Anorexia Nervosa Clinical Trials

The purpose of this study is to investigate areas of the brain responsible for 'liking', 'wanting', and learning in adults with eating disorders using brain imaging techniques, computer tasks, a test meal, and self-report questionnaires and interviews. The investigators will study changes in brain activity using a procedure called functional magnetic resonance imaging (fMRI). This study will include 252 women with an eating disorder (63 AN-restricting type (AN-R), 63 AN-binge eating/purging type (AN-BP), 63 bulimia nervosa (BN)) and 63 healthy controls (HC) aged 18-39. Aim 1: To examine neural differences in 'liking' and 'wanting' in ED relative to HC. Aim 2: To examine differences in instrumental learning for reward and punishment in ED relative to HC. Aim 3: To examine how 'liking' and 'wanting' drive instrumental learning in ED and predict clinical symptoms at baseline and 1 year later. Exploratory Aim: To explore the associations of dopamine function, as measured by neuromelanin MRI (NM-MRI), with ED diagnosis and brain response to 'liking', 'wanting', and learning. Read Less

Occupational therapy is uniquely poised to help address chronic Eating Disorders (EDs) because of our holistic approach to client care. The complex and serious nature of EDs spans so many areas of life and wellbeing, it requires an intervention strategy that addresses the whole person across mental, physical, social, and spiritual realms. Unfortunately, specialized care for EDs can be difficult to find - especially for those not sick enough to be admitted to an inpatient facility but who are still struggling to thrive in daily life. For example, in New Mexico there is only one inpatient treatment center for EDs and no specialized outpatient services. This leaves many people suffering from EDs without options for care because they are not yet sick enough. There is a need for novel interventions in this setting that go beyond the traditional weight and food-focused medical interventions and seek to help empower individuals, work around challenges, and live their lives to the fullest. To meet this need in our community, the study team is developing a preliminary outpatient treatment program. The ROADE (Restorative Occupational Approaches for Disordered Eating) Program is an 8-week, structured, multimodal intervention seeking to reduce psychosocial symptoms and improve self-management skills for disordered eating. The intervention strategies range from: (1) wellness activities like mindfulness meditation to improve interoception, self-acceptance, and as a self-guided coping tool (2) adaptation of health management and self-care occupations to improve daily functioning while navigating ongoing disordered eating symptoms and (3) light exercise like Yoga and lymphatic drainage exercises to reconnect in a positive way with the body, improve digestion, promote relaxation, and reduce muscle tension. The current research investigates the feasibility and acceptability of this intervention while testing preliminary effects on eating disorder symptoms. Read Less

FED-F is a modular treatment that enhances exposure therapy with psychoeducation and cognitive skills teaching how to face fears of (a) food, (b) weight gain, (c) interoception/body, and (d) social situations. The study goals are to (1) refine and test the acceptability and feasibility of FED-F treatment (Phase I), (2) test if this treatment outperforms treatment as usual (TAU) delivered post-acute treatment as adjunctive to stepdown specialty care (Phase II), and (3) to examine if treatment targets the hypothesized mechanism of action: approach behaviors (Phase II). These goals will lead to a highly deployable and accessible virtual treatment targeted at core AN mechanisms that predict relapse. Specific aims are to (1) refine FED-F into a fully virtual format with input from patients and stakeholders and collect preliminary data (N=10) on its feasibility and acceptability (Phase I), (2) conduct a small pilot RCT (randomized controlled trial) of FED-F (n=30) as compared to TAU (n=30; Phase II), and (3) examine if FED-F targets approach/avoidance behaviors and test if this mechanism is associated with clinical outcomes (Phase II). Read Less

No studies of cannabidiol (CBD) have focused on Anorexia Nervosa (AN). Dose, side effects, tolerability, acceptability of pure CBD in AN must be established. The current study is an important first step in the investigation of CBD for AN. Cannabis products have been recently legalized in many states, and CBD in particular has been shown to reduce anxiety. Therefore, CBD may represent a promising new treatment for AN. The endocannabinoid system is involved in the regulation of functions relevant to eating disorders. Furthermore, data suggest that eating disorders are associated with alterations of the endocannabinoid system. Prior attempts to target the endocannabinoid system in AN have focused on CB1 receptor agonists that can increase anxiety. Moreover, CBD may be particularly beneficial in decreasing anxiety in AN via its action at serotonin receptors. Lastly, the impact of CBD on eating behavior and weight in AN must be determined. The current study seeks to explore these hypotheses using the aims in the following section. Read Less

The purpose of this study is to collect preliminary data on the feasibility and acceptability of the randomization of two relapse-prevention treatment conditions after discharge from intensive eating disorder (ED) treatment: an imaginal exposure therapy and a writing and thinking intervention. The second aim to test for (a) differences between the two treatments for the prevention of relapse and (b) preliminary change on clinical ED outcomes (e.g., ED symptoms, fears). The investigators further aim to examine the two treatments target fear extinction and if fear extinction is associated with ED outcomes. The investigators also plan to test if baseline differences in fear conditioning relate to change in ED outcomes across treatment. Read Less

