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NCT Number: NCT03463356

Brief Shame Intervention Study

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.

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Key information

Conditions

Shame Anxiety Disorders Mental Disorders Phobia, Social Phobic Disorders Social Anxiety Disorder

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anxiety Cognition and Emotion Laboratory

Oxford, Ohio, 45212, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Shame Intervention

Behavioral

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.

Primary outcomes

  1. Change in Test of Self-Conscious Affect-3-Short Form

    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.

    Self-report of how likely an individual is to react to 11 scenarios with shame responses

Secondary outcomes

  1. Change in Liebowitz Social Anxiety-Self-Report

    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.

    Self-report of social anxiety symptoms

  2. Change in Brief State Anxiety Measure

    Time frame: Participants report on symptoms experienced during the speech task. Administered at T1 and T4. T4 occurs within ~6 weeks after T1.

    Self-report of levels of anxiety experienced during the speech task

  3. Change in Shame Inventory

    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.

    Self-report of shame symptoms

  4. Change in State Shame and Guilt Measure

    Time frame: Participants report on symptoms experienced during the speech task. Administered at T1 and T4. T4 occurs within ~6 weeks after T1.

    Self-report of levels of shame experienced during the speech task

Other outcomes

  1. Change in Center for Epidemiologic Studies Depression Measure

    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.

    Self-report measure of depressive symptoms

  2. Change in Clinical Perfectionism Measure

    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.

    Self-report measure of perfectionism

  3. Change in Eating Disorder Inventory - 3rd Version

    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.

    Self-report measure of eating disorder symptoms

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

    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.

    Self-report measure of fear of negative evaluation

  5. Change in Self Beliefs about Social Anxiety

    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.

    Self-report measure of social anxiety disorder relevant maladaptive beliefs

Sponsors and collaborators

Lead sponsor

Miami University

Other

Registry information

Official study title

The Development and Evaluation of a Brief Shame Intervention Module: Proof of Concept in Social Anxiety Disorder

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 13, 2018
Registry last updated
Feb 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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