Self-Help And Recovery Guide in Eating Disorders (SHARED)

January 12, 2015 updated by: King's College London

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SE5 8AF
        • King's College London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in body weight at the end of the intervention
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in eating disorder symptoms at the end of the intervention and follow-up
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

January 8, 2015

First Submitted That Met QC Criteria

January 12, 2015

First Posted (Estimate)

January 13, 2015

Study Record Updates

Last Update Posted (Estimate)

January 13, 2015

Last Update Submitted That Met QC Criteria

January 12, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 159490

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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