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Trial record 1 of 1 for:    NCT02336841
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Self-Help And Recovery Guide in Eating Disorders (SHARED)

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ClinicalTrials.gov Identifier: NCT02336841
Recruitment Status : Unknown
Verified January 2015 by King's College London.
Recruitment status was:  Not yet recruiting
First Posted : January 13, 2015
Last Update Posted : January 13, 2015
Sponsor:
Information provided by (Responsible Party):
King's College London

Brief Summary:
The aim of this study is to test a novel guided self-help intervention for patients with Anorexia Nervosa. The 6-week intervention includes the use of self-help materials (i.e. a workbook and short video-clips) and weekly guidance from a peer mentor (i.e. a person recovered from Anorexia Nervosa). Self-reports will be completed at baseline, end of 6 weeks, and 6- and 12 months follow-up. Participants interested in taking part will be randomly allocated to one of two groups.

Condition or disease Intervention/treatment Phase
Anorexia Nervosa Other: Treatment as usual + Recovery MANTRA Other: Treatment as usual + feedback Early Phase 1

Detailed Description:

This trial investigates whether a guided self-care intervention (Recovery MANTRA) is a useful addition to treatment as usual (TAU) for individuals with anorexia nervosa (AN). Recovery MANTRA, a 6-week self-care intervention supplemented by peer mentorship, is a module extension of the Maudsley Model of Treatment for Adults with AN and targets the maintenance factors identified by the cognitive-interpersonal model of the illness.

Patients accessing outpatient services for AN are randomised to either TAU or TAU plus Recovery MANTRA. Outcomes variables include changes in body weight at the end of the intervention (primary) and changes in body weight and eating disorder symptoms at immediate and extended follow-ups (6-months and 12-months; secondary). Change is also assessed for the domains identified by the theoretical model, including, motivation, hope, confidence to change, positive mood, cognitive flexibility, therapeutic alliance and social adjustment. Feedback from peer mentors is gathered to understand the impact of providing guidance on their own well-being.

Results from this exploratory investigation will determine whether a larger clinical trial is justifiable and feasible for this affordable intervention which has potential for high reach and scalability.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of the Feasibility and Effectiveness of the Addition of Self Help And Recovery Guide for Eating Disorders (SHARED) to Treatment as Usual for Anorexia Nervosa
Study Start Date : January 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : October 2017

Arm Intervention/treatment
Experimental: Intervention
Participants in this condition will receive the guided self-help intervention.
Other: Treatment as usual + Recovery MANTRA
Participants in this group will receive the guided self-help intervention including video-clips, a workbook, and guidance from peer mentors, and treatment as usual.

Active Comparator: Control
Participants in this condition will not receive the guided self-help intervention. They will receive treatment as usual and weekly feedback on their eating disorder symptoms for a period of 6 weeks.
Other: Treatment as usual + feedback
Participants in this group will receive treatment as usual and feedback on their eating disorder symptoms.




Primary Outcome Measures :
  1. Changes in body weight at the end of the intervention [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Changes in eating disorder symptoms at the end of the intervention and follow-up [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Referral to one of the participating specialist adult outpatient eating disorder clinics with a primary DSM-5 diagnosis of Anorexia Nervosa or OSFED (Other Specified Feeding or Eating Disorder) with a body mass index (BMI; kg/m2) of 18.5 or below. OSFED will be defined as having features of Anorexia but missing at least two of the four diagnostic criteria.

Exclusion Criteria:

  • Insufficient knowledge of English
  • Severe mental or physical illness needing treatment in its own right (e.g. psychosis or diabetes mellitus).

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): NCT02336841


Locations
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United Kingdom
King's College London
London, United Kingdom, SE5 8AF
Contact: Valentina Cardi, PhD    +447446034855    valentina.cardi@kcl.ac.uk   
Principal Investigator: Janet Treasure, OBE, PhD FRCP FRCPsych         
Sponsors and Collaborators
King's College London
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT02336841    
Other Study ID Numbers: 159490
First Posted: January 13, 2015    Key Record Dates
Last Update Posted: January 13, 2015
Last Verified: January 2015
Keywords provided by King's College London:
Guided Self-Help
Peer Mentoring
Anorexia Nervosa
Eating Disorders
Additional relevant MeSH terms:
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Anorexia
Feeding and Eating Disorders
Anorexia Nervosa
Mental Disorders
Signs and Symptoms, Digestive