Back to resultsThe Remote Family Support Programs for Eating Disorders
Primary Purpose
Eating Disorders
Status
Recruiting
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
The remote family support program
Sponsored by
About this trial
This is an interventional treatment trial for Eating Disorders focused on measuring Family support, Interpersonal psychotherapy
Eligibility Criteria
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
Sites / Locations
- Fujika KatsukiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
The remote family support program plus TAU
Treatment as Usual
Arm Description
Behavioral: The remote family support program Remote family support programs consist of interpersonal psychotherapy (IPT) and family psychoeducation.
Treatment as usual administrated by physician.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in the total Social Provisions Scale-10 item (SPS-10) score of participants
Parents' perception of social support is measured using SPS-10.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05840614
Brief Title
The Remote Family Support Programs for Eating Disorders
Official Title
The Effectiveness of a Remote Family Support Programs for Families of Patients With Eating Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 18, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nagoya City University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders
Keywords
Family support, Interpersonal psychotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
The remote family support program plus TAU
Arm Type
Experimental
Arm Description
Behavioral: The remote family support program Remote family support programs consist of interpersonal psychotherapy (IPT) and family psychoeducation.
Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
Treatment as usual administrated by physician.
Intervention Type
Behavioral
Intervention Name(s)
The remote family support program
Intervention Description
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 Outcome Measure Information:
Title
Change in the total Active Listening Attitude Scale (ALAS) score of participants
Description
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.
Time Frame
Base-line, four weeks, and eight weeks
Secondary Outcome Measure Information:
Title
Change in the total Social Provisions Scale-10 item (SPS-10) score of participants
Description
Parents' perception of social support is measured using SPS-10.
Time Frame
Base-line, four weeks, and eight weeks
Other Pre-specified Outcome Measures:
Title
Loneliness
Description
Parents' loneliness is evaluated using the University of California Los Angeles Loneliness Scale (ULS).
Time Frame
Base-line, four weeks, and eight weeks
Title
Mental health
Description
Psychological distress experienced by the participants is assessed using the Kessler Psychological Distress Scale (K6).
Time Frame
Base-line, four weeks, and eight weeks
Title
Family functioning
Description
Family functioning is assessed using the Family Assessment Device (FAD).
Time Frame
Base-line, four weeks, and eight weeks
Title
Eating disorder behaviors
Description
Information on behaviors and attitudes of patients with eating disorders obtained from their parents is measured using the Anorectic Behavior Observation Scale (ABOS).
Time Frame
Base-line, four weeks, and eight weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fujika Katsuki, Ph.D.
Phone
+81-52-853-8048
Email
katsuki@med.nagoya-cu.ac.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fujika Katsuki, Ph.D.
Organizational Affiliation
Nagoya City University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fujika Katsuki
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
467-8601
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fujika Katsuki, Dr
Phone
+81-52-853-8048
Email
katsuki@med.nagoya-cu.ac.jp
First Name & Middle Initial & Last Name & Degree
Norio Watanabe, Dr
Email
noriowncu@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Remote Family Support Programs for Eating Disorders
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