Public SpeakingNCT00842946
Exposure With Acceptance-Based Versus Habituation-Based Rationale for Public Speaking Anxiety
A study testing Exposure w/ Acceptance-Based Rationale and Exposure w/ Habituation-Based Rationale in people with Public Speaking and Social Fear, run by Drexel University at 1 site in United States.
Trial summary
The purpose of this study is to compare two exposure-based behavioral group treatments for public speaking anxiety. Specifically, exposure within the context of psychological acceptance will be compared to exposure within a standard habituation context. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Public Speaking, Social Fear
- What is being tested?
- Exposure w/ Acceptance-Based Rationale and Exposure w/ Habituation-Based Rationale
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Nov 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinically diagnosable public speaking anxiety (per DSM-IV-TR criteria for nongeneralized social anxiety disorder)
- Aged 18-65
- Residence in the greater Philadelphia area
Who cannot join
- Pervasive developmental disability
- Acute suicide potential
- Inability to travel to the treatment site
- Certain comorbid Axis I diagnoses, namely:
- generalized SAD
- schizophrenia or other psychotic disorder
- current substance dependence
- Comorbid diagnoses of Major Depressive or other mood or anxiety disorders are acceptable ONLY if clearly secondary to the diagnosis of public speaking anxiety
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare two exposure-based behavioral group treatments for public speaking anxiety. Specifically, exposure within the context of psychological acceptance will be compared to exposure within a standard habituation context. It is hypothesized that participants receiving exposure within the context of psychological acceptance will experience a greater decrease in anxiety and greater improvement in quality of life compared to the habituation-based group.
Read the detailed description
Social Anxiety Disorder (SAD) is a potentially debilitating condition affecting approximately 12% of the population at some point in their life (Ruscio et al., 2008). Nongeneralized SAD refers to individuals whose fears are limited to one or two social situations, most commonly public speaking. Empirically supported treatments for public speaking anxiety generally include an exposure component involving participation in anxiety-provoking public speaking situations (usually simulated situations using an audience of confederates and/or fellow participants, as well as actual public speaking situations in the community). Exposure is often presented within the context of habituation, but cognitively- based therapies utilize a rationale for exposure based on cognitive restructuring and belief modification. Research investigating the incremental benefit of adding other treatment components to exposure has yielded mixed results; however, there is preliminary evidence that the context in which exposure is presented can have an impact on treatment outcome. Recently, acceptance-based therapies have begun to frame exposure as an opportunity to increase one's willingness to experience anxiety while engaging in valued behaviors, rather than as a vehicle for modifying maladaptive cognitions and reducing anxiety. However, little research has been conducted on the efficacy of acceptance-based therapies for public speaking anxiety, and no component control studies have examined the utility of an acceptance/cognitive defusion rationale and context for exposure for public speaking anxiety. The present study will compare two exposure-based treatments for public speaking anxiety in a clinical sample. Specifically, exposure within an acceptance/defusion context will be compared to exposure with a habituation-based rationale.
Hypotheses:
- Participants receiving exposure within an acceptance/defusion context will experience a greater reduction in anxiety and behavioral avoidance, and greater improvement in measures of quality of life, compared to participants receiving exposure within a habituation rationale, at post-treatment.
- Acceptance, defusion, and mindfulness will mediate treatment outcome. Specifically, greater changes on measures of these three constructs will account for a significant portion of the effect of treatment condition on the dependent variables.
- Lower baseline levels of public speaking anxiety and overall anxiety will be associated with higher baseline quality of life, mindfulness, acceptance, defusion, and social skills.
- Baseline levels of acceptance, defusion, and mindfulness will predict overall treatment response, regardless of intervention condition.
- Conditions
- Public Speaking, Social Fear
- Being tested
- Exposure w/ Acceptance-Based Rationale, Exposure w/ Habituation-Based Rationale
- Medical subject headings
- Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure w/ Acceptance-Based RationaleBehavioural
Treatment focuses on the ineffectiveness of participants' past attempts to control or reduce their anxiety in public speaking situations. Acceptance of one's private experiences (thoughts, feelings, sensations) will be introduced. "Willingness" to experience unwanted thoughts and feelings while simultaneously engaging in valued activities, especially those related to public speaking, is stressed. Techniques designed to foster psychological acceptance are practiced prior to and during exposure exercises, as well as assigned for homework between sessions.
