NCT03463356

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

March 1, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 13, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

February 7, 2019

Status Verified

February 1, 2019

Enrollment Period

5 months

First QC Date

March 1, 2018

Last Update Submit

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

EXPERIMENTAL

Participants will complete a two shame intervention sessions approximately one week apart.

Behavioral: Shame Intervention

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.

Shame Intervention

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Anxiety Cognition and Emotion Laboratory

Oxford, Ohio, 45212, United States

Location

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • Marie Parsons, M.A.

    Miami University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: non-concurrent multiple baseline design
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

Locations