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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ through completion of post-intervention follow-up, within 2 weeks of final intervention

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 9Eligibility criteria met