Using Bilateral Stimulation (A Pre-existing Trauma Technique) After Eating to Reduce Anxiety in People Recovering From Eating Disorders
2026. május 21. frissítette: San Francisco State University
Bilateral Stimulation Versus Standard Care in the Treatment of Food Anxiety in Eating Disorder Patients: A Pilot Study
The goal of this clinical trial was to evaluate whether bilateral stimulation (BLS) could reduce anxiety and emotional distress after eating in people recovering from eating disorders in outpatient treatment with the primary researcher.
The main question it aimed to answer were:
Did bilateral stimulation reduce anxiety, depression, and/or eating disorder thoughts when used after eating a fear food?
Researchers compared participants who received standard treatment alone to those who received standard treatment plus bilateral stimulation after meals to determine whether BLS reduced emotional distress and negative thoughts related to eating.
Participants:
- Completed surveys assessing anxiety, depression, and eating disorder symptoms at the beginning and end of 4 consecutive sessions (4-12 weeks in total depending on the frequency of client appointments).
- Chose to participate in either a standard treatment group or an intervention group
Participants in the intervention group also:
- Ate 1 meal per week before or during session, including a "fear food" (defined as food avoided out of fear of what might happen, i.e., weight gain, vomiting, guilt/shame).
- Completed brief questionnaires about their thoughts and feelings after eating
- Participated in 3-5 minutes of bilateral stimulation (side-to-side tapping) guided by the researcher
- Reported on changes in their thoughts and emotions following the intervention
The intervention was delivered over 4 consecutive sessions alongside standard treatment.
A tanulmány áttekintése
Állapot
Befejezve
Körülmények
Beavatkozás / kezelés
Tanulmány típusa
Beavatkozó
Beiratkozás (Tényleges)
8
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
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California
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San Francisco, California, Egyesült Államok, 94132
- San Francisco State University
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Nem
Leírás
Inclusion Criteria:
- (1) aged older than 18 years;
- (2) had a current DSM-5 diagnosis of anorexia nervosa, bulimia nervosa, binge eating disorder, or other specified feeding and eating disorder;
- (3) were deemed to be medically stable, defined as not requiring the use of a feeding tube; had a heart rate between 51-119 beats per minute at rest and blood pressure greater than 70/40 and less than 180/120 mmHg at rest;
- (4) attending appointments at will;
- (5) gave full consent (signed informed consent); and
- (6) could choose to discontinue treatment and/or the study at any time with no consequences.
Exclusion Criteria:
- (1) aged under 18 years;
- (2) had a current DSM-5 diagnosis of Pica syndrome, cyclical vomiting syndrome, or subclinical eating disorder;
- (3) had medical instability, defined as a heart rate less than 50 or more than 120 beats per minute at rest, a blood pressure greater than 180/120 or less than 70/40 mmHg at rest, or orthostatic vital signs accompanied by fainting; and
- (4) had acute suicide risk.
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Nem véletlenszerű
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Nincs beavatkozás: Standard Outpatient Eating Disorder Treatment (ST)
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|
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Kísérleti: Standard Outpatient Eating Disorder Treatment plus Bilateral Stimulation (ST+BLS)
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Participants in the intervention group (ST+BLS) completed 4 consecutive sessions.
In each session, participants ate a meal or snack, including a self-identified "fear food."
After eating, they completed a brief questionnaire assessing thoughts, emotions, and eating disorder urges, and identified preferred thoughts and feelings.
The researcher guided the BLS protocol and provided structured prompts, while participants actively performed the bilateral stimulation by engaging in alternating side-to-side tapping (e.g., shoulders, thighs, or feet), selecting the method most comfortable to them.
Participants completed three 20-second rounds of tapping while focusing sequentially on: (1) their experience of the meal, (2) desired thoughts, and (3) desired emotional states.
Brief discussions occurred between rounds.
After BLS, participants completed a follow-up questionnaire assessing changes in thoughts and feelings.
The researcher also completed a clinician-rated form.
Más nevek:
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Change From Pre- to Post-Bilateral Stimulation in Self-Reported Anxious Mood After Eating in the Standard Treatment Plus BLS Group Across 4 Sessions
Időkeret: Across 4 consecutive sessions, completed over 4-12 weeks.
|
Anxious mood was assessed immediately before and after bilateral stimulation following eating episodes in the ST+BLS group.
Participants rated anxious mood on a researcher-developed 1-10 numeric rating scale, where 1 indicated "not at all anxious" and 10 indicated "extremely anxious."
Anxious mood was defined as worries, anticipation of the worst, fearful anticipation, or irritability.
Higher scores indicated greater anxious mood.
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Across 4 consecutive sessions, completed over 4-12 weeks.
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Change From Pre- to Post-Bilateral Stimulation in Self-Reported Depressed Mood After Eating in the Standard Treatment Plus BLS Group Across 4 Sessions
Időkeret: Across 4 consecutive sessions, completed over 4-12 weeks.
|
Depressed mood was assessed immediately before and after bilateral stimulation following eating episodes in the ST+BLS group.
