AzTrials
AzTrials

Eating DisordersNCT04778423

Feasibility and Acceptability of AVATAR Therapy in Eating Disorders.

A study testing Avatar Therapy in people with Eating Disorders, run by King's College London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This project will answer the overarching research question "What is the feasibility of developing and implementing AVATAR therapy to reduce the power of the eating disorder voice in patients with eating disorders?". AVATAR therapy for eating disorders has been developed based on AVATAR therapy for psychosis. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Eating Disorders
What is being tested?
Avatar Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited Kingdom
Study dates
5 Aug 2021to 31 Jan 2022
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 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • diagnosis of anorexia nervosa or atypical anorexia nervosa (e.g. restored weight but presence of abnormal eating disorder cognitions and behaviors), bulimia nervosa or binge eating disorder
  • availability of a laptop and internet connection for the assessments and sessions

Who cannot join

  • diagnosis of psychosis, alcohol use disorder, substance use disorder
  • insufficient level of English to engage in the therapy

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • King's College London

    London

Other trials in United Kingdom

About this study

Official title: AVATAR Therapy to Reduce the Power of the Eating Disorder Voice in Eating Disorders: Collaborative Development and Feasibility Testing

This project will answer the overarching research question "What is the feasibility of developing and implementing AVATAR therapy to reduce the power of the eating disorder voice in patients with eating disorders?". AVATAR therapy for eating disorders has been developed based on AVATAR therapy for psychosis. The feasibility of using AVATAR therapy in eating disorders will be tested using non-concurrent multiple baselines single case experimental design. The first stage (A1) will involve participants being randomly allocated to either a two, three or four week-baseline. The second will be the intervention phase (B) where participants will receive the AVATAR treatment which will last approximately 6 weeks. The third stage (A2) will be a 4-week follow-up period after the intervention phase, where participants will also complete a qualitative interview.

Read the detailed description

This project will answer the overarching research question "What is the feasibility of developing and implementing AVATAR therapy to reduce the power of the eating disorder voice in patients with eating disorders?". The aims are: 1) To use a collaborative approach that involves patients, carers and clinicians to adapt the AVATAR therapy in psychosis for patients with eating disorders. 2) To assess the feasibility of using this therapy in eating disorders.

Aim 1. To use a collaborative approach that involves patients, carers and clinicians to adapt the AVATAR therapy in psychosis for patients with eating disorders

Methods: Two collaborative workshops will be organised with a total of 16 people with lived experience of the illness (patients or carers) and 16 clinicians (approximately eight people/workshop), to review the contents of AVATAR therapy for eating disorders developed based on AVATAR therapy for psychosis. We will describe the structure and content of the therapy manual and will encourage the members of the group to provide feedback. The workshop will be video recorded. We will revise the therapy manual based on an iterative process of feedback and review. Outcome: the outcome will consist of a revised version of the AVATAR therapy manual.

Aim 2. To assess the feasibility of using AVATAR therapy in eating disorders

General procedure

Participants will be recruited through online advertisements and flyers placed at South London and Maudsley Hospital NHS Trust. They will be able to contact the researchers involved in the study by email. The researchers will then send the study information sheet by email and will assess eligibility to take part, should the participants wish to take part. Once eligibility is confirmed, participants will received a link to Qualtrics. Survey settings will eliminate the possibility of missing or repeated data. Participants will freely access the survey via a web link on the Internet. The online survey will include completion of the baseline questionnaires (described below). At the end of the intervention, and four-week follow-up, participants will receive two more links to Qualtrics, to complete the end-of-intervention and follow-up questionnaires, respectively. Following completion of the baseline questionnaires, participants will be invited to take part in the AVATAR therapy (described below), which will be delivered by one of the clinical researchers in the team. AVATAR therapy will be delivered remotely using a secure encrypted video-call system which will enable the delivery of the therapy in accordance with the clinical manual.

Design The project will use a non-concurrent multiple baselines single case experimental design (SCED) divided into three stages (A1BA2). The first stage (A1) will involve participants being randomly allocated to either a two, three or four week-baseline. The second will be the intervention phase (B) where participants will receive the AVATAR treatment which will last approximately 6 weeks. The third stage (A2) will be a 4-week follow-up period after the intervention phase, where participants will also complete a qualitative interview. Participants will be randomly allocated to variable baselines using a random number generator.

Sample size justification

We propose collecting data from 50 individuals. This is supported by scholars who suggest numbers ranging from 24 to 50 for feasibility studies.

AVATAR therapy for eating disorders

The therapy will be delivered by the members of the research team. In the first session (assessment), following a clinical assessment of the role of the eating disorder voice, participants will create a computerised representation of the eating disorder voice (avatar) on a computer. They will be able to manipulate the facial and voice characteristics of the avatar and will be asked to provide examples of the critical eating disorder comments most often spoken by the avatar. In the following sessions (6-8 therapy sessions), participants will interact with the avatar displayed on the computer screen for 5-10 minutes. The therapist will facilitate the dialogue by speaking the avatar's voice as well as their own (therapist) voice from a different room. The therapist will have a video link with the participant and therefore will be able to monitor the participants' responses to the avatar. The participant will be able to press a "stop" button should they want to stop the session. The main goal during the interaction with the avatar is for participants to stand up to the critical comments made by the avatar and build a sense of power, control and self-awareness in the context of the eating disorder voice. The sessions will be conducted remotely, using a personal laptop or computer. This will provide patients with the opportunity to practise answering back to the eating disorder voice during a meal, a time at which the eating disorder voice is loudest. The content of the sessions has been adapted from AVATAR for psychosis and is subject to further review as outlined in Research Aim 1.

