Self-Help And Recovery Guide in Eating Disorders

Early Phase 1

• Conditions: Anorexia Nervosa
• Interventions: Other: Treatment as usual + Recovery MANTRA; Other: Treatment as usual + feedback

• Registration Number: NCT02336841
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2015-01
• Study Start: 2015-01
• Study First Submitted: 2015-01-08
• Study First Submitted QC: 2015-01-12
• Last Update Submitted: 2015-01-12
• Study First Posted: 2015-01-13
• Last Update Posted: 2015-01-13
• Primary Completion: 2016-12
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Treatment as usual + Recovery MANTRA	Participants in this condition will receive the guided self-help intervention.
Control	Treatment as usual + feedback	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.

Primary Outcome Measures

Name	Time	Method
Changes in body weight at the end of the intervention	3 years

Secondary Outcome Measures

Name	Time	Method
Changes in eating disorder symptoms at the end of the intervention and follow-up	3 years

Trial Locations

Locations (1)

King's College London; 🇬🇧 London, United Kingdom