NCT05840614

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 18, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 21, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 3, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
Last Updated

July 29, 2025

Status Verified

July 1, 2025

Enrollment Period

1.5 years

First QC Date

April 21, 2023

Last Update Submit

July 24, 2025

Conditions

Keywords

Family support, Interpersonal psychotherapy

Outcome Measures

Primary Outcomes (1)

  • 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.

    Base-line, four weeks, and eight weeks

Secondary Outcomes (1)

  • Change in the total Social Provisions Scale-10 item (SPS-10) score of participants

    Base-line, four weeks, and eight weeks

Other Outcomes (4)

  • Loneliness

    Base-line, four weeks, and eight weeks

  • Mental health

    Base-line, four weeks, and eight weeks

  • Family functioning

    Base-line, four weeks, and eight weeks

  • +1 more other outcomes

Study Arms (2)

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.

Behavioral: The remote family support program

Treatment as Usual

NO INTERVENTION

Treatment as usual administrated by physician.

Interventions

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.

The remote family support program plus TAU

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • The participants cannot read or write in Japanese
  • The participants cannot use the Zoom meeting system
  • Researcher of this study and their families

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fujika Katsuki

Nagoya, Aichi-ken, 467-8601, Japan

Location

Related Publications (2)

  • 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.

  • Katsuki 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.

Related Links

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Fujika Katsuki, Ph.D.

    Nagoya City University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 21, 2023

First Posted

May 3, 2023

Study Start

March 18, 2023

Primary Completion

August 30, 2024

Study Completion

October 30, 2024

Last Updated

July 29, 2025

Record last verified: 2025-07

Locations