Clinical trial NCT03317379: 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
Overall status: COMPLETED
Phase: NA
Conditions: Eating Disorder
Anorexia Nervosa
Bulimia Nervosa
Binge-Eating Disorder
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2017-10-23
Enrollment: 60
Sex: ALL
Minimum age (years): 14
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Body Mass Index
timeFrame: Baseline (month 0, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
measure: Binge Days
timeFrame: Baseline through Week 28
measure: Body Dissatisfaction Subscale of the Eating Disorder Symptom Inventory (EPSI)
timeFrame: Baseline, Month 3, Month 6
measure: Cognitive Restraint Subscale of the Eating Disorder Symptom Inventory (EPSI)
timeFrame: Baseline, Month 3, Month 6
measure: Restricting Subscale of the Eating Disorder Symptom Inventory (EPSI)
timeFrame: Baseline, Month 3, Month 6
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
References: