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临床试验/NCT04869423
NCT04869423Unknown不适用

Effects of Dog-assisted Therapy in Adolescents With Eating Disorders: a Controlled Trial.

Daniel Collado-Mateo2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2021年4月30日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
32
试验地点
2
主要终点
Changes in Health-related quality of life

研究概览

简要总结

This study aims to improve eating disorders symptomatology, mental, psychosocial and physical health, quality of life, strength and body composition of adolescents with eating disorders by the development of a dog-assisted therapy program.

The current research will involve thirty-two patients distributed equally in a control and an experimental group. The intervention group will participate once a week in a dog-assisted therapy of seven weeks. Moreover, all the included patients will participate in an assessment session before and after the intervention to compare the effects of the dog-assisted therapy within and between groups in anxiety, depression, character, behavior, eating disorder evolution, health-related quality of life, treatment satisfaction, strength and body composition.

Based on previous studies on different populations, it is expected that, compared to the control group, the experimental group may experience a potential reduction in anxiety, depression and symptoms, while improving quality of life, strength, body composition and behavior.

详细描述

Animal-Assisted Therapies (AAT) have proved to increase self-esteem, social capacity and impulse control while reducing anxiety and depression. Thus, AAT could be an innovative and effective therapy to improve the mental, social and physical health of adolescents with eating disorders.

Based on previous studies on different populations, it is expected that, compared to the control group, the experimental group may experience a potential reduction in anxiety, depression and symptoms, while improving quality of life, strength, body composition and behavior.

Thirty-two adolescents, younger than 18 years and diagnosed with eating disorders from the University Hospital Niño Jesus will participate in this study. The informed consent must be signed to be included in the study.

The intervention will consist of 7 weeks conducted once a week (50 minutes each session). It will include three parts: 1) a welcome part aimed to get in touch with the dog, 2) a main part, where participants will be taught basic notions about dog training and then try to train the dogs. In this part, the patients will perform different activities and exercises with the dog. 3) A closing part to say goodbye to the dogs.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Investigator)

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Adolescents in the Psychiatry and Psychology Service of the Niño Jesús University Hospital
  • Patients diagnosed with eating disorders
  • Adolescents with the willingness to participate and availability to assist
  • Having read and signed the written informed consent.

排除标准

  • Patients with dog-allergy or dog phobia
  • Adolescents with a history of impulsive animal aggression

结局指标

主要结局

Changes in Health-related quality of life

时间窗: At baseline and inmediately after the intervention (within 7 days after the last session)

Measured by the Kidscreen-10, which consists of 10 items scored on a 5-point Likert scale. Scores range between 10 and 50, and a higher score means better health-related quality of life.

Changes in Eating disorder symptoms

时间窗: At baseline and inmediately after the intervention (within 7 days after the last session)

Measured by the EDI-2 questionnaire to evaluate the evolution of anorexia nervosa and bulimia nervosa normal symptoms. The EDI 2 is a 91 item scale with 8 subscales - (Drive for thinness, Bulimia, body dissatisfaction, ineffectiveness, perfection, interpersonal distrust, interoceptive awareness and maturity fears.). Respondents rate each item from 5 (usually), to 0 (never). Higher scores mean more severe symptoms.

次要结局

  • Changes in Strength(At baseline and inmediately after the intervention (within 7 days after the last session))
  • Changes in Depression(At baseline and inmediately after the intervention (within 7 days after the last session))
  • Changes in Body mass(At baseline and inmediately after the intervention (within 7 days after the last session))
  • Changes in Behavior(At baseline and inmediately after the intervention (within 7 days after the last session))
  • Changes in Anxiety(At baseline and inmediately after the intervention (within 7 days after the last session))
  • Treatment satisfaction(Inmediately after the intervention (within 7 days after the last session))
  • Changes in Adolescent character(At baseline and inmediately after the intervention (within 7 days after the last session))

研究者

发起方
Daniel Collado-Mateo
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Daniel Collado-Mateo

Assistant Professor

Universidad Rey Juan Carlos

研究点 (2)

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