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Self-Compassion Enhanced CBT vs. Standard CBT for Social Anxiety (SCE-CBT) (SCE-CBT)

Primary Purpose

Social Anxiety Disorder

Status
Completed
Phase
Not Applicable
Locations
Romania
Study Type
Interventional
Intervention
Self-Compassion Enhanced Cognitive-Behavioral Therapy
Cognitive-Behavioral Therapy
Sponsored by
Babes-Bolyai University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Anxiety Disorder focused on measuring social phobia, compassion, shame

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Babes-Bolyai University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Self-Compassion Enhanced Cognitive-Behavioral Therapy

Cognitive-Behavioral Therapy

Arm Description

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

Standard Group Cognitive-Behavioral Therapy for social anxiety

Outcomes

Primary Outcome Measures

Changes in social anxiety symptoms using (Liebowitz Social Anxiety Scale; Leibowitz, 1987)
Self-reported measure of social anxiety symptoms
Changes in social anxiety symptoms using SPIN (Social Phobia Inventory; Connor et al., 2000)
Self-reported measure of social anxiety symptoms
Changes in social anxiety symptoms using SIAS (Social Interaction Anxiety Scale; Mattick & Clarke, 1998)
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)
Self-reported measure of predisposition to experience shame
Changes in social anxiety disorder clinical status
DSM-5 semi-structured interview for social anxiety disorder

Secondary Outcome Measures

Changes in self-compassion using SCS (Self-Compassion Scale; Neff, 2003)
Self-reported measure of self-compassion
Changes in self-compassion using SCSs (Self-Compassion Scale Short Form; Raes et al., 2011)
Self-reported measure of self-compassion
Changes in depressive symptoms using BDI-II (Beck Depression Inventory-II; Beck, 1996)
Self-reported measure of depressive symptoms
Changes in positive and negative affect using PANAS (Positive and Negative Affect Schedule; Watson & Clark, 1999)
Self-reported measure of positive and negative affect
Changes in positive and negative emotions using PDA (Profile of Affective Distress; Opriș & Macavei, 2005)
Self-reported measure of positive and negative emotions
Changes in irrational and rational thinking using ABS-II (Attitudes and Beliefs Scale- 2; DiGiuseppe, Leaf, Exner, & Robin, 1988)
Self-reported measure of rational and irrational beliefs
Changes in emotion regulation using ERQ (Emotion Regulation Questionnaire; Gross & John, 2003)
Self-reported measure of the use of suppression and reappraisal
Changes in emotion regulation using DERS (Difficulties in Emotion Regulation Scale; Gratz & Roemer, 2004)
Self-reported measure on emotion regulation strategies
Changes in rational and irrational beliefs using GABS (General Attitudes and Beliefs Scale; Bernard, 1998)
Self-reported measure of rational and irrational beliefs
Changes in social phobia related thoughts using BFNE (Brief Fear of Negative Evaluation Scale; Leary, 1983)
Self-reported measure of social phobia relevant negative thoughts
Changes in shame with PFQ-2 (Personal Feelings Questionnaire-2; Harder & Zalma, 1990)
Self-reported measure of shame

Full Information

First Posted
December 30, 2015
Last Updated
July 17, 2018
Sponsor
Babes-Bolyai University
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1. Study Identification

Unique Protocol Identification Number
NCT02646865
Brief Title
Self-Compassion Enhanced CBT vs. Standard CBT for Social Anxiety (SCE-CBT)
Acronym
SCE-CBT
Official Title
A Randomized Controlled Trial on the Efficacy of Self-Compassion Enhanced CBT vs. Standard CBT for Social Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Babes-Bolyai University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder
Keywords
social phobia, compassion, shame

