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BACKGROUND: Eating disorders (EDs), such as (atypical) Anorexia (AN) and Bulimia Nervosa (BN), are difficult to treat, causing socioeconomic impediments. Although enhanced cognitive behavioral therapy (CBT-E) is widely considered clinically effective, it may not be the most beneficial treatment for (atypical) AN and BN patients who do not show a rapid response after the first 4 weeks (8 sessions) of a CBT-E treatment. Alternatively, group schema therapy (GST) may be a valuable treatment for this ED population. Even though GST for EDs has yielded promising preliminary findings, the current body of evidence requires expansion. On top of that, data on cost-effectiveness is lacking. In light of these gaps, we aim to describe a protocol to examine whether GST is more (1) clinically effective and (2) cost-effective than CBT-E for (atypical) AN and BN patients, who do not show a rapid response after the first 4 weeks of treatment. Additionally, we will conduct (3) process evaluations for both treatments. METHODS: Using a multicenter RCT design, 232 Dutch (atypical) AN and BN patients with a CBT-E referral will be recruited from five treatment centers. Clinical effectiveness and cost-effectiveness will be measured before treatment, directly after treatment, at 6 and at 12 months follow-up. In order to rate process evaluation, patient experiences and the degree to which treatments are implemented according to protocol will be measured. In order to assess the quality of life and the achievement of personalized goals, interviews will be conducted at the end of treatment. Data will be analyzed, using a regression-based approach to mixed modelling, multivariate sensitivity analyses and coding trees for qualitative data. We hypothesize GST to be superior to CBT-E in terms of clinical effectiveness and cost-effectiveness for patients who do not show a rapid response to the first 4 weeks of a CBT-E treatment. DISCUSSION: To our knowledge, this is the first study protocol describing a multicenter RCT to explore the three aforementioned objectives. Related risks in performing the study protocol have been outlined. The expected findings may serve as a guide for healthcare stakeholders to optimize ED care trajectories. TRIAL REGISTRATION: clinicaltrials.gov (NCT05812950).
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Trastornos de Alimentación y de la Ingestión de Alimentos , Calidad de Vida , Humanos , Análisis Costo-Beneficio , Terapia de Esquemas , Resultado del Tratamiento , Trastornos de Alimentación y de la Ingestión de Alimentos/terapia , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Multicéntricos como AsuntoRESUMEN
BACKGROUND: Schema therapy is effective for most outpatients with personality disorders (PDs). However, a subgroup does not sufficiently benefit from outpatient programmes. Despite its common clinical use, a thorough evaluation of day treatment group schema therapy (GST) is lacking. AIMS: This study aimed to investigate the effectiveness of day treatment GST for patients with PDs. METHODS AND PROCEDURES: Negative core beliefs were the primary outcome in a multiple baseline single-case design, measured weekly before and during 30 weeks of day treatment GST. Secondary outcomes included severity of primary PD, early maladaptive schemas (EMS), schema modes and general psychopathology measured before and after day treatment GST. Intervention effects were evaluated through visual inspection and randomization test analysis, with a reliable change index calculated for the secondary outcome measures. OUTCOMES AND RESULTS: A total of 79% of treatment completers showed a significant positive effect of day treatment GST with large effect sizes (Cohen's d: 0.96-10.04). Secondary outcomes supported these findings: 56% had a significant decrease in the severity of primary PD and 53% in general psychopathology. In addition, 63% of EMS and 72% of schema modes (87.5% for functional schema modes) showed significant positive reliable changes. CONCLUSIONS AND IMPLICATIONS: This is the first empirical study that demonstrated the effectiveness of day treatment GST in patients with severe PDs. Day treatment GST can serve as a stepped care treatment option for nonresponsive patients in outpatient programmes. Further randomized controlled (cost-)effectiveness research is necessary to substantiate these findings and investigate the specific patient populations for which day treatment is essential.
