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

21 de mayo de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

8

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • California
      • San Francisco, California, Estados Unidos, 94132
        • San Francisco State University

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: Standard Outpatient Eating Disorder Treatment (ST)
Experimental: Standard Outpatient Eating Disorder Treatment plus Bilateral Stimulation (ST+BLS)
Conductual: 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.
Otros nombres:
  • BLS

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change From Pre- to Post-Bilateral Stimulation in Self-Reported Anxious Mood After Eating in the Standard Treatment Plus BLS Group Across 4 Sessions
Periodo de tiempo: 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
Periodo de tiempo: 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.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Change From Baseline to End of Treatment in Body Weight (4-12 Weeks)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

San Francisco State University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

30 de mayo de 2023

Finalización primaria (Actual)

16 de octubre de 2023

Finalización del estudio (Actual)

8 de diciembre de 2023

Fechas de registro del estudio

Enviado por primera vez

1 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

14 de mayo de 2026

Publicado por primera vez (Actual)

22 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

27 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

21 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2022-258

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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