Online Imaginal Exposure Therapy for Eating Disorders Trial

NCT06818695 | Not Yet Recruiting

• 1 other identifier: 162510
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anorexia Nervosa

Keywords

Intervention Study; Anorexia Nervosa; Imaginal Exposure; Waiting List Controls; Parallel Group Design

Outcome Measures

Primary Outcomes (2)

• Eating Disorder Examination Questionnaire

  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

  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 Outcomes (5)

• Fear of Food Measure (FOFM)

  From initial session to the end of the intervention at 5 weeks

• Eating Disorder Fears Interview (EFI)

  From initial session to the end of intervention at 5 weeks

• Eating Disorder Fears Questionnaire (EFQ)

  From initial session to the end of intervention at 5 weeks

• Penn State Worry Questionnaire (PSWQ)

  From initial session to end of intervention at 5 weeks.

• Beck Depression Inventory II (BDI-II)

  From the initial session to the end of the intervention at 5 weeks.

Study Arms (2)

Treatment Arm

EXPERIMENTAL

Participants will receive imaginal exposure for Anorexia Nervosa

Other: Imaginal Exposure for Anorexia Nervosa

Waitlist Control

ACTIVE COMPARATOR

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)

Interventions

Imaginal Exposure for Anorexia Nervosa OTHER

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.

Treatment Arm

Treatment as Usual (TAU) OTHER

TAU includes specialist nurse monitoring, occasional medical reviews, and dietetic support (depending on the individual's particular needs)

Waitlist Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University College, London: lead
• North East London Foundation Trust: collaborator

Study Sites (1)

North East London Foundation Trust Eating Disorder Service

London, Barking, IG11 7RS, United Kingdom

Location

Related Publications (1)

• Levinson 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.

  PMID: 32794449 BACKGROUND

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Officials

• Lucy Serpell

  University College, London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amber L Cameron, BA Experimental Psychology

CONTACT

+44 7703329648; ucju575@ucl.ac.uk

Lucy Serpell

CONTACT

l.serpell@ucl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 10, 2025
• Study Start: April 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)