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Brief Shame Intervention Study

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ClinicalTrials.gov Identifier: NCT03463356
Recruitment Status : Recruiting
First Posted : March 13, 2018
Last Update Posted : March 15, 2018
Sponsor:
Information provided by (Responsible Party):
Elise Clerkin, Miami University

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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.




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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03463356


Contacts
Contact: Marie Parsons, M.A. 2056177841 parsone4@miamioh.edu
Contact: Elise Clerkin, Ph.D. 513-529-2483 clerkiem@miamioh.edu

Locations
United States, Ohio
Anxiety Cognition and Emotion Laboratory Recruiting
Oxford, Ohio, United States, 45212
Contact: Marie Parsons, M.A.    205-617-7841    parsone4@miamioh.edu   
Contact: Elise Clerkin, Ph.D.    513-529-2483    clerkiem@miamioh.edu   
Sponsors and Collaborators
Miami University
Investigators
Principal Investigator: Marie Parsons, M.A. Miami University

Responsible Party: Elise Clerkin, Associate Professor, Miami University
ClinicalTrials.gov Identifier: NCT03463356     History of Changes
Other Study ID Numbers: 01474r
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018
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