Clinical trial NCT02646865: Self-Compassion Enhanced CBT vs. Standard CBT for Social Anxiety (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
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety Disorder
Keywords: social phobia
compassion
shame
Lead sponsor: Babes-Bolyai University
Sponsor class: OTHER
First posted: 2016-01-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in social anxiety symptoms using (Liebowitz Social Anxiety Scale; Leibowitz, 1987)
timeFrame: (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
measure: Changes in social anxiety symptoms using SPIN (Social Phobia Inventory; Connor et al., 2000)
timeFrame: (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
measure: Changes in social anxiety symptoms using SIAS (Social Interaction Anxiety Scale; Mattick & Clarke, 1998)
timeFrame: (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
measure: Changes in shame-proneness using TOSCA-3 (Test of Self-Conscious Affect-3; Tangney, Dearing, Wagner, & Gramzow, 2000)
timeFrame: (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
measure: Changes in social anxiety disorder clinical status
timeFrame: at the end of the therapy
Secondary outcomes:
measure: Changes in self-compassion using SCS (Self-Compassion Scale; Neff, 2003)
timeFrame: (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
measure: Changes in self-compassion using SCSs (Self-Compassion Scale Short Form; Raes et al., 2011)
timeFrame: (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
measure: Changes in depressive symptoms using BDI-II (Beck Depression Inventory-II; Beck, 1996)
timeFrame: (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
measure: Changes in positive and negative affect using PANAS (Positive and Negative Affect Schedule; Watson & Clark, 1999)
timeFrame: (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
measure: Changes in positive and negative emotions using PDA (Profile of Affective Distress; Opriș & Macavei, 2005)
timeFrame: (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
measure: Changes in irrational and rational thinking using ABS-II (Attitudes and Beliefs Scale- 2; DiGiuseppe, Leaf, Exner, & Robin, 1988)
timeFrame: (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
measure: Changes in emotion regulation using ERQ (Emotion Regulation Questionnaire; Gross & John, 2003)
timeFrame: (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
measure: Changes in emotion regulation using DERS (Difficulties in Emotion Regulation Scale; Gratz & Roemer, 2004)
timeFrame: (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
measure: Changes in rational and irrational beliefs using GABS (General Attitudes and Beliefs Scale; Bernard, 1998)
timeFrame: (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
measure: Changes in social phobia related thoughts using BFNE (Brief Fear of Negative Evaluation Scale; Leary, 1983)
timeFrame: (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
measure: Changes in shame with PFQ-2 (Personal Feelings Questionnaire-2; Harder & Zalma, 1990)
timeFrame: (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
Other outcomes:
Locations:
city: Cluj-Napoca
country: Romania
facility: Babes-Bolyai University
state: Cluj
Study officials:
References:
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.
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.
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.
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.
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.
citation: Heimberg, RG, & Becker, RE. Cognitive-behavioral group therapy for social phobia: Basic mechanisms and clinical strategies. Guilford Press, 2002.
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.