Eating DisordersORPNCT04862247
Online Relapse Prevention Study
A study testing Imaginal Exposure Condition and Writing and Thinking Condition in people with Eating Disorders and Anorexia Nervosa, run by University of Louisville at 1 site in United States.
Trial summary
The purpose of this study is to collect preliminary data on the feasibility and acceptability of the randomization of two relapse-prevention treatment conditions after discharge from intensive eating disorder (ED) treatment: an imaginal exposure therapy and a writing and thinking intervention. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Eating Disorders, Anorexia Nervosa, Bulimia Nervosa
- What is being tested?
- Imaginal Exposure Condition and Writing and Thinking Condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2021to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over the age of 18
- discharged from intensive treatment within the last four months (inpatient, residential, partial hospital/day program, intensive outpatient program)
- currently meet criteria for anorexia nervosa, other specified feeding and eating disorder-atypical anorexia nervosa, or bulimia nervosa
Who cannot join
- high and active suicidality, psychosis, mania, or medical compromised status will be excluded, as these comorbidities would make it difficult to complete study procedures
- under the age of 18
- does not meet criteria for anorexia nervosa, other specified feeding and eating disorder-atypical anorexia nervosa, or bulimia nervosa.
- discharged from intensive treatment more than four months ago
Trial locations and contacts
1 site in 1 country.
United States1 site
Eating Anxiety Treatment Laboratory and Clinic
Louisville, Kentucky, 40292
About this study
Official title: A Pilot Randomized Control Trial of a Relapse Prevention Online Exposure Protocol for Eating Disorders and Mechanisms of Change
The purpose of this study is to collect preliminary data on the feasibility and acceptability of the randomization of two relapse-prevention treatment conditions after discharge from intensive eating disorder (ED) treatment: an imaginal exposure therapy and a writing and thinking intervention. The second aim to test for (a) differences between the two treatments for the prevention of relapse and (b) preliminary change on clinical ED outcomes (e.g., ED symptoms, fears). The investigators further aim to examine the two treatments target fear extinction and if fear extinction is associated with ED outcomes. The investigators also plan to test if baseline differences in fear conditioning relate to change in ED outcomes across treatment.
- Conditions
- Eating Disorders, Anorexia Nervosa, Bulimia Nervosa, Anorexia Nervosa, Atypical, Other Specified Feeding or Eating Disorder
- Being tested
- Imaginal Exposure Condition, Writing and Thinking Condition
- Keywords
- Relapse Prevention, Treatment, Eating Disorder Symptoms, Therapy
- Medical subject headings
- Feeding and Eating Disorders, Anorexia Nervosa, Bulimia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imaginal Exposure ConditionBehavioural
Participants will be asked to think and write about an eating related fear or anxiety. Specifically, they will be asked to spend 20-30 minutes writing about a specific fear or anxiety they have, then another 20-35 minutes re-reading and imagining that what they have written is happening.
Writing and Thinking ConditionBehavioural
Participants will be asked to think and write about their eating disorder using specific prompts designed to help them process their eating disorder. Specifically, they will be asked to spend 20-30 minutes writing their eating disorder, then another 20-35 minutes re-reading what they wrote.
| Study group | Role | What they receive |
|---|---|---|
| Imaginal Exposure Condition | Experimental | 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. Receives: Behavioral: Imaginal Exposure Condition |
| Writing and Thinking Condition | Active comparator | 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. Receives: Behavioral: Writing and Thinking Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Eating Disorder Relapse
First, the investigators will define relapse as moving from one stage of remission to another (e.g., remission to partial remission or partial remission to currently ill). Second, the investigators will define relapse as re-entry into a more intensive treatment setting (e.g., moving from outpatient to partial hospitalization).
Measured: 6-Month Follow-Up
Change in Eating Disorder Symptoms using the EDE-Q
The Eating Disorder Examination Questionnaire (EDEQ), a self-reported measure, is assessed at multiple time points throughout the duration of the study and is used to examine the attitudes and behaviors in individuals with eating disorder symptoms.
Measured: Up to 6-Month Follow-Up
Re-admission Percentage
Using the Treatment Interview, we will assess all current and past treatment experiences, dates of treatment, and primary type of treatment. Re-admission will be assessed at follow up timepoints and defined as re-entry into a more intensive treatment setting.
