Trial Outcomes & Findings for Evaluation of the Communities of Healing Mentorship/Support Group Program: Assessment of Preliminary Efficacy (NCT NCT03317379)

NCT ID: NCT03317379

Last Updated: 2021-08-19

Results Overview

kg/m2

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

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

Results posted on

2021-08-19

Participant Flow

Participant milestones

Participant milestones
Measure
Peer Mentorship
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. Peer mentorship: Weekly meetings with a recovered peer mentor once per week. Dyads discuss eating disorder symptoms and how to overcome them. Recovery Record use with mentor: 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.
Social Support Mentorship
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. Social support mentorship: 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).
Wait List
Participants are on a wait list and then get matched with either type of mentor (of their choice) 6 months later
Overall Study
STARTED
20
18
22
Overall Study
Completed Intervention
16
6
0
Overall Study
COMPLETED
20
15
20
Overall Study
NOT COMPLETED
0
3
2

Reasons for withdrawal

Reasons for withdrawal
Measure
Peer Mentorship
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. Peer mentorship: Weekly meetings with a recovered peer mentor once per week. Dyads discuss eating disorder symptoms and how to overcome them. Recovery Record use with mentor: 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.
Social Support Mentorship
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. Social support mentorship: 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).
Wait List
Participants are on a wait list and then get matched with either type of mentor (of their choice) 6 months later
Overall Study
Lost to Follow-up
0
3
2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Peer Mentorship
n=20 Participants
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. Peer mentorship: Weekly meetings with a recovered peer mentor once per week. Dyads discuss eating disorder symptoms and how to overcome them. Recovery Record use with mentor: 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.
Social Support Mentorship
n=18 Participants
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. Social support mentorship: 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).
Wait List
n=22 Participants
Participants are on a wait list and then get matched with either type of mentor (of their choice) 6 months later
Total
n=60 Participants
Total of all reporting groups
Age, Continuous
27.9 years
STANDARD_DEVIATION 7.6 • n=5 Participants
31.0 years
STANDARD_DEVIATION 5.0 • n=7 Participants
27.1 years
STANDARD_DEVIATION 7.5 • n=5 Participants
28.5 years
STANDARD_DEVIATION 7.0 • n=4 Participants
Sex/Gender, Customized
Female
20 Participants
n=5 Participants
17 Participants
n=7 Participants
22 Participants
n=5 Participants
59 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
2 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
18 Participants
n=5 Participants
18 Participants
n=7 Participants
22 Participants
n=5 Participants
58 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Asian
2 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
3 Participants
n=4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
Race (NIH/OMB)
White
16 Participants
n=5 Participants
17 Participants
n=7 Participants
20 Participants
n=5 Participants
53 Participants
n=4 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
2 Participants
n=4 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants

PRIMARY outcome

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

Population: 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.

kg/m2

Outcome measures

Outcome measures
Measure
Peer Mentorship
n=15 Participants
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. Peer mentorship: Weekly meetings with a recovered peer mentor once per week. Dyads discuss eating disorder symptoms and how to overcome them. Recovery Record use with mentor: 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.
Social Support Mentorship
n=14 Participants
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. Social support mentorship: 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).
Wait List
n=16 Participants
Participants are on a wait list and then get matched with either type of mentor (of their choice) 6 months later
Body Mass Index
Baseline (month 0)
21.9 kg/m2
Standard Deviation 3.6
20.7 kg/m2
Standard Deviation 2.7
21.5 kg/m2
Standard Deviation 4.0
Body Mass Index
Month 1
21.9 kg/m2
Standard Deviation 4.0
21.1 kg/m2
Standard Deviation 2.8
21.5 kg/m2
Standard Deviation 4.5
Body Mass Index
Month 2
22.6 kg/m2
Standard Deviation 3.8
21.4 kg/m2
Standard Deviation 3.3
21.6 kg/m2
Standard Deviation 4.9
Body Mass Index
Month 3
21.6 kg/m2
Standard Deviation 4.1
21.6 kg/m2
Standard Deviation 4.1
21.7 kg/m2
Standard Deviation 3.7
Body Mass Index
Month 4
21.3 kg/m2
Standard Deviation 3.5
21.3 kg/m2
Standard Deviation 3.5
24.4 kg/m2
Standard Deviation 3.4
Body Mass Index
Month 5
21.8 kg/m2
Standard Deviation 4.2
21.8 kg/m2
Standard Deviation 4.2
23.5 kg/m2
Standard Deviation 3.4
Body Mass Index
Month 6
22.8 kg/m2
Standard Deviation 4.3
22.8 kg/m2
Standard Deviation 4.3
23.4 kg/m2
Standard Deviation 4.1

