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Online Relapse Prevention Methods for Eating Disorders (ORP Trial)

N/A
Recruiting
Led By Cheri A Levinson, PhD
Research Sponsored by University of Louisville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
discharged from intensive treatment within the last month (inpatient, residential, partial hospital/day program, intensive outpatient program)
over the age of 18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month follow up and 6 month follow up
Awards & highlights

ORP Trial Summary

This trial is testing two different methods for preventing relapse after treatment for eating disorders: imaginal exposure therapy and writing and thinking intervention. The goal is to see if either method is more effective than the other, and if so, to understand why.

Who is the study for?
This trial is for adults over 18 who've recently left intensive treatment for eating disorders like anorexia or bulimia. It's not suitable for those with severe mental health issues, medical instability, or anyone discharged from care over a month ago.Check my eligibility
What is being tested?
The study compares two relapse-prevention methods post-eating disorder treatment: imaginal exposure therapy and a writing/thinking task. It aims to see which better prevents relapse and improves symptoms and fears related to eating disorders.See study design
What are the potential side effects?
While specific side effects are not detailed, interventions may trigger emotional discomfort due to confronting fears in the case of imaginal exposure, or stress from introspection during writing tasks.

ORP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I was discharged from an intensive care program within the last month.
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I am over 18 years old.
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I have been diagnosed with anorexia, atypical anorexia, or bulimia.

ORP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month follow up and 6 month follow up
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month follow up and 6 month follow up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Eating Disorder Symptoms using the EDE-Q
Rate of Eating Disorder Relapse
Re-admission Percentage
Secondary outcome measures
Change in Eating Disorder Symptoms
Change in Positive and Negative Affect
Change in State Anxiety
+2 more

ORP Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Imaginal Exposure ConditionExperimental Treatment1 Intervention
Participants will complete one phone session including education about the treatment followed by four online sessions of imaginal exposure across a one month time period. Each session is separated by 1 week.
Group II: Writing and Thinking ConditionActive Control1 Intervention
Participants will complete one phone session including education about the treatment followed by four online sessions of a writing and thinking intervention across a one month time period. Each session is separated by 1 week.

Find a Location

Who is running the clinical trial?

University of LouisvilleLead Sponsor
336 Previous Clinical Trials
75,810 Total Patients Enrolled
7 Trials studying Eating Disorders
830 Patients Enrolled for Eating Disorders
National Institute of Mental Health (NIMH)NIH
2,776 Previous Clinical Trials
2,673,630 Total Patients Enrolled
61 Trials studying Eating Disorders
25,030 Patients Enrolled for Eating Disorders
King's College LondonOTHER
717 Previous Clinical Trials
25,754,860 Total Patients Enrolled
4 Trials studying Eating Disorders
472 Patients Enrolled for Eating Disorders

Media Library

Imaginal Exposure Condition Clinical Trial Eligibility Overview. Trial Name: NCT04862247 — N/A
Eating Disorders Research Study Groups: Imaginal Exposure Condition, Writing and Thinking Condition
Eating Disorders Clinical Trial 2023: Imaginal Exposure Condition Highlights & Side Effects. Trial Name: NCT04862247 — N/A
Imaginal Exposure Condition 2023 Treatment Timeline for Medical Study. Trial Name: NCT04862247 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants aged 50 and over eligible for this clinical experiment?

"The cut-off points for participation in this research are 18 years old and 65 years old, respectively."

Answered by AI

Are there any remaining recruitment opportunities for participants in this research?

"Affirmative, the information available on clinicaltrials.gov signals that this medical experiment is presently seeking participants. Originally posted on June 4th 2021, it has most recently been updated on April 1st 2022 with a target of 130 patients from one site."

Answered by AI

What results are researchers aiming to attain with this trial?

"The principal result that will be surveyed over the 6-month follow up is a shift in eating disorder symptoms, as quantified using the EDE-Q. Additionally, patients' state anxiety and positive/negative affect levels will be assessed utilizing Subjective Units of Distress (SUDS) and State Positive & Negative Affect Schedule respectively; while Brief State Anxiety Measure will also be employed to measure fluctuating states of tension at the start and end of each session."

Answered by AI

Who is eligible to join this research project?

"This research initiative seeks 130 volunteers aged 18-65 with a diagnosis of bulimia nervosa. In addition, they must have recently concluded intensive treatment by way of hospitalization, residential care, partial hospital/day program or an intensive outpatient program and meet the criteria for either anorexia nervosa, other specified feeding and eating disorder-atypical anorexia nervosa or bulimia nervosa."

Answered by AI

What is the enrollment size for this investigation?

"Affirmative. Evidenced by the clinicaltrials.gov page, this medical experiment is recruiting participants actively. The trial was first posted on June 4th 2021 and updated as recently as April 1st 2022; it expects to recruit 130 patients from one site."

Answered by AI

Who else is applying?

What state do they live in?
New York
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
~7 spots leftby Jun 2024