NCT04064255

Brief Summary

Background: Dysfunctional body image is a strong predictor of maintenance and relapse in anorexia nervosa, making treatment of such clinically and financially important. Studies have shown that cognitive behavioural based group therapies and mirror exposure interventions are effective in improving body image in adults with eating disorders; however research into individual body image treatments for adolescents with anorexia nervosa is limited. Practical Body Image (PBI) is a novel, manualised, individual treatment designed for adolescents with anorexia nervosa for which the evidence base is not yet established. This research will therefore contribute to the evidence base for the treatment of body image in adolescents with anorexia nervosa and inform the effectiveness of a new treatment. The research will be funded by Newbridge House, an inpatient unit for children and adolescents with eating disorders. Research Questions: Does Practical Body Image improve body image and psychological wellbeing in adolescent inpatients with anorexia nervosa? Does a mirror exposure intervention improve body image and psychological wellbeing in adolescent inpatients with anorexia nervosa after completion of the rest of the programme? Design: Patients aged 11-18, fulfilling DSM-V criteria for anorexia nervosa and receiving treatment at Newbridge House will be recruited for participation in the research study. Participants will be randomly allocated to either a case or control group. Allocation will be based on a non-blind randomised controlled trial. Cases will receive PBI in addition to treatment as usual and will be compared with controls who just receive treatment as usual. Both groups will complete a set of questionnaires at baseline, 7 weeks and 10 weeks.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

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

June 23, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

August 21, 2019

Completed
Last Updated

August 21, 2019

Status Verified

August 1, 2019

Enrollment Period

1.8 years

First QC Date

June 23, 2016

Last Update Submit

August 19, 2019

Conditions

Keywords

Body ImageAnorexia NervosaAdolescentsMirror exposure

Outcome Measures

Primary Outcomes (1)

  • Body Image Acceptance and Action Questionnaire

    A validated self-report measure assessing change in cognitive flexibility and acceptance relatively to body image. The measure consists of 12 questions.

    Assessed at baseline, 7 weeks and 10 weeks.

Secondary Outcomes (4)

  • Youth Eating Disorder Examination Questionnaire

    Assessed at baseline, 7 weeks and 10 weeks.

  • Body Image Avoidance Questionnaire

    Assessed at baseline, 7 weeks and 10 weeks.

  • Physical Appearance State and Trait Anxiety Scale: Trait Version

    Assessed at baseline, 7 weeks and 10 weeks.

  • Healthy weight body acceptance scale

    Assessed at baseline, 7 weeks and 10 weeks.

Study Arms (2)

Case: Practical Body Image + Treatment as Usual

ACTIVE COMPARATOR

The Case arm involves Practical Body Image + treatment as usual. Practical Body Image is based on a cognitive behavioural model of body image addressing thoughts, feelings, behaviours and misperceptions. PBI is designed to be administered over 10 weeks (6 weekly sessions over 6 weeks, followed by 8 twice weekly sessions over 4 weeks). Treatment as usual refers to the standard inpatient treatment programme at Newbridge House which includes: individual therapy, occupational therapy, drama therapy, family therapy, dietetic support, nursing support, yoga and medication prescribed by a consultant psychiatrist.

Other: Practical Body Image (session 1 - 7)Other: Practical Body Image (session 8 - 14)

Control: Treatment as Usual Only

NO INTERVENTION

Control arm involves treatment as usual only. Treatment as usual refers to the standard inpatient treatment programme at Newbridge House which includes: individual therapy, occupational therapy, drama therapy, family therapy, dietetic support, nursing support, yoga and medication prescribed by a consultant psychiatrist.

Interventions

Practical body image therapy

Case: Practical Body Image + Treatment as Usual

Twice weekly mirror exposure plus ending session

Case: Practical Body Image + Treatment as Usual

Eligibility Criteria

Age11 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Inpatients at Newbridge House
  • Aged 11-18
  • At or above 90% of minimum healthy weight
  • Primary diagnosis of Anorexia Nervosa

You may not qualify if:

  • Previously received treatment at Newbridge House (readmission)
  • Patients with a primary diagnosis other than Anorexia Nervosa
  • Aged under 11 years
  • Any patients with severe learning difficulty
  • Active psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Stice E. Risk and maintenance factors for eating pathology: a meta-analytic review. Psychol Bull. 2002 Sep;128(5):825-48. doi: 10.1037/0033-2909.128.5.825.

    PMID: 12206196BACKGROUND
  • Fairburn CG, Peveler RC, Jones R, Hope RA, Doll HA. Predictors of 12-month outcome in bulimia nervosa and the influence of attitudes to shape and weight. J Consult Clin Psychol. 1993 Aug;61(4):696-8. doi: 10.1037//0022-006x.61.4.696.

    PMID: 8370866BACKGROUND
  • Keel PK, Dorer DJ, Franko DL, Jackson SC, Herzog DB. Postremission predictors of relapse in women with eating disorders. Am J Psychiatry. 2005 Dec;162(12):2263-8. doi: 10.1176/appi.ajp.162.12.2263.

    PMID: 16330589BACKGROUND
  • Morgan JF, Lazarova S, Schelhase M, Saeidi S. Ten session body image therapy: efficacy of a manualised body image therapy. Eur Eat Disord Rev. 2014 Jan;22(1):66-71. doi: 10.1002/erv.2249. Epub 2013 Sep 5.

    PMID: 24006359BACKGROUND
  • Key A, George CL, Beattie D, Stammers K, Lacey H, Waller G. Body image treatment within an inpatient program for anorexia nervosa: the role of mirror exposure in the desensitization process. Int J Eat Disord. 2002 Mar;31(2):185-90. doi: 10.1002/eat.10027.

    PMID: 11920979BACKGROUND
  • Legenbauer T, Schutt-Stromel S, Hiller W, Vocks S. Predictors of improved eating behaviour following body image therapy: a pilot study. Eur Eat Disord Rev. 2011 Mar-Apr;19(2):129-37. doi: 10.1002/erv.1017.

    PMID: 25363718BACKGROUND
  • Nye S, Cash TF. Outcomes of manualized cognitive-behavioral body image therapy with eating disordered women treated in a private clinical practice. Eat Disord. 2006 Jan-Feb;14(1):31-40. doi: 10.1080/10640260500403840.

    PMID: 16757447BACKGROUND
  • Delinsky SS, Wilson GT. Mirror exposure for the treatment of body image disturbance. Int J Eat Disord. 2006 Mar;39(2):108-16. doi: 10.1002/eat.20207.

    PMID: 16231342BACKGROUND

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Officials

  • John F Morgan, Medicine

    Yorkshire Centre for Eating Disorders, Leeds and York NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Psychiatrist

Study Record Dates

First Submitted

June 23, 2016

First Posted

August 21, 2019

Study Start

September 1, 2016

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

August 21, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share