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Self-Compassion Enhanced Cognitive-Behavioral Therapy
Arm Type
Experimental
Arm Description
Group Cognitive-Behavioral Therapy for social anxiety enhanced with exercises targeting self-compassion
Arm Title
Cognitive-Behavioral Therapy
Arm Type
Active Comparator
Arm Description
Standard Group Cognitive-Behavioral Therapy for social anxiety
Intervention Type
Behavioral
Intervention Name(s)
Self-Compassion Enhanced Cognitive-Behavioral Therapy
Intervention Description
12 group sessions of CBT for social anxiety based on Heimberg & Becker's (2002) protocol with additional self-compassion exercises integrated into the treatment
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-Behavioral Therapy
Intervention Description
12 group sessions of CBT for social anxiety based on Heimberg & Becker's (2002) protocol
Primary Outcome Measure Information:
Title
Changes in social anxiety symptoms using (Liebowitz Social Anxiety Scale; Leibowitz, 1987)
Description
Self-reported measure of social anxiety symptoms
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
Title
Changes in social anxiety symptoms using SPIN (Social Phobia Inventory; Connor et al., 2000)
Description
Self-reported measure of social anxiety symptoms
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
Title
Changes in social anxiety symptoms using SIAS (Social Interaction Anxiety Scale; Mattick & Clarke, 1998)
Description
Self-reported measure of social anxiety symptoms
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
Title
Changes in shame-proneness using TOSCA-3 (Test of Self-Conscious Affect-3; Tangney, Dearing, Wagner, & Gramzow, 2000)
Description
Self-reported measure of predisposition to experience shame
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
Title
Changes in social anxiety disorder clinical status
Description
DSM-5 semi-structured interview for social anxiety disorder
Time Frame
at the end of the therapy
Secondary Outcome Measure Information:
Title
Changes in self-compassion using SCS (Self-Compassion Scale; Neff, 2003)
Description
Self-reported measure of self-compassion
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
Title
Changes in self-compassion using SCSs (Self-Compassion Scale Short Form; Raes et al., 2011)
Description
Self-reported measure of self-compassion
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
Title
Changes in depressive symptoms using BDI-II (Beck Depression Inventory-II; Beck, 1996)
Description
Self-reported measure of depressive symptoms
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
Title
Changes in positive and negative affect using PANAS (Positive and Negative Affect Schedule; Watson & Clark, 1999)
Description
Self-reported measure of positive and negative affect
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
Title
Changes in positive and negative emotions using PDA (Profile of Affective Distress; Opriș & Macavei, 2005)
Description
Self-reported measure of positive and negative emotions
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
Title
Changes in irrational and rational thinking using ABS-II (Attitudes and Beliefs Scale- 2; DiGiuseppe, Leaf, Exner, & Robin, 1988)
Description
Self-reported measure of rational and irrational beliefs
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
Title
Changes in emotion regulation using ERQ (Emotion Regulation Questionnaire; Gross & John, 2003)
Description
Self-reported measure of the use of suppression and reappraisal
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
Title
Changes in emotion regulation using DERS (Difficulties in Emotion Regulation Scale; Gratz & Roemer, 2004)
Description
Self-reported measure on emotion regulation strategies
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
Title
Changes in rational and irrational beliefs using GABS (General Attitudes and Beliefs Scale; Bernard, 1998)
Description
Self-reported measure of rational and irrational beliefs
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
Title
Changes in social phobia related thoughts using BFNE (Brief Fear of Negative Evaluation Scale; Leary, 1983)
Description
Self-reported measure of social phobia relevant negative thoughts
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
Title
Changes in shame with PFQ-2 (Personal Feelings Questionnaire-2; Harder & Zalma, 1990)
Description
Self-reported measure of shame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Babes-Bolyai University
City
Cluj-Napoca
State/Province
Cluj
ZIP/Postal Code
400015
Country
Romania

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Gilbert, P, Miles, JNV.Sensitivity to social put-down: Its relationship to perceptions of social rank, shame, social anxiety, depression, anger and self-other blame. Personality and Individual Differences, 29: 757-774, 2000.
Results Reference
background
Citation
Gilbert, P.The relationship of shame, social anxiety and depression: The role of the evaluation of social rank. Clin Psychol Psychother, 7: 174-189, 2000.
Results Reference
background
PubMed Identifier
20591613
Citation
Fergus TA, Valentiner DP, McGrath PB, Jencius S. Shame- and guilt-proneness: relationships with anxiety disorder symptoms in a clinical sample. J Anxiety Disord. 2010 Dec;24(8):811-5. doi: 10.1016/j.janxdis.2010.06.002. Epub 2010 Jun 11.
Results Reference
background
PubMed Identifier
23620782
Citation
Hedman E, Strom P, Stunkel A, Mortberg E. Shame and guilt in social anxiety disorder: effects of cognitive behavior therapy and association with social anxiety and depressive symptoms. PLoS One. 2013 Apr 19;8(4):e61713. doi: 10.1371/journal.pone.0061713. Print 2013.
Results Reference
background
Citation
Gilbert, P, Procter, S. Compassionate mind training for people with high shame and self-criticism: Overview and pilot study of a group therapy approach. Clinical Psychology and Psychotherapy, 13(6): 353-379, 2006.
Results Reference
background
Citation
Heimberg, RG, & Becker, RE. Cognitive-behavioral group therapy for social phobia: Basic mechanisms and clinical strategies. Guilford Press, 2002.
Results Reference
background
Citation
Lutwak, N, Ferrari, JR.. Shame-related social anxiety: Replicating a link with various social interaction measures. Anxiety, stress, and coping, 10(4): 335-34, 1997.
Results Reference
background

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Self-Compassion Enhanced CBT vs. Standard CBT for Social Anxiety (SCE-CBT)

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