- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07914712
Be Body Brave: Digital Written Exposure Therapy for Eating Disorders (BBB)
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Cheri A Levinson, Ph.D.
- Telefonnummer: 502-852-7795
- E-Mail: cheri.levinson@louisville.edu
Studieren Sie die Kontaktsicherung
- Name: Rachel Butler
- E-Mail: rachel.butler@louisville.edu
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Current diagnosis of any active eating disorder except ARFID
- Ages 18-65
Exclusion Criteria:
- Active Suicidality
- Active Mania
- Active psychosis
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver 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. |
|
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. |
Imaginal exposure related to eating disorders allows participants to be "exposed" to their eating disorder fear by imagining fear-based scenarios. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Eating disorder behaviors
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
BMI
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Psychische Störungen
- Anzeichen und Symptome, Verdauungstrakt
- Pathologische Zustände, Anzeichen und Symptome
- Anzeichen und Symptome
- Binge-Eating-Störung
- Ernährungs- und Essstörungen
- Magersucht
- Bulimie
- Verhaltenstherapie
- Psychotherapie
- Verhaltensdisziplinen und Aktivitäten
- Desensibilisierung, psychologisch
- Implosivtherapie
Andere Studien-ID-Nummern
- 26.0140
- 1R01MH143686-01 (US NIH Stipendium/Vertrag)
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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