Individual-level associations between implementation leadership, climate, and anticipated outcomes: a time-lagged mediation analysis.

BACKGROUND: Leaders can improve implementation outcomes by developing an organizational climate conducive to the implementation of evidence-based practices (EBP). This study tested the lagged associations between individual-level perceptions of implementation leadership, implementation climate, and three anticipated implementation outcomes, that is EBP acceptability, appropriateness, and feasibility. METHODS: Screening tools and treatment methods for posttraumatic stress disorder were implemented in 43 Norwegian mental health services. A sample of 494 child and adult mental health care professionals (M = 43 years, 78% female) completed surveys addressing perceptions of first-level leaders' (n = 47) implementation leadership and their clinics' implementation climate. Single-level structural equation models estimating both direct, indirect, and total effects were used to investigate whether perceived implementation climate mediated the association between perceived implementation leadership and perceived acceptability, appropriateness, and feasibility of screening tools and treatment methods. RESULTS: Regarding the treatment methods, implementation leadership was associated with therapists' perceptions of acceptability, appropriateness, and feasibility. Implementation climate also mediated between implementation leadership and the outcomes. Regarding the screening tools, implementation leadership was not associated with the outcomes. However, implementation climate mediated between implementation leadership and therapists' perceptions of acceptability and feasibility, but not appropriateness. Analyses with the implementation climate subscales showed stronger associations for therapists' perceptions of the treatment methods than of screening tools. CONCLUSIONS: Leaders may promote positive implementation outcomes, both directly and through implementation climate. With regard to the effect sizes and explained variance, results indicated that both implementation leadership and implementation climate were more strongly associated with the therapists' perceptions of the treatment methods, implemented by one group of therapists, than the screening tools, implemented by all therapists. This may imply that implementation leadership and climate may have stronger effects for smaller implementation teams within a larger system than for system-wide implementations or when the clinical interventions being implemented are more complex rather than simple ones. TRIAL REGISTRATION: ClinicalTrials NCT03719651, 25 October 2018.

Implementation of evidence-based treatment for PTSD in Norway: clinical outcomes and impact of probable complex PTSD.

Background: Posttraumatic stress disorder (PTSD) is a long-lasting and debilitating psychological disorder that affects a large portion of the population. Treatments such as Cognitive therapy for PTSD (CT-PTSD) and Eye movement desensitization and reprocessing (EMDR) have been shown to be effective and cost-efficient in clinical trials, but uptake and evidence of positive outcomes in real-world clinical services are limited. Implementation efforts have been hampered by providers' concerns about the feasibility of trauma-focused treatments in more complex presentations (i.e. Complex PTSD). Objective: To evaluate the effectiveness of CT-PTSD and EMDR in a real-world setting, as implemented in Norwegian outpatient mental health clinics for adults, and investigate the impact of probable Complex PTSD status on treatment outcomes. Methods: Clinicians from 15 different outpatient clinics received training and supervision in EMDR or CT-PTSD as part of a national implementation project. 104 clinicians recruited and treated 196 participants with PTSD. Symptoms of PTSD, depression and anxiety were assessed session-by-session and used to estimate pre-post effect sizes. Mixed-models were employed to investigate the impact of complex PTSD. Results: Both EMDR and CT-PTSD were associated with significant reductions in PTSD symptoms, with large effect sizes. Probable Complex PTSD was associated with higher levels of symptoms before and after treatment but did not significantly impact the effectiveness of treatment. Conclusion: The use of evidence-based treatments for PTSD in routine clinical service is associated with good treatment outcomes, also for patients with Complex PTSD.

