Online Imaginal Exposure Therapy for Eating Disorders Trial

April 4, 2025 updated by: University College, London

Efficacy of Online Imaginal Exposure Therapy for Individuals With Anorexia Nervosa

The goal of this clinical trial is to learn if an imaginal exposure intervention first conducted by Levinson and colleagues (2020) can produce similar promising results in individuals with anorexia on the waiting list of an NHS eating disorder service. The main question it aims to answer is:

  1. How effective is Imaginal Exposure Therapy in reducing eating disorder symptoms and increasing weight in patients with AN?

    The secondary research questions are:

  2. How effective is Imaginal Exposure Therapy in reducing anxiety and fear related outcomes around food and eating?
  3. How effective is Imaginal Exposure Therapy in improving patients' general anxiety and depression symptoms?

Researchers will compare the results of individuals in the treatment condition to individual's in the control condition to explore the efficacy of the intervention on eating disorder and eating disorder fear symptomology, and body weight.

Participants in the intervention group will receive 4 sessions of online exposure therapy, and participants in the control group will remain on the waiting list with treatment as usual (primarily nurse monitoring).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Study design type: The study will have a parallel group design. Approximately half of the participants will be randomised to receive our intervention, IE for AN. The other half will remain on the waitlist for the service and receive treatment as usual (TAU), which includes specialist nurse monitoring, occasional medical reviews, and dietetic support (depending on the individual's particular needs). This study design will allow us to directly assess the efficacy of the IE intervention, as compared to standard waiting list monitoring, on participants' weight and AN symptoms.

Sampling: Potential participants will be identified by the direct care team; any details not obtained through the study questionnaires will be obtained through digital medical records. The researchers will request information where needed through the direct care team. Participants will be recruited through the NELFT ED service post referral triage, while patients are on the waiting list. Participants will be the adults on the waiting list for receiving AN treatment at NELFT.

Procedure: Following informed consent, participation in the trial will last 5 weeks.

Week 1: All participants will, where possible, come to the service in-person to be weighed. All participants will complete a set of psychometric questionnaires during this appointment. The IE group will also complete the Eating Disorder Fear Interview (Levinson et al., 2019), administered in order to identify a fear to target in exposure therapy. If not possible to attend in-person, this primary appointment will be held on Zoom. All baseline appointments will be with a study coordinator.

Week 2: First online imaginal exposure. Week 3: Second online imaginal. Week 4: Third online imaginal exposure. Week 5: Fourth online imaginal exposure and participants will complete the final battery of online questionnaires. They will then come to the service in-person to be weighed again.

Study Type

Interventional

Enrollment (Estimated)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Amber L Cameron, BA Experimental Psychology
  • Phone Number: +44 7703329648
  • Email: ucju575@ucl.ac.uk

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients on the North East London Foundation Trust Eating Disorder waiting list.
  • Patients who are over the age of 18 years old.
  • Patients of all genders.
  • Patients who have a primary diagnosis of Anorexia Nervosa.
  • Patients who are willing and able to provide written informed consent.

Exclusion Criteria:

  • Patients on the waiting list who are under the age of 18.
  • Females who are pregnant, planning pregnancy or breastfeeding.
  • Patients involved in concurrent research which is likely to interfere with the imaginal exposure intervention.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Arm
Participants will receive imaginal exposure for Anorexia Nervosa
Other: Imaginal Exposure for Anorexia Nervosa
Imaginal exposure aims to use the power of imagining the fearful situation to heighten anxiety and by not engaging in imaginative restriction or other eating disorder behaviours, the individual, in theory, can habituate to the anxiety until it naturally subsides.
Active Comparator: Waitlist Control
Participants in this arm will remain on the waitlist for the service and receive treatment as usual (TAU), which includes specialist nurse monitoring, occasional medical reviews, and dietetic support (depending on the individual's particular needs).
Other: Treatment as Usual (TAU)
TAU includes specialist nurse monitoring, occasional medical reviews, and dietetic support (depending on the individual's particular needs)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eating Disorder Examination Questionnaire
Time Frame: From initial interview till the end of treatment after 5 weeks
A 28-item questionnaire aiming to assess the characteristics, range, frequency and severity of behaviours associated with clinical eating disorders such as Anorexia Nervosa, Bulimia Nervosa, Binge Eating Disorder and OSFED. It consists of 4 subscales: Restraint, Eating Concern, Shape Concern and Weight Concern and overall global score. Higher scores are indicative of more severe eating difficulties and the scale is used as an assessment and diagnostic tool.
From initial interview till the end of treatment after 5 weeks
Body Mass Index
Time Frame: From initial session until the end of intervention at 5 weeks
BMI is a measure using an individual's tissue mass (weight) and height to determine body mass index, which is categorised into the following: Underweight (under 18.5 kg/m2), Normal Weight (18.5-24.9) Overweight (25-29.9) and Obese (30 or more).
From initial session until the end of intervention at 5 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fear of Food Measure (FOFM)
Time Frame: From initial session to the end of the intervention at 5 weeks
Designed by Levinson et al., specifically to assess improvement in Eating Related Anxiety over the course of Imagined Exposure Therapy. It consists of 3 subscales: Anxiety about Eating, Food Avoidance Behaviours, and Feared Concerns.
From initial session to the end of the intervention at 5 weeks
Eating Disorder Fears Interview (EFI)
Time Frame: From initial session to the end of intervention at 5 weeks
Designed by Levinson et al., the EFI is a semi-structured interview consisting of 31 items designed to assess common ED fears such as food, weight gain and consequences of weight gain (judgement). This interview can also be used in tandem with Eating Disorder clinical assessment interviews to attain a more in depth understanding of treatment aims and goals.
From initial session to the end of intervention at 5 weeks
Eating Disorder Fears Questionnaire (EFQ)
Time Frame: From initial session to the end of intervention at 5 weeks
Designed by Levinson et al., the EFQ is a 30 item self-report measure designed to assess common ED fears such as gaining weight, consequences of weight gain, and eating in public.
From initial session to the end of intervention at 5 weeks
Penn State Worry Questionnaire (PSWQ)
Time Frame: From initial session to end of intervention at 5 weeks.
A 16 Item Questionnaire assessing traits of worrying in adults. The scale measures three dimensions of worrying: excessive, generality and uncontrollable.
From initial session to end of intervention at 5 weeks.
Beck Depression Inventory II (BDI-II)
Time Frame: From the initial session to the end of the intervention at 5 weeks.
The BDI-II is a 21 item self report inventory measuring severity of depression in adolescents and adults.
From the initial session to the end of the intervention at 5 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Collaborators

North East London Foundation Trust

Investigators

  • Principal Investigator: Lucy Serpell, University College, London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

February 7, 2025

First Submitted That Met QC Criteria

February 7, 2025

First Posted (Actual)

February 10, 2025

Study Record Updates

Last Update Posted (Actual)

April 6, 2025

Last Update Submitted That Met QC Criteria

April 4, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 162510

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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