Evaluation of the Communities of Healing Mentorship/Support Group Program: Assessment of Preliminary Efficacy

Anorexia Nervosa Clinical Trial

Official title:

Evaluation of the Communities of Healing Mentorship/Support Group Program: Assessment of Preliminary Efficacy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03317379
• Other study ID #: 7533
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: June 30, 2021

Study information

• Verified date: August 2021
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of the study is to evaluate two 6-month adjunct interventions (peer mentorship and social support mentorship) for individuals with eating disorders. Individuals will be randomized to peer-mentorship, social support mentorship, or a wait-list and eating disorder symptoms will be evaluated at baseline and post-treatment.

Description:

Eating disorders are serious mental illnesses associated with significant morbidity and high relapse rates. Patients are at especially high risk of relapse after leaving structured treatment (e.g., hospitalization). Adjunct interventions targeting patients' motivation and participation in treatment at these times may help patients recover from eating disorders. Project HEAL is a non-profit organization whose mission is to reduce suffering caused by eating disorders, and they have recently developed two adjunct, mentorship-based interventions for patients in recovery. In the peer mentorship condition, individuals meet weekly with a peer mentor who has previously recovered from an eating disorder in order to discuss symptoms and coping strategies. In the social support mentorship condition, individuals meet weekly with a social support mentor who has not personally struggled with an eating disorder in order to engage in activities unrelated to the eating disorder. The aim of the current study is to evaluate the feasibility and efficacy of this intervention. The design of the study is a three-arm randomized controlled trial comparing peer mentorship, social-support mentorship, and wait-list control conditions. Participants in the study will be randomized to one of the three conditions for six months. Wait-list participants will subsequently receive either type of mentorship. Participants will complete assessments of their eating disorder symptoms at baseline, monthly throughout the course of the study, and one year after beginning the study. Outcomes will be compared between groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 30, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 45 Years

Eligibility

Inclusion Criteria:

• Current or past 6 months AN, BN, or BED

• Recent (within 6 months) discharge from structured treatment

• Involved in outpatient treatment at an appropriate level of care

• Medical stability

• Access to smart phone or computer to complete study assessments

Exclusion Criteria:

• Evidence of needing specialized treatment for another medical or mental health condition

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Binge-Eating Disorder
• Bulimia
• Bulimia Nervosa
• Disease
• Eating Disorder
• Feeding and Eating Disorders

Intervention

Behavioral:
• Peer mentorship
Weekly meetings with a recovered peer mentor once per week. Dyads discuss eating disorder symptoms and how to overcome them.
• Social support mentorship
Weekly meetings with a social support mentor who has not personally struggled with an eating disorder, once per week. Dyads engage in activities unrelated to the eating disorder (e.g., a movie, a community event, volunteer work).
• Recovery Record use with mentor
Recovery Record is a smart phone or web-based application designed to provide recovery support to eating disorder patients. Includes a number of features aimed to promote recovery, such as a meal tracking, prompts for completing meals/snacks, tracking for additional symptoms such as stress and mood, motivational messages, information about coping strategies, and capacity to share logged data with clinicians and mentors.

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York State Psychiatric Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Mass Index	kg/m2	Baseline (month 0, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
Primary	Binge Days	Units on a scale from 0 - 4 ( 0 = 0 days; 1 = A few (1-2) days; 2 = About half (3-4) days; 4 = Most (5-6) days; 4 = All (7) days Range was 0 - 4	Baseline through Week 28
Primary	Body Dissatisfaction Subscale of the Eating Disorder Symptom Inventory (EPSI)	The Eating Pathology Symptoms Inventory (EPSI) is a self-report questionnaire that includes 8 subscales and we used the Body Dissatisfaction subscale. Each item is rated on a 5-point Likert-style scale (0 = Never; 4= Often) to describe how well each item describes the participant's experiences. Scores are derived by summing responses across the questions included in each subscale. The range for Body dissatisfaction is 0 - 28. Higher scores are reflective of greater eating pathology.	Baseline, Month 3, Month 6
Primary	Cognitive Restraint Subscale of the Eating Disorder Symptom Inventory (EPSI)	The Eating Pathology Symptoms Inventory (EPSI) is a self-report questionnaire that includes 8 subscales and we used the Cognitive Restraint subscale. Each item is rated on a 5-point Likert-style scale (0 = Never; 4= Often) to describe how well each item describes the participant's experiences. Scores are derived by summing responses across the questions included in each subscale. The range for Cognitive Restraint is 0 - 12. Higher scores are reflective of greater eating pathology.	Baseline, Month 3, Month 6
Primary	Restricting Subscale of the Eating Disorder Symptom Inventory (EPSI)	The Eating Pathology Symptoms Inventory (EPSI) is a self-report questionnaire that includes 8 subscales and we used the Restricting subscale. Each item is rated on a 5-point Likert-style scale (0 = Never; 4= Often) to describe how well each item describes the participant's experiences. Scores are derived by summing responses across the questions included in each subscale. The range for Restricting is 0 - 24. Higher scores are reflective of greater eating pathology.	Baseline, Month 3, Month 6