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

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

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.

Study Overview

• Status: Completed
• Conditions: Social Anxiety Disorder
• Intervention / Treatment: Behavioral: Self-Compassion Enhanced Cognitive-Behavioral Therapy; Behavioral: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Romania
  • Cluj
    • Cluj-Napoca, Cluj, Romania, 400015
      • Babes-Bolyai University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Babes-Bolyai University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• Heimberg, RG, & Becker, RE. Cognitive-behavioral group therapy for social phobia: Basic mechanisms and clinical strategies. Guilford Press, 2002.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: December 30, 2015
• First Submitted That Met QC Criteria: January 4, 2016
• First Posted (Estimate): January 6, 2016

Study Record Updates

• Last Update Posted (Actual): July 18, 2018
• Last Update Submitted That Met QC Criteria: July 17, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: compassion; social phobia; shame
• Additional Relevant MeSH Terms: Mental Disorders; Phobic Disorders; Anxiety Disorders; Phobia, Social
• Other Study ID Numbers: UBB-CLINPSY-2016-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No