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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 maio de 2026 atualizado 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

8

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Sem intervenção: Standard Outpatient Eating Disorder Treatment (ST)
Experimental: Standard Outpatient Eating Disorder Treatment plus Bilateral Stimulation (ST+BLS)
Comportamental: 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.
Outros nomes:
  • BLS

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change From Pre- to Post-Bilateral Stimulation in Self-Reported Anxious Mood After Eating in the Standard Treatment Plus BLS Group Across 4 Sessions
Prazo: 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
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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.

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Change From Baseline to End of Treatment in Body Weight (4-12 Weeks)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

San Francisco State University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

30 de maio de 2023

Conclusão Primária (Real)

16 de outubro de 2023

Conclusão do estudo (Real)

8 de dezembro de 2023

Datas de inscrição no estudo

Enviado pela primeira vez

1 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

14 de maio de 2026

Primeira postagem (Real)

22 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

27 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

21 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 2022-258

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

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

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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