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Confirming the Efficacy of an Adaptive Component to Family-Based Treatment for Adolescent Anorexia Nervosa: Study Protocol for a Randomized Controlled Trial.

ABSTRACT: Family-based treatment (FBT) has the largest evidence base for treating adolescents with anorexia nervosa (AN); 35-50% of cases remit at the end-of-treatment and remain remitted 3-4 years after treatment. Studies of FBT demonstrate that weight restoration by session 4 (of 2.4 kgs) predicts remission at end of treatment in 85-90% of cases. One way to improve outcomes is to tailor treatments to patients depending on successful weight restoration at session 4. Pilot data found that by adding three sessions of Intensive Parental Coaching (IPC) after session 4 improved outcomes in early non-responders. Further, data suggest that the mechanism underlying FBT is early improvements in parental self-efficacy related to re-feeding their child. This manuscript describes a study protocol to examine whether adding IPC to FBT improves outcomes in early non-responders and confirm whether change in parental self-efficacy is the mechanism by which FBT works. This two-site randomized controlled trial (RCT) will randomize 60 adolescents with a DSM-5 diagnosis of AN (30 per site) who are between the ages of 12-18 years old and do not gain 2.4 kgs by session 4 of FBT. Randomized participants will either continue standard FBT or receive the three sessions of IPC and then continue FBT as usual. Both arms include up to 18 sessions over the course of 9 months. Blinded assessments will be conducted at baseline, 3-month within-treatment, end of treatment, and at 6 and 12-month follow-up. Parental-self efficacy will be assessed using the Parent versus Anorexia Scale at all major assessment time points and at each of the first eight sessions of treatment. The primary outcome is achievement of weight remission (> 94% expected mean percent body mass index (BMI) adjusted for age, height, and gender). Clinical Trial Registration:http://www.ClinicalTrials.gov, identifier NCT03097874.

SUBMITTER: L'Insalata A

PROVIDER: S-EPMC7028765 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Confirming the Efficacy of an Adaptive Component to Family-Based Treatment for Adolescent Anorexia Nervosa: Study Protocol for a Randomized Controlled Trial.

L'Insalata Alexa A Trainor Claire C Bohon Cara C Mondal Sangeeta S Le Grange Daniel D Lock James J

Frontiers in psychiatry 20200212

Family-based treatment (FBT) has the largest evidence base for treating adolescents with anorexia nervosa (AN); 35-50% of cases remit at the end-of-treatment and remain remitted 3-4 years after treatment. Studies of FBT demonstrate that weight restoration by session 4 (of 2.4 kgs) predicts remission at end of treatment in 85-90% of cases. One way to improve outcomes is to tailor treatments to patients depending on successful weight restoration at session 4. Pilot data found that by adding three ...[more]

PMID: 32116856

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Project description:IntroductionMulti-family therapy (MFT) is a recommended treatment for adolescent anorexia nervosa internationally. Despite recent significant advances in single-family therapy, the evidence base for MFT remains relatively small. Several individual and family factors have been associated with poorer outcomes in single-family therapy, many of which may be addressed or ameliorated by MFT if delivered early in treatment. This trial aims to determine the feasibility and acceptability of adding a five-day multi-family therapy group to the early stages of family therapy for anorexia nervosa. Secondary objectives are to explore effect size changes in key individual and family factors across treatment.MethodsThis feasibility trial will use a randomised controlled design. Sixty adolescents (age 10-17 inclusive) with anorexia nervosa or atypical anorexia nervosa and their parents will be recruited from a community-based specialist eating disorder service in London, UK. Participants will be randomly allocated to receive six months of eating disorder focussed family therapy with a five-day MFT group (experimental group) or without (control group). Block randomisation will be conducted by the King's Clinical Trials Unit and researchers will be blind to participants' intervention allocation. Feasibility, acceptability and secondary outcomes measures will be collected at baseline, post-MFT, end of treatment, six-month and 12-month follow-up. Feasibility and acceptability will be assessed according to trial sign-up rates, retention, measure completion rates and satisfaction. Secondary outcomes include physical health improvements, changes in psychiatric symptoms, emotion regulation and reflective function capacity, expressed emotion, parental difficulties and therapeutic alliance. Descriptive data and exploration analysis of trends and effect sizes will be reported upon at trial completion.DiscussionThe five-day MFT program developed for this study is novel, brief and more accessible than previous MFT models. The inclusion of a data collection point during treatment and follow-up will allow for an investigation of trends during and after treatment. This will allow exploration and comparison of future potential mediators and moderators of MFT and FT-AN outcomes and how these may differ between treatments.Trial registrationISRCTN registry; ISRCTN93437752 , on 27 January 2021.

