Pub Date : 2024-01-01Epub Date: 2024-07-29DOI: 10.1159/000540212
Jan Philipp Klein, Alexander Rozental, Svenja Sürig, Steffen Moritz
Background: The effectiveness of psychological interventions is undisputed. But while in other fields of health care the safety of interventions is studied alongside effectiveness, adverse events (AEs) have only recently been assessed in clinical studies of psychological interventions. This critical review summarizes the definition, assessment and current research status of AEs of psychological interventions.
Summary: AEs are defined as any untoward event or unfavorable change that occurs in the course of a psychological intervention. AEs that are caused by the intervention can be classified into side effects of correctly applied treatment, malpractice (i.e., incorrectly applied treatment) and unethical conduct (e.g., sexual abuse). Ideally, they are assessed by independent raters or alternatively by self-report questionnaires that should also cover serious adverse events (SAEs, e.g., suicide attempts or self-injurious behaviors). About 1 to 2 in 3 patients report at least 1 AE and results of meta-analyses suggest that treatments might differ in frequency and/or severity of AE and in treatment acceptability (measured as dropout rates).
Key messages: Measures of AEs and SAEs as well as more nuanced descriptions of dropout should be included in all clinical studies of psychological interventions. If this happens, we might learn that psychological interventions differ with respect to AEs, SAEs and acceptability. As many psychological interventions are about equally effective, they might one day be chosen based on differences in their safety profile rather than their differential effectiveness. Ideally, reducing AEs might also lead to more effective interventions.
{"title":"Adverse Events of Psychological Interventions: Definitions, Assessment, Current State of the Research and Implications for Research and Clinical Practice.","authors":"Jan Philipp Klein, Alexander Rozental, Svenja Sürig, Steffen Moritz","doi":"10.1159/000540212","DOIUrl":"10.1159/000540212","url":null,"abstract":"<p><strong>Background: </strong>The effectiveness of psychological interventions is undisputed. But while in other fields of health care the safety of interventions is studied alongside effectiveness, adverse events (AEs) have only recently been assessed in clinical studies of psychological interventions. This critical review summarizes the definition, assessment and current research status of AEs of psychological interventions.</p><p><strong>Summary: </strong>AEs are defined as any untoward event or unfavorable change that occurs in the course of a psychological intervention. AEs that are caused by the intervention can be classified into side effects of correctly applied treatment, malpractice (i.e., incorrectly applied treatment) and unethical conduct (e.g., sexual abuse). Ideally, they are assessed by independent raters or alternatively by self-report questionnaires that should also cover serious adverse events (SAEs, e.g., suicide attempts or self-injurious behaviors). About 1 to 2 in 3 patients report at least 1 AE and results of meta-analyses suggest that treatments might differ in frequency and/or severity of AE and in treatment acceptability (measured as dropout rates).</p><p><strong>Key messages: </strong>Measures of AEs and SAEs as well as more nuanced descriptions of dropout should be included in all clinical studies of psychological interventions. If this happens, we might learn that psychological interventions differ with respect to AEs, SAEs and acceptability. As many psychological interventions are about equally effective, they might one day be chosen based on differences in their safety profile rather than their differential effectiveness. Ideally, reducing AEs might also lead to more effective interventions.</p>","PeriodicalId":20744,"journal":{"name":"Psychotherapy and Psychosomatics","volume":" ","pages":"308-315"},"PeriodicalIF":16.3,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141793187","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-01-01Epub Date: 2024-01-09DOI: 10.1159/000535777
Andre F Carvalho, Chih-Wei Hsu, Eduard Vieta, Marco Solmi, Wolfgang Marx, Michael Berk, Chih-Sung Liang, Ping-Tao Tseng, Liang-Jen Wang
Introduction: This study aimed to estimate all-cause mortality in patients after a first-episode mania (FEM) and examine whether six guideline-recommended medications can reduce mortality.
Methods: The cohort included population-based FEM samples and matched controls from Taiwan, spanning 2007 to 2018. The primary outcomes assessed were all-cause/suicide-related mortality, while the secondary outcome focused on mortality associated with pharmacological treatments. We compared mortality in post-FEM patients and age-/sex-matched controls without any diagnosed bipolar disorders and patients with and without psychopharmacological treatment using Cox regression analysis, respectively. Statistics were presented with time-to-event adjusted hazard ratios (AHRs) and 95% confidence intervals (CIs).
