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Be Body Brave: Digital Written Exposure Therapy for Eating Disorders (BBB)

30. oktober 2026 oppdatert av: Cheri Levinson, University of Louisville

A Randomized Controlled Trial of Digital Written Exposure Therapy for Eating Disorders: Improving Access to Care

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 posttreatment, 1-month, 6-month, and 12-month follow-up questionnaires assessing eating disorder symptoms, quality of life, and clinical impairment.

Studieoversikt

Status

Har ikke rekruttert ennå

Studietype

Intervensjonell

Registrering (Antatt)

900

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

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

Exclusion Criteria:

  • Active Suicidality
  • Active Mania
  • Active psychosis

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 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.

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

Eksperimentell: 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.

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Eating disorder behaviors
Tidsramme: 6 weeks

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.

6 weeks
Fear of weight gain
Tidsramme: 6 weeks

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.

6 weeks
Body image disturbance (State Body Disturbances)
Tidsramme: 6 weeks

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.

6 weeks
Food avoidance
Tidsramme: 6 weeks

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.

6 weeks
Fear of food
Tidsramme: 6 weeks

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.

6 weeks
Eating disorder fears
Tidsramme: 6 weeks

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.

6 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
BMI
Tidsramme: 6 weeks

We will assess BMI by measuring weight and height via scale during assessments. We will calculate BMI using the formula kg/m^2.

6 weeks
Barriers to Treatment Access
Tidsramme: 6 weeks

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."

6 weeks
Quality of Life Scale
Tidsramme: 6 weeks

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.

6 weeks
Clinical Impairment Assessment
Tidsramme: 6 weeks

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.

6 weeks
Weight suppression
Tidsramme: 6 weeks

We will record highest adult weight 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.

6 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. januar 2027

Primær fullføring (Antatt)

1. januar 2030

Studiet fullført (Antatt)

1. juli 2031

Datoer for studieregistrering

Først innsendt

22. oktober 2026

Først innsendt som oppfylte QC-kriteriene

30. oktober 2026

Først lagt ut (Faktiske)

4. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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