- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00842946
Exposure With Acceptance-Based Versus Habituation-Based Rationale for Public Speaking Anxiety
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19102
- Drexel University
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Exposure w/ Acceptance-Based Rationale
Behavioral exposure within the context of psychological acceptance.
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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.
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Aktiv komparator: Exposure w/ Habituation-Based Rationale
Behavioral exposure within the context of habituation.
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Number of Participants in Remission (Per Structured Clinical Interview for DSM-IV Axis I Disorders (SCID))
Tidsramme: 6-weeks post-treatment
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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
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: James D Herbert, Ph.D., Drexel University
- Studieleder: Evan M Forman, Ph.D., Drexel University
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- DRX-17819
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