Brief Shame Intervention Study

• ClinicalTrials.gov Identifier: NCT03463356
• Recruitment Status: Completed
• First Posted: March 13, 2018
• Last Update Posted: February 7, 2019
• Sponsor: Miami University
• Information provided by (Responsible Party): Elise Clerkin, Miami University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Shame; Social Anxiety Disorder	Behavioral: Shame Intervention	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 14 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: non-concurrent multiple baseline design
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Development and Evaluation of a Brief Shame Intervention Module: Proof of Concept in Social Anxiety Disorder
• Actual Study Start Date: February 15, 2018
• Actual Primary Completion Date: June 30, 2018
• Actual Study Completion Date: June 30, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Change in Test of Self-Conscious Affect-3-Short Form [ Time Frame: 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. ]
   Self-report of how likely an individual is to react to 11 scenarios with shame responses

Secondary Outcome Measures :

1. Change in Liebowitz Social Anxiety-Self-Report [ Time Frame: 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. ]
   Self-report of social anxiety symptoms
2. Change in Brief State Anxiety Measure [ Time Frame: Participants report on symptoms experienced during the speech task. Administered at T1 and T4. T4 occurs within ~6 weeks after T1. ]
   Self-report of levels of anxiety experienced during the speech task
3. Change in Shame Inventory [ Time Frame: 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. ]
   Self-report of shame symptoms
4. Change in State Shame and Guilt Measure [ Time Frame: Participants report on symptoms experienced during the speech task. Administered at T1 and T4. T4 occurs within ~6 weeks after T1. ]
   Self-report of levels of shame experienced during the speech task

Other Outcome Measures:

1. Change in Center for Epidemiologic Studies Depression Measure [ Time Frame: 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. ]
   Self-report measure of depressive symptoms
2. Change in Clinical Perfectionism Measure [ Time Frame: 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. ]
   Self-report measure of perfectionism
3. Change in Eating Disorder Inventory - 3rd Version [ Time Frame: 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. ]
   Self-report measure of eating disorder symptoms
4. Change in Brief Fear of Negative Evaluation Measure-II [ Time Frame: 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. ]
   Self-report measure of fear of negative evaluation
5. Change in Self Beliefs about Social Anxiety [ Time Frame: 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. ]
   Self-report measure of social anxiety disorder relevant maladaptive beliefs

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Ohio

Anxiety Cognition and Emotion Laboratory

Oxford, Ohio, United States, 45212

Sponsors and Collaborators

Miami University

Investigators

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

More Information

• Responsible Party: Elise Clerkin, Associate Professor, Miami University
• ClinicalTrials.gov Identifier: NCT03463356
• Other Study ID Numbers: 01474r
• First Posted: March 13, 2018
• Last Update Posted: February 7, 2019
• Last Verified: February 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Anxiety Disorders; Phobia, Social; Mental Disorders; Phobic Disorders