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Clinical Trials/NCT02646865
NCT02646865
Completed
Not Applicable

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

Babes-Bolyai University1 site in 1 country60 target enrollmentJanuary 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Social Anxiety Disorder
Sponsor
Babes-Bolyai University
Enrollment
60
Locations
1
Primary Endpoint
Changes in social anxiety symptoms using SIAS (Social Interaction Anxiety Scale; Mattick & Clarke, 1998)
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
January 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Babes-Bolyai University
Responsible Party
Principal Investigator
Principal Investigator

Diana-Mirela Candea

PhD Candidate

Babes-Bolyai University

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

Time Frame: (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)

Time Frame: (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)

Time Frame: (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

Time Frame: 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)

Time Frame: (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

Secondary Outcomes

  • 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)

Study Sites (1)

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