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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:
Participants in the intervention group also:
The intervention was delivered over 4 consecutive sessions alongside standard treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Outpatient Eating Disorder Treatment (ST) | No Intervention | ||
| Standard Outpatient Eating Disorder Treatment plus Bilateral Stimulation (ST+BLS) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bilateral Stimulation | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Pre- to Post-Bilateral Stimulation in Self-Reported Anxious Mood After Eating in the Standard Treatment Plus BLS Group Across 4 Sessions | 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 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to End of Treatment in Body Weight (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 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco State University | San Francisco | California | 94132 | United States |
All collected IPD can be shared upon reasonable request in accordance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA)
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Dec 8, 2023 |
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Non-randomized study with two groups: control and intervention. Participants self-selected groups.
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|
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| 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 | 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 | 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 | 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. |
| Change From Baseline to End of Treatment in Heart Rate (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 Laboratory Values Related to Nutritional Status (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 Blood Pressure (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 |
| Apr 30, 2026 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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