Randomized, placebo-controlled study investigating the use of physiologic, transdermal estrogen for low bone mass in adult women with anorexia nervosa. Read Less

Social processing and cognition are often altered in patients with eating disorders. The goal of this clinical trial is to assess two different social therapeutic interventions -- one educational, one interactive -- for their effectiveness in improving clinical outcomes in patients with eating disorders. Patients in both interventions will receive education about social function in eating disorders, but those in the interactive treatment group will complete an additional collaborative art task. Participants will: attend a baseline study visit to complete clinical interviews, cognitive testing, and behavioral tasks complete a pre-intervention assessment with questionnaires attend eight sessions of their assigned treatment group over the course of 12 weeks complete three virtual follow-up assessments 4, 8, and 12 months from their baseline attend a final study visit to repeat some clinical interviews, cognitive testing, and behavioral tasks Researchers will compare changes in eating disorder, mood, and anxiety symptoms as well as test results from baseline and final study visits for each group to see if patients can be treated effectively with education alone or if an interactive group component produces additional benefits cognitive and behavioral task performance are associated with recovery or illness state. Read Less

Anorexia Nervosa is a serious life-threatening illness with a typical age of onset in adolescence; if not effectively treated, it has the potential to significantly impact adolescent development and quality of life. Research on executive functioning in anorexia nervosa indicates that it may be a viable target for intervention that could improve outcome. The current project focuses on determining whether or not the investigators can improve set-shifting in affected adolescents in the hopes that improvements in set-shifting will, ultimately, improve outcome. Read Less

With an incidence rate of about 1%, Anorexia Nervosa (AN) is a serious mental disorder associated with high mortality, morbidity, and cost. AN in youth is more responsive to early treatment but becomes highly resistant once it has taken an enduring course. The first-line treatment for adolescents with AN is Family Based Treatment (FBT). While FBT can be delivered using videoconferencing (FBT-V), therapists' limited availability hampers scalability. Guided self-help (GSH) versions of efficacious treatments have been used to scale and increase access to care. The main aim of this proposed comparative effectiveness study is to confirm that clinical improvements in GSH-FBT are achieved with greater efficiency than FBT-V in generalizable clinical settings. Read Less

The investigators will recruit individuals with broadly-defined AN (n = 80) who are currently in or have recently participated in higher-level eating disorder treatment (e.g., residential, partial hospitalization/day treatment, intensive outpatient treatment). Interested participants will sign consent, complete eligibility assessments, and will be randomized to receive Positive Affect Treatment for Anorexia Nervosa (PAT-AN) or Psychoeducation and Behavioral Therapy (PBT) through teletherapy shortly following discharge from higher level of care. Participants can participate in most other forms of outpatient treatment while receiving the research intervention. Participants will engage in 24 weeks of PAT-AN or PBT starting in the first 3 months post-discharge. At each session, the investigators will complete brief measures assessing treatment acceptability, affect, and eating disorder symptoms. Participants will also complete an assessment battery of self-report, EMA, and neurocognitive measures evaluating primary outcomes (BMI; eating disorder symptoms), secondary outcomes (depression, anxiety, and suicidality), and presumed treatment mechanisms at baseline, end of treatment (EOT), and 3-month follow-up (FU). All assessments will be remotely delivered via HIPAA-compliant platforms. Read Less

This randomized, controlled effectiveness trial will assess outcomes, implementation, and mechanisms of two psychological treatments for adolescent anorexia nervosa (AN) delivered in the home setting, in the context of community-based mental health. Adolescents with AN-spectrum disorders (n=50) and their caregivers will be randomly assigned to either family-based treatment or integrated family therapy delivered in the home. Caregivers and adolescents will provide data on weight, eating, and putative treatment mechanisms, including caregiver self-efficacy, adolescent distress, and generalizability of treatment skills. Treatment feasibility, acceptability, and appropriateness will be measured among providers and participating families. The proposed study has clear potential to advance scientific and clinical understanding of the real-world effectiveness of psychological treatments for AN, including whether adapting them for the home setting may improve accessibility and effects on treatment outcome Read Less

The proposed project is an intensive multi family therapy (MFT) intervention involving patients with anorexia nervosa and their families. MFT interventions are informed from the principles of the family based treatment (FBT)/family therapy for Anorexia Nervosa (FT-AN) models. This program will offer families in vivo/virtual support while connecting with other families to increase knowledge of eating disorders and develop skills related to successfully supporting their adolescent during difficult times, including meal support and affect regulation. Our objective is to explore the influence of the MFT intervention on the primary outcome measures in eating disorder treatment, including weight, expressed emotion and eating disorder symptomatology. Read Less