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临床试验/NCT02646865
NCT02646865已完成不适用

A Randomized Controlled Trial on the Efficacy of Self-Compassion Enhanced CBT vs. Standard CBT for Social Anxiety

Babes-Bolyai University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年1月1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
发起方
入组人数
60
试验地点
2
主要终点
Changes in social anxiety symptoms using SIAS (Social Interaction Anxiety Scale; Mattick & Clarke, 1998)

研究概览

简要总结

This study evaluates the addition of a self-compassion training in the treatment of social anxiety disorder. Half of the participants will receive a self-compassion enhanced group cognitive-behavioral therapy, while the other half will receive standard group cognitive-behavioral therapy.

详细描述

There is growing evidence showing that shame is associated with social anxiety. Also, empirical data shows that individuals with social anxiety have higher levels of shame compared with healthy individuals and that shame might play an important role in the maintenance of social anxiety symptoms. Although cognitive-behavioral therapy for social anxiety seems to reduce the level of shame-proneness, the magnitude of this reduction is a small one.

The purpose of this study is to test whether adding a self-compassion component (which seems to be effective in reducing shame feelings) to a cognitive-behavioral protocol would increase the efficacy of the treatment in reducing both shame-proneness and social anxiety symptoms compared with a standard cognitive-behavioral intervention.

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
Double (Participant, Outcomes Assessor)

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

  • subjects diagnosed with Social Anxiety Disorders using the DSM-5 criteria
  • subjects that have SAD as the primary diagnosis according to DSM-5 criteria
  • exceed the cutoff scores on SPIN, SIAS, and LSAS-SR

排除标准

  • subjects that score over 29 points at BDI-II
  • display suicidal ideation (i.e., exceed a score of 2 on the suicide item of BDI-II)
  • undergo other forms of treatment for SAD
  • have a diagnosis of psychosis, bipolar disorder or personality disorders according to DSM-5 criteria

研究组 & 干预措施

Self-Compassion Enhanced Cognitive-Behavioral Therapy

Experimental

Group Cognitive-Behavioral Therapy for social anxiety enhanced with exercises targeting self-compassion

干预措施: Self-Compassion Enhanced Cognitive-Behavioral Therapy (Behavioral)

Cognitive-Behavioral Therapy

Active Comparator

Standard Group Cognitive-Behavioral Therapy for social anxiety

干预措施: Cognitive-Behavioral Therapy (Behavioral)

结局指标

主要结局

Changes in social anxiety symptoms using SIAS (Social Interaction Anxiety Scale; Mattick & Clarke, 1998)

时间窗: (1) baseline; (2) after 6 weeks from the start of the treatment; (2) at the of end of treatment (12 weeks after the start of the treatment); (3) 6 months after the end of treatment

Self-reported measure of social anxiety symptoms

Changes in shame-proneness using TOSCA-3 (Test of Self-Conscious Affect-3; Tangney, Dearing, Wagner, & Gramzow, 2000)

时间窗: (1) baseline; (2) after 3, 6, 9 weeks from the start of the treatment; (2) at the of end of treatment (12 weeks after the start of the treatment); (3) 6 months after the end of the treatment

Self-reported measure of predisposition to experience shame

Changes in social anxiety symptoms using (Liebowitz Social Anxiety Scale; Leibowitz, 1987)

时间窗: (1) baseline; (2) weekly for 11 weeks starting with the second week of treatment (2) at the of end of treatment (12 weeks after the start of the treatment) ; (3) 6 months after the end of treatment

Self-reported measure of social anxiety symptoms

Changes in social anxiety disorder clinical status

时间窗: at the end of the therapy

DSM-5 semi-structured interview for social anxiety disorder

Changes in social anxiety symptoms using SPIN (Social Phobia Inventory; Connor et al., 2000)

时间窗: (1) baseline; (2) after 6 weeks from the start of the treatment; (2) at the of end of treatment (12 weeks after the start of the treatment); (3) 6 months after the end of treatment

Self-reported measure of social anxiety symptoms

次要结局

  • Changes in self-compassion using SCSs (Self-Compassion Scale Short Form; Raes et al., 2011)((1) baseline; (2) weekly for 11 weeks starting with the second week of treatment (2) at the of end of treatment (12 weeks after the start of the treatment); (3) 6 months after the end of treatment)
  • Changes in irrational and rational thinking using ABS-II (Attitudes and Beliefs Scale- 2; DiGiuseppe, Leaf, Exner, & Robin, 1988)((1) baseline; (2) after 6 weeks from the start of the treatment; (2) at the of end of treatment (12 weeks after the start of the treatment); (3) 6 months after the end of treatment)
  • Changes in emotion regulation using ERQ (Emotion Regulation Questionnaire; Gross & John, 2003)((1) baseline; (2) after 6 weeks from the start of the treatment; (2) at the of end of treatment (12 weeks after the start of the treatment); (3) 6 months after the end of treatment)
  • Changes in emotion regulation using DERS (Difficulties in Emotion Regulation Scale; Gratz & Roemer, 2004)((1) baseline; (2) after 6 weeks from the start of the treatment; (2) at the of end of treatment (12 weeks after the start of the treatment); (3) 6 months after the end of treatment)
  • Changes in positive and negative affect using PANAS (Positive and Negative Affect Schedule; Watson & Clark, 1999)((1) baseline; (2) weekly for 11 weeks starting with the second week of treatment (2) at the of end of treatment (12 weeks after the start of the treatment); (3) 6 months after the end of treatment)
  • Changes in self-compassion using SCS (Self-Compassion Scale; Neff, 2003)((1) baseline; (2) after 6 weeks from the start of the treatment; (2)at the of end of treatment (12 weeks after the start of the treatment); (3) 6 months after the end of treatment)
  • Changes in rational and irrational beliefs using GABS (General Attitudes and Beliefs Scale; Bernard, 1998)((1) baseline; (2) after 6 weeks from the start of the treatment; (2) at the of end of treatment (12 weeks after the start of the treatment); (3) 6 months after the end of treatment)
  • Changes in social phobia related thoughts using BFNE (Brief Fear of Negative Evaluation Scale; Leary, 1983)((1) baseline; (2) weekly for 11 weeks starting with the second week of treatment (2) at the of end of treatment (12 weeks after the start of the treatment); (3) 6 months after the end of treatment)
  • Changes in depressive symptoms using BDI-II (Beck Depression Inventory-II; Beck, 1996)((1) baseline; (2) after 6 weeks from the start of the treatment; (2) at the of end of treatment (12 weeks after the start of the treatment); (3) 6 months after the end of treatment)
  • Changes in positive and negative emotions using PDA (Profile of Affective Distress; Opriș & Macavei, 2005)((1) baseline; (2) after 6 weeks from the start of the treatment; (2) at the of end of treatment (12 weeks after the start of the treatment); (3) 6 months after the end of treatment)
  • Changes in shame with PFQ-2 (Personal Feelings Questionnaire-2; Harder & Zalma, 1990)((1) baseline; (2) weekly for 11 weeks starting with the second week of treatment (2) at the of end of treatment (12 weeks after the start of the treatment); (3) 6 months after the end of treatment)

研究者

发起方
Babes-Bolyai University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Diana-Mirela Candea

PhD Candidate

Babes-Bolyai University

研究点 (2)

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