Exposure w/ Habituation-Based RationaleBehavioural
Exposure to feared public speaking situations are accompanied by explanations of behavioral principles, including classical/operant conditioning and habituation. The process of associating public speaking situations with unwanted feelings of anxiety will be discussed, as well as negative reinforcement of escape and avoidance behaviors. The underlying principle of habituation is reviewed. When engaging in exposure exercises (both in session and assigned homework exercises), participants will be encouraged to remain in the feared speaking situation until their subjective ratings of anxiety decrease.
| Study group | Role | What they receive |
|---|---|---|
| Exposure w/ Acceptance-Based Rationale | Experimental | Behavioral exposure within the context of psychological acceptance. Receives: Behavioral: Exposure w/ Acceptance-Based Rationale |
| Exposure w/ Habituation-Based Rationale | Active comparator | Behavioral exposure within the context of habituation. Receives: Behavioral: Exposure w/ Habituation-Based Rationale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants in Remission (Per Structured Clinical Interview for DSM-IV Axis I Disorders (SCID))
The SCID (First, Spitzer, Gibbon, \& Williams, 1996) is an extensively utilized structured diagnostic interview based on DSM-IV criteria. Estimates of interrater reliability range from moderate to high for most Axis I disorders (e.g., Williams et al., 1992; Zanarini
\& Frankenburg, 2001).
Measured: 6-weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Public SpeakingStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Herbert, Drexel University
- Investigators
- James D Herbert, Ph.D., Study director, Drexel UniversityEvan M Forman, Ph.D., Study director, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00842946
- Sponsor's protocol ID
- DRX-17819
- Status last verified
- May 2014
- First submitted
- 11 Feb 2009
- Last updated
- 2 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
England, E.L., Herbert, J.D., Forman, E.M., Rabin, S.J., Juarascio, A., & Goldstein, S. (2012). Acceptance-based exposure therapy for public speaking anxiety. Journal of Contextual Behavioral Science, 1(1), 66-72.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exposure With Acceptance-Based Versus Habituation-Based Rationale for Public Speaking Anxiety
- ClinicalTrials.gov ID
- NCT00842946
- Acronym / sponsor ID
- DRX-17819
- Conditions
- Public Speaking, Social Fear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 12 Feb 2009 (estimated)
- Results
- Posted 2 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare two exposure-based behavioral group treatments for public speaking anxiety. Specifically, exposure within the context of psychological acceptance will be compared to exposure within a standard habituation context. It is hypothesized that participants receiving exposure within the context of psychological acceptance will experience a greater decrease in anxiety and greater improvement in quality of life compared to the habituation-based group.
Detailed description
Social Anxiety Disorder (SAD) is a potentially debilitating condition affecting approximately 12% of the population at some point in their life (Ruscio et al., 2008). Nongeneralized SAD refers to individuals whose fears are limited to one or two social situations, most commonly public speaking. Empirically supported treatments for public speaking anxiety generally include an exposure component involving participation in anxiety-provoking public speaking situations (usually simulated situations using an audience of confederates and/or fellow participants, as well as actual public speaking situations in the community). Exposure is often presented within the context of habituation, but cognitively- based therapies utilize a rationale for exposure based on cognitive restructuring and belief modification. Research investigating the incremental benefit of adding other treatment components to exposure has yielded mixed results; however, there is preliminary evidence that the context in which exposure is presented can have an impact on treatment outcome. Recently, acceptance-based therapies have begun to frame exposure as an opportunity to increase one's willingness to experience anxiety while engaging in valued behaviors, rather than as a vehicle for modifying maladaptive cognitions and reducing anxiety. However, little research has been conducted on the efficacy of acceptance-based therapies for public speaking anxiety, and no component control studies have examined the utility of an acceptance/cognitive defusion rationale and context for exposure for public speaking anxiety. The present study will compare two exposure-based treatments for public speaking anxiety in a clinical sample. Specifically, exposure within an acceptance/defusion context will be compared to exposure with a habituation-based rationale.