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Psicoterapia de Grupo , Humanos , Psicoterapia de Grupo/métodos , Terapia de Esquemas , Trastornos de la Personalidad/terapia , Resultado del TratamientoRESUMEN
BACKGROUND: Group schema therapy (GST) is increasingly popular as a treatment for personality disorders (PDs), including Cluster-C PDs. Individual ST has proven to be effective for Cluster-C PD patients, while the evidence for GST is limited. This study aimed to investigate the effectiveness of GST for Cluster-C PD. Moreover, differences between the specific Cluster-C PDs (avoidant PD, dependent PD and obsessive-compulsive PD) were explored. METHODS: A multicentre open trial was conducted, including 137 patients with a Cluster-C PD (avoidant PD: n = 107, dependent PD: n = 11 and obsessive-compulsive PD: n = 19). Patients received 30 weekly GST sessions with a maximum of 180 min of individual ST and five optional monthly booster sessions. Outcome measures including Cluster-C PD severity, general psychopathological symptoms, quality of life, functional impairment, happiness, PD-related beliefs, self-esteem, self-ideal discrepancy, schemas and schema modes were assessed at baseline until 2-year follow-up with semi-structured interviews and self-report measures. Change over time and differences between the specific Cluster-C PDs were analysed with mixed regression analyses. RESULTS: The outcome measures showed significant improvements for all Cluster-C PDs, with medium to large effect sizes after 2 years. A treatment dropout rate of 11.7% was found. There were some indications for differences between the Cluster-C PDs in severity at baseline, change trajectories and effectiveness of GST. CONCLUSIONS: This study demonstrated that GST is a promising treatment for Cluster-C PDs. The following step is a randomized controlled trial to further document the (cost-)effectiveness of GST.
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Psicoterapia de Grupo , Terapia de Esquemas , Humanos , Proyectos Piloto , Calidad de Vida , Trastornos de la Personalidad/terapia , Trastornos de la Personalidad/diagnósticoRESUMEN
BACKGROUND: Adaptive cognitive emotion regulation (CER) strategies toward eating play a very important role in obesity and according to schema therapy, patients with obesity learn that don't respond to their emotional stimuli by eating. Thus, this study aimed to evaluate the effectiveness of an online video-based group schema therapy in improvement of the CER strategies and body mass index (BMI) in women who had undergone bariatric surgery. METHODS: Forty women who had undergone sleeve gastrectomy were selected and randomly divided into two groups of control and experimental. The experimental group received 10 weekly 90-min sessions of group schema therapy, the control group did not receive any intervention at all. Both groups completed the CER strategies questionnaire during pre-test, post-test and follow-up stages, and the data were analyzed using a multivariate analysis of covariance (MANCOVA) through SPSS software (version 20). RESULTS: Our results indicated that the experimental group demonstrated significantly higher adaptive CER strategies (P = 0.0001, F = 31.15) and significantly lower maladaptive CER strategies (P = 0.001, F = 9.42), significantly lower BMI (P = 0.001, F = 23.48), as compared to the control condition, following the group schema therapy after the follow-up stage. CONCLUSION: The findings demonstrated that group schema therapy could lead to an increases in adaptive CER strategies and a decrease in maladaptive CER strategies and BMI in women who had undergone bariatric surgery. TRIAL REGISTRATION: IRCT, IRCT20180523039802N2. Registered 5 August 2020, http://www.irct.com/IRCT20180523039802N2 .
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Cirugía Bariátrica , Regulación Emocional , Femenino , Humanos , Cognición/fisiología , Obesidad/cirugía , Terapia de EsquemasRESUMEN
BACKGROUND: Cluster-C personality disorders (PDs), characterized by a high level of fear and anxiety, are related to high levels of distress, societal dysfunctioning and chronicity of various mental health disorders. Evidence for the optimal treatment is extremely scarce. Nevertheless, the need to treat these patients is eminent. In clinical practice, group therapy is one of the frequently offered approaches, with two important frameworks: schema therapy and psychodynamic therapy. These two frameworks suggest different mechanisms of change, but until now, this has not yet been explored. The purpose of the present G-FORCE trial is to find evidence on the differential (cost)effectiveness of two forms of schema group therapy and psychodynamic group therapy in the routine clinical setting of an outpatient clinic and to investigate the underlying working mechanisms and predictors of outcome of these therapies. METHODS: In this mono-centre pragmatic randomized clinical trial, 290 patients with Cluster-C PDs or other specified PD with predominantly Cluster-C traits, will be randomized to one of three treatment conditions: group schema therapy for Cluster-C (GST-C, 1 year), schema-focused group therapy (SFGT, 1.5 year) or psychodynamic group therapy (PG, 2 years). Randomization will be pre-stratified on the type of PD. Change in severity of PD (APD-IV) over 24 months will be the primary outcome measure. Secondary outcome measures are personality functioning, psychiatric symptoms and quality of life. Potential predictors and mediators are selected and measured repeatedly. Also, a cost-effectiveness study will be performed, primarily based on a societal perspective, using both clinical effects and quality-adjusted life years. The time-points of assessment are at baseline, start of treatment and after 1, 3, 6, 9, 12, 18, 24 and 36 months. DISCUSSION: This study is designed to evaluate the effectiveness and cost-effectiveness of three formats of group psychotherapy for Cluster-C PDs. Additionally, predictors, procedure and process variables are analysed to investigate the working mechanisms of the therapies. This is the first large RCT on group therapy for Cluster-C PDs and will contribute improving the care of this neglected patient group. The absence of a control group can be considered as a limitation. TRIAL REGISTRATION: CCMO, NL72826.029.20 . Registered on 31 August 2020, first participant included on 18 October 2020.
