Brief Shame Intervention Study

Social Anxiety Disorder Clinical Trial

Official title:

The Development and Evaluation of a Brief Shame Intervention Module: Proof of Concept in Social Anxiety Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03463356
• Other study ID #: 01474r
• Status: Completed
• Phase: N/A
• Start date: February 15, 2018
• Est. completion date: June 30, 2018

Study information

• Verified date: February 2019
• Source: Miami University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The current project will develop and test a brief 2-session shame intervention in individuals diagnosed with social anxiety disorder (SAD). Using a non-concurrent multiple baseline design, the investigators will determine whether the brief shame intervention leads to reductions in trait self-reported shame and state shame in response to an in vivo stressor task. The investigators will also evaluate the effect of changes in shame on trait SAD symptoms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

-= 18 years old

• fluent in English, in terms of verbal and written competence

• meet diagnostic criteria for social anxiety disorder (as assessed by the Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders; Tolin et al., 2016)

• have elevated levels of shame (i.e., score 1 SD above the Test of Self-Conscious Affect-3 [TOSCA-3] means reported by an unselected undergraduate sample [M = 33.62, SD = 8.64])

• endorse a desire to decrease their levels of shame and/or social anxiety.

Exclusion Criteria:

• currently receiving cognitive-behavioral therapy specifically for social anxiety or shame

• have begun taking or had a change in dosage of psychotropic medication in the past six weeks

• do not achieve baseline stability

Related Conditions & MeSH terms

• Anxiety Disorders
• Phobia, Social
• Shame
• Social Anxiety Disorder

Intervention

Behavioral:
• Shame Intervention
In the Shame Intervention, participants will meet with a therapist and learn to: 1) Recognize the experience of shame, 2) Understand the connection between shame and social anxiety, 3) Identify shame triggers and vulnerabilities, 4) Identify the thoughts and behaviors that keep participants stuck in shame, and 5) Learn how to use new, healthier thoughts and behaviors that will help participants move through and decrease shame.

Locations

Country	Name	City	State
United States	Anxiety Cognition and Emotion Laboratory	Oxford	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Miami University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Center for Epidemiologic Studies Depression Measure	Self-report measure of depressive symptoms	Participants report on symptoms experienced during the past week. Administered at T1, T4, and T5. T4 occurs within ~6 weeks after T1. T5 occurs ~1 month after T4.
Other	Change in Clinical Perfectionism Measure	Self-report measure of perfectionism	Participants report on symptoms experienced during the past month. Administered at T1, T4, and T5. T4 occurs within ~6 weeks after T1. T5 occurs ~1 month after T4.
Other	Change in Eating Disorder Inventory - 3rd Version	Self-report measure of eating disorder symptoms	Participants report on typical experience of symptoms. Administered at T1, T4, and T5. T4 occurs within ~6 weeks after T1. T5 occurs ~1 month after T4.
Other	Change in Brief Fear of Negative Evaluation Measure-II	Self-report measure of fear of negative evaluation	Participants report on typical experience of symptoms. Administered at T1, T4, and T5. T4 occurs within ~6 weeks after T1. T5 occurs ~1 month after T4.
Other	Change in Self Beliefs about Social Anxiety	Self-report measure of social anxiety disorder relevant maladaptive beliefs	Participants report on typical experience of symptoms. Administered at T1, T4, and T5. T4 occurs within ~6 weeks after T1. T5 occurs ~1 month after T4.
Primary	Change in Test of Self-Conscious Affect-3-Short Form	Self-report of how likely an individual is to react to 11 scenarios with shame responses	Participants indicate likelihood of responses to scenarios. Administered at B1-B5 and T1-T5. B1-B5 occur ~1 week apart. T1 occurs ~1 week after the final baseline. T1-T4 each occur within ~2 weeks of each other. T5 occuring ~1 month after T4.
Secondary	Change in Liebowitz Social Anxiety-Self-Report	Self-report of social anxiety symptoms	Participants report on symptoms during the past week. Administered at T1-T5. T1-T4 each occur within ~2 weeks of each other. T5 occurs ~1 month after T4.
Secondary	Change in Brief State Anxiety Measure	Self-report of levels of anxiety experienced during the speech task	Participants report on symptoms experienced during the speech task. Administered at T1 and T4. T4 occurs within ~6 weeks after T1.
Secondary	Change in Shame Inventory	Self-report of shame symptoms	Participants report on typical experience of symptoms. Administered at T1, T4, and T5. T4 occurs within ~6 weeks after T1. T5 occurs ~1 month after T4.
Secondary	Change in State Shame and Guilt Measure	Self-report of levels of shame experienced during the speech task	Participants report on symptoms experienced during the speech task. Administered at T1 and T4. T4 occurs within ~6 weeks after T1.