Measured: 1 Month Follow Up and 6 Month Follow Up
Secondary outcomes (5)
Change in State Anxiety
Subjective Units of Distress(SUDS) is a valid and reliable behavioral measure of state anxiety used during each treatment session to measure anxiety and distress and will be collected before, during, and after each session. Additionally, the Brief State Anxiety Measure is a 6-item measure with acceptable reliability and validity and sensitivity to fluctuations in state anxiety levels and will be collected at the beginning and end of each session.
Measured: Treatment Session 1 through 5
Change in State Fear of Food
State Fear of Food Measure will be used to assess food anxiety, food avoidance, and feared concerns and will be collected at the beginning and end of each session.
Measured: Treatment Session 2 through 5
Change in Positive and Negative Affect
State Positive and Negative Affect Schedule will be used to assess positive and negative affect at the beginning and end of each session.
Measured: Treatment Session 2 through 5
Change in Eating Disorder Symptoms
Eating Disorder-15 is a 15-item measure of eating disorder cognitions and behaviors, which will be collected at the beginning of each treatment session.
Measured: Treatment Session 2 through 5
Fear Extinction
FLARe is a validated smart-phone behavioral assessment of fear learning that will assess target engagement at baseline, post, and one and six month follow-ups.
Measured: Up to 6 Month Follow Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start4 Jun 2021
- Primary completion1 Feb 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), King's College London
- Responsible party
- Principal investigator, Cheri Levinson, University of Louisville
- Investigators
- Cheri A Levinson, PhD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04862247
- Sponsor's protocol ID
- IRB#20.0626
- Other IDs
- 1R34MH124799-01
- Acronym
- ORP
- Status last verified
- Mar 2025
- First submitted
- 23 Apr 2021
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Farrell NR, Brosof LC, Vanzhula IA, Christian C, Bowie OR, Levinson CA. [Exploring Mechanisms of Action in Exposure-Based Cognitive Behavioral Therapy for Eating Disorders: The Role of Eating-Related Fears and Body-Related Safety Behaviors]. Behav Ther. 2019 Nov;50(6):1125-1135. doi: 10.1016/j.beth.2019.01.008. Epub 2019 Feb 12. French.
PubMed 31735247Levinson CA, Brosof LC, Ma J, Fewell L, Lenze EJ. Fear of food prospectively predicts drive for thinness in an eating disorder sample recently discharged from intensive treatment. Eat Behav. 2017 Dec;27:45-51. doi: 10.1016/j.eatbeh.2017.11.004. Epub 2017 Nov 9.
PubMed 29145095Levinson CA, Christian C, Vanzhula IA. Manipulating the theoretical framing of exposure therapy for eating disorders impacts clinicians' treatment preferences. Eat Weight Disord. 2020 Oct;25(5):1205-1212. doi: 10.1007/s40519-019-00751-3. Epub 2019 Jul 17.
PubMed 31317512Murray SB, Strober M, Craske MG, Griffiths S, Levinson CA, Strigo IA. Fear as a translational mechanism in the psychopathology of anorexia nervosa. Neurosci Biobehav Rev. 2018 Dec;95:383-395. doi: 10.1016/j.neubiorev.2018.10.013. Epub 2018 Oct 28.
PubMed 30392878Reilly EE, Anderson LM, Gorrell S, Schaumberg K, Anderson DA. Expanding exposure-based interventions for eating disorders. Int J Eat Disord. 2017 Oct;50(10):1137-1141. doi: 10.1002/eat.22761. Epub 2017 Aug 16.
PubMed 28815659Levinson CA, Christian C, Ram SS, Vanzhula I, Brosof LC, Michelson LP, Williams BM. Eating disorder symptoms and core eating disorder fears decrease during online imaginal exposure therapy for eating disorders. J Affect Disord. 2020 Nov 1;276:585-591. doi: 10.1016/j.jad.2020.07.075. Epub 2020 Jul 21.
PubMed 32794449Levinson CA, Rapp J, Riley EN. Addressing the fear of fat: extending imaginal exposure therapy for anxiety disorders to anorexia nervosa. Eat Weight Disord. 2014 Dec;19(4):521-4. doi: 10.1007/s40519-014-0115-6. Epub 2014 Apr 2. No abstract available.