PRIMARY outcome

Timeframe: Baseline through Week 28

Population: Number of participants with BN or BED

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

Outcome measures

Outcome measures
Measure
Peer Mentorship
n=5 Participants
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. Peer mentorship: Weekly meetings with a recovered peer mentor once per week. Dyads discuss eating disorder symptoms and how to overcome them. Recovery Record use with mentor: 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.
Social Support Mentorship
n=4 Participants
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. Social support mentorship: 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).
Wait List
n=6 Participants
Participants are on a wait list and then get matched with either type of mentor (of their choice) 6 months later
Binge Days
Baseline
1.0 units on a scale
Standard Error 0.7
1 units on a scale
Standard Error 2
1.3 units on a scale
Standard Error 1.0
Binge Days
Week 1
0.67 units on a scale
Standard Error .58
1.33 units on a scale
Standard Error 2.3
1.0 units on a scale
Standard Error 1.0
Binge Days
Week 2
1.25 units on a scale
Standard Error 0.5
.33 units on a scale
Standard Error .57
1.3 units on a scale
Standard Error 1.4
Binge Days
Week 3
0.67 units on a scale
Standard Error 0.58
1 units on a scale
Standard Error 2
.7 units on a scale
Standard Error .5
Binge Days
Week 4
1 units on a scale
Standard Error 0
0 units on a scale
Standard Error 0
.8 units on a scale
Standard Error .8
Binge Days
Week 5 Week 5
1.5 units on a scale
Standard Error 1.0
1.3 units on a scale
Standard Error 2.3
1.2 units on a scale
Standard Error .8
Binge Days
Week 6
.67 units on a scale
Standard Error .58
0.5 units on a scale
Standard Error 0.7
1.5 units on a scale
Standard Error .8
Binge Days
Week 7
0 units on a scale
Standard Error 0
1.0 units on a scale
Standard Error 1.7
.3 units on a scale
Standard Error .6
Binge Days
Week 8
0.25 units on a scale
Standard Error 0.50
1.3 units on a scale
Standard Error 1.5
1.1 units on a scale
Standard Error 1.3
Binge Days
Week 9
1 units on a scale
Standard Error 0
2 units on a scale
Standard Error 0
.6 units on a scale
Standard Error .5
Binge Days
Week 10
1 units on a scale
Standard Error 0
1 units on a scale
Standard Error 0
1.0 units on a scale
Standard Error 1.4
Binge Days
Week 11
0 units on a scale
Standard Error 0
1 units on a scale
Standard Error 0
.8 units on a scale
Standard Error 1.0
Binge Days
Week 12
0.50 units on a scale
Standard Error 0.71
0 units on a scale
Standard Error 0
1.8 units on a scale
Standard Error 1.0
Binge Days
Week 13
1 units on a scale
Standard Error 0
1 units on a scale
Standard Error 0
.7 units on a scale
Standard Error .7
Binge Days
Week 14
1 units on a scale
Standard Error 0
0 units on a scale
Standard Error 0
1.0 units on a scale
Standard Error 1.4
Binge Days
Week 15
0 units on a scale
Standard Error 0
1 units on a scale
Standard Error 0
1.0 units on a scale
Standard Error 0.9
Binge Days
Week 16
.43 units on a scale
Standard Error .79
2 units on a scale
Standard Error 0
0.7 units on a scale
Standard Error 0.8
Binge Days
Week 17
.5 units on a scale
Standard Error .7
2 units on a scale
Standard Error 0
1.0 units on a scale
Standard Error 1.0
Binge Days
Week 18
1 units on a scale
Standard Error 0
1 units on a scale
Standard Error 0
1.4 units on a scale
Standard Error 1.2
Binge Days
Week 19
0 units on a scale
Standard Error 0
0 units on a scale
Standard Error 0
1.0 units on a scale
Standard Error 1.4
Binge Days
Week 20
1 units on a scale
Standard Error 0
0 units on a scale
Standard Error 0
1.2 units on a scale
Standard Error 1.3
Binge Days
Week 21
1 units on a scale
Standard Error 0
0 units on a scale
Standard Error 0
1.3 units on a scale
Standard Error 1.0
Binge Days
Week 22
1 units on a scale
Standard Error 0
3 units on a scale
Standard Error 0
0.9 units on a scale
Standard Error 0.7
Binge Days
Week 23
0 units on a scale
Standard Error 0
0 units on a scale
Standard Error 0
1.8 units on a scale
Standard Error 1.0
Binge Days
Week 24
1 units on a scale
Standard Error 0
1.4 units on a scale
Standard Error 1.4
Binge Days
Week 25
1 units on a scale
Standard Error 0
3 units on a scale
Standard Error 0
0 units on a scale
Standard Error 0
Binge Days
Week 26
.13 units on a scale
Standard Error .35
0 units on a scale
Standard Error 0
1.3 units on a scale
Standard Error 1.3

