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

Primary Purpose

Eating Disorder, Anorexia Nervosa, Bulimia Nervosa

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer mentorship
Social support mentorship
Recovery Record use with mentor
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Eating Disorder

Eligibility Criteria

14 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Peer mentorship

Social support mentorship

Wait list

Arm Description

Participants meet weekly with an adult peer mentor who has recovered from an eating disorder. The focus of meetings is on eating disorder symptoms and how to overcome them. The goal of this program is to reduce eating disorder symptoms directly by receiving support and guidance from someone who has been through it.

Participants meet weekly with an adult mentor who has not personally struggled with an eating disorder but who is dedicated to offering support. During weekly meetings, participants and mentors (and possibly 1-2 other mentees) engage in activities unrelated to the eating disorder. The goal of this program is to reduce eating disorder symptoms indirectly by exploring aspects of self outside the eating disorder.

Participants are on a wait list and then get matched with either type of mentor (of their choice) 6 months later

Outcomes

Primary Outcome Measures

Body Mass Index
kg/m2
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
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 12, 2017
Last Updated
August 16, 2021
Sponsor
New York State Psychiatric Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03317379
Brief Title
Evaluation of the Communities of Healing Mentorship/Support Group Program: Assessment of Preliminary Efficacy
Official Title
Evaluation of the Communities of Healing Mentorship/Support Group Program: Assessment of Preliminary Efficacy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorder, Anorexia Nervosa, Bulimia Nervosa, Binge-Eating Disorder

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomization occurs at the beginning of each individual's participation in the study. Participants are randomized to one condition and not re-randomized during any portion of the study
Masking
None (Open Label)
Masking Description
Since this is a behavioral intervention, participants, care providers, and investigators are aware of each patient's randomization. Outcomes are assessed electronically.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peer mentorship
Arm Type
Experimental
Arm Description
Participants meet weekly with an adult peer mentor who has recovered from an eating disorder. The focus of meetings is on eating disorder symptoms and how to overcome them. The goal of this program is to reduce eating disorder symptoms directly by receiving support and guidance from someone who has been through it.
Arm Title
Social support mentorship
Arm Type
Active Comparator
Arm Description
Participants meet weekly with an adult mentor who has not personally struggled with an eating disorder but who is dedicated to offering support. During weekly meetings, participants and mentors (and possibly 1-2 other mentees) engage in activities unrelated to the eating disorder. The goal of this program is to reduce eating disorder symptoms indirectly by exploring aspects of self outside the eating disorder.
Arm Title
Wait list
Arm Type
No Intervention
Arm Description
Participants are on a wait list and then get matched with either type of mentor (of their choice) 6 months later
Intervention Type
Behavioral
Intervention Name(s)
Peer mentorship
Intervention Description
Weekly meetings with a recovered peer mentor once per week. Dyads discuss eating disorder symptoms and how to overcome them.
Intervention Type
Behavioral
Intervention Name(s)
Social support mentorship
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Recovery Record use with mentor
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body Mass Index
Description
kg/m2
Time Frame
Baseline (month 0, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
Title
Binge Days
Description
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
Time Frame
Baseline through Week 28
Title
Body Dissatisfaction Subscale of the Eating Disorder Symptom Inventory (EPSI)
Description
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.
Time Frame
Baseline, Month 3, Month 6
Title
Cognitive Restraint Subscale of the Eating Disorder Symptom Inventory (EPSI)
Description
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.
Time Frame
Baseline, Month 3, Month 6
Title
Restricting Subscale of the Eating Disorder Symptom Inventory (EPSI)
Description
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.
Time Frame
Baseline, Month 3, Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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