ClinicalTrials.gg
Not yet recruitingNCT07914712BBBUpdated Nov 6, 2026

Be Body Brave: Digital Written Exposure Therapy for Eating Disorders

An interventional study of Imaginal exposure and Eating disorder journaling in Eating Disorders, sponsored by University of Louisville. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by University of Louisville · Not applicable, Interventional, and Treatment

Updated Nov 4, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
900
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Current eating disorder (ED) treatment options are both inaccessible (80% of people with EDs do not access treatment) and not entirely successful (most people with an ED do not reach full remission). Imaginal exposure therapy, or what the investigators call Be Body Brave (BBB), is self-guided treatment that offers a solution to both of these issues: online modules reduce barriers to access treatment, and exposure therapy has the potential to shift cognitive beliefs in eating disorders, creating lasting change. This study aims to determine the effectiveness of BBB and identify the optimal timing for implementation of exposure therapy for eating disorders. Participants will complete five sessions of digital imaginal exposure and complete post-treatment, 1-month, 6-month, and 12-month follow-up questionnaires assessing eating disorder symptoms, quality of life, and clinical impairment.

02

Conditions studied

  • Eating Disorders

Keywords

  • Eating disorders
  • Treatment
  • Anorexia nervosa
  • Digital mental health interventions
  • Bulimia nervosa
  • Other specified feeding and eating disorder
  • Atypical anorexia nervosa
  • Binge eating disorder
03

In context

Feeding and Eating Disorders

645 studies on the registry are indexed under Feeding and Eating Disorders; 153 are open to participants now.

This study's planned enrollment of 900 is above the median of 71 across 452 interventional studies indexed under Feeding and Eating Disorders.

Browse Feeding and Eating Disorders studies →

Lead sponsor

University of Louisville is the lead sponsor of 291 studies on the registry; 54 are open to participants now.

Of its 19 completed or terminated interventional studies of FDA-regulated products, 7 (37%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Current diagnosis of any active eating disorder except ARFID
  • Ages 18-65

Exclusion criteria

Exclusion Criteria:

  • Active Suicidality
  • Active Mania
  • Active psychosis
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
900 participants (estimated)

Study arms

  • Active comparator
    Eating Disorder Journaling Condition

    Participants in the ED Journaling condition will receive five sessions of treatment, one week apart. They will be given general psychoeducation on eating disorders during the first session and will write about anything having to do with their ED during the remaining four sessions. Participants in the ED Journaling condition will also receive feedback and reminders between sessions.

    Behavioral: Eating disorder journaling

  • Experimental
    Be Body Brave Condition

    Participants randomly assigned to BBB will receive 5 weeks of exclusively remote treatment addressing ED-related fears, one week apart, delivered via REDCap. They will be given psychoeducation on exposure therapy during the first session and will write about and imagine an ED fear during the remaining four sessions. Between sessions, participants receive feedback and notifications reminding them to complete the next session and encouraging them to continue facing their fear.

    Behavioral: Imaginal exposure

Interventions

  • BehavioralImaginal exposure

    Imaginal exposure related to eating disorders allows participants to be "exposed" to their eating disorder fear by imagining fear-based scenarios.

  • BehavioralEating disorder journaling

    Generic journaling about eating disorders allows for a comparable condition to the imaginal exposure condition.

06

What researchers measure

Primary outcomes

  1. Eating disorder behaviors

    Eating Disorder Examination Questionnaire 6.0 (EDE-Q) will be used to measure change in eating disorder symptoms. The EDE-Q has a minimum global score of 0 and a maximum global score of 132. Higher scores indicate more severe eating pathology.

    Time frame: 6 weeks

  2. Fear of weight gain

    Fear of weight gain will be assessed via the Fear of Food Measure, which assesses three cognitive-behavioral dimensions of fear of food: anxiety about food, avoidance behaviors, and fear of weight gain. The fear of weight gain has a minimum global score of 0 and a maximum global score of 2,900. Higher scores indicate worse fear of weight gain.

    Time frame: 6 weeks

  3. Body image disturbance (State Body Disturbances)

    Body Disturbances will be collected via the Eating Disorder-15 (ED-15), which is a 15-item measure of eating disorder cognitions and behaviors, which will be collected at the beginning of each treatment session. The ED-15 includes ten questions that together have a minimum global score of 0 and a maximum global score of 60. There are also 5 items that are open-ended integer questions. Higher scores indicate worse body and eating disturbances.

    Time frame: 6 weeks

  4. Food avoidance

    Avoidance will be measured with the Fear Approach and Avoidance Measure (FAAM), a measure that quantifies approach and avoidance behaviors related to food, body, and weight. The FAAM has a minimum global score of 0 and a maximum global score of 495. Higher scores indicate worse food avoidance.

    Time frame: 6 weeks

  5. Fear of food

    The Fear of Food Measure (FOFM) assesses three cognitive-behavioral dimensions of fear of food: anxiety about food, avoidance behaviors, and fear of weight gain. It has strong factor, convergent, divergent, and construct validity. The FOFM includes 23 questions that have a minimum global score of 23 and a maximum global score of 161. There are also ten items that together have a minimum global score of 0 and a maximum global score of 1000. All together, the scale has a minimum global score of 23 and a maximum global score of 1,161. Higher scores indicate worse fear of food.

