The Remote Family Support Programs for Eating Disorders

Study Overview
=================
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).

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

Conditions
-----------------
Eating Disorders

Intervention / Treatment
-----------------
* Behavioral: The remote family support program


Participation Criteria
=================
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The remote family support program plus TAU<br>Behavioral: The remote family support program Remote family support programs consist of interpersonal psychotherapy (IPT) and family psychoeducation. | Behavioral: The remote family support program<br>* 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.<br>|
| No Intervention: Treatment as Usual<br>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 | 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 | Parents' perception of social support is measured using SPS-10. | Base-line, four weeks, and eight weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Family support, Interpersonal psychotherapy