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Evaluation of Practical Body Image Therapy for Anorexia Nervosa V1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04064255
Recruitment Status : Completed
First Posted : August 21, 2019
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
John Morgan, Leeds and York Partnership NHS Foundation Trust

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.


Condition or disease Intervention/treatment Phase
Body Image Exposure Other: Practical Body Image (session 1 - 7) Other: Practical Body Image (session 8 - 14) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study Evaluating Practical Body Image (PBI): A Body Image Therapy With Mirror Exposure for Adolescent Inpatients With Anorexia Nervosa
Actual Study Start Date : September 2016
Actual Primary Completion Date : July 2018
Actual Study Completion Date : July 1, 2018

Arm Intervention/treatment
Active Comparator: Case: Practical Body Image + Treatment as Usual

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)
Practical body image therapy

Other: Practical Body Image (session 8 - 14)
Twice weekly mirror exposure plus ending session

No Intervention: Control: Treatment as Usual Only

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.




Primary Outcome Measures :
  1. Body Image Acceptance and Action Questionnaire [ Time Frame: Assessed at baseline, 7 weeks and 10 weeks. ]
    A validated self-report measure assessing change in cognitive flexibility and acceptance relatively to body image. The measure consists of 12 questions.


Secondary Outcome Measures :
  1. Youth Eating Disorder Examination Questionnaire [ Time Frame: Assessed at baseline, 7 weeks and 10 weeks. ]
    This is the youth version of the EDE-Q which is a validated self-report measure assessing change in eating disorder psychopathology using four sub-scales measuring weight concern, shape concern, dietary restraint and eating concern. The measure consists of 39 questions.

  2. Body Image Avoidance Questionnaire [ Time Frame: Assessed at baseline, 7 weeks and 10 weeks. ]
    A validated self-report measure assessing change in body image avoidance divided into three sub-scales including social avoidance, clothing avoidance and personal grooming. The measure consists of 12 questions.

  3. Physical Appearance State and Trait Anxiety Scale: Trait Version [ Time Frame: Assessed at baseline, 7 weeks and 10 weeks. ]
    A validated self-report measure assessing change in trait anxiety relating to physical appearance. The measure consists of 16 questions.

  4. Healthy weight body acceptance scale [ Time Frame: Assessed at baseline, 7 weeks and 10 weeks. ]
    A non validated self-report measure assessing change in what having a healthy weight body means to a person, acceptance of having a healthy weight body and the motivation and confidence to accept having a healthy weight body. The measure consists of 4 questions.



Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Inpatients at Newbridge House
  2. Aged 11-18
  3. At or above 90% of minimum healthy weight
  4. Primary diagnosis of Anorexia Nervosa

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04064255


Sponsors and Collaborators
Newbridge House
Investigators
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Principal Investigator: John F Morgan, Medicine Yorkshire Centre for Eating Disorders, Leeds and York NHS Foundation Trust
Publications:
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Responsible Party: John Morgan, Consultant Psychiatrist, Leeds and York Partnership NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04064255    
Other Study ID Numbers: NBPBI1992
First Posted: August 21, 2019    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by John Morgan, Leeds and York Partnership NHS Foundation Trust:
Body Image
Anorexia Nervosa
Adolescents
Mirror exposure
Additional relevant MeSH terms:
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Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders