NCT03317379

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

Completed NA Results posted Last updated 19 August 2021

What this trial tests

NA trial testing Peer mentorship in Eating Disorder in 60 participants. Completed in 30 June 2021.

Timeline

1 October 2017

Primary endpoint
31 May 2021

30 June 2021

Quick facts

Lead sponsor	New York State Psychiatric Institute
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	60
Start date	1 October 2017
Primary completion	31 May 2021
Estimated completion	30 June 2021
Sites	1 location across United States

Drugs / interventions tested

• Peer mentorship
• Social support mentorship
• Recovery Record use with mentor

Conditions studied

• Eating Disorder — all drugs for Eating Disorder →
• Anorexia Nervosa — all drugs for Anorexia Nervosa →
• Bulimia Nervosa — all drugs for Bulimia Nervosa →
• Binge-Eating Disorder — all drugs for Binge-Eating Disorder →

Sponsor

New York State Psychiatric Institute

Who can join

Adults 14 to 45, any sex, with Eating Disorder or Anorexia Nervosa. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Body Mass Index Primary · Baseline (month 0, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6

kg/m2

Baseline (month 0)

Group	Value	95% CI
Peer Mentorship	21.9	± 3.6
Social Support Mentorship	20.7	± 2.7
Wait List	21.5	± 4.0

Month 1

Group	Value	95% CI
Peer Mentorship	21.9	± 4.0
Social Support Mentorship	21.1	± 2.8
Wait List	21.5	± 4.5

Month 2

Group	Value	95% CI
Peer Mentorship	22.6	± 3.8
Social Support Mentorship	21.4	± 3.3
Wait List	21.6	± 4.9

Month 3

Group	Value	95% CI
Peer Mentorship	21.6	± 4.1
Social Support Mentorship	21.6	± 4.1
Wait List	21.7	± 3.7

Month 4

Group	Value	95% CI
Peer Mentorship	21.3	± 3.5
Social Support Mentorship	21.3	± 3.5
Wait List	24.4	± 3.4

Month 5

Group	Value	95% CI
Peer Mentorship	21.8	± 4.2
Social Support Mentorship	21.8	± 4.2
Wait List	23.5	± 3.4

Month 6

Group	Value	95% CI
Peer Mentorship	22.8	± 4.3
Social Support Mentorship	22.8	± 4.3
Wait List	23.4	± 4.1

Binge Days Primary · 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

Baseline

Group	Value	95% CI
Peer Mentorship	1.0	± 0.7
Social Support Mentorship	1	± 2
Wait List	1.3	± 1.0

Week 1

Group	Value	95% CI
Peer Mentorship	0.67	± .58
Social Support Mentorship	1.33	± 2.3
Wait List	1.0	± 1.0

Week 2

Group	Value	95% CI
Peer Mentorship	1.25	± 0.5
Social Support Mentorship	.33	± .57
Wait List	1.3	± 1.4

Week 3

Group	Value	95% CI
Peer Mentorship	0.67	± 0.58
Social Support Mentorship	1	± 2
Wait List	.7	± .5

Week 4

Group	Value	95% CI
Peer Mentorship	1	± 0
Social Support Mentorship	0	± 0
Wait List	.8	± .8

Week 5 Week 5

Group	Value	95% CI
Peer Mentorship	1.5	± 1.0
Social Support Mentorship	1.3	± 2.3
Wait List	1.2	± .8

Week 6

Group	Value	95% CI
Peer Mentorship	.67	± .58
Social Support Mentorship	0.5	± 0.7
Wait List	1.5	± .8

Week 7

Group	Value	95% CI
Peer Mentorship	0	± 0
Social Support Mentorship	1.0	± 1.7
Wait List	.3	± .6

Body Dissatisfaction Subscale of the Eating Disorder Symptom Inventory (EPSI) Primary · 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.

Baseline

Group	Value	95% CI
Peer Mentorship	23.5	± 4.3
Social Support Mentorship	19.9	± 6.3
Wait List	21.2	± 8.0

Month 3

Group	Value	95% CI
Peer Mentorship	19.6	± 6.9
Social Support Mentorship	19.4	± 6.0
Wait List	20.7	± 6.1

Month 6

Group	Value	95% CI
Peer Mentorship	18.2	± 7.5
Social Support Mentorship	21.2	± 6.2
Wait List	20.9	± 6.5

Cognitive Restraint Subscale of the Eating Disorder Symptom Inventory (EPSI) Primary · 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.

Baseline

Group	Value	95% CI
Peer Mentorship	7.1	± 2.8
Social Support Mentorship	7.3	± 3.0
Wait List	7.1	± 2.4

Month 3

Group	Value	95% CI
Peer Mentorship	6.2	± 3.3
Social Support Mentorship	6.8	± 3.0
Wait List	7.3	± 2.1

Month 6

Group	Value	95% CI
Peer Mentorship	5.6	± 2.8
Social Support Mentorship	7.0	± 2.7
Wait List	7.4	± 2.3

Restricting Subscale of the Eating Disorder Symptom Inventory (EPSI) Primary · 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.

Baseline

Group	Value	95% CI
Peer Mentorship	11.5	± 7.2
Social Support Mentorship	10.8	± 6.4
Wait List	8.4	± 4.6

Month 3

Group	Value	95% CI
Peer Mentorship	11.7	± 6.6
Social Support Mentorship	10.6	± 5.9
Wait List	9.6	± 4.9

Month 6

Group	Value	95% CI
Peer Mentorship	9.5	± 6.1
Social Support Mentorship	10.2	± 5.2
Wait List	9.4	± 4.9

Adverse events — posted to ClinicalTrials.gov

Time frame: Information about adverse events was collected throughout the 6-month randomized study period.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Peer Mentorship

Serious: 1/20 (5%)

Deaths: 0/20

Social Support Mentorship

Serious: 0/18 (0%)

Deaths: 0/18

Wait List

Serious: 5/22 (23%)

Deaths: 0/22

Serious adverse events (3 terms)

Reaction	System	Peer Mentorship	Social Support Mentorship	Wait List
Inpatient psychiatric hospitalization	Psychiatric disorders	—	—	—
Medical hospitalization for medical instability due to anorexia nervosa	Metabolism and nutrition disorders	—	—	—
Complication of spinal surgery	Surgical and medical procedures	—	—	—

Other adverse events (2 terms — click to expand)

Reaction	System	Peer Mentorship	Social Support Mentorship	Wait List
Higher level of care for eating disorder	Psychiatric disorders	—	—	—
Ankle injury	Musculoskeletal and connective tissue disorders	—	—	—

Most-reported serious reactions: Inpatient psychiatric hospitalization, Medical hospitalization for medical instability due to anorexia nervosa, Complication of spinal surgery.

Data from ClinicalTrials.gov NCT03317379 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Peer mentorship as an adjunct intervention for the treatment of eating disorders: A pilot randomized trial.
   Ranzenhofer LM, Ranzenhofer LM, Wilhelmy M, Hochschild A, et al · · 2020 · cited 24× · PMID 32159243 · DOI 10.1002/eat.23258