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临床试验/NCT05275322
NCT05275322Unknown不适用

Online Group Psychological Intervention for People With Emotional Disorders Using the Unified Protocol

University of Buenos Aires1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
1
主要终点
Beck Depression Inventory II

研究概览

简要总结

Participants will receive an online synchronous group therapy based on the Unified Protocol (UP) model for 11 subsequent weeks, with 90-minute meetings. After every session, they will be sent the chapter with the notions addressed in the session from the UP's patient manual (Barlow et al., 2011) and the scales to work with during the week.

Participants in the waiting list will complete the evaluation scales at the same time as people in the intervention group (before the intervention, in the middle, after the intervention, three months after and six months after). After this period they will receive the group therapy based on the UP.

The group admission criteria are: 1) being 18 years old or older; 2) submitting the informed consent; 3) agreeing to participate in all the scheduled sessions; 4) agreeing to have the sessions recorded (both audio and video) for oversight purposes; 5) submitting a primary diagnosis of an anxiety disorder (e.g., panic disorder; agoraphobia; social anxiety disorder; generalized anxiety disorder; unspecific anxiety disorder), unipolar depression (major depressive disorder; dysthymia), obsessive-compulsive disorder, or post-traumatic stress disorder, according to DSM criteria and disrupting individuals' daily life or causing significant discomfort.

The group exclusion criteria are: 1) comorbidity with psychotic disorders, bipolar disorder, eating disorders, borderline personality disorder, or active severe suicidal ideation, and 2) currently receiving pharmacological treatment. All candidates who are not included in the group will be informed of this decision and will be given information on places to seek treatment. Evaluations will be carried out via video calls on the Google Meet platform, using the MINI (Ferrando et al., 2000) and SCID-II (Grilo, Anez & McGlashan, 2003) diagnostic interviews.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
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
否

入选标准

  • •being 18 years old or older; 2) submitting the informed consent; 3) agreeing to participate in all the scheduled sessions; 4) agreeing to have the sessions recorded (both audio and video) for oversight purposes; 5) submitting a primary diagnosis of an anxiety disorder (e.g., panic disorder; agoraphobia; social anxiety disorder; generalized anxiety disorder; unspecific anxiety disorder), unipolar depression (major depressive disorder; dysthymia), obsessive-compulsive disorder, or post-traumatic stress disorder, according to DSM criteria and disrupting individuals' daily life or causing significant discomfort.

排除标准

  • •comorbidity with psychotic disorders, bipolar disorder, eating disorders, borderline personality disorder, or active severe suicidal ideation, and 2) currently receiving pharmacological treatment.

研究组 & 干预措施

Waiting list group

No Intervention

Treatment group

Experimental

干预措施: Unified Protocol (Behavioral)

结局指标

主要结局

Beck Depression Inventory II

时间窗: 5 weeks

Beck Depression Inventory II (BDI II; Beck et al, 2006; Argentine adaptation by Brenlla \& Rodríguez, 2006). The BDI II is a questionnaire designed to gauge how severe people's depressive symptoms are. It includes 21 items that probe the typical symptoms of a depressive episode. Every item features 4 options, ranging from 0 (not at all) to 3 (severe, nearly unbearable), on a Likert-type scale. It was validated and adapted to Argentina's population, with an adequate internal consistency and a Cronbach alpha coefficient of .88.

Beck Anxiety Inventory

时间窗: 5 weeks

Beck Anxiety Inventory (BAI; Beck et al., 1988; Argentine adaptation by Vizioli \& Pagano, 2020). The BAI is an inventory designed to measure the severity of anxiety symptoms. It consists of 21 items, each addressing an anxiety symptom. Every item is rated on a Likert scale answer format that goes from 0 (not at all) to 4 (it upset me very much). This instrument was validated and adapted to Argentina's setting, with a Cronbach alpha coefficient of 0.93.

次要结局

  • Positive and Negative Affect Schedule(5 weeks)
  • Difficulties in Emotion Regulation Scale(5 weeks)

研究者

发起方
University of Buenos Aires
申办方类型
Other
责任方
Principal Investigator
主要研究者

Cristian Javier Garay

Professor

University of Buenos Aires

研究点 (1)

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