The Remote Family Support Programs for Eating Disorders

Sponsor
Nagoya City University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05840614
Collaborator
(none)
56
1
2
15.4
3.6

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: The remote family support program
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
56 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effectiveness of a Remote Family Support Programs for Families of Patients With Eating Disorders
Actual Study Start Date :
Mar 18, 2023
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in the total Active Listening Attitude Scale (ALAS) score of participants [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 Outcome Measures

  1. Change in the total Social Provisions Scale-10 item (SPS-10) score of participants [Base-line, four weeks, and eight weeks]

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

Other Outcome Measures

  1. Loneliness [Base-line, four weeks, and eight weeks]

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

  2. Mental health [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 [Base-line, four weeks, and eight weeks]

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

  4. Eating disorder behaviors [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fujika Katsuki Nagoya Aichi Japan 467-8601

Sponsors and Collaborators

  • Nagoya City University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fujika Katsuki, Professor, Nagoya City University
ClinicalTrials.gov Identifier:
NCT05840614
Other Study ID Numbers:
  • NagoyaCU
First Posted:
May 3, 2023
Last Update Posted:
May 3, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fujika Katsuki, Professor, Nagoya City University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 3, 2023