- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07600970
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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California
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San Francisco, California, Forenede Stater, 94132
- San Francisco State University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Ingen indgriben: Standard Outpatient Eating Disorder Treatment (ST)
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|
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Eksperimentel: 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.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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
Tidsramme: 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.
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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
Tidsramme: 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.
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Across 4 consecutive sessions, completed over 4-12 weeks.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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
Tidsramme: 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.
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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
Tidsramme: 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.
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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
Tidsramme: 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.
|
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
Tidsramme: 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.
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change From Baseline to End of Treatment in Body Weight (4-12 Weeks)
Tidsramme: 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.
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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)
Tidsramme: 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.
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4-12 weeks
|
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Change From Baseline to End of Treatment in Heart Rate (4-12 Weeks)
Tidsramme: 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)
Tidsramme: 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
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2022-258
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Kliniske forsøg med Spiseforstyrrelser
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University of Sao Paulo General HospitalAktiv, ikke rekrutterende
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University of Turin, ItalyAfsluttetMindful Eating Intervention | Bæredygtige kostpræferencerItalien
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ShireAfsluttetBinge-eating DisorderAustralien
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Lindner Center of HOPEUniversity of CincinnatiAfsluttet
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University of North Carolina, Chapel HillThe Hilda & Preston Davis Foundation; Global Foundation for Eating DisordersAfsluttetSpiseforstyrrelse | Binge-eating DisorderForenede Stater
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Axsome Therapeutics, Inc.Tilmelding efter invitationBinge-Eating DisorderForenede Stater
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BioprojetAfsluttet
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Sao Jose do Rio Preto Medical SchoolFundação de Amparo à Pesquisa do Estado de São PauloAfsluttetBinge-Eating Disorder | Spiseforstyrrelser | Spiseadfærd | Spiseforstyrrelse | Binge Eating Disorder forbundet med fedmeBrasilien
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Ali RezaiAktiv, ikke rekrutterendeBinge-Eating DisorderForenede Stater
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Massachusetts General HospitalRekrutteringBinge-eating DisorderForenede Stater
Kliniske forsøg med Bilateral Stimulation
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Oregon Health and Science UniversityRekrutteringFor tidlig fødsel | Forældre-barn relationer | Stress reaktion | Hospitalisme hos børnForenede Stater
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Institut National de la Santé Et de la Recherche...Rekruttering
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Qilu Hospital of Shandong UniversityIkke rekrutterer endnu
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Shanghai Mental Health CenterXuhui Mental Health CenterRekrutteringSkizofreni | Kognitiv svækkelse | Gentagen transkraniel magnetisk stimulering | Negative symptomer ved skizofreni | Dorsolateral præfrontal cortexKina
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University Health Network, TorontoWeston Brain InstituteRekrutteringFrontotemporal demens | Dyb hjernestimulationCanada
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Wuhan UniversityAktiv, ikke rekrutterendeDysfagi efter ekstubationKina
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Stanford UniversityAfsluttetBehandlingsresistent depressionForenede Stater
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University of Rome Foro ItalicoAfsluttet
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Waypoint Centre for Mental Health CareRekruttering
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University Hospital TuebingenGerman Center for Mental Health (DZPG; www.dzpg.org)Ikke rekrutterer endnuStørre depressiv lidelse