Hypotheses:
- Participants receiving exposure within an acceptance/defusion context will experience a greater reduction in anxiety and behavioral avoidance, and greater improvement in measures of quality of life, compared to participants receiving exposure within a habituation rationale, at post-treatment.
- Acceptance, defusion, and mindfulness will mediate treatment outcome. Specifically, greater changes on measures of these three constructs will account for a significant portion of the effect of treatment condition on the dependent variables.
- Lower baseline levels of public speaking anxiety and overall anxiety will be associated with higher baseline quality of life, mindfulness, acceptance, defusion, and social skills.
- Baseline levels of acceptance, defusion, and mindfulness will predict overall treatment response, regardless of intervention condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposure w/ Acceptance-Based Rationale | Experimental | Behavioral: Exposure w/ Acceptance-Based RationaleBehavioral exposure within the context of psychological acceptance. |
| Exposure w/ Habituation-Based Rationale | Active comparator | Behavioral: Exposure w/ Habituation-Based RationaleBehavioral exposure within the context of habituation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinically diagnosable public speaking anxiety (per DSM-IV-TR criteria for nongeneralized social anxiety disorder)
- Aged 18-65
- Residence in the greater Philadelphia area
Key exclusion criteria (8 listed)
- Pervasive developmental disability
- Acute suicide potential
- Inability to travel to the treatment site
- Certain comorbid Axis I diagnoses, namely:
- Comorbid diagnoses of Major Depressive or other mood or anxiety disorders are acceptable ONLY if clearly secondary to the diagnosis of public speaking anxiety
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 |
|---|---|---|
| Exposure w/ Acceptance-Based RationaleTreatment focuses on the ineffectiveness of participants' past attempts to control or reduce their anxiety in public speaking situations. Acceptance of one's private experiences (thoughts, feelings, sensations) will be introduced. "Willingness" to experience unwanted thoughts and feelings while simultaneously engaging in valued activities, especially those related to public speaking, is stressed. Techniques designed to foster psychological acceptance are practiced prior to and during exposure exercises, as well as assigned for homework between sessions. | Behavioural | Exposure w/ Acceptance-Based Rationale |
| Exposure w/ Habituation-Based RationaleExposure to feared public speaking situations are accompanied by explanations of behavioral principles, including classical/operant conditioning and habituation. The process of associating public speaking situations with unwanted feelings of anxiety will be discussed, as well as negative reinforcement of escape and avoidance behaviors. The underlying principle of habituation is reviewed. When engaging in exposure exercises (both in session and assigned homework exercises), participants will be encouraged to remain in the feared speaking situation until their subjective ratings of anxiety decrease. | Behavioural | Exposure w/ Habituation-Based Rationale |
Primary outcome
Number of Participants in Remission (Per Structured Clinical Interview for DSM-IV Axis I Disorders (SCID))
Time frame: 6-weeks post-treatment
The SCID (First, Spitzer, Gibbon, \& Williams, 1996) is an extensively utilized structured diagnostic interview based on DSM-IV criteria. Estimates of interrater reliability range from moderate to high for most Axis I disorders (e.g., Williams et al., 1992; Zanarini \& Frankenburg, 2001).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationEngland, E.L., Herbert, J.D., Forman, E.M., Rabin, S.J., Juarascio, A., & Goldstein, S. (2012). Acceptance-based exposure therapy for public speaking anxiety. Journal of Contextual Behavioral Science, 1(1), 66-72.
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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.
James D Herbert, Ph.D. study director
Drexel University
Evan M Forman, Ph.D. study director
Drexel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure w/ Acceptance-Based Rationale and Exposure w/ Habituation-Based Rationale in people with Public Speaking and Social Fear, run by Drexel 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 3 inclusion and 8 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 2 Jun 2014. 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?
Yes. Results are posted in the registry (first posted 2 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants in Remission (Per Structured Clinical Interview for DSM-IV Axis I Disorders (SCID)) (time frame: 6-weeks post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00842946, which also lists 1 linked publication.
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 2 Jun 2014.