search
Back to results

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

Primary Purpose

Anorexia Nervosa

Status
Unknown status
Phase
Early Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Treatment as usual + Recovery MANTRA
Treatment as usual + feedback
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa focused on measuring Guided Self-Help, Peer Mentoring, Anorexia Nervosa, Eating Disorders

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • King's College London

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

Participants in this condition will receive the guided self-help intervention.

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.

Outcomes

Primary Outcome Measures

Changes in body weight at the end of the intervention

Secondary Outcome Measures

Changes in eating disorder symptoms at the end of the intervention and follow-up

Full Information

First Posted
January 8, 2015
Last Updated
January 12, 2015
Sponsor
King's College London
search

1. Study Identification

Unique Protocol Identification Number
NCT02336841
Brief Title
Self-Help And Recovery Guide in Eating Disorders
Acronym
SHARED
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 Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
October 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
Keywords
Guided Self-Help, Peer Mentoring, Anorexia Nervosa, Eating Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants in this condition will receive the guided self-help intervention.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment as usual + Recovery MANTRA
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment as usual + feedback
Intervention Description
Participants in this group will receive treatment as usual and feedback on their eating disorder symptoms.
Primary Outcome Measure Information:
Title
Changes in body weight at the end of the intervention
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Changes in eating disorder symptoms at the end of the intervention and follow-up
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Facility Information:
Facility Name
King's College London
City
London
ZIP/Postal Code
SE5 8AF
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valentina Cardi, PhD
Phone
+447446034855
Email
valentina.cardi@kcl.ac.uk
First Name & Middle Initial & Last Name & Degree
Janet Treasure, OBE, PhD FRCP FRCPsych

12. IPD Sharing Statement

Citations:
PubMed Identifier
32373032
Citation
Cardi V, Albano G, Salerno L, Lo Coco G, Ambwani S, Schmidt U, Macdonald P, Treasure J. The Feasibility of Using Guided Self-Help in Anorexia Nervosa: An Analysis of Drop-Out From the Study Protocol and Intervention Adherence. Front Psychol. 2020 Apr 16;11:707. doi: 10.3389/fpsyg.2020.00707. eCollection 2020.
Results Reference
derived
PubMed Identifier
32064663
Citation
Ambwani S, Cardi V, Albano G, Cao L, Crosby RD, Macdonald P, Schmidt U, Treasure J. A multicenter audit of outpatient care for adult anorexia nervosa: Symptom trajectory, service use, and evidence in support of "early stage" versus "severe and enduring" classification. Int J Eat Disord. 2020 Aug;53(8):1337-1348. doi: 10.1002/eat.23246. Epub 2020 Feb 17.
Results Reference
derived
PubMed Identifier
25885697
Citation
Cardi V, Ambwani S, Crosby R, Macdonald P, Todd G, Park J, Moss S, Schmidt U, Treasure J. Self-Help And Recovery guide for Eating Disorders (SHARED): study protocol for a randomized controlled trial. Trials. 2015 Apr 16;16:165. doi: 10.1186/s13063-015-0701-6.
Results Reference
derived

Learn more about this trial

Self-Help And Recovery Guide in Eating Disorders

We'll reach out to this number within 24 hrs