Antecedentes: El trastorno de estrés postraumático (TEPT) es un trastorno psicológico duradero y debilitante que afecta a una gran parte de la población. Se ha mostrado que los tratamientos como la Terapia cognitiva para el TEPT (CT-PTSD en su sigla en inglés) y la Desensibilización y Reprocesamiento por Movimiento ocular (EMDR en su sigla en inglés) son efectivos y rentables en ensayos clínicos, pero la uso y la evidencia de resultados positivos en los servicios clínicos del mundo real son limitadas. Los esfuerzos de implementación se han visto obstaculizados por las preocupaciones de los proveedores sobre la viabilidad de los tratamientos centrados en el trauma en presentaciones más complejas (es decir, TEPT complejo).Objetivo: Evaluar la efectividad de CT-PTSD y EMDR en un entorno del mundo real, tal como se implementa en las clínicas noruegas de salud mental ambulatorias para adultos, e investigar el impacto del probable TEPT complejo en los resultados del tratamiento.Métodos: Los clínicos de 15 clínicas ambulatorias diferentes recibieron capacitación y supervisión en EMDR o CT-PTSD como parte de un proyecto de implementación nacional. 104 clínicos reclutaron y trataron a 196 participantes con TEPT. Los síntomas de TEPT, depresión y ansiedad se evaluaron sesión a sesión y se usaron para estimar los tamaños del efecto antes y después. Se emplearon modelos mixtos para investigar el impacto del TEPT complejo.Resultados: Tanto EMDR como CT-PTSD se asociaron con reducciones significativas en los síntomas de TEPT, con tamaño de los efectos de gran magnitud. El TEPT complejo probable se asoció con niveles más altos de síntomas antes y después del tratamiento, pero no tuvo un impacto significativo en la efectividad del tratamiento.Conclusión: El uso de tratamientos basados ⁣⁣en la evidencia para el TEPT en el servicio clínico de rutina se asocia con buenos resultados del tratamiento, también para pacientes con TEPT complejo.

Group treatment for complex dissociative disorders: a randomized clinical trial.

BACKGROUND: Patients with complex dissociative disorders (CDD) report high levels of childhood- abuse experiences, clinical comorbidity, functional impairment, and treatment utilization. Although a few naturalistic studies indicate that these patients can benefit from psychotherapy, no randomized controlled trials have been reported with this patient-group. The current study evaluates a structured protocolled group treatment delivered in a naturalistic clinical setting to patients with CDD, as an add-on to individual treatment. METHODS: Fifty nine patients with CDD were randomized to 20 sessions of stabilizing group-treatment, conjoint with individual therapy, or individual therapy alone, in a delayed-treatment design. The treatment was based on the manual Coping with Trauma-Related Dissociation. The primary outcome was Global Assessment of Functioning (GAF), while secondary outcomes were PTSD and dissociative symptoms, general psychopathology, and interpersonal difficulties. RESULTS: Mixed effect models showed no condition x time interaction during the delayed treatment period, indicating no immediate differences between conditions in the primary outcome. Similar results were observed for secondary outcomes. Within-group effects were non-significant in both conditions from baseline to end of treatment, but significant improvements in psychosocial function, PTSD symptoms, and general psychopathology were observed over a 6-months follow-up period. CONCLUSION: In the first randomized controlled trial for the treatment of complex dissociative disorders, stabilizing group treatment did not produce immediate superior outcomes. Treatment was shown to be associated with improvements in psychological functioning. TRIAL REGISTRATION: Clinical Trials ( NCT02450617 ).

A stepped-wedge randomized trial investigating the effect of the Leadership and Organizational Change for Implementation (LOCI) intervention on implementation and transformational leadership, and implementation climate.

