ClinicalTrials.gg
CompletedNCT03463356Updated Feb 7, 2019

Brief Shame Intervention Study

An interventional study of Shame Intervention in Shame and Social Anxiety Disorder, sponsored by Miami University. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2019-02-07.

Sponsored by Miami University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Not applicable
Ages
18 Years to 100 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 187 studies in Phobia, Social with a site in United States — 23 open to participants now, 29 under way, 1 of them phase 3. Phobia, Social · United States.

Enrollment
164th of 178
14 · median 64
Started
2018
with 7 others
No phase
100 of 187
17 open now
Registered
110th of 187
by date

Among the 187 studies in Phobia, Social with a site in United States, this one is the 164th largest by enrollment of the 178 interventional ones that give a count, is one of 8 that started in 2018, is one of 100 with no phase, and was the 110th registered.

Phobia, Social

368 studies on the registry are indexed under Phobia, Social; 59 are open to participants now.

Browse Phobia, Social studies →

Open to participants now

23 of the 187 studies in Phobia, Social with a site in United States are open now. Recruiting first, the newest first:

18 more — sign in →

All 23 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 46 Phobia, Social studies recruiting now, 10 (22%) set no upper age limit and 34 (74%) stop at 75 or younger; 14 take children under 18; 8 take healthy volunteers.

This study: 18 Years to 100 Years · all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • Shame
  • Social Anxiety Disorder

Browse trials for

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    Shame Intervention

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

    Behavioral: Shame Intervention

Interventions

  • BehavioralShame 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.

06

What researchers measure

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

    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 outcomes

  1. Change in Liebowitz Social Anxiety-Self-Report

    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.

  2. Change in Brief State Anxiety Measure

    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.

  3. Change in Shame Inventory

    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.

  4. Change in State Shame and Guilt Measure

    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 outcomes

  1. Change in Center for Epidemiologic Studies Depression Measure

    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.

  2. Change in Clinical Perfectionism Measure

    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.

  3. Change in Eating Disorder Inventory - 3rd Version

    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.

  4. Change in Brief Fear of Negative Evaluation Measure-II

    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.

  5. Change in Self Beliefs about Social Anxiety

    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.

07

Study locations

1 site
  • Anxiety Cognition and Emotion Laboratory
    Oxford, Ohio 45212, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2018 to primary completion in Jun 2018, 4 months.

Of 142 non-industry interventional studies with no phase under Phobia, Social, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 44. This study's 4 months is below that.

Counting every sponsor, half of 148 studies reached it within 28 months; a quarter within 14 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 1, 2018
First posted
Mar 13, 2018
StartActual
Feb 15, 2018
Primary completionActual
Jun 30, 2018
CompletionActual
Jun 30, 2018
Last update
Feb 7, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 7, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03463356
Lead sponsor
Miami University
Responsible party
Elise Clerkin (Associate Professor, Miami University) — Principal investigator
First posted
Mar 13, 2018
Start date
Feb 15, 2018
Primary completion
Jun 30, 2018
Completion
Jun 30, 2018
Last update
Feb 7, 2019

Study contacts

Marie Parsons, M.A.
principal investigator · Miami University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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