over 2 years of follow-up, the majority of patients experienced subthreshold or major depressive symptoms regardless of former study treatment with CBASP or SP. This calls for a long-term perspective implementing staging and innovative treatment approaches such as the sequential model or modular psychotherapy.