Clinical trial NCT05840614: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Eating Disorders
Keywords: Family support, Interpersonal psychotherapy
Lead sponsor: Nagoya City University
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 56
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Change in the total Active Listening Attitude Scale (ALAS) score of participants
timeFrame: Base-line, four weeks, and eight weeks
Secondary outcomes:
measure: Change in the total Social Provisions Scale-10 item (SPS-10) score of participants
timeFrame: Base-line, four weeks, and eight weeks
Other outcomes:
measure: Loneliness
timeFrame: Base-line, four weeks, and eight weeks
measure: Mental health
timeFrame: Base-line, four weeks, and eight weeks
measure: Family functioning
timeFrame: Base-line, four weeks, and eight weeks
measure: Eating disorder behaviors
timeFrame: Base-line, four weeks, and eight weeks
Locations:
city: Nagoya
country: Japan
facility: Fujika Katsuki
state: Aichi
Study officials:
affiliation: Nagoya City University
name: Fujika Katsuki, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: