NCT07600970

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 30, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2023

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 1, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

5 months

First QC Date

May 1, 2026

Last Update Submit

May 14, 2026

Conditions

Keywords

eating disorderfood anxietyfear foodexposure therapyeye movement desensitization and reprocessing

Outcome Measures

Primary Outcomes (2)

  • 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.

Secondary Outcomes (4)

  • 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

    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

    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

    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

    Baseline to end of treatment, 4-12 weeks.

Other Outcomes (3)

  • Change From Baseline to End of Treatment in Body Weight (4-12 Weeks)

    4-12 weeks

  • Change From Baseline to End of Treatment in Heart Rate and Blood Pressure (4-12 Weeks)

    4-12 weeks

  • Change From Baseline to End of Treatment in Laboratory Values Related to Nutritional Status (4-12 Weeks)

    4-12 weeks

Study Arms (2)

Standard Outpatient Eating Disorder Treatment (ST)

NO INTERVENTION

Standard Outpatient Eating Disorder Treatment plus Bilateral Stimulation (ST+BLS)

EXPERIMENTAL
Behavioral: Bilateral Stimulation

Interventions

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.

Also known as: BLS
Standard Outpatient Eating Disorder Treatment plus Bilateral Stimulation (ST+BLS)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (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.

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Francisco State University

San Francisco, California, 94132, United States

Location

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Non-randomized study with two groups: control and intervention. Participants self-selected groups.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2026

First Posted

May 22, 2026

Study Start

May 30, 2023

Primary Completion

October 16, 2023

Study Completion

December 8, 2023

Last Updated

May 22, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

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

Locations