PRIMARY outcome

Timeframe: Baseline, Month 3, Month 6

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

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.

Outcome measures

Outcome measures
Measure
Peer Mentorship
n=20 Participants
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. Peer mentorship: Weekly meetings with a recovered peer mentor once per week. Dyads discuss eating disorder symptoms and how to overcome them. Recovery Record use with mentor: 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.
Social Support Mentorship
n=18 Participants
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. Social support mentorship: 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).
Wait List
n=21 Participants
Participants are on a wait list and then get matched with either type of mentor (of their choice) 6 months later
Body Dissatisfaction Subscale of the Eating Disorder Symptom Inventory (EPSI)
Baseline
23.5 units on scale
Standard Deviation 4.3
19.9 units on scale
Standard Deviation 6.3
21.2 units on scale
Standard Deviation 8.0
Body Dissatisfaction Subscale of the Eating Disorder Symptom Inventory (EPSI)
Month 3
19.6 units on scale
Standard Deviation 6.9
19.4 units on scale
Standard Deviation 6.0
20.7 units on scale
Standard Deviation 6.1
Body Dissatisfaction Subscale of the Eating Disorder Symptom Inventory (EPSI)
Month 6
18.2 units on scale
Standard Deviation 7.5
21.2 units on scale
Standard Deviation 6.2
20.9 units on scale
Standard Deviation 6.5

PRIMARY outcome

Timeframe: Baseline, Month 3, Month 6

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

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.

Outcome measures

Outcome measures
Measure
Peer Mentorship
n=20 Participants
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. Peer mentorship: Weekly meetings with a recovered peer mentor once per week. Dyads discuss eating disorder symptoms and how to overcome them. Recovery Record use with mentor: 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.
Social Support Mentorship
n=18 Participants
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. Social support mentorship: 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).
Wait List
n=21 Participants
Participants are on a wait list and then get matched with either type of mentor (of their choice) 6 months later
Cognitive Restraint Subscale of the Eating Disorder Symptom Inventory (EPSI)
Baseline
7.1 units on scale
Standard Deviation 2.8
7.3 units on scale
Standard Deviation 3.0
7.1 units on scale
Standard Deviation 2.4
Cognitive Restraint Subscale of the Eating Disorder Symptom Inventory (EPSI)
Month 3
6.2 units on scale
Standard Deviation 3.3
6.8 units on scale
Standard Deviation 3.0
7.3 units on scale
Standard Deviation 2.1
Cognitive Restraint Subscale of the Eating Disorder Symptom Inventory (EPSI)
Month 6
5.6 units on scale
Standard Deviation 2.8
7.0 units on scale
Standard Deviation 2.7
7.4 units on scale
Standard Deviation 2.3

