Clinical trial NCT04810624: Relapse Prevention and Changing Habits in Anorexia Nervosa
Official title: Optimizing Relapse Prevention and Changing Habits in Anorexia Nervosa
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Anorexia Nervosa
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: Columbia University
name: Brown University
name: National Institute of Mental Health (NIMH)
First posted: 2021-03-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This study aims to optimize a treatment package for the relapse prevention treatment of AN. In the Preparation Phase, we examined accessibility and feasibility of the treatment package.

In the current Optimization Phase, we will identify which components of treatment contribute to positive outcomes after acute hospitalization. We will carefully evaluate maintenance of remission, measured by rate of weight loss and end-of-trial status.

Detailed description: While many approaches to reducing relapse after hospital care have been tried, there is little information about which treatment elements confer benefit. This trial, Relapse Prevention and Changing Habits (REACH+), targets the habitual control of maladaptive behavior to support patients with AN in the 6 months after acute treatment, a time of high vulnerability to relapse. Each component of REACH+ addresses a question that is critical to answer in order to identify and optimize a relapse prevention treatment package that balances efficacy and burden. We will test the acceptability and feasibility of 5 components that together target habits: 1) Behavioral, 2) Cognitive, 3)Motivation, 4) Food Monitoring, and 5) Skill Consolidation. In the Preparation Phase, 10 participants were enrolled, and accessibility and feasibility of the treatment package was examined. The current Optimization Phase includes a finalized treatment manual (including an online platform) and will test each component's contribution to weight maintenance after acute treatment.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Anorexia Nervosa at hospital admission
* Medically Stable
* Internet capability with videoconferencing
* Weight restored (BMI \> 19 kg/m2) at New York State Psychiatric Institute

Exclusion Criteria:

* Current substance use or other comorbid disorder requiring specialized treatment
* Pregnancy
* Imminent risk of suicide
* Serious medical illness
* Daily psychotropic medication other than antidepressants (medications that are known effect weight are exclusionary, i.e. stimulants, olanzapine, mirtazapine)
* Participation in outside psychotherapy or structured treatment program (support groups will be allowed). Individuals who are discharged on medications would need to have a non-study psychiatrist.

Primary outcomes:
measure: Weight maintenance
timeFrame: 6-month end of treatment
Secondary outcomes:
measure: Habit strength
timeFrame: 6-month end of treatment
measure: Weight/shape distortion
timeFrame: 6-month end of treatment
measure: Intrinsic motivation
timeFrame: 6-month end of treatment
measure: Dietary restriction
timeFrame: 6-month end of treatment
measure: Skill consolidation
timeFrame: 6-month end of treatment
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
References:
citation: Steinglass JE, Attia E, Glasofer DR, Wang Y, Ruggiero J, Walsh BT, Thomas JG. Optimizing relapse prevention and changing habits (REACH+) in anorexia nervosa. Int J Eat Disord. 2022 Jun;55(6):851-857. doi: 10.1002/eat.23724. Epub 2022 Apr 30.