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临床试验/NCT05840614
NCT05840614已完成不适用

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

Nagoya City University1 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2023年3月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
67
试验地点
1
主要终点
Change in the total Active Listening Attitude Scale (ALAS) score of participants

研究概览

简要总结

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •The participants cannot read or write in Japanese
  • •The participants cannot use the Zoom meeting system
  • •Researcher of this study and their families

研究组 & 干预措施

The remote family support program plus TAU

Experimental

Behavioral: The remote family support program Remote family support programs consist of interpersonal psychotherapy (IPT) and family psychoeducation.

干预措施: The remote family support program (Behavioral)

Treatment as Usual

No Intervention

Treatment as usual administrated by physician.

结局指标

主要结局

Change in the total Active Listening Attitude Scale (ALAS) score of participants

时间窗: 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.

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fujika Katsuki

Professor

Nagoya City University

研究点 (1)

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