PRIMARY outcome

Timeframe: Baseline, Month 3, Month 6

Population: Not every participant completed this measure at every timepoint.

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.

Outcome measures

Outcome measures
Measure
Peer Mentorship
n=20 Participants
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. Peer mentorship: Weekly meetings with a recovered peer mentor once per week. Dyads discuss eating disorder symptoms and how to overcome them. Recovery Record use with mentor: 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.
Social Support Mentorship
n=18 Participants
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. Social support mentorship: 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).
Wait List
n=21 Participants
Participants are on a wait list and then get matched with either type of mentor (of their choice) 6 months later
Restricting Subscale of the Eating Disorder Symptom Inventory (EPSI)
Baseline
11.5 units on a scale
Standard Deviation 7.2
10.8 units on a scale
Standard Deviation 6.4
8.4 units on a scale
Standard Deviation 4.6
Restricting Subscale of the Eating Disorder Symptom Inventory (EPSI)
Month 3
11.7 units on a scale
Standard Deviation 6.6
10.6 units on a scale
Standard Deviation 5.9
9.6 units on a scale
Standard Deviation 4.9
Restricting Subscale of the Eating Disorder Symptom Inventory (EPSI)
Month 6
9.5 units on a scale
Standard Deviation 6.1
10.2 units on a scale
Standard Deviation 5.2
9.4 units on a scale
Standard Deviation 4.9

Adverse Events

Peer Mentorship

Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths

Social Support Mentorship

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Wait List

Serious events: 5 serious events
Other events: 10 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Peer Mentorship
n=20 participants at risk
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. Peer mentorship: Weekly meetings with a recovered peer mentor once per week. Dyads discuss eating disorder symptoms and how to overcome them. Recovery Record use with mentor: 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.
Social Support Mentorship
n=18 participants at risk
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. Social support mentorship: 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).
Wait List
n=22 participants at risk
Participants are on a wait list and then get matched with either type of mentor (of their choice) 6 months later
Surgical and medical procedures
Complication of spinal surgery
5.0%
1/20 • Number of events 1 • Information about adverse events was collected throughout the 6-month randomized study period.
Information about participants health status and health care utilization was collected as part of mid- and post-treatment outcome surveys. Additionally, participants could report an event to the study team or to their mentor, and these events were logged in the participants' chart and included in AE report.
0.00%
0/18 • Information about adverse events was collected throughout the 6-month randomized study period.
Information about participants health status and health care utilization was collected as part of mid- and post-treatment outcome surveys. Additionally, participants could report an event to the study team or to their mentor, and these events were logged in the participants' chart and included in AE report.
0.00%
0/22 • Information about adverse events was collected throughout the 6-month randomized study period.
Information about participants health status and health care utilization was collected as part of mid- and post-treatment outcome surveys. Additionally, participants could report an event to the study team or to their mentor, and these events were logged in the participants' chart and included in AE report.
Psychiatric disorders
Inpatient psychiatric hospitalization
0.00%
0/20 • Information about adverse events was collected throughout the 6-month randomized study period.
Information about participants health status and health care utilization was collected as part of mid- and post-treatment outcome surveys. Additionally, participants could report an event to the study team or to their mentor, and these events were logged in the participants' chart and included in AE report.
0.00%
0/18 • Information about adverse events was collected throughout the 6-month randomized study period.
Information about participants health status and health care utilization was collected as part of mid- and post-treatment outcome surveys. Additionally, participants could report an event to the study team or to their mentor, and these events were logged in the participants' chart and included in AE report.
13.6%
3/22 • Number of events 3 • Information about adverse events was collected throughout the 6-month randomized study period.
Information about participants health status and health care utilization was collected as part of mid- and post-treatment outcome surveys. Additionally, participants could report an event to the study team or to their mentor, and these events were logged in the participants' chart and included in AE report.
Metabolism and nutrition disorders
Medical hospitalization for medical instability due to anorexia nervosa
0.00%
0/20 • Information about adverse events was collected throughout the 6-month randomized study period.
Information about participants health status and health care utilization was collected as part of mid- and post-treatment outcome surveys. Additionally, participants could report an event to the study team or to their mentor, and these events were logged in the participants' chart and included in AE report.
0.00%
0/18 • Information about adverse events was collected throughout the 6-month randomized study period.
Information about participants health status and health care utilization was collected as part of mid- and post-treatment outcome surveys. Additionally, participants could report an event to the study team or to their mentor, and these events were logged in the participants' chart and included in AE report.
9.1%
2/22 • Number of events 2 • Information about adverse events was collected throughout the 6-month randomized study period.
Information about participants health status and health care utilization was collected as part of mid- and post-treatment outcome surveys. Additionally, participants could report an event to the study team or to their mentor, and these events were logged in the participants' chart and included in AE report.

