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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Social Anxiety Disorder

Intervention / Treatment
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* Behavioral: Self-Compassion Enhanced Cognitive-Behavioral Therapy
* Behavioral: Cognitive-Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-Compassion Enhanced Cognitive-Behavioral Therapy<br>Group Cognitive-Behavioral Therapy for social anxiety enhanced with exercises targeting self-compassion | Behavioral: Self-Compassion Enhanced Cognitive-Behavioral Therapy<br>* 12 group sessions of CBT for social anxiety based on Heimberg & Becker's (2002) protocol with additional self-compassion exercises integrated into the treatment<br>|
| Active Comparator: Cognitive-Behavioral Therapy<br>Standard Group Cognitive-Behavioral Therapy for social anxiety | Behavioral: Cognitive-Behavioral Therapy<br>* 12 group sessions of CBT for social anxiety based on Heimberg & Becker's (2002) protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in social anxiety symptoms using (Liebowitz Social Anxiety Scale; Leibowitz, 1987) | Self-reported measure of social anxiety symptoms | (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 social anxiety symptoms using SPIN (Social Phobia Inventory; Connor et al., 2000) | Self-reported measure of social anxiety symptoms | (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 anxiety symptoms using SIAS (Social Interaction Anxiety Scale; Mattick & Clarke, 1998) | Self-reported measure of social anxiety symptoms | (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-proneness using TOSCA-3 (Test of Self-Conscious Affect-3; Tangney, Dearing, Wagner, & Gramzow, 2000) | Self-reported measure of predisposition to experience shame | (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 | 
| Changes in social anxiety disorder clinical status | DSM-5 semi-structured interview for social anxiety disorder | at the end of the therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in self-compassion using SCS (Self-Compassion Scale; Neff, 2003) | Self-reported measure of self-compassion | (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 self-compassion using SCSs (Self-Compassion Scale Short Form; Raes et al., 2011) | Self-reported measure of self-compassion | (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) | Self-reported measure of depressive symptoms | (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) | Self-reported measure of positive and negative affect | (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 positive and negative emotions using PDA (Profile of Affective Distress; Opriș & Macavei, 2005) | Self-reported measure of positive and negative emotions | (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 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 | (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) | Self-reported measure of the use of suppression and reappraisal | (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) | Self-reported measure on emotion regulation strategies | (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) | Self-reported measure of rational and irrational beliefs | (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) | Self-reported measure of social phobia relevant negative thoughts | (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 shame with PFQ-2 (Personal Feelings Questionnaire-2; Harder & Zalma, 1990) | Self-reported measure of shame | (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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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social phobia, compassion, shame