Back to resultsBrief Shame Intervention Study
Primary Purpose
Shame, Social Anxiety Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Shame Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Shame
Eligibility 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
Sites / Locations
- Anxiety Cognition and Emotion Laboratory
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Shame Intervention
Arm Description
Participants will complete a two shame intervention sessions approximately one week apart.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Change in Liebowitz Social Anxiety-Self-Report
Self-report of social anxiety symptoms
Change in Brief State Anxiety Measure
Self-report of levels of anxiety experienced during the speech task
Change in Shame Inventory
Self-report of shame symptoms
Change in State Shame and Guilt Measure
Self-report of levels of shame experienced during the speech task
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03463356
Brief Title
Brief Shame Intervention Study
Official Title
The Development and Evaluation of a Brief Shame Intervention Module: Proof of Concept in Social Anxiety Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
February 15, 2018 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Miami University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shame, Social Anxiety Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
non-concurrent multiple baseline design
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Shame Intervention
Arm Type
Experimental
Arm Description
Participants will complete a two shame intervention sessions approximately one week apart.
Intervention Type
Behavioral
Intervention Name(s)
Shame Intervention
Intervention Description
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 Measure Information:
Title
Change in Test of Self-Conscious Affect-3-Short Form
Description
Self-report of how likely an individual is to react to 11 scenarios with shame responses
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.
Secondary Outcome Measure Information:
Title
Change in Liebowitz Social Anxiety-Self-Report
Description
Self-report of social anxiety symptoms
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.
Title
Change in Brief State Anxiety Measure
Description
Self-report of levels of anxiety experienced during the speech task
Time Frame
Participants report on symptoms experienced during the speech task. Administered at T1 and T4. T4 occurs within ~6 weeks after T1.
Title
Change in Shame Inventory
Description
Self-report of shame symptoms
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.
Title
Change in State Shame and Guilt Measure
Description
Self-report of levels of shame experienced during the speech task
Time Frame
Participants report on symptoms experienced during the speech task. Administered at T1 and T4. T4 occurs within ~6 weeks after T1.
Other Pre-specified Outcome Measures:
Title
Change in Center for Epidemiologic Studies Depression Measure
Description
Self-report measure of depressive symptoms
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.
Title
Change in Clinical Perfectionism Measure
Description
Self-report measure of perfectionism
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.
Title
Change in Eating Disorder Inventory - 3rd Version
Description
Self-report measure of eating disorder symptoms
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.
Title
Change in Brief Fear of Negative Evaluation Measure-II
Description
Self-report measure of fear of negative evaluation
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.
Title
Change in Self Beliefs about Social Anxiety
Description
Self-report measure of social anxiety disorder relevant maladaptive beliefs
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Parsons, M.A.
Organizational Affiliation
Miami University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anxiety Cognition and Emotion Laboratory
City
Oxford
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Brief Shame Intervention Study
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