NCT00842946

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 12, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

June 2, 2014

Completed
Last Updated

June 2, 2014

Status Verified

May 1, 2014

Enrollment Period

9 months

First QC Date

February 11, 2009

Results QC Date

May 1, 2014

Last Update Submit

May 1, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Exposure w/ Acceptance-Based Rationale

EXPERIMENTAL

Behavioral exposure within the context of psychological acceptance.

Behavioral: Exposure w/ Acceptance-Based Rationale

Exposure w/ Habituation-Based Rationale

ACTIVE COMPARATOR

Behavioral exposure within the context of habituation.

Behavioral: Exposure w/ Habituation-Based Rationale

Interventions

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/ Acceptance-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.

Exposure w/ Habituation-Based Rationale

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinically diagnosable public speaking anxiety (per DSM-IV-TR criteria for nongeneralized social anxiety disorder)
  • Aged 18-65
  • Residence in the greater Philadelphia area

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Drexel University

Philadelphia, Pennsylvania, 19102, United States

Location

Related 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.

    RESULT

MeSH Terms

Conditions

Speech

Condition Hierarchy (Ancestors)

Verbal BehaviorCommunicationBehavior

Results Point of Contact

Title
Dr. Erica England
Organization
Department of Veterans Affairs (formerly Drexel University)

Study Officials

  • James D Herbert, Ph.D.

    Drexel University

    STUDY DIRECTOR
  • Evan M Forman, Ph.D.

    Drexel University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychology

Study Record Dates

First Submitted

February 11, 2009

First Posted

February 12, 2009

Study Start

February 1, 2009

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

June 2, 2014

Results First Posted

June 2, 2014

Record last verified: 2014-05

Locations