Brief Shame Intervention Study

Sponsor
Miami University (Other)
Overall Status
Completed
CT.gov ID
NCT03463356
Collaborator
(none)
14
1
1
4.4
3.2

Study Details

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
  • Behavioral: Shame Intervention
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
non-concurrent multiple baseline designnon-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 :
Feb 15, 2018
Actual Primary Completion Date :
Jun 30, 2018
Actual Study Completion Date :
Jun 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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Site City State Country Postal Code
1 Anxiety Cognition and Emotion Laboratory Oxford Ohio United States 45212

Sponsors and Collaborators

  • Miami University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Elise Clerkin, Associate Professor, Miami University
ClinicalTrials.gov Identifier:
NCT03463356
Other Study ID Numbers:
  • 01474r
First Posted:
Mar 13, 2018
Last Update Posted:
Feb 7, 2019
Last Verified:
Feb 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
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:

Study Results

No Results Posted as of Feb 7, 2019