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

NCT03317379 | Completed Results

• 1 other identifier: 7533
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Eating Disorder; Anorexia Nervosa; Bulimia Nervosa; Binge-Eating Disorder

Outcome Measures

Primary Outcomes (5)

• Body Mass Index

  kg/m2

  Baseline (month 0, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6

• 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

• 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

• 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

• 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

Study Arms (3)

Peer mentorship

EXPERIMENTAL

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.

Behavioral: Peer mentorship; Behavioral: Recovery Record use with mentor

Social support mentorship

ACTIVE COMPARATOR

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.

Behavioral: Social support mentorship

Wait list

NO INTERVENTION

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

Interventions

Peer mentorship BEHAVIORAL

Weekly meetings with a recovered peer mentor once per week. Dyads discuss eating disorder symptoms and how to overcome them.

Peer mentorship

Social support mentorship BEHAVIORAL

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).

Social support mentorship

Recovery Record use with mentor BEHAVIORAL

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.

Peer mentorship

Eligibility Criteria

• Age: 14 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Feeding and Eating Disorders; Anorexia Nervosa; Bulimia Nervosa; Binge-Eating Disorder

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Results Point of Contact

• Title: Lisa Ranzenhofer, PhD
• Organization: New York State Psychiatric Institute

lr2840@cumc.columbia.edu

240 671 9040

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Since this is a behavioral intervention, participants, care providers, and investigators are aware of each patient's randomization. Outcomes are assessed electronically.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Psychology (in Psychiatry)

Model Details: 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

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: October 23, 2017
• Study Start: October 1, 2017
• Primary Completion: May 31, 2021
• Study Completion: June 30, 2021
• Last Updated: August 19, 2021
• Results First Posted: August 19, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)