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Completed

NCT Number: NCT02646865

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

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.

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Key information

Conditions

Social Anxiety Disorder Anxiety Disorders Mental Disorders Phobia, Social Phobic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Babes-Bolyai University

Cluj-Napoca, Cluj, 400015, Romania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Cognitive-Behavioral Therapy

Behavioral

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

Primary outcomes

  1. Changes in social anxiety symptoms using (Liebowitz Social Anxiety Scale; Leibowitz, 1987)

    Time frame: (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

    Self-reported measure of social anxiety symptoms

  2. Changes in social anxiety symptoms using SPIN (Social Phobia Inventory; Connor et al., 2000)

    Time frame: (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

    Self-reported measure of social anxiety symptoms

  3. Changes in social anxiety symptoms using SIAS (Social Interaction Anxiety Scale; Mattick & Clarke, 1998)

    Time frame: (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

    Self-reported measure of social anxiety symptoms

  4. Changes in shame-proneness using TOSCA-3 (Test of Self-Conscious Affect-3; Tangney, Dearing, Wagner, & Gramzow, 2000)

    Time frame: (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

    Self-reported measure of predisposition to experience shame

  5. Changes in social anxiety disorder clinical status

    Time frame: at the end of the therapy

    DSM-5 semi-structured interview for social anxiety disorder

Secondary outcomes

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

    Time frame: (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

    Self-reported measure of self-compassion

  2. Changes in self-compassion using SCSs (Self-Compassion Scale Short Form; Raes et al., 2011)

    Time frame: (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

    Self-reported measure of self-compassion

  3. Changes in depressive symptoms using BDI-II (Beck Depression Inventory-II; Beck, 1996)

    Time frame: (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

    Self-reported measure of depressive symptoms

  4. Changes in positive and negative affect using PANAS (Positive and Negative Affect Schedule; Watson & Clark, 1999)

    Time frame: (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

    Self-reported measure of positive and negative affect

  5. Changes in positive and negative emotions using PDA (Profile of Affective Distress; Opriș & Macavei, 2005)

    Time frame: (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

    Self-reported measure of positive and negative emotions

  6. Changes in irrational and rational thinking using ABS-II (Attitudes and Beliefs Scale- 2; DiGiuseppe, Leaf, Exner, & Robin, 1988)

    Time frame: (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

    Self-reported measure of rational and irrational beliefs

  7. Changes in emotion regulation using ERQ (Emotion Regulation Questionnaire; Gross & John, 2003)

    Time frame: (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

    Self-reported measure of the use of suppression and reappraisal

  8. Changes in emotion regulation using DERS (Difficulties in Emotion Regulation Scale; Gratz & Roemer, 2004)

    Time frame: (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

    Self-reported measure on emotion regulation strategies

  9. Changes in rational and irrational beliefs using GABS (General Attitudes and Beliefs Scale; Bernard, 1998)

    Time frame: (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

    Self-reported measure of rational and irrational beliefs

  10. Changes in social phobia related thoughts using BFNE (Brief Fear of Negative Evaluation Scale; Leary, 1983)

    Time frame: (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

    Self-reported measure of social phobia relevant negative thoughts

  11. Changes in shame with PFQ-2 (Personal Feelings Questionnaire-2; Harder & Zalma, 1990)

    Time frame: (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

    Self-reported measure of shame

Sponsors and collaborators

Lead sponsor

Babes-Bolyai University

Other

Registry information

Official study title

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

Acronym: SCE-CBT

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jan 6, 2016
Registry last updated
Jul 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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