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.
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
San Francisco, California, United States, 94132
- San Francisco State University
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
No Intervention: Standard Outpatient Eating Disorder Treatment (ST)
|
|
|
Experimental: Standard Outpatient Eating Disorder Treatment plus Bilateral Stimulation (ST+BLS)
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
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
Time Frame: 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
Time Frame: 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.
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.
|
Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change From Baseline to End of Treatment in Body Weight (4-12 Weeks)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 2022-258
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Eating Disorders
-
NCT06945796CompletedDisordered Eating Behaviors | Eating Pathology | Eating Disorders Symptoms
-
NCT07022873Active, not recruitingDisordered Eating Behaviors | Eating Pathology | Eating Disorder Symptoms
-
NCT06551974RecruitingEating Disorders | Eating Behavior | Eating Disorder Symptom
-
NCT06878976Enrolling by invitationBinge-Eating Disorder
-
NCT05118906CompletedBinge-Eating Disorder
-
NCT06485687Active, not recruitingBinge-Eating Disorder
-
NCT06413433Recruiting
-
NCT05113953Completed
-
NCT05026411Active, not recruitingEating Disorders | Eating Behavior | Orthodontic Appliance Complication | Eating Habit
-
NCT02419326CompletedEating Disorder | Binge-eating Disorder
Clinical Trials on Bilateral Stimulation
-
NCT06292559Recruiting
-
NCT06353243RecruitingPreterm Birth | Parent-Child Relations | Stress Reaction | Hospitalism in Children
-
NCT01682668RecruitingParkinson's Disease
-
NCT00369668CompletedHemiplegia | Cerebrovascular Accident
-
NCT05929014Completed
-
NCT01647269Completed
-
NCT07505940Not yet recruiting
-
NCT05811104Not yet recruitingTreatment Resistant Depression
-
NCT05016830Terminated