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Completed

NCT Number: NCT05840614

The Remote Family Support Programs for 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).

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Key information

Conditions

Eating Disorders Feeding and Eating Disorders Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fujika Katsuki

Nagoya, Aichi-ken, 467-8601, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The remote family support program

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: Base-line, four weeks, and eight weeks

    Parents' perception of social support is measured using SPS-10.

Other outcomes

  1. Loneliness

    Time frame: Base-line, four weeks, and eight weeks

    Parents' loneliness is evaluated using the University of California Los Angeles Loneliness Scale (ULS).

  2. Mental health

    Time frame: Base-line, four weeks, and eight weeks

    Psychological distress experienced by the participants is assessed using the Kessler Psychological Distress Scale (K6).

  3. Family functioning

    Time frame: Base-line, four weeks, and eight weeks

    Family functioning is assessed using the Family Assessment Device (FAD).

  4. Eating disorder behaviors

    Time frame: Base-line, four weeks, and eight weeks

    Information on behaviors and attitudes of patients with eating disorders obtained from their parents is measured using the Anorectic Behavior Observation Scale (ABOS).

Sponsors and collaborators

Lead sponsor

Nagoya City University

Other

Registry information

Official study title

The Effectiveness of a Remote Family Support Programs for Families of Patients With Eating Disorders

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 3, 2023
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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