Results: The study included 54,092 post-FEM patients and 270,460 controls, totaling 2,467,417 person-years of follow-up. Post-FEM patients had higher risks of all-cause mortality (AHR 2.38, 95% CI: 2.31-2.45) and suicide death (10.80, 5.88-19.84) than controls. Lithium (0.62, 0.55-0.70), divalproex (0.89, 0.83-0.95), and aripiprazole (0.81, 0.66-1.00) were associated with reduced all-cause mortality compared to non-users. There were no significant all-cause mortality differences for quetiapine (0.95, 0.89-1.01), risperidone (0.92, 0.82-1.02), and paliperidone (1.24, 0.88-1.76) users. When accounting for drug action onset times in sensitivity analyses, only lithium significantly reduced all-cause mortality (AHR range 0.65-0.72). There were 35 and 16 suicide deaths in post-FEM patients and controls, respectively. No drug had a significant effect on suicide deaths (lithium: 6; divalproex: 7; aripiprazole: 0; quetiapine: 10; risperidone: 4; paliperidone: 1).
Conclusion: Post-FEM patients had a higher risk of all-cause/suicide-related mortality, and lithium treatment might reduce all-cause mortality.
{"title":"Mortality and Lithium-Protective Effects after First-Episode Mania Diagnosis in Bipolar Disorder: A Nationwide Retrospective Cohort Study in Taiwan.","authors":"Andre F Carvalho, Chih-Wei Hsu, Eduard Vieta, Marco Solmi, Wolfgang Marx, Michael Berk, Chih-Sung Liang, Ping-Tao Tseng, Liang-Jen Wang","doi":"10.1159/000535777","DOIUrl":"10.1159/000535777","url":null,"abstract":"<p><strong>Introduction: </strong>This study aimed to estimate all-cause mortality in patients after a first-episode mania (FEM) and examine whether six guideline-recommended medications can reduce mortality.</p><p><strong>Methods: </strong>The cohort included population-based FEM samples and matched controls from Taiwan, spanning 2007 to 2018. The primary outcomes assessed were all-cause/suicide-related mortality, while the secondary outcome focused on mortality associated with pharmacological treatments. We compared mortality in post-FEM patients and age-/sex-matched controls without any diagnosed bipolar disorders and patients with and without psychopharmacological treatment using Cox regression analysis, respectively. Statistics were presented with time-to-event adjusted hazard ratios (AHRs) and 95% confidence intervals (CIs).</p><p><strong>Results: </strong>The study included 54,092 post-FEM patients and 270,460 controls, totaling 2,467,417 person-years of follow-up. Post-FEM patients had higher risks of all-cause mortality (AHR 2.38, 95% CI: 2.31-2.45) and suicide death (10.80, 5.88-19.84) than controls. Lithium (0.62, 0.55-0.70), divalproex (0.89, 0.83-0.95), and aripiprazole (0.81, 0.66-1.00) were associated with reduced all-cause mortality compared to non-users. There were no significant all-cause mortality differences for quetiapine (0.95, 0.89-1.01), risperidone (0.92, 0.82-1.02), and paliperidone (1.24, 0.88-1.76) users. When accounting for drug action onset times in sensitivity analyses, only lithium significantly reduced all-cause mortality (AHR range 0.65-0.72). There were 35 and 16 suicide deaths in post-FEM patients and controls, respectively. No drug had a significant effect on suicide deaths (lithium: 6; divalproex: 7; aripiprazole: 0; quetiapine: 10; risperidone: 4; paliperidone: 1).</p><p><strong>Conclusion: </strong>Post-FEM patients had a higher risk of all-cause/suicide-related mortality, and lithium treatment might reduce all-cause mortality.</p>","PeriodicalId":20744,"journal":{"name":"Psychotherapy and Psychosomatics","volume":" ","pages":"36-45"},"PeriodicalIF":22.8,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10880805/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139404172","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-01-01Epub Date: 2024-02-21DOI: 10.1159/000536490
Giovanni A Fava, Nicoletta Sonino, David C Aron, Richard Balon, Carmen Berrocal Montiel, Jianxin Cao, John Concato, Ajandek Eory, Ralph I Horwitz, Chiara Rafanelli, Ulrich Schnyder, Hongxing Wang, Thomas N Wise, Jesse H Wright, Stephan Zipfel, Chiara Patierno
