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NCT Number: NCT06818695

Online Imaginal Exposure Therapy for Eating Disorders Trial

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).

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Key information

Conditions

Anorexia Nervosa Feeding and Eating Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

North East London Foundation Trust Eating Disorder Service

London, Barking, IG11 7RS, United Kingdom

Location contact

Emilia Severs

CONTACT

[email protected]

Lucy Serpell

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 as usual (TAU)

Other

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

Primary outcomes

  1. 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.

  2. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amber L Cameron, BA Experimental Psychology

CONTACT

[email protected]

+44 7703329648

Lucy Serpell

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University College, London

Other

Collaborators

  • North East London Foundation Trust

Registry information

Official study title

Efficacy of Online Imaginal Exposure Therapy for Individuals With Anorexia Nervosa

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 10, 2025
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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