Brief Shame Intervention Study

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

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.

Study Overview

• Status: Completed
• Conditions: Social Anxiety Disorder; Shame
• Intervention / Treatment: Behavioral: Shame Intervention

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Oxford, Ohio, United States, 45212
      • Anxiety Cognition and Emotion Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Shame Intervention; Participants will complete a two shame intervention sessions approximately one week apart.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: Miami University
• Investigators: Principal Investigator: Marie Parsons, M.A., Miami University

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2018
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: March 1, 2018
• First Submitted That Met QC Criteria: March 6, 2018
• First Posted (Actual): March 13, 2018

Study Record Updates

• Last Update Posted (Actual): February 7, 2019
• Last Update Submitted That Met QC Criteria: February 6, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Phobic Disorders; Anxiety Disorders; Phobia, Social
• Other Study ID Numbers: 01474r

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No