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

21 maja 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

8

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • California
      • San Francisco, California, Stany Zjednoczone, 94132
        • San Francisco State University

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nielosowe
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Brak interwencji: Standard Outpatient Eating Disorder Treatment (ST)
Eksperymentalny: Standard Outpatient Eating Disorder Treatment plus Bilateral Stimulation (ST+BLS)
Behawioralne: 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.
Inne nazwy:
  • BLS

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change From Pre- to Post-Bilateral Stimulation in Self-Reported Anxious Mood After Eating in the Standard Treatment Plus BLS Group Across 4 Sessions
Ramy czasowe: 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
Ramy czasowe: 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.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Change From Baseline to End of Treatment in Body Weight (4-12 Weeks)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

San Francisco State University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

30 maja 2023

Zakończenie podstawowe (Rzeczywisty)

16 października 2023

Ukończenie studiów (Rzeczywisty)

8 grudnia 2023

Daty rejestracji na studia

Pierwszy przesłany

1 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

14 maja 2026

Pierwszy wysłany (Rzeczywisty)

22 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

27 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

21 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 2022-258

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

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

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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