Clinical interviewing is the basic method to understand how a person feels and what are the presenting complaints, obtain medical history, evaluate personal attitudes and behavior related to health and disease, give the patient information about diagnosis, prognosis, and treatment, and establish a bond between patient and physician that is crucial for shared decision making and self-management. However, the value of this basic skill is threatened by time pressures and emphasis on technology. Current health care trends privilege expensive tests and procedures and tag the time devoted to interaction with the patient as lacking cost-effectiveness. Instead, the time spent to inquire about problems and life setting may actually help to avoid further testing, procedures, and referrals. Moreover, the dialogue between patient and physician is an essential instrument to increase patient's motivation to engage in healthy behavior. The aim of this paper was to provide an overview of clinical interviewing and its optimal use in relation to style, flow and hypothesis testing, clinical domains, modifications according to settings and goals, and teaching. This review points to the primacy of interviewing in the clinical process. The quality of interviewing determines the quality of data that are collected and, eventually, of assessment and treatment. Thus, interviewing deserves more attention in educational training and more space in clinical encounters than it is currently receiving.
{"title":"Clinical Interviewing: An Essential but Neglected Method of Medicine.","authors":"Giovanni A Fava, Nicoletta Sonino, David C Aron, Richard Balon, Carmen Berrocal Montiel, Jianxin Cao, John Concato, Ajandek Eory, Ralph I Horwitz, Chiara Rafanelli, Ulrich Schnyder, Hongxing Wang, Thomas N Wise, Jesse H Wright, Stephan Zipfel, Chiara Patierno","doi":"10.1159/000536490","DOIUrl":"10.1159/000536490","url":null,"abstract":"<p><p>Clinical interviewing is the basic method to understand how a person feels and what are the presenting complaints, obtain medical history, evaluate personal attitudes and behavior related to health and disease, give the patient information about diagnosis, prognosis, and treatment, and establish a bond between patient and physician that is crucial for shared decision making and self-management. However, the value of this basic skill is threatened by time pressures and emphasis on technology. Current health care trends privilege expensive tests and procedures and tag the time devoted to interaction with the patient as lacking cost-effectiveness. Instead, the time spent to inquire about problems and life setting may actually help to avoid further testing, procedures, and referrals. Moreover, the dialogue between patient and physician is an essential instrument to increase patient's motivation to engage in healthy behavior. The aim of this paper was to provide an overview of clinical interviewing and its optimal use in relation to style, flow and hypothesis testing, clinical domains, modifications according to settings and goals, and teaching. This review points to the primacy of interviewing in the clinical process. The quality of interviewing determines the quality of data that are collected and, eventually, of assessment and treatment. Thus, interviewing deserves more attention in educational training and more space in clinical encounters than it is currently receiving.</p>","PeriodicalId":20744,"journal":{"name":"Psychotherapy and Psychosomatics","volume":" ","pages":"94-99"},"PeriodicalIF":16.3,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139932630","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-01-01Epub Date: 2024-03-15DOI: 10.1159/000538076
Kurt Kroenke
{"title":"Restoring and Preserving the Clinical Interview.","authors":"Kurt Kroenke","doi":"10.1159/000538076","DOIUrl":"10.1159/000538076","url":null,"abstract":"","PeriodicalId":20744,"journal":{"name":"Psychotherapy and Psychosomatics","volume":" ","pages":"85-87"},"PeriodicalIF":22.8,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140143965","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-01-01Epub Date: 2024-04-30DOI: 10.1159/000538428
Thanos Karatzias, Mark Shevlin, Marylène Cloitre, Walter Busuttil, Katherine Graham, Laura Hendrikx, Philip Hyland, Natasha Biscoe, Dominic Murphy
Introduction: Complex PTSD (CPTSD) is a relatively new condition in ICD-11. This pilot randomised controlled trial aimed to compare a four-module intervention developed to target all symptoms of ICD-11 CPTSD, namely Enhanced Skills in Affective and Interpersonal Regulation (ESTAIR) with treatment as usual (TAU). The purpose of the study was to assess feasibility, safety, acceptability, and preliminary outcomes at the end of treatment and 3-month follow-up.
