The Remote Family Support Programs for Eating Disorders

Eating Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05840614
• Other study ID #: NagoyaCU
• Status: Recruiting
• Phase: N/A
• Start date: March 18, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2023
• Source: Nagoya City University
• Contact: Fujika Katsuki, Ph.D.
• Phone: +81-52-853-8048
• Email: katsuki[@]med.nagoya-cu.ac.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Eating Disorders
• Feeding and Eating Disorders

Intervention

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.

Locations

Country	Name	City	State
Japan	Fujika Katsuki	Nagoya	Aichi

Sponsors (1)

Lead Sponsor	Collaborator
Nagoya City University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Loneliness	Parents' loneliness is evaluated using the University of California Los Angeles Loneliness Scale (ULS).	Base-line, four weeks, and eight weeks
Other	Mental health	Psychological distress experienced by the participants is assessed using the Kessler Psychological Distress Scale (K6).	Base-line, four weeks, and eight weeks
Other	Family functioning	Family functioning is assessed using the Family Assessment Device (FAD).	Base-line, four weeks, and eight weeks
Other	Eating disorder behaviors	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
Primary	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	Change in the total Social Provisions Scale-10 item (SPS-10) score of participants	Parents' perception of social support is measured using SPS-10.	Base-line, four weeks, and eight weeks