Brief Shame Intervention Study
The Development and Evaluation of a Brief Shame Intervention Module: Proof of Concept in Social Anxiety Disorder
1 other identifier
interventional
14
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 15, 2018
CompletedFirst Submitted
Initial submission to the registry
March 1, 2018
CompletedFirst Posted
Study publicly available on registry
March 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2018
CompletedFebruary 7, 2019
February 1, 2019
5 months
March 1, 2018
February 6, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
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.
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.
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.
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.
Other Outcomes (5)
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.
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.
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.
- +2 more other outcomes
Study Arms (1)
Shame Intervention
EXPERIMENTALParticipants will complete a two shame intervention sessions approximately one week apart.
Interventions
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.
Eligibility Criteria
You may qualify if:
- ≥ 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Miami Universitylead
Study Sites (1)
Anxiety Cognition and Emotion Laboratory
Oxford, Ohio, 45212, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marie Parsons, M.A.
Miami University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 1, 2018
First Posted
March 13, 2018
Study Start
February 15, 2018
Primary Completion
June 30, 2018
Study Completion
June 30, 2018
Last Updated
February 7, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share