Methods: A total of N = 56 eligible veterans with CPTSD were randomised to either ESTAIR (n = 28) or TAU (n = 28). Linear mixed models were conducted to assess CPTSD severity, the primary outcome, as measured by the International Trauma Questionnaire (ITQ).
Results: Treatment dropout in ESTAIR and TAU was low and equivalent (18% vs. 11%; χ2 (1) = 1.19, p = 0.275), and study retention was high, supporting the feasibility of the study. No serious adverse effects and very few adverse effects occurred, none of which were deemed related to the study. ESTAIR provided significantly greater reduction in CPTSD severity across time for ITQ PTSD (p < 0.001) and DSO (p < 0.001) symptoms. CPTSD pre-to-post effect sizes for ESTAIR were large (PTSD d = 1.78; DSO d = 2.00). Remission of probable CPTSD diagnosis at post-treatment was substantially greater in ESTAIR compared to TAU with only 13.6% versus 84% (p < 0.001) retaining the diagnosis.
Conclusion: A trial of ESTAIR versus TAU for the treatment of ICD-11 CPTSD indicates the potential efficacy of ESTAIR as well as its feasibility, safety, and acceptability.
导言:复杂创伤后应激障碍(CPTSD)在 ICD-11 中是一个相对较新的病症。这项随机对照试验旨在比较针对 ICD-11 CPTSD 所有症状而开发的四模块干预方法,即增强情感和人际关系调节技能(ESTAIR)与常规治疗(TAU)。研究的目的是评估治疗的可行性、安全性、可接受性以及治疗结束和 3 个月随访的初步结果:共有 N = 56 名符合条件的 CPTSD 退伍军人被随机分配到 ESTAIR(n = 28)或 TAU(n = 28)。采用线性混合模型来评估 CPTSD 的严重程度,这是主要结果,由国际创伤问卷(ITQ)来衡量:结果:ESTAIR 和 TAU 的治疗退出率较低且相当(18% vs. 11%; χ2 (1) = 1.19, p = 0.275),研究保留率较高,证明了研究的可行性。未出现严重不良反应,不良反应极少,且均与研究无关。在不同时间段,ESTAIR 对 ITQ PTSD(p < 0.001)和 DSO(p < 0.001)症状的 CPTSD 严重程度有明显降低。ESTAIR 的 CPTSD 前后效应大小较大(创伤后应激障碍 d = 1.78;创伤后应激障碍 d = 2.00)。ESTAIR与TAU相比,治疗后CPTSD可能诊断的缓解率要高得多,只有13.6%对84%(p <0.001)保留了诊断:ESTAIR与TAU治疗ICD-11 CPTSD的试验表明,ESTAIR具有潜在的疗效、可行性、安全性和可接受性。
{"title":"Enhanced Skills Training in Affective and Interpersonal Regulation versus Treatment as Usual for ICD-11 Complex PTSD: A Pilot Randomised Controlled Trial (The RESTORE Trial).","authors":"Thanos Karatzias, Mark Shevlin, Marylène Cloitre, Walter Busuttil, Katherine Graham, Laura Hendrikx, Philip Hyland, Natasha Biscoe, Dominic Murphy","doi":"10.1159/000538428","DOIUrl":"10.1159/000538428","url":null,"abstract":"<p><strong>Introduction: </strong>Complex PTSD (CPTSD) is a relatively new condition in ICD-11. This pilot randomised controlled trial aimed to compare a four-module intervention developed to target all symptoms of ICD-11 CPTSD, namely Enhanced Skills in Affective and Interpersonal Regulation (ESTAIR) with treatment as usual (TAU). The purpose of the study was to assess feasibility, safety, acceptability, and preliminary outcomes at the end of treatment and 3-month follow-up.</p><p><strong>Methods: </strong>A total of N = 56 eligible veterans with CPTSD were randomised to either ESTAIR (n = 28) or TAU (n = 28). Linear mixed models were conducted to assess CPTSD severity, the primary outcome, as measured by the International Trauma Questionnaire (ITQ).