    Time frame: 6 weeks

  6. Eating disorder fears

    The Eating Disorder Fear Inventory (EFI) assesses ED fears, such as fear of weight gain and associated consequences. It will be used to generate the "most feared" consequence of weight gain to focus on during exposure therapy. The EFI has a minimum global score of 28 and a maximum global score of 280. Higher scores indicate worse eating disorder fears.

    Time frame: 6 weeks

Secondary outcomes

  1. BMI

    BMI will be assessed by measuring weight and height via scale during assessments. BMI will be calculated using the formula kg/m\^2.

    Time frame: 6 weeks

  2. Barriers to Treatment Access

    The Barriers to Treatment Access measure is a 15-item questionnaire assessing factors that may have hindered or prevented participants' access to eating disorder treatment due to financial, sociocultural, geographical, and identification barriers. The BTA is a qualitative measure, so there is no range of values or a "score."

    Time frame: 6 weeks

  3. Quality of Life Scale

    Quality of Life Scale (QOLS) asks about various facets of life satisfaction. The QOLS is a valid instrument for measuring quality of life across groups and cultures. The QOLS has a minimum global score of 16 and a maximum global score of 112. Lower scores indicate worse quality of life.

    Time frame: 6 weeks

  4. Clinical Impairment Assessment

    The Clinical Impairment Assessment (CIA) assesses how eating habits, exercising, or feelings about eating, shape or weight have affected participant livelihood. The CIA is a reliable and valid global measure of psychosocial impairment secondary to ED symptoms. The CIA has a minimum global score of 0 and a maximum global score of 88. Higher scores indicate worse clinical impairment.

    Time frame: 6 weeks

  5. Weight suppression

    Highest adult weight will be recorded to assess weight suppression (i.e., difference between highest weight since reaching adult height and current body weight), to partially account for medical, nutritional status, and the impact of weight loss and/or gain. Weight will be measured in pounds.

    Time frame: 6 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Reilly EE, Anderson LM, Gorrell S, Schaumberg K, Anderson DA. Expanding exposure-based interventions for eating disorders. Int J Eat Disord. 2017 Oct;50(10):1137-1141. doi: 10.1002/eat.22761. Epub 2017 Aug 16. PubMed 28815659 ↗
  • Levinson CA, Rapp J, Riley EN. Addressing the fear of fat: extending imaginal exposure therapy for anxiety disorders to anorexia nervosa. Eat Weight Disord. 2014 Dec;19(4):521-4. doi: 10.1007/s40519-014-0115-6. Epub 2014 Apr 2. No abstract available. PubMed 24691784 ↗
  • Levinson CA, Ralph-Nearman C, Brown ML, Gardner T, Cardi V, Treasure J, Purves K, Eley TC. A pilot randomized control trial of online exposure for eating disorders and mechanisms of change delivered after discharge from intensive eating disorder care: A registered report. Int J Eat Disord. 2021 Nov;54(11):2066-2074. doi: 10.1002/eat.23603. Epub 2021 Sep 4. PubMed 34480773 ↗
  • Levinson CA, Christian C, Ram SS, Vanzhula I, Brosof LC, Michelson LP, Williams BM. Eating disorder symptoms and core eating disorder fears decrease during online imaginal exposure therapy for eating disorders. J Affect Disord. 2020 Nov 1;276:585-591. doi: 10.1016/j.jad.2020.07.075. Epub 2020 Jul 21. PubMed 32794449 ↗
  • Glasofer DR, Albano AM, Simpson HB, Steinglass JE. Overcoming fear of eating: A case study of a novel use of exposure and response prevention. Psychotherapy (Chic). 2016 Jun;53(2):223-31. doi: 10.1037/pst0000048. PubMed 27267508 ↗
  • Butler RM, Heimberg RG. Exposure therapy for eating disorders: A systematic review. Clin Psychol Rev. 2020 Jun;78:101851. doi: 10.1016/j.cpr.2020.101851. Epub 2020 Mar 21. PubMed 32224363 ↗
  • Butler RM, Crumby EK, Christian C, Brosof LC, Vanzhula IA, Levinson CA. Facing Eating Disorder Fears: An Open Trial Adapting Prolonged Exposure to the Treatment of Eating Disorders. Behav Ther. 2024 Mar;55(2):347-360. doi: 10.1016/j.beth.2023.07.008. Epub 2023 Jul 22. PubMed 38418045 ↗

Individual participant data

Plan to share: No

09

Updates

2 registry updates since Sep 25, 2026
Secondary outcomes
2 description edited
What changed in the outcomes
  • DescriptionBMI: how it is measured was reworded
  • DescriptionWeight suppression: how it is measured was reworded
Nov 6, 2026
Registered
First appeared on the registry
Nov 4, 2026
Show all 2 updates
  1. Nov 6, 2026
    Secondary outcomes 2 description edited
    What changed in the outcomes
    • DescriptionBMI: how it is measured was reworded
    • DescriptionWeight suppression: how it is measured was reworded
    + 2 other changes: verification date and description
  2. Nov 4, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07914712
Responsible party
Cheri Levinson (Director, University of Louisville) — Principal investigator
First posted
Nov 4, 2026
Start date
Jan 1, 2027 (estimated)
Primary completion
Jan 1, 2030 (estimated)
Completion
Jul 1, 2031 (estimated)
Last update
Nov 6, 2026

Study contacts

Cheri A Levinson, Ph.D.
Contact
cheri.levinson@louisville.edu
502-852-7795
Rachel Butler
Contact
rachel.butler@louisville.edu

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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