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Psicoterapia de Grupo , Terapia de Esquemas , Humanos , Calidad de Vida/psicología , Psicoterapia de Grupo/métodos , Trastornos de la Personalidad/diagnóstico , Trastornos de la Personalidad/terapia , Trastornos de la Personalidad/psicología , Trastornos de Ansiedad , Resultado del Tratamiento , Psicoterapia/métodos , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
BACKGROUND: Given the high prevalence of Cluster-C Personality Disorders (PDs) in clinical populations, disease burden, high societal costs and poor prognosis of comorbid disorders, a major gain in health care can be achieved if Cluster-C PDs are adequately treated. The only controlled cost-effectiveness study published so far found Individual Schema Therapy (IST) to be superior to Treatment as Usual (TAU). Group ST (GST) might improve cost-effectiveness as larger numbers can be treated in (>50%) less time compared to IST. However, to date there is no RCT supporting its (cost-) effectiveness. The overall aim of this study is to assess the evidence for GST for Cluster-C PDs and to improve treatment allocation for individual patients. Three main questions are addressed: 1) Is GST for Cluster-C PDs (cost-)effective compared to TAU? 2) Is GST for Cluster-C PDs (cost-) effective compared to IST? 3) Which patient-characteristics predict better response to GST, IST, or TAU? METHODS: In a multicenter RCT, the treatment conditions GST, IST, and TAU are compared in 378 Cluster-C PD patients within 10 sites. GST and IST follow treatment protocols and are completed within 1 year. TAU is the optimal alternative treatment available at the site according to regular procedures. Severity of the Cluster-C PD is the primary outcome, assessed with clinical interviews by independent raters blind for treatment. Functioning and wellbeing are important secondary outcomes. Assessments take place at week 0 (baseline), 17 (mid-GST), 34 (post-GST), 51 (post-booster sessions of GST), and 2 years (FU). Patient characteristics predicting better response to a specific treatment are studied, e.g., childhood trauma, autistic features, and introversion. A tool supporting patients and clinicians in matching treatment to patient will be developed. An economic evaluation investigates the cost-effectiveness and cost-utility from a societal perspective. A process evaluation by qualitative methods explores experiences of participants, loved ones and therapists regarding recovery, quality of life, and improving treatment. DISCUSSION: This study will determine the (cost-)effectiveness of treatments for Cluster-C PDs regarding treatment type as well as optimal matching of patient to treatment and deliver insight into which aspects help Cluster-C-PD patients recover and create a fulfilling life. TRIAL REGISTRATION: Dutch Trial Register: NL9209 . Registered on 28-01-2021.
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Psicoterapia de Grupo , Terapia de Esquemas , Análisis Costo-Beneficio , Humanos , Estudios Multicéntricos como Asunto , Trastornos de la Personalidad/terapia , Psicoterapia de Grupo/métodos , Calidad de Vida , Resultado del TratamientoRESUMEN
This article presents an adaptation of group schema therapy (GST) developed for patients with severe anxiety. An anonymized case presentation exemplifies the adaptation. GST was originally developed to treat clients with maladaptive personality traits but has been applied to a variety of disorders in recent years. For patients with severe anxiety, who have not responded to other treatments, GST may be a promising approach. The paper presents the GST model, the evidence supporting it, and its adaptation for the treatment of anxiety. The case presentation illustrates the therapeutic process and GST interventions. Finally, the clinical outcome and the implications for implementing GST are discussed.
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Psicoterapia de Grupo , Terapia de Esquemas , Trastornos de Ansiedad/terapia , Humanos , PsicoterapiaRESUMEN
This article presents a clinical illustration of group schema therapy (GST) for cluster-C personality disorders (CL-C PDs) to provide therapists an example on how one can perform GST for CL-C PDs and break through persistent avoidance and control mechanisms. A summary of evidence supporting the effectiveness of GST for CL-C PD's is given followed by an overview of basic principles of schema therapy and GST. A case presentation next illustrates the application of GST principles and interventions in the GST CL-C protocol, which improve clients understanding of emotional core needs and development of adaptive ways of getting needs better met, instead of avoiding life. Implications of the case for future applications of GST for CL-C PDs are discussed.