</p><p><strong>Results: </strong>Treatment dropout in ESTAIR and TAU was low and equivalent (18% vs. 11%; χ2 (1) = 1.19, p = 0.275), and study retention was high, supporting the feasibility of the study. No serious adverse effects and very few adverse effects occurred, none of which were deemed related to the study. ESTAIR provided significantly greater reduction in CPTSD severity across time for ITQ PTSD (p < 0.001) and DSO (p < 0.001) symptoms. CPTSD pre-to-post effect sizes for ESTAIR were large (PTSD d = 1.78; DSO d = 2.00). Remission of probable CPTSD diagnosis at post-treatment was substantially greater in ESTAIR compared to TAU with only 13.6% versus 84% (p < 0.001) retaining the diagnosis.</p><p><strong>Conclusion: </strong>A trial of ESTAIR versus TAU for the treatment of ICD-11 CPTSD indicates the potential efficacy of ESTAIR as well as its feasibility, safety, and acceptability.</p>","PeriodicalId":20744,"journal":{"name":"Psychotherapy and Psychosomatics","volume":" ","pages":"203-215"},"PeriodicalIF":16.3,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11152001/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140871106","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-01-01Epub Date: 2024-08-21DOI: 10.1159/000539809
Tania Marie Lincoln, Björn Schlier, Rebecca Müller, Mark Hayward, Anne-Katharina Fladung, Niklas Bergmann, Kerem Böge, Jürgen Gallinat, Candelaria Mahlke, Uwe Gonther, Thomas Lang, Cornelia Exner, Anika Buchholz, Katharina Stahlmann, Antonia Zapf, Geraldine Rauch, Matthias Pillny
Introduction: There is a significant demand for interventions that reduce distress related to auditory verbal hallucinations (AVHs). AVH distress is associated with the way voice hearers relate with AVHs. We aimed to establish the feasibility of a randomized controlled trial to demonstrate that adding "Relating Therapy" (RT) to treatment as usual (TAU) is superior to TAU in reducing AVH distress.
Methods: We conducted a multicenter, parallel, single-blind, randomized controlled feasibility trial in five mental health centers in Germany. Participants were ≥19 years of age, had persistent and distressing AVHs, and had a diagnosis of a schizophrenia-spectrum disorder. RT was delivered over a maximum of 16 sessions within 5 months. Blind assessments were conducted at baseline and at 5 and 9 months. Feasibility outcomes were the number of patients recruited and retained, and safety and therapist adherence. The primary endpoint was the distress factor score of the AVH subscale of the Psychotic Symptoms Rating Scales at 9 months.
Results: Eighty-five of 177 enrolled participants were randomized into RT + TAU (n = 43) or TAU (n = 42). Feasibility was excellent with 87% retention at 9 months, 86% reaching treatment uptake criteria, 98% therapist adherence, and no unexpected serious adverse reactions. Compared to TAU, RT + TAU showed nonsignificant trends toward less AVH distress (b = -2.40, SE = 1.52, p = 0.121, 90% CI (-4.94 to 0.15) and stronger improvement on all but one of the secondary outcomes.
Conclusion: A randomized controlled trial of RT is feasible, safe, and well accepted. Our results provide an encouraging basis to further test the efficacy of RT in a definitive multicenter trial.
