Using Bilateral Stimulation (A Pre-existing Trauma Technique) After Eating to Reduce Anxiety in People Recovering From Eating Disorders
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.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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California
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San Francisco、California、美国、94132
- San Francisco State University
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预:Standard Outpatient Eating Disorder Treatment (ST)
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实验性的: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.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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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
大体时间: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
大体时间: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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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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
大体时间: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
大体时间: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
大体时间: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
大体时间: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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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change From Baseline to End of Treatment in Body Weight (4-12 Weeks)
大体时间: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)
大体时间: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)
大体时间:4-12 weeks
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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)
大体时间:4-12 weeks
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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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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 2022-258
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
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Bilateral Stimulation的临床试验
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Mayo ClinicNational Institute of Mental Health (NIMH)招聘中
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RS MedicalAccelerated Care Plus; Research Institute of Health and Science (RIHSE)完全的