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临床试验/NCT06063278
NCT06063278招募中不适用

Step by Step Group Therapy for Bulimia Nervosa: Effectiveness and Mechanisms of Change.

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年5月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
2
主要终点
Eating Attitudes Test, E-40.

研究概览

简要总结

This a pseudo-randomized clinical trial that examines if a specific group therapy for BN is effective in improving its symptomatology, and what variables mediate such improvements. To do so a sample of 100 patients with BN will be pseudorandomized in a Group Therapy for BN or in a control waiting list group. Patients will be assessed at baseline, at the end of the group therapy and at 2 year follow up.

详细描述

This is a controlled non randomized study that will compare a group of patients with BN that participate in the SBS group therapy with a group of BN patients who will be in wait list as a control condition.

Patients for this single center trial will be recruited from the outpatient facility of the Hospital de la Santa Creu I Sant Pau (Barcelona, Spain).

After assessed for eligibility participants will be given a set of self -report questionnaires. After the questionnaires are completed participants will be allocated to wait list condition or to the treatment arm. Time between assessment and starting the SBS group will be a month or least. Participants will be administered the same questionnaires the following month after finishing the treatment or after 3 to 4 months after the first assessment for the control condition.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnostic of Bulimia Nervosa

排除标准

  • Not understanding Spanish or Catalan Language

结局指标

主要结局

Eating Attitudes Test, E-40.

时间窗: 3 months

A self report questionarie that assesses eating disorder symptomatology. The range of scores is 0-78. Higher scores mean higher eating disorders sympthoms.

Bulimic Investigatory Test Edinburgh, BITE

时间窗: 3 months

A self report questionarie that assesses bulimia nervosa symptomatology.The range of scores is 0-30. Higher scores mean higher bulimic sympthoms

Body Shape Questionnaire, BSQ-34

时间窗: 3 months

A self report questionarie that assesses eating disorder symptomatology. The score is ranging between 34-204 points. Higher scores point to an increased level of concern on body shape.

Eating Disorder Inventory, EDI

时间窗: 3 months

A self report questionarie that assesses eating disorder symptomatology. The range of scores is 0-192. Higher scores mean higher eating disorders sympthoms

次要结局

  • Working alliance Inventory -short, WAIS.(3 months)
  • Autism-Spectrum Quotient, AQ(3 months)
  • Rosenberg Self-Esteem Scale, RSE.(3 months)
  • Quality of Life Enjoyment and Satisfaction Questionnaire, Q-LES-Q.(3 months)
  • Difficulties in Emotion Regulation Scale (DERS).(3 months)
  • State -Trait Anxiety Inventory, STAI.(3 months)
  • Beck Depression Inventory, BDI-II(3 months)

研究者

发起方
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
申办方类型
Other
责任方
Sponsor

研究点 (2)

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