Using Bilateral Stimulation (A Pre-existing Trauma Technique) After Eating to Reduce Anxiety in People Recovering From Eating Disorders
2026年5月21日 更新者：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.
調査の概要
研究の種類
介入
入学 (実際)
8
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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California
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San Francisco、California、アメリカ、94132
- San Francisco State University
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：Standard Outpatient Eating Disorder Treatment (ST)
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実験的：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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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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
時間枠：Across 4 consecutive sessions, completed over 4-12 weeks.
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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
時間枠：Across 4 consecutive sessions, completed over 4-12 weeks.
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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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change From Baseline to End of Treatment in Body Weight (4-12 Weeks)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2023年5月30日
一次修了 (実際)
2023年10月16日
研究の完了 (実際)
2023年12月8日
試験登録日
最初に提出
2026年5月1日
QC基準を満たした最初の提出物
2026年5月14日
最初の投稿 (実際)
2026年5月22日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月27日
QC基準を満たした最後の更新が送信されました
2026年5月21日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2022-258
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
All collected IPD can be shared upon reasonable request in accordance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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摂食障害の臨床試験
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Western University, Canadaまだ募集していません
Bilateral Stimulationの臨床試験
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Biotronik SE & Co. KG完了
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Biotronik SE & Co. KG完了心臓ペーシング、人工ドイツ, イスラエル, 香港, オーストリア, チェコ共和国, オーストラリア, ブラジル, カナダ, スロバキア, スペイン