Feasibility outcomes

(1) Recruitment of 80% or more of the targeted sample size in 18 months, (2) Adherence to protocol: 80% retention rate at 6-8 weeks (end of therapy), (3) Adherence to AVATAR therapy: 80% of patients completing at least 5 sessions (based on average attendance of 5 sessions in the psychosis trial), (4) Participants' satisfaction with the AVATAR therapy (80% of participants reporting a satisfaction rating of 7 or over, on a Likert scale ranging from 0 "not satisfied at all" to 10 "very satisfied"), (5) Estimation of effect size and standard deviation of change in power of the eating disorder voice and eating disorder symptoms. In addition to these parameters, we will record any issues related to the technical functioning or operation of the intervention.

Being tested
Avatar Therapy
Medical subject headings
Feeding and Eating Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Avatar TherapyOther

    In the first session (assessment), participants will create a computerised representation of the eating disorder voice (avatar) on a computer. They will be able to manipulate the facial and voice characteristics of the avatar and will be asked to provide examples of the critical eating disorder comments most often spoken by the avatar. In the following sessions (6-8 therapy sessions), participants will interact with the avatar displayed on the computer screen for 5-10 minutes.The main goal during the interaction with the avatar is for participants to stand up to the critical comments made by the avatar and build a sense of power, control and self-awareness in the context of the eating disorder voice. The sessions will be conducted remotely, using a personal laptop or computer. This will provide patients with the opportunity to practise answering back to the eating disorder voice during a meal, a time at which the eating disorder voice is loudest.

Study groups in NCT04778423
Study groupRoleWhat they receive
Avatar TherapyExperimentalAVATAR therapy for eating disorders
Receives: Other: Avatar Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of AVATAR therapy for eating disorder

    Recruitment of 80% or more of the targeted sample size in 18 months and 80% retention to the study protocol at 6-8 weeks (end of therapy).

    Measured: 18 months

Secondary outcomes (6)
  1. Adherence

    Adherence to AVATAR therapy: 80% of patients completing at least 5 sessions (based on average attendance of 5 sessions in the psychosis's trial)

    Measured: 18 months

  2. Acceptability

    Participants' satisfaction with the AVATAR therapy (80% of participants reporting a satisfaction rating over 7, on a Likert scale ranging from 0 "not satisfied at all" to 10 "very satisfied"

    Measured: 18 months

  3. Eating disorder voice characteristics

    Estimation of effect size and standard deviation of change in power of the eating disorder voice which will be measured by the auditory hallucination subscale of the psychotic symptom rating scale adapted for eating disorders, the beliefs about the voices questionnaires adapted for eating disorders and a brief weekly survey to assess the content and perceived power of the eating disorder voice.

    Measured: 12 to 15 weeks depending on the baseline allocation

  4. Eating disorder symptoms

    Eating disorder symptoms will be measured by the Eating disorder examination questionnaire (EDE-Q)

    Measured: 12 to 15 weeks depending on the baseline allocation

  5. Anxiety and depression

    Measured by the Depression, Anxiety and stress scales (DASS-21)

    Measured: 12 to 15 weeks depending on the baseline allocation

  6. Self-criticism and self-compassion

    Measured by self-criticism and self-compassion scale

    Measured: 12 to 15 weeks depending on the baseline allocation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2021
  2. Study start5 Aug 2021
  3. Primary completion31 Jan 2022
  4. Study completion31 Jan 2022

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04778423
Sponsor's protocol ID
292346
Status last verified
Feb 2021
First submitted
19 Feb 2021
Last updated
2 Mar 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Noordenbos G, Aliakbari N, Campbell R. The relationship among critical inner voices, low self-esteem, and self-criticism in eating disorders. Eat Disord. 2014;22(4):337-51. doi: 10.1080/10640266.2014.898983. Epub 2014 Mar 28.

    PubMed 24678635
  • Pugh M, Waller G. The anorexic voice and severity of eating pathology in anorexia nervosa. Int J Eat Disord. 2016 Jun;49(6):622-5. doi: 10.1002/eat.22499. Epub 2016 Feb 15.

    PubMed 26875724
  • Falconer CJ, King JA, Brewin CR. Demonstrating mood repair with a situation-based measure of self-compassion and self-criticism. Psychol Psychother. 2015 Dec;88(4):351-65. doi: 10.1111/papt.12056. Epub 2015 Feb 5.

    PubMed 25663161
  • Fairburn CG, Beglin SJ. Assessment of eating disorders: interview or self-report questionnaire? Int J Eat Disord. 1994 Dec;16(4):363-70.

    PubMed 7866415
  • Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.

    PubMed 7726811
  • Craig TK, Rus-Calafell M, Ward T, Leff JP, Huckvale M, Howarth E, Emsley R, Garety PA. AVATAR therapy for auditory verbal hallucinations in people with psychosis: a single-blind, randomised controlled trial. Lancet Psychiatry. 2018 Jan;5(1):31-40. doi: 10.1016/S2215-0366(17)30427-3. Epub 2017 Nov 23.

    PubMed 29175276
  • Thompson A, Calissano C, Treasure J, Ball H, Montague A, Ward T, Cardi V. A case series to test the acceptability, feasibility and preliminary efficacy of AVATAR therapy in anorexia nervosa. J Eat Disord. 2023 Oct 13;11(1):181. doi: 10.1186/s40337-023-00900-1.

    PubMed 37833732

Questions about this trial

What is this clinical trial studying?

A study testing Avatar Therapy in people with Eating Disorders, run by King's 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 2 inclusion and 2 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 2 Mar 2022. 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?

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?

Feasibility of AVATAR therapy for eating disorder (time frame: 18 months). 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 NCT04778423, which also lists 7 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 2 Mar 2022; AzTrials last refreshed its copy on 7 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in