Adaptive design trials in eating disorder research: A scoping review.

OBJECTIVE: This scoping review sought to map the breadth of literature on the use of adaptive design trials in eating disorder research. METHOD: A systematic literature search was conducted in Medline, Scopus, PsycInfo, Emcare, Econlit, CINAHL and ProQuest Dissertations and Theses. Articles were included if they reported on an intervention targeting any type of eating disorder (including anorexia nervosa, bulimia nervosa, binge-eating disorder, and other specified feeding or eating disorders), and employed the use of an adaptive design trial to evaluate the intervention. Two independent reviewers screened citations for inclusion, and data abstraction was performed by one reviewer and verified by a second. RESULTS: We identified five adaptive design trials targeting anorexia nervosa, bulimia nervosa and binge-eating disorder conducted in the USA and Australia. All employed adaptive treatment arm switching based on early response to treatment and identified a priori stopping rules. None of the studies included value of information analysis to guide adaptive design decisions and none included lived experience perspectives. DISCUSSION: The limited use of adaptive designs in eating disorder trials represents a missed opportunity to improve enrolment targets, attrition rates, treatment outcomes and trial efficiency. We outline the range of adaptive methodologies, how they could be applied to eating disorder research, and the specific operational and statistical considerations relevant to adaptive design trials. PUBLIC SIGNIFICANCE: Adaptive design trials are increasingly employed as flexible, efficient alternatives to fixed trial designs, but they are not often used in eating disorder research. This first scoping review identified five adaptive design trials targeting anorexia nervosa, bulimia nervosa and binge-eating disorder that employed treatment arm switching adaptive methodology. We make recommendations on the use of adaptive design trials for future eating disorder trials.

OBJETIVO: Esta revisión exploratoria buscó mapear el alcance de la literatura sobre el uso de ensayos de diseño adaptativo en la investigación de trastornos de conducta alimentaria. MÉTODO: Se realizó una búsqueda sistemática de literatura en Medline, Scopus, PsycInfo, Econlit y CINAHL. Se incluyeron artículos que informaban sobre una intervención dirigida a cualquier tipo de trastorno de conducta alimentaria (incluyendo anorexia nerviosa, bulimia nerviosa, trastorno por atracón y otros trastornos de la conducta alimentaria o de la ingestión de alimentos especificados) y empleaban el uso de un ensayo de diseño adaptativo para evaluar la intervención. Dos revisores independientes examinaron las citas para su inclusión, y la abstracción de datos fue realizada por un revisor y verificada por otro. RESULTADOS: Identificamos cinco ensayos de diseño adaptativo dirigidos a la anorexia nerviosa, bulimia nerviosa y trastorno por atracón realizados en Estados Unidos y Australia. Todos emplearon el cambio adaptativo de brazo de tratamiento basado en la respuesta temprana al tratamiento e identificaron reglas de detención a priori. Ninguno de los estudios incluyó análisis del Valor de la Información para guiar las decisiones de diseño adaptativo y ninguno incluyó perspectivas de experiencia vivida. DISCUSIÓN: El uso limitado de diseños adaptativos en ensayos de trastornos de conducta alimentaria representa una oportunidad perdida para mejorar los objetivos de reclutamiento, tasas de deserción, resultados del tratamiento y eficiencia del ensayo. Esbozamos la gama de metodologías adaptativas, cómo podrían aplicarse a la investigación de trastornos de conducta alimentaria, y las consideraciones operativas y estadísticas específicas relevantes para los ensayos de diseño adaptativo. PÚBLICA SIGNIFICANCIA: Los ensayos de diseño adaptativo se emplean cada vez más como alternativas flexibles y eficientes a los diseños de ensayos fijos, pero no se utilizan con frecuencia en la investigación de trastornos de conducta alimentaria. Esta primera revisión exploratoria identificó cinco ensayos de diseño adaptativo dirigidos a la anorexia nerviosa, bulimia nerviosa y trastorno por atracón que emplearon la metodología adaptativa de cambio de brazo de tratamiento. Hacemos recomendaciones sobre el uso de ensayos de diseño adaptativo para futuros ensayos de trastornos de conducta alimentaria.

Lived experience perspectives on eating disorder research: The use of adaptive trials and research priorities.

OBJECTIVE: This novel study sought to understand lived experience and carer perspectives on the use of adaptive trials to evaluate interventions for eating disorders, in addition to understanding the factors and outcomes of most importance in eating disorder research and treatments from a lived experience perspective. METHOD: A total of 73 people with either lived or carer experience consented, 70 started the questionnaire, and 36 (51%) completed all questions. Participants were asked Likert scale and open-ended questions to understand what factors and outcomes of eating disorder interventions were most important to them and understand their pre-existing knowledge of clinical trials. Two videos were then used to explain randomized controlled trials (RCTs) and adaptive trials and participants were asked their opinions, including perceived benefits and concerns, of each trial type. RESULTS: The thematic analysis found two key themes regarding factors important in eating disorder treatment: Person-centred care and Evidence-based and effective treatment; and two key themes regarding outcomes of treatment: Sustained, full recovery and The bigger picture. Both RCTs and adaptive trials were viewed favorably, however, there was a slight preference for adaptive trials. Key themes for both demonstrated perceived benefits and ethical, practical, and scientific considerations unique to each. DISCUSSION: Findings demonstrate the support of adaptive trials in eating disorder interventions from people with lived experience and their carers. It is recommended that researchers consider the use of adaptive designs and the incorporation of lived experience perspectives when designing future intervention trials. PUBLIC SIGNIFICANCE: This novel study found that the use of adaptive trials in eating disorder intervention research is supported by people with lived experience and carers. Furthermore, the factors and outcomes of most importance to participants in this study are comparable to those previously identified in the emerging literature. The use of adaptive designs and the incorporation of lived experience are recommended in further clinical trials.

Developing a definition of body neutrality and strategies for an intervention.

The aim of this study was to provide a definition for body neutrality and understand the key strategies recommended to improve body neutrality for testing in future interventions. There is minimal academic literature on body neutrality and thus this study focused on examining websites where the concept has been discussed for some time. This was achieved using a realist synthesis of websites and a common elements approach to extract the key definition elements of body neutrality, strategies to improve body neutrality, in addition to the common critiques of both the body positivity and body neutrality movements. The initial search found 175 websites, of which 107 were included in the final synthesis, and common elements analysis followed after removal of duplicates and ineligible websites. Three elements, with several sub-elements, best operationalised the definition of body neutrality. Six strategies were found for development of a body neutrality intervention. This innovative study paves the way for rigorous evaluation of body neutrality. Recommendations for future work are provided, including the use of current measures, creating a new measure, and evaluating prevention and intervention programs including Single Session Interventions (SSIs).

The effectiveness of lived experience involvement in eating disorder treatment: A systematic review.

OBJECTIVE: This systematic review sought to understand the effectiveness of lived experience mentoring, by people recovered from an eating disorder, with clinical samples currently receiving eating disorder treatment. METHODS: The systematic review was conducted using PsycINFO, MEDLINE, Scopus, and ProQuest Dissertations and Theses Global and reviewing reference lists of included papers. Articles were included if they: (1) were intervention studies that included peer (recovered from an eating disorder) involvement, (2) delivered the intervention to clinical samples (or carers with direct involvement in treatment), (3) were in English, and (4) included quantitative results. RESULTS: Eleven studies were included across randomized control trials (RCTs), case series, and a case study; there was variation in quality. Findings varied considerably with some concluding that lived experience mentoring led to significant improvements for mentees, while other studies found no significant differences. Mentor outcomes were often not evaluated. Of those that did assess mentors, there is preliminary evidence for some benefits to participation but also the potential for harm. DISCUSSION: There is a need for further research in this area using high-quality RCTs that address the risk of bias. It is important that lived experience peer mentors are monitored on key outcomes, provided with adequate training and ongoing supervision, and are reimbursed for their involvement. PUBLIC SIGNIFICANCE: This systematic review is the first review to focus on the use of peer mentors recovered from an eating disorder contributing to interventions for people receiving treatment for an eating disorder. All included studies present quantitative results. Given the emerging interest of lived experience mentoring, understanding its effectiveness for both mentees and impacts on mentors continues to be of critical importance.

OBJETIVO: Esta revisión sistemática buscó comprender la efectividad de la consejería de la experiencia vivida por parte de personas recuperadas de un trastorno de la conducta alimentaria, con muestras clínicas que actualmente reciben tratamiento para el trastorno alimentario. MÉTODO: La revisión sistemática se realizó utilizando PsycINFO, MEDLINE, Scopus y ProQuest Dissertations, and Theses Global y revisando las listas de referencias de los artículos incluidos. Los artículos se incluyeron si: (1) eran estudios de intervención que incluían la participación de pares (recuperados de un trastorno de la conducta alimentaria), (2) administraban la intervención a muestras clínicas (o cuidadores con participación directa en el tratamiento), (3) estaban en inglés y (4) incluían resultados cuantitativos. RESULTADOS: Se incluyeron once estudios en ensayos controlados aleatorios (ECA), series de casos y un estudio de caso; hubo variación en la calidad. Los hallazgos variaron considerablemente y algunos concluyeron que la consejería de la experiencia vivida condujo a mejoras significativas para los aprendices, mientras que otros estudios no encontraron diferencias significativas. Los resultados del mentor a menudo no se evaluaron. De los que evaluaron a los mentores, hay evidencia preliminar de algunos beneficios de la participación, pero también del potencial de daño. DISCUSIÓN: Se necesitan estudios de investigación adicionales en esta área que utilicen ECA de alta calidad que aborden el riesgo de sesgo. Es importante que los mentores de pares de la experiencia vivida sean monitoreados en los resultados clave, provistos de capacitación adecuada y supervisión continua, y sean remunerados por su participación.

A pragmatic effectiveness study of 10-session cognitive behavioural therapy (CBT-T) for eating disorders: Targeting barriers to treatment provision.

