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Behavioural Intervention

Floatation-REST, EFT, and IFT for Anorexia

N/A
Recruiting
Led By Emily M Choquette, PhD
Research Sponsored by Laureate Institute for Brain Research, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Primary diagnosis of anorexia nervosa
Weight restored to body mass index (BMI) > 18.5
Must not have
Orthostatic hypotension (defined as a drop of ≥ 20 mmHg in systolic blood pressure (SBP) or a drop of ≥ 10 mm Hg in diastolic blood pressure (DBP) when measured shortly after transitioning from lying down to standing)
Co-morbid diagnoses of Diagnostic and Statistical Manual of Mental Disorders, 5th ed. (DSM-5) bipolar disorder, schizophrenia, or other psychosis spectrum disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through completion of post-intervention follow-up, within 2 weeks of final intervention
Awards & highlights

Summary

This trial aims to study the relationship between how the body feels and body image issues in individuals with anorexia nervosa. 102 participants from the Laureate Eating Disorder Program will be randomly assigned to

Who is the study for?
This trial is for individuals aged 15-40 with a primary diagnosis of anorexia nervosa, BMI >18.5, transitioning from acute to residential care. They must not have started new psychiatric meds within the last week and should exhibit body image dissatisfaction as indicated by specific scale scores.
What is being tested?
The study tests how interoceptive processing affects body image in anorexia nervosa patients. Participants will either undergo floatation-REST (IFT) or watch acceptance/mindfulness videos (EFT). Each receives one intro session and three experimental sessions followed by various assessments.
What are the potential side effects?
Potential side effects are not explicitly listed but may include discomfort or anxiety due to the nature of interventions like floatation-REST or reactions to viewing body-related content in EFT.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My primary diagnosis is anorexia nervosa.
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My BMI is over 18.5.
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I can walk on my own without help.
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I can lay flat comfortably.
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I was assigned female at birth.
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I am between 15 and 40 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My blood pressure drops significantly when I stand up.
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I have been diagnosed with bipolar disorder, schizophrenia, or another psychosis spectrum disorder.
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I have had a seizure in the last year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through completion of post-intervention follow-up, within 2 weeks of final intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion of post-intervention follow-up, within 2 weeks of final intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Perceptual body image dissatisfaction on the Photographic Figure Rating Scale (PFRS)
Secondary study objectives
Appearance evaluation on the Multidimensional Body-Self Relations Questionnaire- Appearance Scales (MBSRQ-AS) Appearance Evaluation Subscale (range 7 to 35, higher scores indicate more satisfaction with appearance)
Appearance orientation on the Multidimensional Body-Self Relations Questionnaire- Appearance Scales (MBSRQ-AS) Appearance Orientation Subscale (range 7 to 35, higher scores indicate more satisfaction with appearance)
Attention regulation on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2)
+17 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Interoceptively Focused Treatment (IFT)Experimental Treatment2 Interventions
The IFT intervention will guide participants through a tailored application of present-moment focus toward experiencing awareness and acceptance of bodily signals and defusing thoughts related to those signals. For example, participants will engage in several exercises to increase awareness of body sensations, thoughts, and emotions. IFT consists of one introduction session with a clinician (\~60 minutes) the introduction session was designed as a brief introduction to acceptance- and mindfulness-based concepts with guided practice exercises and closing time for participants to briefly process challenges to execution of exercises and the experience during the session. This is followed by three IFT sessions which combine acceptance- and mindfulness-based skills practice with floatation-REST (Reduced Environmental Stimulation Therapy via floatation).
Group II: Exteroceptively Focused Treatment (EFT)Active Control1 Intervention
In the EFT condition, exercises are tailored toward experience of the present moment via external environment mindfulness (i.e., attending to experience) and defusion of thoughts. EFT consists of one introduction session with a clinician (\~60 minutes) the introduction session, similar in format to IFT, introduces acceptance- and mindfulness-based concepts. This is followed by three EFT sessions during which participants engage in brief guided skills training followed by video guided skills practice. The EFT condition is designed to increase awareness of the present moment and experience of the environment and view thoughts or emotions that may impact engagement with the current moment in a nonjudgmental way.

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Who is running the clinical trial?

Laureate Institute for Brain Research, Inc.Lead Sponsor
52 Previous Clinical Trials
5,338 Total Patients Enrolled
Emily M Choquette, PhDPrincipal InvestigatorLaureate Institute for Brain Research
~68 spots leftby Jun 2028
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