Eating DisorderNCT03317379

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

A study testing Peer mentorship, Social support mentorship and Recovery Record use with mentor in people with Eating Disorder and Anorexia Nervosa, run by New York State Psychiatric Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 14 to 45 years
Conditions the study is for: Eating Disorder, Anorexia Nervosa, Bulimia Nervosa
What is being tested?: Peer mentorship, Social support mentorship and Recovery Record use with mentor
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: 1 Oct 2017to 30 Jun 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 14 to 45 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

New York State Psychiatric Institute
New York, New York, 10032

Other trials in United States

About this study

Read the 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.

Conditions: Eating Disorder, Anorexia Nervosa, Bulimia Nervosa, Binge-Eating Disorder
Being tested: Peer mentorship, Social support mentorship, Recovery Record use with mentor
Medical subject headings: Feeding and Eating Disorders, Anorexia Nervosa, Bulimia Nervosa, Binge-Eating Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03317379
Study group	Role	What they receive
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. Receives: 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. Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

Body Mass Index
kg/m2
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Month 3, Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 201730 Jun 2021

First posted23 Oct 2017
Study start1 Oct 2017
Primary completion31 May 2021
Study completion30 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Eating DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
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)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03317379
Sponsor's protocol ID: 7533
Status last verified: Aug 2021
First submitted: 12 Oct 2017
Last updated: 19 Aug 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Eating Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Communities of Healing Mentorship/Support Group Program: Assessment of Preliminary Efficacy
ClinicalTrials.gov ID: NCT03317379
Acronym / sponsor ID: 7533
Conditions: Eating Disorder, Anorexia Nervosa, Bulimia Nervosa, Binge-Eating Disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: New York State Psychiatric InstituteUniversity, hospital or other
Study start: 1 Oct 2017 (actual)
Primary completion: 31 May 2021 (actual)
Study completion: 30 Jun 2021 (actual)
First posted: 23 Oct 2017 (actual)
Results: Posted 19 Aug 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
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

Arm	Type	Receives
Peer mentorship	Experimental	Behavioral: Peer mentorship, Behavioral: Recovery Record use with mentorParticipants 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.
Social support mentorship	Active comparator	Behavioral: Social support mentorshipParticipants 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.
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

Who may qualify

Ages: 14 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Peer mentorshipWeekly meetings with a recovered peer mentor once per week. Dyads discuss eating disorder symptoms and how to overcome them.	Behavioural	Peer mentorship
Social support mentorshipWeekly 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).	Behavioural	Social support mentorship
Recovery Record use with mentorRecovery 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.	Behavioural	Peer mentorship

Primary outcome

Body Mass Index
Time frame: Baseline (month 0, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
kg/m2
Binge Days
Time frame: Baseline through Week 28
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)
Time frame: Baseline, Month 3, Month 6
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)
Time frame: Baseline, Month 3, Month 6
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)
Time frame: Baseline, Month 3, Month 6
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.

Results and safety

Results posted to the registry on 19 Aug 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Peer Mentorship	20	20
Social Support Mentorship	18	15
Wait List	22	20

Primary outcome: Body Mass Index

Time frame: Baseline (month 0, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6. Mean (Standard Deviation). Unit: kg/m2

Measure	Peer Mentorship n = 15	Social Support Mentorship n = 14	Wait List n = 16
Baseline (month 0)	21.9 (3.6)	20.7 (2.7)	21.5 (4.0)
Month 1	21.9 (4.0)	21.1 (2.8)	21.5 (4.5)
Month 2	22.6 (3.8)	21.4 (3.3)	21.6 (4.9)
Month 3	21.6 (4.1)	21.6 (4.1)	21.7 (3.7)
Month 4	21.3 (3.5)	21.3 (3.5)	24.4 (3.4)
Month 5	21.8 (4.2)	21.8 (4.2)	23.5 (3.4)
Month 6	22.8 (4.3)	22.8 (4.3)	23.4 (4.1)

Peer Mentorship vs Wait List: estimate of fixed effects: 0.03 (95% CI -0.17 to 0.22), p = .80, Mixed Models Analysis
Peer Mentorship vs Social Support Mentorship: estimate of fixed effects: 0.10 (95% CI -0.10 to 0.30), p = .32, Mixed Models Analysis

Population analysed: Number of subjects with Anorexia Nervosa or Atypical Anorexia Nervosa (n =45). The number of participants with AN or Atypical AN is less than the total sample.