OBJECTIVE: Ten-session cognitive behavioural therapy (CBT-T) for transdiagnostic eating disorders targets several barriers to treatment, including cost, therapist expertise, and lengthy wait lists. METHOD: We used a case series design to investigate the effectiveness of CBT-T delivered by trainee psychologists in a postgraduate training clinic. Participants were randomly allocated to commence treatment either immediately or after a 4-week waitlist period. CBT-T was delivered to 52 patients, by six different trainees under supervision. Measures of eating disorder cognitions and behaviours, quality of life, and general psychopathology were examined in completer and intention-to-treat analyses using multilevel modelling. Last observation carried forward was applied for abstinence, remission, and good outcome analyses to aid comparison with prior studies. RESULTS: Significant improvements, associated with medium to large effect sizes, were found for eating disorder cognitions, behaviours quality of life, and negative affect from baseline to posttreatment, and at 1- and 3-month follow-up. Attrition (38.5%) was comparable with other treatment studies. CONCLUSION: Results provide evidence for the effectiveness of CBT-T delivered by trainee psychologists for transdiagnostic eating disorder patients, thus tackling some important barriers for treatment. Longer follow-up, randomised controlled trial designs, and moderator analyses will provide more robust evidence about which patients do best with a shorter therapy.

Predictors of outcome in cognitive behavioural therapy for eating disorders: An exploratory study.

OBJECTIVE: Early decrease in symptoms is a consistent predictor of good treatment outcome across all eating disorders. The current study explored the predictive value of novel early change variables in a transdiagnostic, non-underweight sample receiving 10-session cognitive behavioural therapy. METHOD: Participants who reported bingeing and/or purging in the week preceding baseline assessment (N = 62) were included in analyses. Early change variables were calculated for novel (body image flexibility, body image avoidance, body checking, and fear of compassion) and established predictors (behavioural symptoms and therapeutic alliance). Outcomes were global eating disorder psychopathology and clinical impairment at posttreatment and three-month follow-up. Intent-to-treat analyses were conducted using linear regression, adjusting for baseline values of the relevant outcome and early change in behavioural symptoms. RESULTS: Early improvement in body image flexibility was the most consistent predictor of good outcome. Early change in body image avoidance and the fear of expressing and receiving compassion to/from others were significant predictors in some analyses. DISCUSSION: Novel early change variables were significant predictors of eating disorder outcomes in this exploratory study. Model testing is required to understand the exact mechanisms by which these variables impact on outcomes, and whether there is potential benefit of modifying existing protocols. ANZCTR TRIAL NUMBER: ACTRN12615001098527.

Body image flexibility: A predictor and moderator of outcome in transdiagnostic outpatient eating disorder treatment.

OBJECTIVE: Predictors of attrition and predictors and moderators of outcome were explored in a transdiagnostic sample of patients who received ten-session cognitive behavioral therapy (CBT-T) for nonunderweight eating disorders. Body image flexibility, a protective positive body image construct, was hypothesized to be a significant moderator. METHOD: Data from two case series were combined to form a sample of 78 participants who received CBT-T. Baseline measures of body image, negative affect, personality, and motivation (readiness to change and self-efficacy) were included as potential predictors. Global eating disorder psychopathology at each assessment point (baseline, mid- and post-treatment, 1- and 3-month follow-up) was the outcome variable. Predictors of attrition were assessed using logistic regression, and multilevel modeling was applied for predictors and moderators of outcome. RESULTS: Body image flexibility emerged as the strongest predictor and moderator of global eating disorder psychopathology, followed by body image avoidance. Body checking, negative affect, personality beliefs, and self-efficacy were significant predictors of global eating disorder psychopathology. DISCUSSION: Higher body image flexibility predicted lower global eating disorder psychopathology at every assessment point. Further research is required to replicate findings and explore the benefit of focusing on positive body image in treatment.

Measures of body image: Confirmatory factor analysis and association with disordered eating.

The current study aimed to examine the factor structure, reliability, and validity of 3 measures of body image disturbance (body image flexibility, body avoidance, and body checking) considered to be relevant to eating disorder psychopathology, with the aim of determining the optimal structure of each for use in treatment planning and outcome monitoring. Additionally, the study aimed to identify which factors had the strongest association with disordered eating. Participants were 328 female undergraduate university students aged 17-25 years. Confirmatory factor analyses were conducted followed by correlational, regression, and t test analyses. The original proposed models were retained for the body image flexibility and body checking measures, while an alternative model was supported for the body image avoidance measure. All 3 solutions were found to have acceptable validity and reliability. Scores on each measure differed significantly between normal and disordered eaters. The body image flexibility measure and selected subscales of the body image avoidance and checking measures had unique associations with eating disorder psychopathology and psychosocial impairment. Results of this study indicate how the assessment of body image can be achieved in treatment of eating disorders in such a way as to reduce participant burden while adequately assessing the body image disturbance that is characteristic of eating disorders. (PsycINFO Database Record