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

NCT02646865 | Completed

• 1 other identifier: UBB-CLINPSY-2016-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Social Anxiety Disorder

Keywords

social phobia; compassion; shame

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (11)

• Changes in self-compassion using SCS (Self-Compassion Scale; Neff, 2003)

  (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)

  (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)

  (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)

  (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)

  (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

Study Arms (2)

Self-Compassion Enhanced Cognitive-Behavioral Therapy

EXPERIMENTAL

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

Behavioral: Self-Compassion Enhanced Cognitive-Behavioral Therapy

Cognitive-Behavioral Therapy

ACTIVE COMPARATOR

Standard Group Cognitive-Behavioral Therapy for social anxiety

Behavioral: Cognitive-Behavioral Therapy

Interventions

Self-Compassion Enhanced Cognitive-Behavioral Therapy BEHAVIORAL

12 group sessions of CBT for social anxiety based on Heimberg \& Becker's (2002) protocol with additional self-compassion exercises integrated into the treatment

Self-Compassion Enhanced Cognitive-Behavioral Therapy

Cognitive-Behavioral Therapy BEHAVIORAL

12 group sessions of CBT for social anxiety based on Heimberg \& Becker's (2002) protocol

Cognitive-Behavioral Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Babes-Bolyai University: lead

Study Sites (1)

Babes-Bolyai University

Cluj-Napoca, Cluj, 400015, Romania

Location

Related Publications (7)

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 20591613 BACKGROUND

• 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.

  PMID: 23620782 BACKGROUND

• 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.

  BACKGROUND

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

  BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Phobia, Social

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Study Record Dates

• First Submitted: December 30, 2015
• First Posted: January 6, 2016
• Study Start: January 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: January 1, 2018
• Last Updated: July 18, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)