Recruiting
Phase 1

Eating Disorders Treatment

Sponsor:

The Miriam Hospital

Code:

NCT03855553

Conditions

Anorexia Nervosa/Bulimia

Anorexia Nervosa Restricting Type

Eating Disorders in Adolescence

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

Interventions

Family Based Treatment

Enhanced Cognitive Behavioral Therapy

Study Details

Brief summary:

The goals of this project are to 1) develop training opportunities for master's-level and pre-doctoral psychology students in evidence-based assessment and treatment of adolescent EDs; 2) to provide the healthcare workforce, including licensed health professionals such as primary care physicians and behavioral health interventionists, with knowledge and competence to recognize early symptoms of and intervention strategies for EDs; and 3) to test the efficacy of delivering two evidence-based treatments for adolescent eating disorders, Family Based Treatment (FBT) and Enhanced Cognitive Behavioral Therapy (CBT-E), in the home-based setting.

Conditions

Anorexia Nervosa/Bulimia

Anorexia Nervosa Restricting Type

Eating Disorders in Adolescence

Study ID

NCT03855553

Start date

Jan 1, 2019

Status verified date

Aug, 2020

Completion date

Jan, 2022

Anticipated

Primary completion date

Jan, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

Inclusion criteria include:

  • meets criteria for AN, atypical AN, or BN according to DSM-5 diagnostic criteria
  • is currently living at home
  • is medically stable for outpatient treatment according to the recommended thresholds of the American Academy of Pediatrics and the Society of Adolescent Medicine (e.g., ≥75% of expected body weight, heartrate ≥50 beats per minute)
  • if on a psychotropic medication, meets all eligibility criteria while on stable dose of psychotropic medication (8 weeks) for a co-morbid condition
  • speaks English
  • be available for long-term follow-up.

Exclusion criteria include:

  • associated physical illness that necessitates hospitalization
  • psychotic illness/other mental illness requiring hospitalization
  • current dependence on drugs or alcohol
  • physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight
  • concurrent involvement in other psychological treatment for an eating disorder
  • developmental delay that would preclude participation in the intervention.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: FBT

10 families will be randomized to receive 10 - 16 weeks of eating disorder treatment for their adolescent.

experimental: CBT-E

10 families will be randomized to receive 10 - 16 weeks of eating disorder treatment for their adolescent.

Interventions

Family Based Treatment

10 families will be randomized to receive 10 - 16 weeks of Family Based Treatment (FBT), the "gold standard" in eating disorder treatment for adolescents. FBT is a highly structured behavioral intervention in which caregivers are charged with the primary task of re-feeding their child and normalizing his or her eating behaviors and weight status.

Enhanced Cognitive Behavioral Therapy

10 families will be randomized to receive 10 - 16 weeks of Enhanced Cognitive Behavioral Therapy (CBT-E), a clinically validated treatment for adolescent eating disorders. CBT-E is a short-term, individual treatment focused on normalizing eating behaviors and modifying underlying cognitions that contribute to the maintenance of eating disorder behaviors (e.g., over-importance of shape and weight in one's self-evaluation).

Primary outcome measure

  • BMI percentile [ Time Frame: post treatment (week 17) ]
  • BMI percentile [ Time Frame: 1 year follow up ]
  • Eating disorder symptomology, as assessed by the EDE-Q. [ Time Frame: post treatment (week 17) ]
  • Eating disorder symptomology, as assessed by the ED-15. [ Time Frame: post treatment (week 17) ]
  • Eating disorder symptomology, as assessed by EDE-Q [ Time Frame: 1 year follow-up ]
  • Eating disorder symptomology, as assessed by ED-15. [ Time Frame: 1 year follow-up ]
  • Perceived efficacy of treatment, as assessed by the TSPE [ Time Frame: post treatment (week 17) ]
  • Perceived efficacy of treatment, as assessed by the CSQ [ Time Frame: post treatment (week 17) ]
  • Perceived efficacy of treatment, as assessed by the CSQ [ Time Frame: 1 year follow-up ]
  • Perceived efficacy of treatment, as assessed by the TSPE. [ Time Frame: 1 year follow-up ]
  • Perceived feasibility of treatment, as assessed by the TSPE. [ Time Frame: post treatment (week 17) ]
  • Perceived feasibility of treatment, as assessed by the CSQ. [ Time Frame: post treatment (week 17) ]

Central Contacts and Locations

Central contacts

Erin R. Stalvey

(401) 793-8962estalvey@lifespan.org

Eva-Molly Dunbar

epetittodunbar@my.uri.edu

Locations

The Weight Control & Diabetes Research Center

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Erin R. Stalvey

401-793-8962estalvey@lifespan.org

Eva-Molly Dunbar

epetittodunbar@my.uri.edu

Principal Investigator:

Andrea B. Goldschmidt, Ph.D.

More Information

Sponsor

The Miriam Hospital

Last update posted

Feb 23, 2021

Last verified

Aug, 2020

Keywords

  • Anorexia Nervosa
  • Bulimia Nervosa
  • Eating Disorders
  • Adolescence
  • Clinical Training
  • Community Outreach
  • Family Based Treatment
  • Enhanced Cognitive Behavioral Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Miriam Hospital on 2021-02-23.