The Remote Family Support Programs for Eating Disorders (NCT05840614) | Clinical Trial Compass
CompletedNot Applicable
The Remote Family Support Programs for Eating Disorders
Japan67 participantsStarted 2023-03-18
Plain-language summary
Eating disorders are serious mental health disorders associated with high levels of mortality, disability, physical and psychological morbidity, and impaired quality of life. Family members who spend the majority of their time with patients of eating disorders experience heavy psychological burden. Remote family support programs consist of interpersonal psychotherapy and family psychoeducation. This study aimed to examine the effectiveness of a remote family support program for eating disorders in an RCT (randomized controlled trial). The specific objective was to conduct a small pilot RCT of the remote family support program (n=28) compared with TAU (n=28).
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The research participants are parents of patients who have been diagnosed with an eating disorder by a physician or have symptoms of an eating disorder; parents may or may not be related by blood.
* The ABOS score measured by the research participants at enrollment is over 8 points.
* Patient age at enrollment ranged from 12 to 29 years.
* The patient has lived with their parents at the time of participating in this study and is expected to live with them during the investigation period.
* Patients may or may not undergo treatment.
* Patients with other psychiatric comorbidities are included.
* Participants with other psychiatric comorbidities are included.
* If multiple family members (e.g., parents) participated in this program, the primary participant is determined, and that person becomes the target research participant.
* Willingness to provide informed consent and comply with the trial protocol.
Exclusion Criteria:
* The participants cannot read or write in Japanese
* The participants cannot use the Zoom meeting system
* Researcher of this study and their families
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in the total Active Listening Attitude Scale (ALAS) score of participants