PubMed 24691784Steinglass JE, Sysko R, Glasofer D, Albano AM, Simpson HB, Walsh BT. Rationale for the application of exposure and response prevention to the treatment of anorexia nervosa. Int J Eat Disord. 2011 Mar;44(2):134-41. doi: 10.1002/eat.20784.
PubMed 20127936Levinson CA, Penwell T, Sandoval-Araujo LE, Johnson M, Grady A, Stancil J, Kong M. A Randomized Controlled Trial of Self-Guided Digital Written Imaginal Exposure Therapy for Eating Disorders in Patients Recently Discharged From Higher Level Specialty Eating Disorder Care. Int J Eat Disord. 2026 Jun 11. doi: 10.1002/eat.70147. Online ahead of print.
PubMed 42276768
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Control Trial of a Relapse Prevention Online Exposure Protocol for Eating Disorders and Mechanisms of Change
- ClinicalTrials.gov ID
- NCT04862247
- Acronym / sponsor ID
- ORP / IRB#20.0626
- Conditions
- Eating Disorders, Anorexia Nervosa, Bulimia Nervosa, Anorexia Nervosa, Atypical, Other Specified Feeding or Eating Disorder
- Keywords
- Relapse Prevention, Treatment, Eating Disorder Symptoms, Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), King's College London
- Study start
- 4 Jun 2021 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 27 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to collect preliminary data on the feasibility and acceptability of the randomization of two relapse-prevention treatment conditions after discharge from intensive eating disorder (ED) treatment: an imaginal exposure therapy and a writing and thinking intervention. The second aim to test for (a) differences between the two treatments for the prevention of relapse and (b) preliminary change on clinical ED outcomes (e.g., ED symptoms, fears). The investigators further aim to examine the two treatments target fear extinction and if fear extinction is associated with ED outcomes. The investigators also plan to test if baseline differences in fear conditioning relate to change in ED outcomes across treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imaginal Exposure Condition | Experimental | Behavioral: Imaginal Exposure ConditionParticipants 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. |
| Writing and Thinking Condition | Active comparator | Behavioral: Writing and Thinking ConditionParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- over the age of 18
- discharged from intensive treatment within the last four months (inpatient, residential, partial hospital/day program, intensive outpatient program)
- currently meet criteria for anorexia nervosa, other specified feeding and eating disorder-atypical anorexia nervosa, or bulimia nervosa
Key exclusion criteria (4 listed)
- high and active suicidality, psychosis, mania, or medical compromised status will be excluded, as these comorbidities would make it difficult to complete study procedures
- under the age of 18
- does not meet criteria for anorexia nervosa, other specified feeding and eating disorder-atypical anorexia nervosa, or bulimia nervosa.
- discharged from intensive treatment more than four months ago
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imaginal Exposure ConditionParticipants will be asked to think and write about an eating related fear or anxiety. Specifically, they will be asked to spend 20-30 minutes writing about a specific fear or anxiety they have, then another 20-35 minutes re-reading and imagining that what they have written is happening. | Behavioural | Imaginal Exposure Condition |
| Writing and Thinking ConditionParticipants will be asked to think and write about their eating disorder using specific prompts designed to help them process their eating disorder. Specifically, they will be asked to spend 20-30 minutes writing their eating disorder, then another 20-35 minutes re-reading what they wrote. | Behavioural | Writing and Thinking Condition |
Primary outcome
Rate of Eating Disorder Relapse
Time frame: 6-Month Follow-Up
First, the investigators will define relapse as moving from one stage of remission to another (e.g., remission to partial remission or partial remission to currently ill). Second, the investigators will define relapse as re-entry into a more intensive treatment setting (e.g., moving from outpatient to partial hospitalization).
Change in Eating Disorder Symptoms using the EDE-Q
Time frame: Up to 6-Month Follow-Up
The Eating Disorder Examination Questionnaire (EDEQ), a self-reported measure, is assessed at multiple time points throughout the duration of the study and is used to examine the attitudes and behaviors in individuals with eating disorder symptoms.