{"title":"Reducing Distress from Auditory Verbal Hallucinations: A Multicenter, Parallel, Single-Blind, Randomized Controlled Feasibility Trial of Relating Therapy.","authors":"Tania Marie Lincoln, Björn Schlier, Rebecca Müller, Mark Hayward, Anne-Katharina Fladung, Niklas Bergmann, Kerem Böge, Jürgen Gallinat, Candelaria Mahlke, Uwe Gonther, Thomas Lang, Cornelia Exner, Anika Buchholz, Katharina Stahlmann, Antonia Zapf, Geraldine Rauch, Matthias Pillny","doi":"10.1159/000539809","DOIUrl":"10.1159/000539809","url":null,"abstract":"<p><strong>Introduction: </strong>There is a significant demand for interventions that reduce distress related to auditory verbal hallucinations (AVHs). AVH distress is associated with the way voice hearers relate with AVHs. We aimed to establish the feasibility of a randomized controlled trial to demonstrate that adding \"Relating Therapy\" (RT) to treatment as usual (TAU) is superior to TAU in reducing AVH distress.</p><p><strong>Methods: </strong>We conducted a multicenter, parallel, single-blind, randomized controlled feasibility trial in five mental health centers in Germany. Participants were ≥19 years of age, had persistent and distressing AVHs, and had a diagnosis of a schizophrenia-spectrum disorder. RT was delivered over a maximum of 16 sessions within 5 months. Blind assessments were conducted at baseline and at 5 and 9 months. Feasibility outcomes were the number of patients recruited and retained, and safety and therapist adherence. The primary endpoint was the distress factor score of the AVH subscale of the Psychotic Symptoms Rating Scales at 9 months.</p><p><strong>Results: </strong>Eighty-five of 177 enrolled participants were randomized into RT + TAU (n = 43) or TAU (n = 42). Feasibility was excellent with 87% retention at 9 months, 86% reaching treatment uptake criteria, 98% therapist adherence, and no unexpected serious adverse reactions. Compared to TAU, RT + TAU showed nonsignificant trends toward less AVH distress (b = -2.40, SE = 1.52, p = 0.121, 90% CI (-4.94 to 0.15) and stronger improvement on all but one of the secondary outcomes.</p><p><strong>Conclusion: </strong>A randomized controlled trial of RT is feasible, safe, and well accepted. Our results provide an encouraging basis to further test the efficacy of RT in a definitive multicenter trial.</p>","PeriodicalId":20744,"journal":{"name":"Psychotherapy and Psychosomatics","volume":" ","pages":"328-339"},"PeriodicalIF":16.3,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11469652/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142018389","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-01-01Epub Date: 2024-01-25DOI: 10.1159/000536040
Zoryana Babiy, Haley Layton, Calan D Savoy, Feng Xie, June S L Brown, Peter J Bieling, David L Streiner, Mark A Ferro, Ryan J Van Lieshout
Introduction: Myriad treatment barriers prevent birthing parents with postpartum depression (PPD) from receiving timely treatment. We aimed to determine whether a peer-delivered online 1-day cognitive behavioral therapy (CBT)-based workshop added to treatment as usual (TAU) improves PPD and its comorbidities and is more cost-effective than TAU alone.
Methods: This parallel-group, randomized controlled trial took place in Ontario, Canada (June 7, 2021, to February 18, 2022). Participants were ≥18 years old, had an infant ≤12 months old, and an Edinburgh Postnatal Depression Scale (EPDS) score ≥10. Participants were allocated to receive the workshop plus TAU (n = 202) or TAU and waitlisted to complete the workshop 12 weeks later (n = 203). The primary outcome was change in PPD (EPDS score) from enrollment to 12 weeks later. The secondary outcome was cost-effectiveness and tertiary outcomes included anxiety, social support, partner relationship quality, the mother-infant relationship, parenting stress, and infant temperament.
Results: Participants had a mean age of 32.3 years (SD = 4.30) and 65% were White. The workshop led to a significant reduction in EPDS scores (15.95-11.37; d = 0.92, p < 0. 01) and was associated with higher odds of exhibiting a clinically significant decrease in EPDS scores (OR = 2.03; 95% CI: 1.26-3.29). The workshop plus TAU was more cost-effective than TAU alone. It also led to improvements in postpartum anxiety, infant-focused anxiety, parenting stress, and infant temperament.
Conclusions: Peer-delivered 1-day CBT-based workshops can improve PPD and are a potentially scalable low-intensity treatment that could help increase treatment access.