BACKGROUND: This study evaluates the Leadership and Organizational Change for Implementation (LOCI) strategy and its effect on implementation leadership, transformational leadership, and implementation climate. METHODS: A stepped wedge cluster randomized study design enrolling 47 first-level leaders from child- and adult-specialized mental health clinics within Norwegian health trusts across three cohorts. All therapists (n = 790) received training in screening of trauma exposure and posttraumatic stress, and a subgroup of therapists (n = 248) received training in evidence-based treatment methods for posttraumatic stress disorder (PTSD). First-level leaders and therapists completed surveys at baseline, 4, 8-, 12-, 16-, and 20-months assessing leadership and implementation climate. General linear mixed-effects models were used to investigate whether the LOCI strategy would lead to greater therapist-rated scores on implementation leadership, transformational leadership, and implementation climate. RESULTS: After introducing the LOCI strategy, there was a significant increase in therapist-rated implementation and transformational leadership and implementation climate. The increase was sustained at all measurement time points compared to non-LOCI conditions, which demonstrated a steady decrease in scores before LOCI. CONCLUSIONS: The LOCI strategy can develop better transformational and implementation leadership skills and contribute to a more positive implementation climate, which may enhance successful EBP implementation. Thus, LOCI can help leaders create an organizational context conducive for effective EBP implementation. TRIAL REGISTRATION: Retrospectively registered: ClinicalTrials NCT03719651 , 25th of October 2018. The trial protocol can be accessed from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6417075/ .

Stabilizing group treatment for childhood-abuse related PTSD: a randomized controlled trial.

Background: Patients with PTSD related to childhood-abuse often experience additional problems such as emotional dysregulation and interpersonal difficulties. Psychotherapy focused on stabilization of symptoms, emotion-regulation, and skills training has been suggested as a treatment for this patient population, either as preparation for further treatment or as a stand-alone intervention. Objective: The present study tests the efficacy of treatment using a group-protocol for stabilizing treatment delivered adjunct with conventional individual therapy. Methods: In a delayed-treatment design with switching replication, a clinically representative sample of 89 patients with PTSD and histories of childhood abuse were randomly assigned to either 20-week stabilizing group treatment or a corresponding waiting-period, both adjunct with conventional individual therapy. After the waiting-period, patients in the control condition were offered group treatment. The primary outcome was psychosocial functioning, measured with interview - assessed Global Assessment of Functioning (GAF), while secondary outcome was self-reported PTSD symptoms. These were measured before treatment, after treatment and at 6 months follow up. The trial was preregistered at Clinical Trials (NCT02450617). Results: We found large within-group effect sizes in both conditions on GAF and moderate effects on PTSD symptoms. Linear mixed-models did not indicate significant differences in treatment trajectories between conditions. Conclusion: Stabilizing group treatment focused on emotional-regulation and skills-training does not improve outcomes beyond individual-treatment alone, and should not be recommended as first-line treatment for this patient-group.

Antecedentes: Los pacientes con trastorno de estrés postraumático (TEPT) asociado a abuso infantil con frecuencia experimentan problemas adicionales como desregulación emocional y dificultades interpersonales. Se ha propuesto a la psicoterapia enfocada en la estabilización de síntomas, la regulación emocional y el entrenamiento en habilidades como un tratamiento para esta población de pacientes, tanto como preparación para algún tratamiento adicional o como una intervención única.Objetivo: Este estudio evalúa la eficacia del tratamiento empleando un protocolo grupal para estabilización realizado junto con la terapia individual convencional.Métodos: El estudio contó con un diseño de inicio retrasado del tratamiento con entrecruzamiento de grupos. Los participantes de una muestra clínicamente representativa de 89 pacientes con TEPT y antecedente de abuso infantil fueron aleatorizados ya sea a un tratamiento grupal para estabilización de 20 semanas o a un tiempo de espera de igual duración. Ambos grupos recibieron terapia individual convencional. Luego del tiempo de espera, a los pacientes en el grupo de control se les ofreció el tratamiento grupal. El resultado principal fue el funcionamiento psicosocial, medido en una entrevista empleando la Evaluación Global de Funcionamiento (GAF, por sus siglas en inglés). El resultado secundario fueron los síntomas del TEPT auto-reportados. Estos fueron medidos antes del tratamiento, después del tratamiento y a los 6 meses de seguimiento. El ensayo clínico fue pre-registrado en "Clinical Trials" (NCT02450617).Resultados: Encontramos tamaños del efecto grandes dentro de los grupos en ambas condiciones con la GAF; además, encontramos tamaños del efecto moderados para los síntomas del TEPT. Los modelos mixtos lineales no mostraron diferencias significativas en las trayectorias del tratamiento entre ambas condiciones.Conclusiones: El tratamiento grupal para estabilización enfocado en la regulación emocional y en el entrenamiento de habilidades no mejoró los resultados clínicos más allá del tratamiento individual como monoterapia y no debería ser recomendado como un tratamiento de primera línea para este grupo de pacientes.

