Eating DisordersNCT05840614
The Remote Family Support Programs for Eating Disorders
A study testing The remote family support program in people with Eating Disorders, run by Nagoya City University at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Eating Disorders
- What is being tested?
- The remote family support program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteJapan
- Study dates
- 18 Mar 2023to 30 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- The participants cannot read or write in Japanese
- The participants cannot use the Zoom meeting system
- Researcher of this study and their families
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of a Remote Family Support Programs for Families of Patients With Eating Disorders
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).
- Conditions
- Eating Disorders
- Being tested
- The remote family support program
- Keywords
- Family support, Interpersonal psychotherapy
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The remote family support programBehavioural
Remote family support programs consist of interpersonal psychotherapy (IPT) and family psychoeducation.
Each session consisted of a lecture, followed by role playing and supportive group therapy. In the first session, we informed the participants about the symptoms of eating disorders and mechanism of IPT; in the second session, we shared details about the characteristics of adolescents; and during the third and fourth sessions, we provided information on effective communication according to IPT.
| Study group | Role | What they receive |
|---|---|---|
| The remote family support program plus TAU | Experimental | Behavioral: The remote family support program Remote family support programs consist of interpersonal psychotherapy (IPT) and family psychoeducation. Receives: Behavioral: The remote family support program |
| Treatment as Usual | No intervention | Treatment as usual administrated by physician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the total Active Listening Attitude Scale (ALAS) score of participants
The ALAS comprises 2 subscales and 20 items: listening attitude (10 items) and listening skills (10 items). Higher the scores indicate better listening attitudes or skills.
Measured: Base-line, four weeks, and eight weeks
Secondary outcomes (1)
Change in the total Social Provisions Scale-10 item (SPS-10) score of participants
Parents' perception of social support is measured using SPS-10.
Measured: Base-line, four weeks, and eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start18 Mar 2023
- Primary completion30 Aug 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nagoya City University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fujika Katsuki, Nagoya City University
- Investigators
- Fujika Katsuki, Ph.D., Principal investigator, Nagoya City University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05840614
- Sponsor's protocol ID
- NagoyaCU
- Status last verified
- Jul 2025
- First submitted
- 21 Apr 2023
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Katsuki F, Sawada H, Kawasaki Y, Kondo M, Yamada A, Watanabe N. Effectiveness of Remote Family Education and Support Program for Parents of Adolescents With Eating Disorders Based on Interpersonal Psychotherapy: A Randomized Controlled Trial. Int J Eat Disord. 2025 Dec;58(12):2281-2291. doi: 10.1002/eat.24541. Epub 2025 Sep 3.
PubMed 40899790Katsuki F, Watanabe N, Kondo M, Sawada H, Yamada A. Remote family education and support program for parents of patients with adolescent and early adulthood eating disorders based on interpersonal psychotherapy: study protocol for a pilot randomized controlled trial. J Eat Disord. 2024 May 17;12(1):61. doi: 10.1186/s40337-024-01013-z.
PubMed 38760800
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Remote Family Support Programs for Families of Patients With Eating Disorders
- ClinicalTrials.gov ID
- NCT05840614
- Acronym / sponsor ID
- NagoyaCU
- Conditions
- Eating Disorders
- Keywords
- Family support, Interpersonal psychotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Nagoya City UniversityUniversity, hospital or other
- Study start
- 18 Mar 2023 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The remote family support program plus TAU | Experimental | Behavioral: The remote family support programBehavioral: The remote family support program Remote family support programs consist of interpersonal psychotherapy (IPT) and family psychoeducation. |
| Treatment as Usual | No intervention | –Treatment as usual administrated by physician. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (3 listed)
- The participants cannot read or write in Japanese
- The participants cannot use the Zoom meeting system
- Researcher of this study and their families
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The remote family support programRemote family support programs consist of interpersonal psychotherapy (IPT) and family psychoeducation. Each session consisted of a lecture, followed by role playing and supportive group therapy. In the first session, we informed the participants about the symptoms of eating disorders and mechanism of IPT; in the second session, we shared details about the characteristics of adolescents; and during the third and fourth sessions, we provided information on effective communication according to IPT. | Behavioural | The remote family support program plus TAU |
Primary outcome
Change in the total Active Listening Attitude Scale (ALAS) score of participants
Time frame: Base-line, four weeks, and eight weeks
The ALAS comprises 2 subscales and 20 items: listening attitude (10 items) and listening skills (10 items). Higher the scores indicate better listening attitudes or skills.
1 secondary outcome
Change in the total Social Provisions Scale-10 item (SPS-10) score of participants
Time frame: Base-line, four weeks, and eight weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Derived from this study: PubMed 40899790Katsuki F, Sawada H, Kawasaki Y, Kondo M, Yamada A, Watanabe N. Effectiveness of Remote Family Education and Support Program for Parents of Adolescents With Eating Disorders Based on Interpersonal Psychotherapy: A Randomized Controlled Trial. Int J Eat Disord. 2025 Dec;58(12):2281-2291. doi: 10.1002/eat.24541. Epub 2025 Sep 3.
- Derived from this study: PubMed 38760800Katsuki F, Watanabe N, Kondo M, Sawada H, Yamada A. Remote family education and support program for parents of patients with adolescent and early adulthood eating disorders based on interpersonal psychotherapy: study protocol for a pilot randomized controlled trial. J Eat Disord. 2024 May 17;12(1):61. doi: 10.1186/s40337-024-01013-z.
- Fujika Katsuki, et. al.: Remote family education and support program for parents of patients with adolescent and early adulthood eating disorders based on interpersonal psychotherapy: study protocol for a pilot randomized controlled trialLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fujika Katsuki, Ph.D. principal investigator
Nagoya City University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The remote family support program in people with Eating Disorders, run by Nagoya City University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the total Active Listening Attitude Scale (ALAS) score of participants (time frame: Base-line, four weeks, and eight weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05840614, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.