Anorexia Nervosa, Anorexia Nervosa in Remission, Eating Disorders
Conditions
Keywords
therapy, eating disorder, anorexia nervosa, treatment, relapse prevention, virtual treatment
Brief summary
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).
Interventions
BEHAVIORALFacing Eating Disorder Fears Condition
The first session consists of diagnosis and general psychoeducation on anorexia nervosa and treatment for anorexia nervosa. After psychoeducation and baseline questionnaires are complete, sessions 2-12 include exposure-based virtual treatment for common eating disorder fears (food, weight gain, body sensations, and social situations).
Sponsors
University of Louisville
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-65 * Meets criteria for DSM-5 defined AN, AN partial remission, or AN full remission, Atypical Anorexia Nervosa (AAN), AAN partial remission, or AAN full remission * Has been discharged from intensive (i.e., inpatient, residential, or partial hospital program) in the past 6 months
Exclusion criteria
* Under 18 * Over 65 * Does not meet criteria for DSM-5 defined AN, AN partial-remission, or AN full-remission * High and active Suicidality * Active Mania * Active psychosis * Medically Compromised Status including extremely low weight (less than or equal to 75% median BMI for age, sex, and height) * Does not meet criteria for DSM-5 defined AN, AN partial remission, or AN full remission, AAN, AAN partial remission, or AAN full remission * Has not been discharged from intensive (i.e., inpatient, residential, or partial hospital program) in the past 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fear of Food Measure (FOFM) | Up to 2-month follow-up | The FOFM is a measure that assesses three cognitive-behavioral dimensions of fear of food: anxiety about food, food avoidance behaviors, and feared concerns (e.g., fear of weight gain). It has strong factor, convergent, divergent, and construct validity. |
| Change in Eating Disorder Examination Questionnaire 6.0 (EDE-Q) | Up to 2-month follow-up | The EDE-Q assesses ED behaviors, thoughts, and outcomes (e.g., fasting, binge eating). The EDE-Q has demonstrated excellent test-retest reliability, internal consistency, good criterion validity and concurrent validity. |
| Change in Eating Disorder Fear Inventory (EFI) | Up to 2-month follow-up | EFI is a semi-structured interview used to assess ED fears, such as fear of weight gain, food, and associated consequences. It will be used to generate fears to focus on during treatment and comprehensively assesses all domains of ED fear. |
| Change in Treatment Interview | Up to 2-month follow-up | The Treatment Interview will assess all current and past treatment experiences (partial hospitalization, residential, etc.), as well as dates of treatment. It will also assess primary type of treatment (CBT vs supportive), as well as current usage of psychotropic medications and duration of illness. |
| Change in Structured Clinical Interview for DSM-5 (SCID-5) | Up to 2-month follow-up | The SCID-5 is a semi-structured interview used to arrive at DSM-5 diagnoses. Participants will complete the ED, anxiety, depression, mania, psychosis, and suicide modules. SCID-5 has strong psychometric properties. |
| Change in Eating Disorder Fear Questionnaire (EFQ) | Up to 2-month follow-up | The EFQ is a measure of five central ED fears: fear of weight gain, fear of social eating, fear of physical sensations, fear of social consequences (from gaining weight), fear of personal consequences (from gaining weight). EFQ has strong factor, convergent, and construct validity and assesses multiple domains of ED fear. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Behavioral Approach Task | Up to 2-month follow-up | The Behavioral Approach Task will be used at each diagnostic assessment. It is a standardized behavioral rating task adapted from Ritzert (2017) for use with specific phobias. This task asks participants to rate their anxiety and likelihood to avoid feared stimuli (e.g., pizza, grocery stores, tight jeans) and is adapted from behavioral ratings obtained when building an exposure hierarchy for the treatment of AN fear, which has been implemented in over 200 patients with AN. |
| Change in Behavioral Inhibition System/Behavioral Activation System (BIS/BAS) | Up to 2-month follow-up | The Behavioral Inhibition System/Behavioral Activation System will assess avoidance and approach tendencies with a well-validated and established measure. |
| Change in Subjective Units of Distress (SUDS) | Up to session 12 | SUDS is a behavioral measure used during exposure treatment to measure anxiety and will be collected throughout each treatment session. The SUDS scale has been shown to be a valid and reliable measure of state anxiety. SUDS ratings can range from 0 (completely calm) to 100 (highest anxiety). |
| Change in State Fear of Food Measure | Up to Session 12 | The state version of the fear of food measure, which assesses food anxiety, food avoidance, and feared concerns (e.g., weight gain), will be used during sessions. This measure will be collected at the beginning and end of each therapy session. |
| Change in Mobile Assessment of Approach and Avoidance | Up to Session 12 | Real-world approach and avoidance behaviors will be assessed via mobile assessment. While momentary assessment is a newer and more innovative method of assessing approach tendencies, the usage of self-report, behavioral, and momentary data will provide the opportunity to compare assessment methodologies in preparation for usage in a larger R01 RCT. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCheri A Levinson, Ph.D.
University of Louisville
Outcome results
None listed