ShameNCT03463356
Brief Shame Intervention Study
A study of Shame and Social Anxiety Disorder, run by Miami University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Shame, Social Anxiety Disorder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2018to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -≥ 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Anxiety Cognition and Emotion Laboratory
Oxford, Ohio, 45212
About this study
Official title: The Development and Evaluation of a Brief Shame Intervention Module: Proof of Concept in Social Anxiety Disorder
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.
- Conditions
- Shame, Social Anxiety Disorder
- Being tested
- Shame Intervention
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shame InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Shame Intervention | Experimental | Participants will complete a two shame intervention sessions approximately one week apart. Receives: Behavioral: Shame Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Self-report of social anxiety symptoms
Measured: 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
Self-report of levels of anxiety experienced during the speech task
Measured: 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
Self-report of shame symptoms
Measured: 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
Self-report of levels of shame experienced during the speech task
Measured: Participants report on symptoms experienced during the speech task. Administered at T1 and T4. T4 occurs within ~6 weeks after T1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start15 Feb 2018
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShameStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- non-concurrent multiple baseline design
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Miami University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elise Clerkin, Miami University
- Investigators
- Marie Parsons, M.A., Principal investigator, Miami University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03463356
- Sponsor's protocol ID
- 01474r
- Status last verified
- Feb 2019
- First submitted
- 1 Mar 2018
- Last updated
- 7 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development and Evaluation of a Brief Shame Intervention Module: Proof of Concept in Social Anxiety Disorder
- ClinicalTrials.gov ID
- NCT03463356
- Acronym / sponsor ID
- 01474r
- Conditions
- Shame, Social Anxiety Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Miami UniversityUniversity, hospital or other
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 13 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- non-concurrent multiple baseline design
| Arm | Type | Receives |
|---|---|---|
| Shame Intervention | Experimental | Behavioral: Shame InterventionParticipants will complete a two shame intervention sessions approximately one week apart. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- -≥ 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shame InterventionIn 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. | Behavioural | Shame Intervention |
Primary outcome
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
4 secondary outcomes
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2019.
- Individual participant dataSharing planned: No
Related trials for Shame
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Shame, Resilience and Well-being After Intimate Partner Violence: an Intervention Study With Replicated Single-Subject Design.
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Resilience and Recovery After Intimate Partner Violence - Evaluation of the EMBER-IPV Protocol
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Shame
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie Parsons, M.A. principal investigator
Miami University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Shame and Social Anxiety Disorder, run by Miami University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2019.