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Cognitive and neural mechanisms of cognitive-behavioral therapy for avoidant/restrictive food intake disorder

回避/限制性食物摄入障碍的认知行为疗法的认知和神经机制

基本信息

批准号：
10570372
负责人：
Kamryn T Eddy
金额：
$ 108.3万
依托单位：
MASSACHUSETTS GENERAL HOSPITAL
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-09-07 至 2025-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10570372
关键词：
Adolescent Adult Advocate Affect Aftercare Age Amygdaloid structure Anterior Brain region Central Nervous System Child Chronic Clinical Clinical Trials Cognitive Cognitive Therapy Counseling Cues Data Dependence Development Disease remission Dose Eating Eating Disorders Evidence based treatment Exhibits Food Fright Functional Magnetic Resonance Imaging Hyperactivity Impairment Individual Intervention Interview Investigational Therapies Learning Malnutrition Manuals Measures Mediating Medical Motivation National Institute of Mental Health Occupational Therapy Outcome Patients Persons Phase Pica Disease Prevention Randomized Randomized, Controlled Trials Recommendation Risk Rumination Disorders Standardization Statistical Data Interpretation Testing Therapeutic Intervention Thinking Validation Work Youth active control arm avoidant restrictive food intake disorder behavior change cingulate cortex clinical trial analysis dietary supplements effectiveness trial efficacy trial food avoidance multidisciplinary neuromechanism novel nutrition pressure prevent psychologic psychosocial response severe mental illness telehealth treatment of anxiety disorders trend

项目摘要

ABSTRACT Avoidant/restrictive food intake disorder (ARFID) affects 3% of children and adolescents and results in nutritional deficiencies, supplement dependence, and psychosocial impairment. ARFID follows a chronic course, and has no evidence-based treatment. The hallmark feature of ARFID is food avoidance, which may be maintained by extreme levels of food neophobia and/or hyperactivation of fear circuitry in response to food cues. Our team has developed a manualized cognitive-behavioral therapy (CBT-AR) that directly targets both food neophobia (cognitive mechanism) and fear circuitry (neural mechanism) to reduce food avoidance (clinical outcome). In line with NIMH’s experimental therapeutics approach, in this exploratory/developmental phased R61/R33, we will leverage a multidisciplinary team of experts in the treatment of ARFID, neural mechanisms of food motivation, and statistical analysis of clinical trials to conduct a mechanistic randomized controlled trial of CBT-AR. First, to establish target engagement, we will randomize 50 youth (ages 10-18yo) with ARFID in a 1:1 ratio to 15 weekly sessions (via telehealth) of CBT-AR vs. nutrition counseling to establish target engagement. We chose nutrition counseling as our active control because it does not include the crucial CBT-AR intervention of exposure, and is therefore unlikely to engage our target mechanisms. We hypothesize that, compared to nutrition counseling, patients randomized to CBT-AR will show significantly greater decreases in food neophobia (cognitive mechanism) and fear circuitry (neural mechanism) in response to food cues during a standardized fMRI food cue paradigm (primary ROI: anterior cingulate cortex [ACC]; secondary ROIs: amygdala, orbitofrontal cortex [OFC]). We will also examine weekly change in food neophobia (cognitive mechanism) to identify the number of sessions at which further benefit ceases, and use this optimized dose of CBT-AR for the R33. We will move on to the R33 if we are able to demonstrate a reduction of at least d=.40 in the CBT-AR group from pre- to post-treatment AND a post-treatment between- group difference of at least d=.40 in CBT-AR vs. nutrition counseling in either food neophobia (cognitive mechanism) OR fear circuitry (Go/No-Go ROI: ACC; neural mechanism). Next, we will randomize 70 youth (ages 10-18yo) with ARFID in a 1:1 fashion to the optimized dose of CBT-AR or the same number of sessions of nutrition counseling to replicate target engagement and establish target validation. We hypothesize that, compared to nutrition counseling, patients randomized to CBT-AR will exhibit significantly greater reductions in food avoidance, and that these reductions in food avoidance will be mediated by reductions in food neophobia (cognitive mechanism) and fear circuitry (neural mechanism) activation. If successful, the proposed intervention (CBT-AR) could fill an important unmet need for those living with ARFID and pave the way for larger-scale efficacy and effectiveness trials.

摘要