Project description:BackgroundAnorexia nervosa (AN) is often diagnosed in adolescence, and most evidence-based treatments for AN in young people involve the family. Family therapies for AN are intensive, outpatient treatments that utilise the parents as the primary resource in the young person's recovery. Research regarding family treatment for AN is often conducted in specialist settings-with relatively little data reporting the translation of this specialised treatment into real-world, non-specialist settings. This systematic review and meta-analysis aims to determine the efficacy of family treatments for adolescents with AN in specialist settings versus non-specialist settings.MethodsThis systematic review and meta-analysis will be conducted according to the preferred reporting items for systematic reviews and meta-analyses guidelines. Retrospective cohort studies, pilot studies, case series, randomised controlled trials and qualitative investigations that present original data and investigated the efficacy of family treatments for adolescents with AN in either a specialist or non-specialist setting will be included in the review. Data will be extracted by two reviewers and study quality will be assessed. The primary outcome, change in weight, will be used to determine via meta-analysis and, depending on study heterogeneity, subgroup analysis or meta-regression whether there is a statistically significant subgroup difference between specialist and non-specialist treatment settings. The review will also consider changes in eating disorder symptomology and related constructs.DiscussionResults from this review will help determine if there is a difference in the efficacy of family treatments for adolescent AN in specialist versus non-specialist treatment settings, primarily in relation to weight recovery. This, in turn, will inform the translation of evidence-based interventions that are generally studied and implemented within specialist centres into the non-specialist health care system.

Project description:BACKGROUND:Web-based preventive interventions can reduce risk and incidence of bulimia and binge eating disorders among young high-risk women. However, their specific effects on core symptoms of anorexia nervosa (AN) are rather weak. OBJECTIVE:The primary objective of this study was to evaluate the efficacy of an indicated, parent-based, Web-based preventive program Eltern als Therapeuten (E@T) in reducing risk factors and symptoms of AN. METHODS:Girls aged between 11 and 17 years were screened by selected risk factors and early symptoms of AN. At-risk families were then randomized to E@T or an assessment-only control condition. Assessments took place at pre- and postintervention (6 weeks later) and at 6- and 12-month follow-up (FU). RESULTS:A total of 12,377 screening questionnaires were handed out in 86 German schools, and 3941 including consent returned. Overall, 477 (447/3941, 12.10%) girls were identified as at risk for AN and 256 of those could be contacted. In all, 66 families (66/256, 25.8% of those contacted) were randomized to the E@T or a wait-list control condition, 43 (43/66, 65%) participated in postassessments, and 27 (27/66, 41%) in 12-month FUs. Due to low participation and high dropout rates of parents, recruitment was terminated prematurely. At 12-month FU, girls' expected body weight (EBW) percentage was significantly greater for intervention participants compared with control participants (group by time interaction beta=21.0 [CI 5.81 to 36.13], P=.007; group by time squared interaction beta=-15.5 [CI -26.6 to -4.49], P=.007; estimated Cohen d=0.42]. No other significant effects were found on risk factors and attitudes of disturbed eating. CONCLUSIONS:Despite a significant increase in girls' EBW percentage, parental participation and adherence to the intervention were low. Overall, parent-based, indicated prevention for children at risk for AN does not seem very promising, although it might be useful for parents who engage in the intervention. TRIAL REGISTRATION:International Standard Randomized Controlled Trial Number (ISRCTN): 18614564; http://www.isrctn.com/ISRCTN18614564 (Archived by WebCite at http://www.webcitation.org/74FTV1EpF).

