Clinical trial NCT03463356: 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
Overall status: COMPLETED
Phase: NA
Conditions: Shame
Social Anxiety Disorder
Lead sponsor: Miami University
Sponsor class: OTHER
First posted: 2018-03-13
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: non-concurrent multiple baseline design
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Test of Self-Conscious Affect-3-Short Form
timeFrame: 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:
measure: Change in Liebowitz Social Anxiety-Self-Report
timeFrame: 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.
measure: Change in Brief State Anxiety Measure
timeFrame: Participants report on symptoms experienced during the speech task. Administered at T1 and T4. T4 occurs within ~6 weeks after T1.
measure: Change in Shame Inventory
timeFrame: 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.
measure: Change in State Shame and Guilt Measure
timeFrame: Participants report on symptoms experienced during the speech task. Administered at T1 and T4. T4 occurs within ~6 weeks after T1.
Other outcomes:
measure: Change in Center for Epidemiologic Studies Depression Measure
timeFrame: 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.
measure: Change in Clinical Perfectionism Measure
timeFrame: 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.
measure: Change in Eating Disorder Inventory - 3rd Version
timeFrame: 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.
measure: Change in Brief Fear of Negative Evaluation Measure-II
timeFrame: 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.
measure: Change in Self Beliefs about Social Anxiety
timeFrame: 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.
Locations:
city: Oxford
country: United States
facility: Anxiety Cognition and Emotion Laboratory
state: Ohio
Study officials:
affiliation: Miami University
name: Marie Parsons, M.A.
role: PRINCIPAL_INVESTIGATOR
References: