NCT02336841

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jan 2015

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 13, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

January 13, 2015

Status Verified

January 1, 2015

Enrollment Period

1.9 years

First QC Date

January 8, 2015

Last Update Submit

January 12, 2015

Conditions

Anorexia Nervosa

Keywords

Guided Self-HelpPeer MentoringAnorexia NervosaEating Disorders

Outcome Measures

Primary Outcomes (1)

  • Changes in body weight at the end of the intervention

    3 years

Secondary Outcomes (1)

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

    3 years

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: Treatment as usual + Recovery MANTRA

Control

ACTIVE COMPARATOR

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

Interventions

Treatment as usual + Recovery MANTRAOTHER

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
Treatment as usual + feedbackOTHER

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

Control

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College London

London, SE5 8AF, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 32373032DERIVED

  • 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.

    PMID: 32064663DERIVED

  • 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.

    PMID: 25885697DERIVED

MeSH Terms

Conditions

Anorexia NervosaFeeding and Eating Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Mental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2015

First Posted

January 13, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2016

Study Completion

October 1, 2017

Last Updated

January 13, 2015

Record last verified: 2015-01

Locations

GB(1)