跳至主要内容
临床试验/NCT02790398
NCT02790398已完成不适用

Transdiagnostic Up-regulation of Positive Affect in Emotional Disorders: A Randomized Pilot Study

Universitat Jaume I2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2014年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
2
主要终点
Change in the Positive and Negative Affect Scale (PANAS) at pre-, post-intervention (up to 4 months) and at 3-month follow-up.

研究概览

简要总结

The aim of this study is to assess the differential effect of two transdiagnostic treatment protocols for emotional disorders (ED) (depression and anxiety disorders) using a randomized pilot study design: a) a transdiagnostic treatment protocol (TTP) based on the Unified Protocol; and b) a version of this protocol that also includes a specific component to address the regulation of positive affect (TTP+PA). Another aim was to assess the acceptability of both treatments by patients. It was hypothesized that the intervention would result in significant differences in favor of the TTP+PA protocol in all measures. Regarding acceptability, it was hypothesized that both treatments (TP and TP+PA) would be well-accepted by the two groups of participants.

详细描述

ED are highly prevalent mental disorders and one of the main causes of disability worldwide. Currently, there is evidence showing the efficacy of transdiagnostic treatments for anxiety disorders, and for comorbid depression and anxiety disorders. An important line of research within the transdiagnostic treatment of ED was initiated by D. H. Barlow. Barlow's theory of triple vulnerability emphasizes the underlying vulnerabilities that are common to ED and help to explain the comorbidity among these diverse conditions. A central aspect within this theoretical perspective is the role of emotion regulation in ED. The regulation of negative emotions in ED has received a great deal of attention in cognitive behavior therapy (CBT) research, and more recently in transdiagnostic ED models like the UP developed by Barlow's team. However, although Barlow underscored the role of low PA in the onset and maintenance of ED, the main objective of the treatment components in the UP is to train patients in negative affect (NA) regulation, but less attention has been paid to the inclusion of treatment components to directly target PA regulation. Moreover, literature has shown that higher levels of PA are associated with better physical and psychological health, healthier lifestyles, and better general functioning. Consequently, an important treatment goal from a transdiagnostic treatment approach would be to increase PA while decreasing NA.

The aim of this study is to compare the differential effect of two transdiagnostic treatment protocols for ED using a randomized pilot study design: a) a transdiagnostic treatment protocol (TTP) based on the Unified Protocol; and b) a version of this protocol that also includes a specific component to address the regulation of positive affect (TTP+PA). Another aim is to assess the acceptability of both treatments by patients. It was hypothesized that the intervention would result in significant differences in favor of the TTP+PA protocol in all measures. Regarding acceptability, it was hypothesized that both treatments (TP and TP+PA) would be well-accepted by the two groups of participants.

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
Single (Participant)

入排标准

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

入选标准

  • 18 years old or older
  • meeting the DSM-IV diagnostic criteria for ED (major depression disorder, dysthimic disorder, generalized anxiety disorder, social anxiety disorder, panic disorder, agoraphobia, obsessive-compulsive disorder, anxiety disorder not otherwise specified, unipolar mood disorder not otherwise specified)
  • ability to understand and read Spanish

排除标准

  • bipolar disorder
  • schizophrenia
  • risk of suicide
  • receiving another psychological treatment during the study
  • in the case of receiving pharmacological treatment, an increase and/or change in this treatment during the study period (a decrease in pharmacological treatment is accepted)

结局指标

主要结局

Change in the Positive and Negative Affect Scale (PANAS) at pre-, post-intervention (up to 4 months) and at 3-month follow-up.

时间窗: Up to 7 months

The PANAS consists of 20 items that evaluate two independent dimensions: positive affect (PA) and negative affect (NA). The range for each scale (10 items on each) is from 10 to 50. The Spanish version has demonstrated high internal consistency (α = 0.89 and 0.91 for PA and NA in women, respectively, and α = 0.87 and 0.89 for PA and NA in men, respectively) in college students.

次要结局

  • Change in the Beck Depression Inventory II (BDI-II) at pre-, post-intervention (up to 4 months) and at 3-month follow-up.(Up to 7 months)
  • Change in the Overall Anxiety Severity and Impairment Scale (OASIS) at pre-, post-intervention (up to 4 months) and at 3-month follow-up.(Up to 7 months)
  • Change in the Quality of Life Inventory (QLI) at pre-, post-intervention (up to 4 months) and at 3-month follow-up.(Up to 7 months)

研究者

发起方
Universitat Jaume I
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验