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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03463356
Other study ID # 01474r
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 15, 2018
Est. completion date June 30, 2018

Study information

Verified date February 2019
Source Miami University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date June 30, 2018
Est. primary completion date June 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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

Study Design


Intervention

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.

Locations

Country Name City State
United States Anxiety Cognition and Emotion Laboratory Oxford Ohio

Sponsors (1)

Lead Sponsor Collaborator
Miami University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in Center for Epidemiologic Studies Depression Measure Self-report measure of depressive symptoms 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.
Other Change in Clinical Perfectionism Measure Self-report measure of perfectionism 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.
Other Change in Eating Disorder Inventory - 3rd Version Self-report measure of eating disorder symptoms 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.
Other Change in Brief Fear of Negative Evaluation Measure-II Self-report measure of fear of negative evaluation 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.
Other Change in Self Beliefs about Social Anxiety Self-report measure of social anxiety disorder relevant maladaptive beliefs 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.
Primary 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 Change in Liebowitz Social Anxiety-Self-Report Self-report of social anxiety symptoms 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.
Secondary Change in Brief State Anxiety Measure Self-report of levels of anxiety experienced during the speech task Participants report on symptoms experienced during the speech task. Administered at T1 and T4. T4 occurs within ~6 weeks after T1.
Secondary Change in Shame Inventory Self-report of shame symptoms 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.
Secondary Change in State Shame and Guilt Measure Self-report of levels of shame experienced during the speech task Participants report on symptoms experienced during the speech task. Administered at T1 and T4. T4 occurs within ~6 weeks after T1.
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