{"title":"One-Day Peer-Delivered Cognitive Behavioral Therapy-Based Workshops for Postpartum Depression: A Randomized Controlled Trial.","authors":"Zoryana Babiy, Haley Layton, Calan D Savoy, Feng Xie, June S L Brown, Peter J Bieling, David L Streiner, Mark A Ferro, Ryan J Van Lieshout","doi":"10.1159/000536040","DOIUrl":"10.1159/000536040","url":null,"abstract":"<p><strong>Introduction: </strong>Myriad treatment barriers prevent birthing parents with postpartum depression (PPD) from receiving timely treatment. We aimed to determine whether a peer-delivered online 1-day cognitive behavioral therapy (CBT)-based workshop added to treatment as usual (TAU) improves PPD and its comorbidities and is more cost-effective than TAU alone.</p><p><strong>Methods: </strong>This parallel-group, randomized controlled trial took place in Ontario, Canada (June 7, 2021, to February 18, 2022). Participants were ≥18 years old, had an infant ≤12 months old, and an Edinburgh Postnatal Depression Scale (EPDS) score ≥10. Participants were allocated to receive the workshop plus TAU (n = 202) or TAU and waitlisted to complete the workshop 12 weeks later (n = 203). The primary outcome was change in PPD (EPDS score) from enrollment to 12 weeks later. The secondary outcome was cost-effectiveness and tertiary outcomes included anxiety, social support, partner relationship quality, the mother-infant relationship, parenting stress, and infant temperament.</p><p><strong>Results: </strong>Participants had a mean age of 32.3 years (SD = 4.30) and 65% were White. The workshop led to a significant reduction in EPDS scores (15.95-11.37; d = 0.92, p < 0. 01) and was associated with higher odds of exhibiting a clinically significant decrease in EPDS scores (OR = 2.03; 95% CI: 1.26-3.29). The workshop plus TAU was more cost-effective than TAU alone. It also led to improvements in postpartum anxiety, infant-focused anxiety, parenting stress, and infant temperament.</p><p><strong>Conclusions: </strong>Peer-delivered 1-day CBT-based workshops can improve PPD and are a potentially scalable low-intensity treatment that could help increase treatment access.</p>","PeriodicalId":20744,"journal":{"name":"Psychotherapy and Psychosomatics","volume":" ","pages":"129-140"},"PeriodicalIF":22.8,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139564722","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-01-01Epub Date: 2023-12-28DOI: 10.1159/000535005
Moritz Elsaesser, Bernd Feige, Levente Kriston, Lea Schumacher, Jasmin Peifer, Martin Hautzinger, Martin Härter, Elisabeth Schramm
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.
{"title":"Longitudinal Clusters of Long-Term Trajectories in Patients with Early-Onset Chronic Depression: 2 Years of Naturalistic Follow-Up after Extensive Psychological Treatment.","authors":"Moritz Elsaesser, Bernd Feige, Levente Kriston, Lea Schumacher, Jasmin Peifer, Martin Hautzinger, Martin Härter, Elisabeth Schramm","doi":"10.1159/000535005","DOIUrl":"10.1159/000535005","url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":20744,"journal":{"name":"Psychotherapy and Psychosomatics","volume":" ","pages":"65-74"},"PeriodicalIF":22.8,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139058620","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-01-01Epub Date: 2024-01-04DOI: 10.1159/000535492
Johannes Kopf-Beck, Celina L Müller, Jeanette Tamm, Julia Fietz, Nils Rek, Leah Just, Zoe Ilona Spock, Katharina Weweck, Keisuke Takano, Martin Rein, Martin E Keck, Samy Egli
Introduction: Schema therapy (ST) reduces depressive symptoms, but clinical trials have not investigated its effectiveness for patients suffering from severe forms of depression and high rates of comorbidities. There is high demand for exploring and improving treatments for this patient group. The objective of the current study was to evaluate whether ST is more effective than individual supportive therapy (IST) and noninferior compared with cognitive behavioral therapy (CBT) in treating depression.
Methods: For this clinical trial, medicated patients were recruited in inpatient and day clinic settings. The major inclusion criteria were age between 18 and 75 years and primary diagnosis of depression without psychotic symptoms. A total of 292 participants were randomized to ST, CBT, or IST and received 7 weeks of psychotherapy (up to 14 individual and 14 group sessions). The primary outcome was change in depression severity after treatment measured by Beck Depression Inventory-II. Primary test for efficacy was superiority of ST over IST. Secondary test was noninferiority of ST compared with CBT. Multilevel modeling was conducted. The results at 6-month follow-up were explored.
