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Using Bilateral Stimulation (A Pre-existing Trauma Technique) After Eating to Reduce Anxiety in People Recovering From Eating Disorders

21 mai 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

8

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • California
      • San Francisco, California, États-Unis, 94132
        • San Francisco State University

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Aucune intervention: Standard Outpatient Eating Disorder Treatment (ST)
Expérimental: Standard Outpatient Eating Disorder Treatment plus Bilateral Stimulation (ST+BLS)
Comportemental: Bilateral Stimulation
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.
Autres noms:
  • BLS

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change From Pre- to Post-Bilateral Stimulation in Self-Reported Anxious Mood After Eating in the Standard Treatment Plus BLS Group Across 4 Sessions
Délai: 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.
Across 4 consecutive sessions, completed over 4-12 weeks.
Change From Pre- to Post-Bilateral Stimulation in Self-Reported Depressed Mood After Eating in the Standard Treatment Plus BLS Group Across 4 Sessions
Délai: 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.
Across 4 consecutive sessions, completed over 4-12 weeks.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
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
Délai: Baseline to end of treatment, 4-12 weeks.
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.
Baseline to end of treatment, 4-12 weeks.
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
Délai: Baseline to end of treatment, 4-12 weeks.
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.
Baseline to end of treatment, 4-12 weeks.
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
Délai: Baseline to end of treatment, 4-12 weeks.
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.
Baseline to end of treatment, 4-12 weeks.
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
Délai: Baseline to end of treatment, 4-12 weeks.
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.
Baseline to end of treatment, 4-12 weeks.

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Change From Baseline to End of Treatment in Body Weight (4-12 Weeks)
Délai: 4-12 weeks
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.
4-12 weeks
Change From Baseline to End of Treatment in Laboratory Values Related to Nutritional Status (4-12 Weeks)
Délai: 4-12 weeks
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.
4-12 weeks
Change From Baseline to End of Treatment in Heart Rate (4-12 Weeks)
Délai: 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.
4-12 weeks
Change From Baseline to End of Treatment in Blood Pressure (4-12 Weeks)
Délai: 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.
4-12 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

San Francisco State University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

30 mai 2023

Achèvement primaire (Réel)

16 octobre 2023

Achèvement de l'étude (Réel)

8 décembre 2023

Dates d'inscription aux études

Première soumission

1 mai 2026

Première soumission répondant aux critères de contrôle qualité

14 mai 2026

Première publication (Réel)

22 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

27 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

21 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2022-258

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

All collected IPD can be shared upon reasonable request in accordance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA)

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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