Self-Help And Recovery Guide in Eating Disorders (SHARED)
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| ClinicalTrials.gov Identifier: NCT02336841 |
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Recruitment Status : Unknown
Verified January 2015 by King's College London.
Recruitment status was: Not yet recruiting
First Posted : January 13, 2015
Last Update Posted : January 13, 2015
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Anorexia Nervosa | Other: Treatment as usual + Recovery MANTRA Other: Treatment as usual + feedback | Early Phase 1 |
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 (Clinical Trial) |
| Estimated Enrollment : | 150 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 Start Date : | January 2015 |
| Estimated Primary Completion Date : | December 2016 |
| Estimated Study Completion Date : | October 2017 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Intervention
Participants in this condition will receive the guided self-help intervention.
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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. |
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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.
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Other: Treatment as usual + feedback
Participants in this group will receive treatment as usual and feedback on their eating disorder symptoms. |
- Changes in body weight at the end of the intervention [ Time Frame: 3 years ]
- Changes in eating disorder symptoms at the end of the intervention and follow-up [ Time Frame: 3 years ]
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| Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02336841
| United Kingdom | |
| King's College London | |
| London, United Kingdom, SE5 8AF | |
| Contact: Valentina Cardi, PhD +447446034855 valentina.cardi@kcl.ac.uk | |
| Principal Investigator: Janet Treasure, OBE, PhD FRCP FRCPsych | |
| Responsible Party: | King's College London |
| ClinicalTrials.gov Identifier: | NCT02336841 |
| Other Study ID Numbers: |
159490 |
| First Posted: | January 13, 2015 Key Record Dates |
| Last Update Posted: | January 13, 2015 |
| Last Verified: | January 2015 |
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Guided Self-Help Peer Mentoring Anorexia Nervosa Eating Disorders |
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Anorexia Feeding and Eating Disorders Anorexia Nervosa Mental Disorders Signs and Symptoms, Digestive |