Department of Psychiatry, Eating and Weight Disorders Program
New York, 10029, United States
Location status: Recruiting
NCT Number: NCT05562258
This project includes developing and testing a coaching approach during the treatment of eating disorders. It is expected that with the addition of support outside of regular treatment, caregivers will experience improvements in emotional taxation and patients will strengthen skills necessary for recovery. Twelve weeks of coaching will be incorporated into standard treatment. Randomization will occur placing participants into (1) parent coaching + patient educational materials or (2) parent educational materials + patient coaching.
Interested in participating?
Request Info12 year–18 year
All sexes
Interventional
Not applicable
New York, 10029, United States
Location status: Recruiting
A total of 70 adolescents with eating disorders between the ages of 12-18 and their parents/caregivers will be enrolled in a randomized-controlled trial comparing parent coaching/patient education to parent education/patient coaching. Measures will include demographics, vitals, parent and patient self-efficacy, quality of life, illness related distress/impairment, and changes in eating disorder symptoms and severity.
During a screening and consenting visit, participants will complete assessments including height, weight, demographics, and interview questions to determine inclusion/exclusion criteria and eating disorder diagnoses. At baseline, patients and parents will complete online questionnaires via a REDCap interface, measuring self-efficacy, quality of life, and illness related distress/impairment.
During the intervention, participants will attend standard therapy sessions for the treatment of eating disorders, and patients and parents will be randomized to either have access to a designated coach or weekly educational materials. Patients and parents assigned to coaching will be able to contact their coach outside of their therapy session time for 15-minute coaching calls. Completed calls will be tracked to document engagement with coaching. Patients and parents assigned to weekly education materials will receive a link, which will direct them to YouTube videos related to the skills covered in therapy for that week. They will also receive a link with a few questions to document engagement with each video.
Follow-up measures will be conducted mid-way through treatment and at the end-of-treatment, and these visits will involve patients and parents repeating the assessments administered during baseline.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This group includes 12 weeks of eating disorder therapy provided to the patient. Outside of therapy, parents will have access to a coach and patients will have access to weekly educational material.
This group includes 12 weeks of eating disorder therapy provided to the patient. Outside of therapy, parents will have access to weekly educational material and patients will have access to a coach.
Time frame: Baseline and 12 weeks
Changes in patient self-efficacy will be measured using the EDRSQ, which is a 23-item instrument that assesses self-efficacy with eating disorder behaviors and attitudes. Total scores range from 1-5 with higher scores indicating greater self-efficacy. Changes in self-efficacy will be calculated using the baseline and 12-week scores from the EDRSQ.
Time frame: Baseline and 12 weeks
Changes in parent efficacy will be measured using the PVA which is a 7-item instrument that assesses parent's level of efficacy with helping their child with an eating disorder. Total scores range from 5-35 with higher scores indicating greater efficacy. Changes in efficacy will be calculated using the baseline and 12-week scores from the PVA.
Time frame: Baseline and 12 weeks
Changes in patient stress will be measured using the DASS. The DASS is a 42-item self-report measure of negative emotional states with subscales of depression, anxiety, and stress symptoms. Each subscale is scored 0-42, with total scores ranging from 0-126. Higher scores indicate more severe psychological distress. Changes in stress will be calculated using the baseline and 12-week total score of the DASS.
Time frame: Baseline and 12 weeks
Changes in parental stress will be measured using the CES-D, which is a 20-item self-report measure evaluating depressive symptoms. Scores range from 0 to 60 with higher scores indicating greater impairment. Changes in stress will be calculated using the baseline and 12-week total score of the CES-D.
Time frame: Baseline and 12 weeks
Patient impairment is measured using the Clinical Impairment Assessment, which is a 16-item self-report measure of impairment from eating disorders. Responses are scored using 0, 1, 2, or 3 and the score is calculated using the sum of all items. Possible scores range between 0 - 48, with higher scores indicating more impairment and lower scores indicating less impairment. Change in impairment will be calculated using the baseline and 12-week scores from CIA.
Time frame: Baseline and 12 weeks
Weight will be measured in the EWDP IP clinic by study staff during all study visits. Change in weight will be calculated using the baseline and 12-week measurements.
Time frame: 12 weeks
Coaching utilization will be measured by tracking the number of contacts to the coach outside of treatment visits. Utilization will be calculated using the sum of contacts throughout the 12-week treatment.
Time frame: 12 weeks
Coaching utilization will be measured by tracking the number of treatment visits attended. Utilization will be calculated using the sum of treatment visits throughout the 12-week treatment.
Contact information is provided by the study sponsor or research team.
Jessica Bibeau, MA
CONTACT
Tom Hildebrandt, PsyD
CONTACT
Icahn School of Medicine at Mount Sinai
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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