Other adverse events

Other adverse events
Measure
Peer Mentorship
n=20 participants at risk
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. Peer mentorship: Weekly meetings with a recovered peer mentor once per week. Dyads discuss eating disorder symptoms and how to overcome them. Recovery Record use with mentor: 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.
Social Support Mentorship
n=18 participants at risk
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. Social support mentorship: 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).
Wait List
n=22 participants at risk
Participants are on a wait list and then get matched with either type of mentor (of their choice) 6 months later
Psychiatric disorders
Higher level of care for eating disorder
25.0%
5/20 • Number of events 5 • Information about adverse events was collected throughout the 6-month randomized study period.
Information about participants health status and health care utilization was collected as part of mid- and post-treatment outcome surveys. Additionally, participants could report an event to the study team or to their mentor, and these events were logged in the participants' chart and included in AE report.
16.7%
3/18 • Number of events 3 • Information about adverse events was collected throughout the 6-month randomized study period.
Information about participants health status and health care utilization was collected as part of mid- and post-treatment outcome surveys. Additionally, participants could report an event to the study team or to their mentor, and these events were logged in the participants' chart and included in AE report.
40.9%
9/22 • Number of events 11 • Information about adverse events was collected throughout the 6-month randomized study period.
Information about participants health status and health care utilization was collected as part of mid- and post-treatment outcome surveys. Additionally, participants could report an event to the study team or to their mentor, and these events were logged in the participants' chart and included in AE report.
Musculoskeletal and connective tissue disorders
Ankle injury
0.00%
0/20 • Information about adverse events was collected throughout the 6-month randomized study period.
Information about participants health status and health care utilization was collected as part of mid- and post-treatment outcome surveys. Additionally, participants could report an event to the study team or to their mentor, and these events were logged in the participants' chart and included in AE report.
0.00%
0/18 • Information about adverse events was collected throughout the 6-month randomized study period.
Information about participants health status and health care utilization was collected as part of mid- and post-treatment outcome surveys. Additionally, participants could report an event to the study team or to their mentor, and these events were logged in the participants' chart and included in AE report.
4.5%
1/22 • Number of events 1 • Information about adverse events was collected throughout the 6-month randomized study period.
Information about participants health status and health care utilization was collected as part of mid- and post-treatment outcome surveys. Additionally, participants could report an event to the study team or to their mentor, and these events were logged in the participants' chart and included in AE report.

Additional Information

Lisa Ranzenhofer, PhD

New York State Psychiatric Institute

Phone: 240 671 9040

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place