Self-Help And Recovery Guide in Eating Disorders

NCT ID: NCT02336841

Last Updated: 2015-01-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2017-10-31

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.

Conditions

Anorexia Nervosa

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

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

Group Type: EXPERIMENTAL

Treatment as usual + Recovery MANTRA

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

Treatment as usual + feedback

Intervention Type: OTHER

Participants in this group will receive treatment as usual and feedback on their eating disorder symptoms.

Interventions

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.

Intervention Type: OTHER

Treatment as usual + feedback

Participants in this group will receive treatment as usual and feedback on their eating disorder symptoms.

Intervention Type: OTHER

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).

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King's College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

King's College London

London, , United Kingdom

Countries

United Kingdom

Facility Contacts

Valentina Cardi, PhD

Role: primary

valentina.cardi@kcl.ac.uk

+447446034855

References

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.

Reference Type: DERIVED

PMID: 32373032 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32064663 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25885697 (View on PubMed)

Other Identifiers

159490

Identifier Type: -

Identifier Source: org_study_id