What side effects are associated with this type of intervention?

Common treatments for eating disorders include psychotherapy (such as cognitive-behavioral therapy and intensive group psychotherapy) and pharmacotherapy (such as antidepressants). Psychotherapy generally has fewer physical side effects but may cause emotional distress as patients confront challenging issues. Antidepressants, particularly tricyclic antidepressants like imipramine, can cause side effects such as dry mouth, constipation, urinary retention, blurred vision, dizziness, and weight gain. Interoception-focused modules, which aim to enhance body awareness and emotional regulation, are less likely to have physical side effects but may still cause emotional discomfort as patients increase their awareness of internal sensations and emotions.

What prior FDA approvals exist?

The provided context does not mention specific FDA-approved drugs for eating disorders directly related to interoception-focused treatments. However, it does reference the use of methylphenidate in a pilot study for bulimia nervosa (BN) with comorbid cluster B personality disorder, showing beneficial effects. Generally, treatments for eating disorders like bulimia nervosa often include psychotherapy and antidepressant medications, such as selective serotonin reuptake inhibitors (SSRIs). For broader FDA-approved treatments, medications like fluoxetine (an SSRI) are commonly used for bulimia nervosa.

What other types of research exist?

Promising novel alternatives for eating disorder treatment in 2024 include: 1) Deep Brain Stimulation (DBS), which has shown improvements in body mass index and comorbid psychopathology in treatment-refractory anorexia nervosa patients; 2) Intensive 5-day neurobiologically-informed multifamily treatment, focusing on temperament and neurobiological factors contributing to anorexia nervosa; and 3) Cognitive-Behavioral Therapy (CBT) tailored to address dysfunctional thoughts, body checking, and body avoidance behaviors.

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Interoception-Focused Therapy for Suicidal Thoughts (RISE Trial)

N/A

Recruiting

Research Sponsored by Auburn University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 or older

History of suicidal ideation or attempt

Must not have

Below the age of 18

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within one week of post-test

Awards & highlights

Summary

This trial aims to help college students with suicidal thoughts or poor body signal awareness understand their body signals and emotions better. The goal is to improve their mental health and reduce harmful behaviors.

Who is the study for?

This trial is for college students aged 18 or older who have experienced suicidal thoughts or have a history of low body awareness, which can relate to eating disorders. It's not open to anyone under the age of 18.

What is being tested?

Project RISE tests a program focusing on improving body awareness and understanding emotions versus 'Healthy Habits' modules covering financial planning and hygiene. Participants are randomly assigned to one of these two approaches.

What are the potential side effects?

Since this study involves behavioral interventions rather than medications, traditional side effects are not expected. However, discussing sensitive topics like suicidality may cause emotional discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have had thoughts of or attempted suicide in the past.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within one week of post-test

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within one week of post-test

This trial's timeline: 3 weeks for screening, Varies for treatment, and within one week of post-test for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Multidimensional Assessment of Interoceptive Awareness

Treatment acceptability

Secondary study objectives

Brief Symptom Inventory

Depression Screening Inventory-Suicidality Subscale

Eating Disorder Examination Questionnaire

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Interoceptive AwarenessExperimental Treatment1 Intervention

The intervention consists of four modules that focus on multiple aspects of interoception including: body awareness, body sensations/movement, eating, health and self-care, emotional awareness, and understanding the self in relation to others.

Group II: Healthy HabitsActive Control1 Intervention

The comparator condition is called "Health Habits" and is matched for time and attention; participants complete modules related to healthy habits such as financial planning, hygiene, stretching, and healthy eating.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for eating disorders include cognitive-behavioral therapy (CBT), pharmacotherapy, and interoception-focused modules. CBT works by modifying dysfunctional beliefs and behaviors related to body image and eating habits, aiming to change the thought patterns that sustain the disorder. Pharmacotherapy, especially with selective serotonin reuptake inhibitors (SSRIs), targets neurochemical imbalances to alleviate symptoms like binge eating and depression. Interoception-focused modules enhance body awareness and emotional regulation, helping patients better understand and respond to their internal cues, which can reduce disordered eating behaviors. These treatments are essential as they address both psychological and physiological aspects, offering a comprehensive approach to managing eating disorders.

Psychotherapy outcome research with bulimia nervosa.Integrating the twelve-step approach with traditional psychotherapy for the treatment of eating disorders.Can we change binge eating behaviour by interventions addressing food-related impulsivity? A systematic review.

Find a Location

Who is running the clinical trial?

Auburn UniversityLead Sponsor

78 Previous Clinical Trials

14,385 Total Patients Enrolled

Media Library

Reconnecting to Internal Sensations and Experiences Clinical Trial Eligibility Overview. Trial Name: NCT05285111 — N/A

Eating Disorder Research Study Groups: Healthy Habits, Interoceptive Awareness

Eating Disorder Clinical Trial 2023: Reconnecting to Internal Sensations and Experiences Highlights & Side Effects. Trial Name: NCT05285111 — N/A

Reconnecting to Internal Sensations and Experiences 2023 Treatment Timeline for Medical Study. Trial Name: NCT05285111 — N/A

~32 spots leftby May 2025

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