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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00842946
Other study ID # DRX-17819
Secondary ID
Status Completed
Phase N/A
First received February 11, 2009
Last updated May 1, 2014
Start date February 2009
Est. completion date November 2009

Study information

Verified date May 2014
Source Drexel University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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. 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.


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:

1. 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.

2. 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.

3. 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.

4. Baseline levels of acceptance, defusion, and mindfulness will predict overall treatment response, regardless of intervention condition.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date November 2009
Est. primary completion date November 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Clinically diagnosable public speaking anxiety (per DSM-IV-TR criteria for nongeneralized social anxiety disorder)

- Aged 18-65

- Residence in the greater Philadelphia area

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Exposure w/ Acceptance-Based Rationale
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 Rationale
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.

Locations

Country Name City State
United States Drexel University Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Drexel University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.

Outcome

Type Measure Description Time frame Safety issue
Primary 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).
6-weeks post-treatment No
See also
  Status Clinical Trial Phase
Completed NCT06086756 - Virtual Reality Intervention for Speech Anxiety N/A
Not yet recruiting NCT04391530 - The Effect of Breath Therapy and Emotional Freedom Technique on Public Speaking Anxiety N/A
Completed NCT03885414 - Virtual Reality Exposure Therapy for Public Speaking Anxiety N/A