Results: Across treatment, ST was not superior to IST. Secondary outcome analyses and completer analyses showed similar results. However, ST showed clinically relevant noninferiority compared with CBT.
Conclusion: ST for depression as part of a psychiatric care program showed clinical noninferiority compared to CBT, without being superior to IST. ST represents a potentially useful addition to the therapeutic repertoire for the treatment of depression but its efficacy, including long-term efficacy, should be evaluated further.
简介模式疗法(ST)可减轻抑郁症状,但临床试验尚未研究其对严重抑郁症和高合并症患者的疗效。针对这一患者群体,探索和改进治疗方法的需求很高。本研究的目的是评估 ST 在治疗抑郁症方面是否比个体支持疗法(IST)更有效,以及与认知行为疗法(CBT)相比是否不具劣势:这项临床试验招募了住院和日间诊所的药物治疗患者。主要纳入标准为年龄在 18 岁至 75 岁之间,主要诊断为无精神病症状的抑郁症。共有 292 名参与者被随机分配到 ST、CBT 或 IST,并接受了为期 7 周的心理治疗(最多 14 次个人治疗和 14 次小组治疗)。主要结果是治疗后抑郁严重程度的变化,由贝克抑郁量表-II测量。主要疗效检验是 ST 优于 IST。次要检验是 ST 与 CBT 相比的非劣效性。进行了多层次建模。结果:结果:在所有治疗中,ST 并不优于 IST。次要结果分析和完成者分析显示了相似的结果。然而,与 CBT 相比,ST 显示出临床相关的非劣势:作为精神病治疗项目的一部分,ST治疗抑郁症的临床效果不优于CBT,但也不优于IST。ST是对抑郁症治疗的一种潜在有益补充,但其疗效(包括长期疗效)仍有待进一步评估。
{"title":"Effectiveness of Schema Therapy versus Cognitive Behavioral Therapy versus Supportive Therapy for Depression in Inpatient and Day Clinic Settings: A Randomized Clinical Trial.","authors":"Johannes Kopf-Beck, Celina L Müller, Jeanette Tamm, Julia Fietz, Nils Rek, Leah Just, Zoe Ilona Spock, Katharina Weweck, Keisuke Takano, Martin Rein, Martin E Keck, Samy Egli","doi":"10.1159/000535492","DOIUrl":"10.1159/000535492","url":null,"abstract":"<p><strong>Introduction: </strong>Schema therapy (ST) reduces depressive symptoms, but clinical trials have not investigated its effectiveness for patients suffering from severe forms of depression and high rates of comorbidities. There is high demand for exploring and improving treatments for this patient group. The objective of the current study was to evaluate whether ST is more effective than individual supportive therapy (IST) and noninferior compared with cognitive behavioral therapy (CBT) in treating depression.</p><p><strong>Methods: </strong>For this clinical trial, medicated patients were recruited in inpatient and day clinic settings. The major inclusion criteria were age between 18 and 75 years and primary diagnosis of depression without psychotic symptoms. A total of 292 participants were randomized to ST, CBT, or IST and received 7 weeks of psychotherapy (up to 14 individual and 14 group sessions). The primary outcome was change in depression severity after treatment measured by Beck Depression Inventory-II. Primary test for efficacy was superiority of ST over IST. Secondary test was noninferiority of ST compared with CBT. Multilevel modeling was conducted. The results at 6-month follow-up were explored.</p><p><strong>Results: </strong>Across treatment, ST was not superior to IST. Secondary outcome analyses and completer analyses showed similar results. However, ST showed clinically relevant noninferiority compared with CBT.</p><p><strong>Conclusion: </strong>ST for depression as part of a psychiatric care program showed clinical noninferiority compared to CBT, without being superior to IST. ST represents a potentially useful addition to the therapeutic repertoire for the treatment of depression but its efficacy, including long-term efficacy, should be evaluated further.</p>","PeriodicalId":20744,"journal":{"name":"Psychotherapy and Psychosomatics","volume":" ","pages":"24-35"},"PeriodicalIF":22.8,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10880804/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139098465","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}