NCT04778423

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 3, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

August 5, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2021

Enrollment Period

6 months

First QC Date

February 19, 2021

Last Update Submit

February 28, 2022

Conditions

Outcome Measures

Primary Outcomes (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).

    18 months

Secondary Outcomes (6)

  • Adherence

    18 months

  • Acceptability

    18 months

  • Eating disorder voice characteristics

    12 to 15 weeks depending on the baseline allocation

  • Eating disorder symptoms

    12 to 15 weeks depending on the baseline allocation

  • Anxiety and depression

    12 to 15 weeks depending on the baseline allocation

  • +1 more secondary outcomes

Study Arms (1)

Avatar Therapy

EXPERIMENTAL

AVATAR therapy for eating disorders

Other: Avatar Therapy

Interventions

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.

Avatar Therapy

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College London

London, United Kingdom

Location

Related Publications (7)

  • 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.

    PMID: 24678635BACKGROUND
  • 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.

    PMID: 26875724BACKGROUND
  • 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.

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

    PMID: 7866415BACKGROUND
  • 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.

    PMID: 7726811BACKGROUND
  • 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.

    PMID: 29175276BACKGROUND
  • 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.

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2021

First Posted

March 3, 2021

Study Start

August 5, 2021

Primary Completion

January 31, 2022

Study Completion

January 31, 2022

Last Updated

March 2, 2022

Record last verified: 2021-02

Locations