Project description:BackgroundAnorexia nervosa (AN) mainly affects women (sex ratio 1/10) and most often starts during adolescence. The prognosis of AN remains poor (10% of deaths and high risk of chronicity). Body dissatisfaction, disturbances in recognition and identification of body sensations are some of the key symptoms of AN. However, there is a contrast between this consensual observation of body image disorders in AN, and the relative deficit of specifically targeted body treatments. Our proposal for a body approach specifically dedicated to AN is based on the understanding that posture, breathing, muscle tension and body perception are closely linked to our psychological and emotional state and are therefore disturbed in patients with AN. The purpose of this monocentric randomized controlled trial is to evaluate if a targeted osteopathic protocol treatment for AN in addition to treatment as usual (TAU) is significantly more effective than TAU alone.MethodsIn total, 72 patients meeting the inclusion criteria will be randomly assigned to one of the two treatment groups: one receiving the specific osteopathic treatment targeted for AN in addition to the TAU (group A) and the other one, receiving TAU only (group B). The patients in group A will receive 5 30-min osteopathic treatment sessions. Soft specific palpatory techniques on the diaphragm, digestive system and cervical region will be performed. The TAU is defined by the multidisciplinary approach recommended by the French health high authority. The primary outcome is the evaluation of interoceptive sensibility and secondary outcomes include clinical and psychopathology-related symptoms with assessment of somatic dysfunctions' evolution. A qualitative study will also be carried out, applying the Interpretative Phenomenological Analysis method. Patients will be included for a maximum of 14 weeks between the inclusion time and the last evaluation.DiscussionIf the results of the study are positive (statistically significant efficacy of this osteopathic treatment protocol), the study will provide arguments in favor of osteopathic sessions as a possible non-invasive additional treatment option in the multidisciplinary care approach for patients with AN.Trial registrationClinicalTrials.gov ID: NCT04666415 , Release Date: December 11, 2020; N° ID-RCB: 2019-A02613-54.

Project description:IntroductionProviding effective nutritional rehabilitation to patients hospitalised with anorexia nervosa (AN) is challenging, partly due to conservative recommendations that advocate feeding patients at low energy intakes. An 'underfeeding syndrome' can develop when patients are not provided with adequate nutrition during treatment, whereby malnourished patients fail to restore weight in a timely matter, and even lose weight. Of particular concern, the reintroduction of carbohydrate in a starved patient can increase the risk of developing electrolyte, metabolic and organ dysfunction. The proposed trial assesses the efficacy and safety of a lower carbohydrate enteral formula (28% carbohydrate) against a standard enteral formula (54% carbohydrate), in adolescent and young adult patients (aged 15-25 years), hospitalised with AN.Methods and analysisThe study employs a double-blind randomised controlled trial design. At admission to hospital, malnourished adolescent and young adults with AN will be randomly allocated to commence feeding on a standard enteral feeding formula (1.5 kcal/mL, 54% carbohydrate) or a lower carbohydrate isocaloric enteral feeding formula (1.5 kcal/mL, 28% carbohydrate). Assessments of nutritional intake, weight and biochemistry (phosphate, magnesium, potassium) will be conducted at baseline and during the first 3 weeks of hospital admission. The primary outcome measure will be incidence of hypophosphatemia. Secondary outcomes include weight gain, oedema, other electrolyte distortion, length of hospital admission, admission to the Intensive Care Unit (ICU) and number of days to reach medical stability, using defined parameters.Ethics and disseminationThe protocol was approved by the Western Sydney Local Health District Human Research Ethics Committee and institutional research governance approvals were granted. Written informed consent will be sought prior to study enrolment. Study findings will be widely disseminated through peer-reviewed publications and conference presentations.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12617000342314); Pre-results.

Dataset Information

Confirming the Efficacy of an Adaptive Component to Family-Based Treatment for Adolescent Anorexia Nervosa: Study Protocol for a Randomized Controlled Trial.

Publications

Confirming the Efficacy of an Adaptive Component to Family-Based Treatment for Adolescent Anorexia Nervosa: Study Protocol for a Randomized Controlled Trial.

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