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Trastornos de la Personalidad/clasificación , Trastornos de la Personalidad/terapia , Psicoterapia de Grupo , Terapia de Esquemas , Adulto , Reacción de Prevención , Humanos , Masculino , Trastornos de la Personalidad/psicologíaRESUMEN
BACKGROUND: Recent research has supported the efficacy of schema therapy as a treatment for personality disorders. A group format has been developed (group schema therapy; GST), which has been suggested to improve both the clinical and cost-effectiveness of the treatment. AIMS: Efficacy studies of GST need to assess treatment fidelity. The aims of the present study were to improve, describe and evaluate a fidelity measure for GST, the Group Schema Therapy Rating Scale - Revised (GSTRS-R). METHOD: Following a pilot study on an initial version of the scale (GSTRS), items were revised and guidelines were modified in order to improve the reliability of the scale. Students highly experienced with the scale rated recorded GST therapy sessions using the GSTRS-R in addition to a group cohesion measure, the Harvard Community Health Plan Group Cohesiveness Scale - II (GCS-II). The scores were used to assess internal consistency and inter-rater reliability. Discriminant validity was assessed by comparing the scores on the GSTRS-R with the GCS-II. RESULTS: The GSTRS-R displayed substantial internal consistency and inter-rater reliability, and adequate discriminate validity, evidenced by a weak positive correlation with the GCS-II. CONCLUSIONS: Overall, the GSTRS-R is a reliable tool that may be useful for evaluating therapist fidelity to GST model, and assisting GST training and supervision. Initial validity was supported by a weak association with GCS-II, indicating that although associated with cohesiveness, the instrument also assesses factors specific to GST. Limitations are discussed.
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Trastornos de la Personalidad/psicología , Trastornos de la Personalidad/terapia , Terapia Psicoanalítica/normas , Psicometría , Psicoterapia de Grupo/normas , Adolescente , Adulto , Anciano , Humanos , Persona de Mediana Edad , Estudios Multicéntricos como Asunto , Proyectos Piloto , Ensayos Clínicos Controlados Aleatorios como Asunto , Reproducibilidad de los Resultados , Adulto JovenRESUMEN
BACKGROUND: Social anxiety disorder (SAD) with comorbid avoidant personality disorder (APD) has a high prevalence and is associated with serious psychosocial problems and high societal costs. When patients suffer from both SAD and APD, the Dutch multidisciplinary guidelines for personality disorders advise offering prolonged cognitive behavioral therapy (CBT). Recently there is increasing evidence for the effectiveness of schema therapy (ST) for personality disorders such as borderline personality disorder and cluster C personality disorders. Since ST addresses underlying personality characteristics and maladaptive coping strategies developed in childhood, this treatment might be particularly effective for patients with SAD and comorbid APD. To our knowledge, there are no studies comparing CBT with ST in this particular group of patients. This superiority trial aims at comparing the effectiveness of these treatments. As an additional goal, predictors and underlying mechanisms of change will be explored. METHODS/DESIGN: The design of the study is a multicentre two-group randomized controlled trial (RCT) in which the treatment effect of group cognitive behavioral therapy (GCBT) will be compared to that of group schema therapy (GST) in a semi-open group format. A total of 128 patients aged 18-65 years old will be enrolled. Patients will receive 30 sessions of GCBT or GST during a period of approximately 9 months. Primary outcome measures are the Liebowitz Social Anxiety Scale Self-Report (LSAS-SR) for social anxiety disorder and the newly developed Avoidant Personality Disorder Severity Index (AVPDSI) for avoidant personality disorder. Secondary outcome measures are the MINI section SAD, the SCID-II section APD, the Schema Mode Inventory (SMI-2), the Inventory of Depressive Symptomatology Self-Report (IDS-SR), the World Health Organization Quality of Life-BREF (WHOQOL-BREF), the Difficulties in Emotion Regulation Scale (DERS), the Rosenberg Self-Esteem Scale (RSES) and the Acceptance and Action Questionnaire (AAQ-II). Data will be collected at the start, halfway and at the end of the treatment, followed by measurements at 3, 6 and 12 months post-treatment. DISCUSSION: The trial will increase our knowledge on the effectiveness and applicability of both treatment modalities for patients suffering from both diagnoses. TRIAL REGISTRATION: Dutch Trial Register: NTR3921 . Registered on 25 March 2013.