Participants rated depressed mood on a researcher-developed 1-10 numeric rating scale, where 1 indicated "not at all depressed" and 10 indicated "extremely depressed."
Depressed mood was defined as numb, dissociative, shut down, hopeless, lack of pleasure, or depressed.
Higher scores indicated greater depressed mood.
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Across 4 consecutive sessions, completed over 4-12 weeks.
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Change From Baseline to End of Treatment in State Anxiety as Assessed by the State-Trait Anxiety Inventory in Standard Treatment Versus Standard Treatment Plus BLS
Időkeret: Baseline to end of treatment, 4-12 weeks.
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State anxiety was assessed using the State-Trait Anxiety Inventory (STAI) at baseline and end of treatment.
Scores ranged from 20 to 80, with higher scores indicating greater anxiety/worse outcome.
Change scores were compared descriptively between the standard treatment group and the standard treatment plus BLS group.
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Baseline to end of treatment, 4-12 weeks.
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Change From Baseline to End of Treatment in Trait Anxiety as Assessed by the State-Trait Anxiety Inventory in Standard Treatment Versus Standard Treatment Plus BLS
Időkeret: Baseline to end of treatment, 4-12 weeks.
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Trait anxiety was assessed using the State-Trait Anxiety Inventory (STAI) at baseline and end of treatment.
Scores ranged from 20 to 80, with higher scores indicating greater anxiety/worse outcome.
Change scores were compared descriptively between the standard treatment group and the standard treatment plus BLS group.
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Baseline to end of treatment, 4-12 weeks.
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Change From Baseline to End of Treatment in Depressive Symptoms as Assessed by the Beck Depression Inventory-II in Standard Treatment Versus Standard Treatment Plus BLS
Időkeret: Baseline to end of treatment, 4-12 weeks.
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Depressive symptoms were assessed using the Beck Depression Inventory-II (BDI-II) at baseline and end of treatment.
Scores ranged from 0 to 63, with higher scores indicating greater depressive symptoms/worse outcome.
Change scores were compared descriptively between the standard treatment group and the standard treatment plus BLS group.
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Baseline to end of treatment, 4-12 weeks.
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Change From Baseline to End of Treatment in Eating Disorder Symptoms as Assessed by the Eating Disorder Examination Questionnaire-Short in Standard Treatment Versus Standard Treatment Plus BLS
Időkeret: Baseline to end of treatment, 4-12 weeks.
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Eating disorder symptoms were assessed using the Eating Disorder Examination Questionnaire-Short (EDE-QS) at baseline and end of treatment.
Scores ranged from 0 to 36, with higher scores indicating greater eating disorder symptoms/worse outcome.
Change scores were compared descriptively between the standard treatment group and the standard treatment plus BLS group.
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Baseline to end of treatment, 4-12 weeks.
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Egyéb eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Change From Baseline to End of Treatment in Body Weight (4-12 Weeks)
Időkeret: 4-12 weeks
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Body weight (measured in kilograms) was planned to be assessed using blind weight measurements or weights obtained during clinical appointments.
Due to the short study duration and logistical barriers, insufficient data were available for analysis.
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4-12 weeks
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Change From Baseline to End of Treatment in Laboratory Values Related to Nutritional Status (4-12 Weeks)
Időkeret: 4-12 weeks
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Laboratory values, including metabolic and hematologic measures related to nutritional status (measured in grams or milligrams per deciliter), were planned to be collected through standard blood draws ordered by licensed medical providers.
Due to the short study duration and logistical barriers, insufficient data were available for analysis.
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4-12 weeks
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Change From Baseline to End of Treatment in Heart Rate (4-12 Weeks)
Időkeret: 4-12 weeks
|
Heart rate (measured in beats per minute) was planned to be assessed during clinical appointments or via supervised home monitoring.
Due to the short study duration and logistical barriers, insufficient data were available for analysis.
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4-12 weeks
|
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Change From Baseline to End of Treatment in Blood Pressure (4-12 Weeks)
Időkeret: 4-12 weeks
|
Blood pressure (measured in millimeters mercury for blood pressure) was planned to be assessed during clinical appointments or via supervised home monitoring.
Due to the short study duration and logistical barriers, insufficient data were available for analysis.
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4-12 weeks
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Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
2023. május 30.
Elsődleges befejezés (Tényleges)
2023. október 16.
A tanulmány befejezése (Tényleges)
2023. december 8.
Tanulmányi regisztráció dátumai
Először benyújtva
2026. május 1.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2026. május 14.
Első közzététel (Tényleges)
2026. május 22.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2026. május 27.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2026. május 21.
Utolsó ellenőrzés
2026. május 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 2022-258
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IGEN
IPD terv leírása
All collected IPD can be shared upon reasonable request in accordance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA)
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