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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peer mentorship | Behavioral | Weekly meetings with a recovered peer mentor once per week. Dyads discuss eating disorder symptoms and how to overcome them. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Institute | New York | New York | 10032 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | May 22, 2018 |
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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
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Since this is a behavioral intervention, participants, care providers, and investigators are aware of each patient's randomization. Outcomes are assessed electronically.
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| 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). |
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| 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. |
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| Baseline, Month 3, Month 6 |
| FG001 | 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). |
| FG002 | Wait List | Participants are on a wait list and then get matched with either type of mentor (of their choice) 6 months later |
| Completed Intervention | Completed intervention defined as participated in intervention for at least 20 weeks (out of 6 months) |
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| COMPLETED | Completion defined as completion of at least one follow-up study interval |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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). |
| BG002 | Wait List | Participants are on a wait list and then get matched with either type of mentor (of their choice) 6 months later |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Information about sex/gender for 1 participant in Social Support arm not reported due to privacy/confidentiality issue. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Body Mass Index | kg/m2 | 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. | Posted | Mean | Standard Deviation | kg/m2 | Baseline (month 0, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6 |
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| Primary | 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 | Number of participants with BN or BED | Posted | Mean | Standard Error | units on a scale | Baseline through Week 28 |
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| Primary | 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. | Not every person completed this measure at every time point. | Posted | Mean | Standard Deviation | units on scale | Baseline, Month 3, Month 6 |
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| Primary | 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. | Not every participant filled out this measure at every time point. | Posted | Mean | Standard Deviation | units on scale | Baseline, Month 3, Month 6 |
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| Primary | 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. | Not every participant completed this measure at every timepoint. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 3, Month 6 |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 20 | 1 | 20 | 5 | 20 |
| EG001 | 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). | 0 | 18 | 0 | 18 | 3 | 18 |
| EG002 | Wait List | Participants are on a wait list and then get matched with either type of mentor (of their choice) 6 months later | 0 | 22 | 5 | 22 | 10 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Complication of spinal surgery | Surgical and medical procedures | Non-systematic Assessment | Pt had planned spinal surgery for which she was taken off blood thinner, and she then had a blood clot form in her leg, resulting in an inpatient hospitalization. She spent several days in the hospital and then recuperated at home. |
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| Inpatient psychiatric hospitalization | Psychiatric disorders | Systematic Assessment | Two patients had psychiatric hospitalization for suicidal ideation |
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| Medical hospitalization for medical instability due to anorexia nervosa | Metabolism and nutrition disorders | Systematic Assessment | Two patients were hospitalized for medical complications of anorexia nervosa and then treated for anorexia nervosa in an inpatient setting |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Higher level of care for eating disorder | Psychiatric disorders | Non-systematic Assessment | Higher level of care for eating disorder includes residential treatment, partial hospitalization/day program, or intensive outpatient treatment |
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| Ankle injury | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Ankle injury of unknown type |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa Ranzenhofer, PhD | New York State Psychiatric Institute | 240 671 9040 | lr2840@cumc.columbia.edu |
| Feb 4, 2021 |
| Prot_ICF_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 23, 2018 | Apr 27, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D000856 | Anorexia Nervosa |
| D052018 | Bulimia Nervosa |
| D056912 | Binge-Eating Disorder |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Month 1 |
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| Month 2 |
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| Month 3 |
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| Month 4 |
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| Month 5 |
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| Month 6 |
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| .32 |
.05 is the a priori threshold for statistical significance. |
| estimate of fixed effects |
| 0.10 |
| Standard Error of the Mean |
| 0.1 |
| 2-Sided |
| 95 |
| -0.10 |
| 0.30 |
| Superiority |
| OG002 | Wait List | Participants are on a wait list and then get matched with either type of mentor (of their choice) 6 months later |
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| OG001 | 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). |
| OG002 | Wait List | Participants are on a wait list and then get matched with either type of mentor (of their choice) 6 months later |
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| OG001 | 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). |
| OG002 | Wait List | Participants are on a wait list and then get matched with either type of mentor (of their choice) 6 months later |
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| OG001 |
| 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). |
| OG002 | Wait List | Participants are on a wait list and then get matched with either type of mentor (of their choice) 6 months later |
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