The Remote Family Support Programs for Eating Disorders

April 21, 2023 updated by: Fujika Katsuki, Nagoya City University

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The remote family support program plus TAU
Behavioral: The remote family support program Remote family support programs consist of interpersonal psychotherapy (IPT) and family psychoeducation.
Behavioral: The remote family support program

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.
No Intervention: Treatment as Usual
Treatment as usual administrated by physician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Base-line, four weeks, and eight weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Base-line, four weeks, and eight weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Loneliness
Time Frame: Base-line, four weeks, and eight weeks
Parents' loneliness is evaluated using the University of California Los Angeles Loneliness Scale (ULS).
Base-line, four weeks, and eight weeks
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).
Base-line, four weeks, and eight weeks
Family functioning
Time Frame: Base-line, four weeks, and eight weeks
Family functioning is assessed using the Family Assessment Device (FAD).
Base-line, four weeks, and eight weeks
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).
Base-line, four weeks, and eight weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nagoya City University

Investigators

  • Principal Investigator: Fujika Katsuki, Ph.D., Nagoya City University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2023

Primary Completion (Anticipated)

June 30, 2024

Study Completion (Anticipated)

June 30, 2024

Study Registration Dates

First Submitted

April 21, 2023

First Submitted That Met QC Criteria

April 21, 2023

First Posted (Actual)

May 3, 2023

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

April 21, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NagoyaCU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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