Anorexia NervosaNCT06818695
Online Imaginal Exposure Therapy for Eating Disorders Trial
A study testing Imaginal Exposure for Anorexia Nervosa and Treatment as Usual (TAU) in people with Anorexia Nervosa, run by University College, London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Imaginal Exposure for Anorexia Nervosa and Treatment as Usual (TAU)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2025to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lucy Serpell contact
United Kingdom1 site
North East London Foundation Trust Eating Disorder Service
London, Barking, IG11 7RS
Lucy Serpell, l.serpell@ucl.ac.uk
Emilia Severs, emilia.severs@nelft.nhs.uk
About this study
Official title: 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:
- How effective is Imaginal Exposure Therapy in reducing eating disorder symptoms and increasing weight in patients with AN? The secondary research questions are:
- How effective is Imaginal Exposure Therapy in reducing anxiety and fear related outcomes around food and eating?
- How effective is Imaginal Exposure Therapy in improving patients' general anxiety and depression symptoms?
Read more
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).
Read the 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.
- Conditions
- Anorexia Nervosa
- Being tested
- Imaginal Exposure for Anorexia Nervosa, Treatment as Usual (TAU)
- Keywords
- Intervention Study, Anorexia Nervosa, Imaginal Exposure, Waiting List Controls, Parallel Group Design
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imaginal Exposure for Anorexia NervosaOther
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.
TAU includes specialist nurse monitoring, occasional medical reviews, and dietetic support (depending on the individual's particular needs)
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Participants will receive imaginal exposure for Anorexia Nervosa Receives: 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). Receives: Other: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: From initial session until the end of intervention at 5 weeks
Secondary outcomes (5)
Fear of Food Measure (FOFM)
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.
Measured: From initial session to the end of the intervention at 5 weeks
Eating Disorder Fears Interview (EFI)
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.
Measured: From initial session to the end of intervention at 5 weeks
Eating Disorder Fears Questionnaire (EFQ)
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.
Measured: From initial session to the end of intervention at 5 weeks
Penn State Worry Questionnaire (PSWQ)
A 16 Item Questionnaire assessing traits of worrying in adults. The scale measures three dimensions of worrying: excessive, generality and uncontrollable.
Measured: From initial session to end of intervention at 5 weeks.
Beck Depression Inventory II (BDI-II)
The BDI-II is a 21 item self report inventory measuring severity of depression in adolescents and adults.
Measured: From the initial session to the end of the intervention at 5 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study startApr 2025 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- 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
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- North East London Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Lucy Serpell, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06818695
- Sponsor's protocol ID
- 162510
- Status last verified
- Apr 2025
- First submitted
- 7 Feb 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32794449
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Online Imaginal Exposure Therapy for Individuals With Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT06818695
- Acronym / sponsor ID
- 162510
- Conditions
- Anorexia Nervosa
- Keywords
- Intervention Study, Anorexia Nervosa, Imaginal Exposure, Waiting List Controls, Parallel Group Design
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- North East London Foundation Trust
- Study start
- Apr 2025 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 10 Feb 2025 (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 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:
- How effective is Imaginal Exposure Therapy in reducing eating disorder symptoms and increasing weight in patients with AN? The secondary research questions are:
- How effective is Imaginal Exposure Therapy in reducing anxiety and fear related outcomes around food and eating?
- 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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Other: Imaginal Exposure for Anorexia NervosaParticipants will receive imaginal exposure for Anorexia Nervosa |
| Waitlist Control | Active comparator | Other: Treatment as Usual (TAU)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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 for Anorexia NervosaImaginal 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. | Other | Treatment Arm |
| Treatment as Usual (TAU)TAU includes specialist nurse monitoring, occasional medical reviews, and dietetic support (depending on the individual's particular needs) | Other | Waitlist Control |
Primary outcome
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.
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).
5 secondary outcomes
Fear of Food Measure (FOFM)
Time frame: 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
Eating Disorder Fears Questionnaire (EFQ)
Time frame: 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.
Beck Depression Inventory II (BDI-II)
Time frame: From the initial session to the end of the intervention at 5 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- 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.
- 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.
Lucy Serpell contact
Lucy Serpell principal investigator
University College, London
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 for Anorexia Nervosa and Treatment as Usual (TAU) in people with Anorexia Nervosa, run by University College, London at 1 site in United Kingdom.
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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 6 Apr 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 Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amber L Cameron, BA Experimental Psychology (+44 7703329648, ucju575@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eating Disorder Examination Questionnaire (time frame: From initial interview till the end of treatment after 5 weeks). The study lists 2 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 NCT06818695, which also lists 1 linked publication.
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 6 Apr 2025.