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

Social Anxiety Disorder Clinical Trial

— SCE-CBT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02646865
• Other study ID #: UBB-CLINPSY-2016-1
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: January 2018

Study information

• Verified date: July 2018
• Source: Babes-Bolyai University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Phobia, Social
• Social Anxiety Disorder

Intervention

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
• Cognitive-Behavioral Therapy
12 group sessions of CBT for social anxiety based on Heimberg & Becker's (2002) protocol

Locations

Country	Name	City	State
Romania	Babes-Bolyai University	Cluj-Napoca	Cluj

Sponsors (1)

Lead Sponsor	Collaborator
Babes-Bolyai University

Country where clinical trial is conducted

Romania, 

References & Publications (7)

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. — View 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.

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.

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.

Hedman E, Ström P, Stünkel A, Mörtberg 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. — View Citation

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Changes in social anxiety disorder clinical status	DSM-5 semi-structured interview for social anxiety disorder	at the end of the therapy
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Changes in positive and negative emotions using PDA (Profile of Affective Distress; Opri? & 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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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