Re-admission Percentage
Time frame: 1 Month Follow Up and 6 Month Follow Up
Using the Treatment Interview, we will assess all current and past treatment experiences, dates of treatment, and primary type of treatment. Re-admission will be assessed at follow up timepoints and defined as re-entry into a more intensive treatment setting.
5 secondary outcomes
Change in State Anxiety
Time frame: Treatment Session 1 through 5
Change in State Fear of Food
Time frame: Treatment Session 2 through 5
Change in Positive and Negative Affect
Time frame: Treatment Session 2 through 5
Change in Eating Disorder Symptoms
Time frame: Treatment Session 2 through 5
Fear Extinction
Time frame: Up to 6 Month Follow Up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Background: PubMed 31735247Farrell NR, Brosof LC, Vanzhula IA, Christian C, Bowie OR, Levinson CA. [Exploring Mechanisms of Action in Exposure-Based Cognitive Behavioral Therapy for Eating Disorders: The Role of Eating-Related Fears and Body-Related Safety Behaviors]. Behav Ther. 2019 Nov;50(6):1125-1135. doi: 10.1016/j.beth.2019.01.008. Epub 2019 Feb 12. French.
- Background: PubMed 29145095Levinson CA, Brosof LC, Ma J, Fewell L, Lenze EJ. Fear of food prospectively predicts drive for thinness in an eating disorder sample recently discharged from intensive treatment. Eat Behav. 2017 Dec;27:45-51. doi: 10.1016/j.eatbeh.2017.11.004. Epub 2017 Nov 9.
- Background: PubMed 31317512Levinson CA, Christian C, Vanzhula IA. Manipulating the theoretical framing of exposure therapy for eating disorders impacts clinicians' treatment preferences. Eat Weight Disord. 2020 Oct;25(5):1205-1212. doi: 10.1007/s40519-019-00751-3. Epub 2019 Jul 17.
- Background: PubMed 30392878Murray SB, Strober M, Craske MG, Griffiths S, Levinson CA, Strigo IA. Fear as a translational mechanism in the psychopathology of anorexia nervosa. Neurosci Biobehav Rev. 2018 Dec;95:383-395. doi: 10.1016/j.neubiorev.2018.10.013. Epub 2018 Oct 28.
- Background: PubMed 28815659Reilly EE, Anderson LM, Gorrell S, Schaumberg K, Anderson DA. Expanding exposure-based interventions for eating disorders. Int J Eat Disord. 2017 Oct;50(10):1137-1141. doi: 10.1002/eat.22761. Epub 2017 Aug 16.
- Background: PubMed 32794449Levinson CA, Christian C, Ram SS, Vanzhula I, Brosof LC, Michelson LP, Williams BM. Eating disorder symptoms and core eating disorder fears decrease during online imaginal exposure therapy for eating disorders. J Affect Disord. 2020 Nov 1;276:585-591. doi: 10.1016/j.jad.2020.07.075. Epub 2020 Jul 21.
- Background: PubMed 24691784Levinson CA, Rapp J, Riley EN. Addressing the fear of fat: extending imaginal exposure therapy for anxiety disorders to anorexia nervosa. Eat Weight Disord. 2014 Dec;19(4):521-4. doi: 10.1007/s40519-014-0115-6. Epub 2014 Apr 2. No abstract available.
- Background: PubMed 20127936Steinglass JE, Sysko R, Glasofer D, Albano AM, Simpson HB, Walsh BT. Rationale for the application of exposure and response prevention to the treatment of anorexia nervosa. Int J Eat Disord. 2011 Mar;44(2):134-41. doi: 10.1002/eat.20784.
- Derived from this study: PubMed 42276768Levinson CA, Penwell T, Sandoval-Araujo LE, Johnson M, Grady A, Stancil J, Kong M. A Randomized Controlled Trial of Self-Guided Digital Written Imaginal Exposure Therapy for Eating Disorders in Patients Recently Discharged From Higher Level Specialty Eating Disorder Care. Int J Eat Disord. 2026 Jun 11. doi: 10.1002/eat.70147. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheri A Levinson, PhD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imaginal Exposure Condition and Writing and Thinking Condition in people with Eating Disorders and Anorexia Nervosa, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Eating Disorder Relapse (time frame: 6-Month Follow-Up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04862247, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.