Psychometric properties of the International Trauma Questionnaire (ITQ) examined in a Norwegian trauma-exposed clinical sample.

BACKGROUND: The International Trauma Questionnaire (ITQ) is a self-report measure for post-traumatic stress disorder (PTSD) and complex post-traumatic stress disorder (CPTSD), corresponding to the diagnostic criteria in the International Classification of Diseases, 11th Revision (ICD-11). A 12-item version of the ITQ based on samples from English-speaking countries has been presented, and the wider generalizability to other languages needs to be examined. OBJECTIVE: The current study examines the psychometric properties of scores from a longer, preliminary 22-item version of the ITQ and the current reduced 12-item version by means of generalizability theory (G-theory) and confirmatory factor analysis (CFA). METHOD: The 22-item version of the ITQ was translated into Norwegian and administered to patients in two trauma treatment trials (total N = 202). A generalizability study was used to investigate the psychometric properties of scores reflecting CPTSD. G-theory was also used to investigate alternative measurement designs to optimize the sufficient number of items that provide acceptable generalizability and dependability of scores. Model fit to the theoretical factor structure was then examined by CFA, both for the 22-item version and for the 12-item version of the ITQ. RESULTS: The two subscales negative self-concept and relational disturbances had acceptable generalizability coefficients. We found substantial measurement error related to affective dysregulation, mainly attributable to affective hyperactivation. A latent factor structure model with two separate affective dysregulation factors: hyperactivation and deactivation, represented the data well in the 22-item version. The proposed confirmatory structure model for the 12-item short form did not converge in the CFA. CONCLUSION: This study supports the applicability of the ITQ in a non-English-speaking country and provides support for the validity of the Norwegian translation. Further research is needed to improve the psychometric properties of the affective dysregulation subscale.

Antecedentes: El Cuestionario Internacional de Trauma (ITQ en su sigla en inglés) es una medida de autoreporte para el trastorno de estrés postraumático (TEPT) y el trastorno de estrés postraumático complejo (TEPT-C), que corresponde a los criterios de diagnóstico de la CIE-11. Recientemente, se presentó una versión de ITQ de 12 ítems basada en muestras de países de habla inglesa, y es necesario examinar la posibilidad de generalización a otros idiomas.Objetivo: El presente estudio examina las propiedades psicométricas de los puntajes de una versión preliminar más larga de 22 ítems del ITQ y la versión reducida actual de 12 ítems por medio de la Teoría de la Generalización (TG) y el Análisis Factorial Confirmatorio (AFC).Método: La versión de 22 ítems de ITQ fue traducida al noruego y fue administrada a los pacientes en dos ensayos de tratamiento de trauma (total N = 202). Se usó un estudio de Generalización para investigar las propiedades psicométricas de las puntuaciones que reflejan el TEPT-C. La TG también se usó para investigar los diseños de medición alternativos para optimizar el número de ítems suficientes para proporcionar una generalización y confiabilidad aceptables de los puntajes. El ajuste del modelo a la estructura factorial teórica se examinó mediante un análisis factorial confirmatorio, tanto para la versión de 22 ítems como para la versión de 12 ítems del ITQ.Resultados: Las dos subescalas de autoconcepto negativo y la de perturbación en las relaciones tenían coeficientes de generalización aceptables. Encontramos un error de medición sustancial relacionado con la desregulación afectiva, principalmente atribuible a la hiperactivación afectiva. Un modelo de estructura factorial latente con dos factores de desregulación afectiva separados, hiperactivación y desactivación, representó bien los datos en la versión de 22 ítems. El modelo de estructura confirmatoria propuesto para el formato corto de 12 ítems no convergió en el análisis AFC.Conclusión: El presente estudio respalda la aplicabilidad de ITQ en un país de habla no inglesa, y brinda soporte para la validez de la traducción al noruego. Se necesita más investigación para mejorar las propiedades psicométricas de la subescala de desregulación afectiva.