Primary outcome: Binge Days

Time frame: Baseline through Week 28. Mean (Standard Error). Unit: units on a scale

Measure	Peer Mentorship n = 5	Social Support Mentorship n = 4	Wait List n = 6
Baseline	1.0 (0.7)	1 (2)	1.3 (1.0)
Week 1	0.67 (.58)	1.33 (2.3)	1.0 (1.0)
Week 2	1.25 (0.5)	.33 (.57)	1.3 (1.4)
Week 3	0.67 (0.58)	1 (2)	.7 (.5)
Week 4	1 (0)	0 (0)	.8 (.8)
Week 5 Week 5	1.5 (1.0)	1.3 (2.3)	1.2 (.8)
Week 6	.67 (.58)	0.5 (0.7)	1.5 (.8)
Week 7	0 (0)	1.0 (1.7)	.3 (.6)

Peer Mentorship vs Wait List: estimate of fixed effects: .14 (95% CI 0.03 to 0.24), p = 0.01, Mixed Models Analysis
Peer Mentorship vs Social Support Mentorship: estimate of fixed effects: 0.08 (95% CI -.07 to 0.23), p = 0.28, Mixed Models Analysis

Population analysed: Number of participants with BN or BED

Primary outcome: Body Dissatisfaction Subscale of the Eating Disorder Symptom Inventory (EPSI)

Time frame: Baseline, Month 3, Month 6. Mean (Standard Deviation). Unit: units on scale

Measure	Peer Mentorship n = 20	Social Support Mentorship n = 18	Wait List n = 21
Baseline	23.5 (4.3)	19.9 (6.3)	21.2 (8.0)
Month 3	19.6 (6.9)	19.4 (6.0)	20.7 (6.1)
Month 6	18.2 (7.5)	21.2 (6.2)	20.9 (6.5)

Peer Mentorship vs Wait List: estimate of fixed effects: 0.61 (95% CI 0.06 to 1.16), p = 0.03, Mixed Models Analysis
Peer Mentorship vs Social Support Mentorship: estimate of fixed effects: 0.68 (95% CI 0.09 to 1.27), p = 0.02, Mixed Models Analysis

Population analysed: Not every person completed this measure at every time point.

Primary outcome: Cognitive Restraint Subscale of the Eating Disorder Symptom Inventory (EPSI)

Time frame: Baseline, Month 3, Month 6. Mean (Standard Deviation). Unit: units on scale

Measure	Peer Mentorship n = 20	Social Support Mentorship n = 18	Wait List n = 21
Baseline	7.1 (2.8)	7.3 (3.0)	7.1 (2.4)
Month 3	6.2 (3.3)	6.8 (3.0)	7.3 (2.1)
Month 6	5.6 (2.8)	7.0 (2.7)	7.4 (2.3)

Peer Mentorship vs Wait List: estimate of fixed effects: 0.20 (95% CI -0.02 to 0.42), p = 0.08, Mixed Models Analysis
Peer Mentorship vs Social Support Mentorship: estimate of fixed effects: 0.18 (95% CI -0.04 to 0.41), p = 0.12, Mixed Models Analysis

Population analysed: Not every participant filled out this measure at every time point.

Adverse events

Time frame: Information about adverse events was collected throughout the 6-month randomized study period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Peer Mentorship	1 of 20 (5%)	5 of 20 (25%)	0 of 20
Social Support Mentorship	0 of 18 (0%)	3 of 18 (16.7%)	0 of 18
Wait List	5 of 22 (22.7%)	10 of 22 (45.5%)	0 of 22

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body Mass Index (time frame: Baseline (month 0, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03317379.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2021.