Testing the leadership and organizational change for implementation (LOCI) intervention in Norwegian mental health clinics: a stepped-wedge cluster randomized design study protocol.

BACKGROUND: Alignment across levels of leadership within an organization is needed for successful implementation of evidence-based practice. The leadership and organizational change for implementation (LOCI) intervention is a multi-faceted multilevel implementation strategy focusing on enhancing first-level general and implementation leadership while also engaging with organization upper management to develop an organizational climate for implementation. The aim of the project is to evaluate the effectiveness of LOCI in supporting the implementation of evidence-based treatment for PTSD in child- and adult-specialized mental health clinics in health trusts in Norway. METHODS: The study design is a stepped-wedge cluster randomized trial with enrollment of clinics in three cohorts. Executives, clinic leaders, and therapists will be asked to complete surveys assessing leadership and implementation climate. Surveys will be completed at baseline, 4, 8, 12, 16, and 20 months. Results from surveys will be shared with executives and clinic leaders to inform the subsequent creation of tailored leadership and climate development plans for enhanced implementation. Patients will complete surveys measuring traumatic events and post-traumatic stress symptoms during the therapy process. Therapy sessions will be audio or video recorded and scored for fidelity as part of training. DISCUSSION: This study aims to provide knowledge on how to improve leadership and organizational climate to enhance effective implementation of evidence-based treatments in mental health services. TRIAL REGISTRATION: The study has been registrated in ClinicalTrials with ID NCT03719651 .

Trauma-related altered states of consciousness in post-traumatic stress disorder patients with or without comorbid dissociative disorders.

Background: The four-dimensional ('4-D') model has been proposed as a theoretical framework to understand and delineate trauma-related dissociative experiences, categorizing symptoms into trauma-related altered states of consciousness (TRASC) and normal waking consciousness (NWC), which occur along four dimensions: time, thought, body and emotion. Objective: The main aim of the present study was to evaluate the validity of this model in patients with post-traumatic stress disorder (PTSD), with and without comorbid dissociative disorders. Method: The predictions of the 4-D model were tested in 142 patients with PTSD, with (N = 46) and without (N = 96) comorbid dissociative disorders. Results: As predicted by the 4-D model, experiences of TRASC were less frequent and more specifically related to other measures of dissociation, dissociative disorder comorbidity and a history of childhood sexual abuse compared to experiences of NWC. The predicted lower intercorrelation of TRASC was not supported. Conclusion: The 4-D model represents a promising framework for understanding dissociation across trauma-related disorders.

Antecedentes: El 'modelo 4-D' ha sido propuesto como un marco teórico para entender y delinear las experiencias disociativas relacionadas al trauma, categorizando los síntomas en estados alterados de conciencia relacionados al trauma (TRASC en su sigla en inglés) y la conciencia en vigilia normal (NWC en sus siglas en inglés), que ocurren a lo largo de cuatro dimensiones: (1) tiempo; (2) pensamiento; (3) cuerpo; y (4) emoción. El principal objetivo del presente estudio fue evaluar la validez de este modelo en pacientes con Trastorno de Estrés Postraumático (TEPT), con y sin trastornos disociativos comórbidos.Métodos: Los predictores del modelo 4-D fueron probados en 142 pacientes con TEPT, con (N=46) y sin (N=96) trastornos disociativos comórbidos.Resultados: Como predice el modelo 4-D, las experiencias de los TRASC fueron menos frecuentes y más específicamente relacionados a otras medidas de disociación, comorbilidad del trastorno disociativo y una historia de abuso sexual infantil en comparación a las experiencias de NWC. La predicción de la intercorrelación más baja de los TRASC no fue confirmada.Conclusión: El modelo 4-D representa un prometedor marco para el entendimiento de la disociación de forma transversal en los trastornos relacionados al trauma.