NCT04790864

Brief Summary

Different conceptualizations of public speaking anxiety exist to which it can be either considered as a qualitatively distinct subtype of social phobia or a quantitatively less severe form of a more impairing generalized social phobia. However, the prevalence of public speaking fears can be regarded as high and there is considerable evidence for interference with work or education. In addition, public speaking anxiety can cause marked distress suggesting that the impairment, at least in some individuals, is high enough to warrant professional treatment. Cognitive behavioral therapy (CBT) has turned out as an effective treatment for social phobia in general but also for public speaking anxiety. Nevertheless, some aspects hinder the successful delivery of CBT to anxious individuals. On the one hand, individuals are sometimes uncertain if the severity of their symptoms and impairment justifies professional treatment. On the other hand, groups are required for conducting exposure interventions. This study tries to circumvent these limitations by lowering the access to treatment and by providing treatment in a group of anxious individuals. Large-group one-session treatments have been shown to be feasible in the treatment of specific phobias and fears and investigations revealed first evidence regarding their efficacy. The COVID-19 pandemic makes it impossible to conduct face-to-face group sessions, so an online setting making use of a videoconference tool has been chosen. In this study, the investigators plan to conduct an online large-group one-session treatment to reduce public speaking anxiety comprising different cognitive and behavioral techniques. First, anxiety and its function in general as well as factors causing, defining and maintaining public speaking anxiety are addressed in a psychoeducation phase. Second, different speaking tasks are conducted to expose the individuals to their feared situation on the one hand and to address common cognitive processes characterizing public speaking anxiety, e.g. self-focused attention, on the other hand. The exercises will be conducted in smaller groups. Participants will be recruited from a community sample. They are invited to self-screen their public speaking anxiety to see if the intervention is suitable for them. The only exclusion criterion is not having the appropriate technical equipment for participation in a videoconference. Public speaking anxiety as well as cognitive facets of social phobia will be assessed two months before treatment, two days before and one day after treatment and at one month and six months follow up to investigate long-term effects of the intervention. Besides the aim of supporting a general feasibility and efficacy of the intervention, the study focusses on the role of expectancy violation. Recent theoretical frameworks suggest that expectancy violation is the core mechanism behind successful exposure therapy. Nevertheless, only a few studies to date manipulated expectancy violation experimentally to confirm its importance. Thus, participants in this study will be randomly allocated to two different treatment conditions. After completion of the treatment, one half of the participants will elaborate a worksheet that addresses basic contentual information concerning the treatment without a specific attempt to highlight the discrepancy between anticipated and actual outcomes. For example, participants will be asked how they would explain public speaking anxiety and exposure therapy to a friend and what advantages they see in conducting treatments like this in groups (BASIC task). The other group will receive a worksheet with questions aimed at enhancing the processing of what was learned during treatment in terms of expectancy violation. For example, they are asked if what they were most worried about occured and what actually happened compared to what they predicted to happen (EV task).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

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

January 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2021

Completed
Last Updated

April 27, 2022

Status Verified

April 1, 2022

Enrollment Period

4 months

First QC Date

March 5, 2021

Last Update Submit

April 26, 2022

Conditions

Keywords

large-group treatmentone-session treatmentonline interventionpublic speaking anxietyexpectancy violation

Outcome Measures

Primary Outcomes (1)

  • change on self statements during public speaking scale (german version; Hofmann & Heinrichs, 2001)

    10 items, 6-point Likert scale (0 - 5), large change in a negative direction means better outcome

    two days before the intervention and one month after the intervention [compared to the change between the assessment time points after registration and two days before treatment]

Secondary Outcomes (3)

  • change on self statements during public speaking scale (german version; Hofmann & Heinrichs, 2001)

    after registration for the study, two days before the intervention, one day after the intervention, one month after the intervention (already specified as primary outcome measure), six months after the intervention

  • change on social cognitions questionnaire (german version; Stangier, Heidenreich, Ehlers, & Clark, 1996)

    after registration for the study, two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention

  • change on fear of negative evaluation scale short form (german version; Kemper, Lutz, & Neuser, 2011)

    after registration for the study, two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention

Other Outcomes (6)

  • change on positive mental health scale (german version; Lukat, Margraf, Lutz, van der Feld, & Becker, 2015)

    after registration for the study, two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention

  • change on generalized self efficacy scale (german version; Schwarzer & Jerusalem, 1999)

    two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention

  • change on satisfaction with life scale (german version; Glaesmer, Grande, Braehler, & Roth, 2011)

    two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention

  • +3 more other outcomes

Study Arms (2)

Online large-group one-session treatment with post-treatment exercise targeting expectancy violation

EXPERIMENTAL
Behavioral: Online large-group one-session treatment with post-treatment exercise targeting expectancy violation

Online large-group one-session treatment with post-treatment control exercise

ACTIVE COMPARATOR
Behavioral: Online large-group one-session treatment with post-treatment control exercise

Interventions

The treatment is aimed at reducing public speaking anxiety by using cognitive and behavioral techniques. Following a psychoeducation phase, different speaking tasks are conducted to expose the individuals to their feared situation on the one hand and to address common cognitive processes characterizing public speaking anxiety, e.g. self-focused attention, on the other hand. The exercises will be conducted in smaller groups. After treatment, participants receive a worksheet with questions aimed at enhancing the processing of what was learned during treatment in terms of expectancy violation. For example, they are asked if what they were most worried about occured and what actually happened compared to what they predicted to happen. This should highlight the discrepancy between anticipated and actual outcomes. The intervention is conducted in an online group format via videoconference with a duration of approximately 5 hours.

Online large-group one-session treatment with post-treatment exercise targeting expectancy violation

The treatment is aimed at reducing public speaking anxiety by using cognitive and behavioral techniques. Following a psychoeducation phase, different speaking tasks are conducted to expose the individuals to their feared situation on the one hand and to address common cognitive processes characterizing public speaking anxiety, e.g. self-focused attention, on the other hand. The exercises will be conducted in smaller groups. After treatment, participants receive a worksheet that addresses basic contentual information concerning the treatment without a specific attempt to highlight the discrepancy between anticipated and actual outcomes. For example, participants will be asked how they would explain public speaking anxiety and exposure therapy to a friend and what advantages they see in conducting treatments like this in groups. The intervention is conducted in an online group format via videoconference with a duration of approximately 5 hours.

Online large-group one-session treatment with post-treatment control exercise

Eligibility Criteria

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

You may qualify if:

  • Aged 18 years or above
  • participants self-screen their public speaking anxiety and generalized social anxiety; participation is recommended if public speaking anxiety is moderate to high and if generalized social anxiety is low (this criterion is not explicitly checked by the investigator as there is only a recommendation and participants can register even though they do not receive a recommendation for participation)

You may not qualify if:

  • Not having the appropriate technical equipment for participation in a videoconference

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruhr-University of Bochum

Bochum, 44801, Germany

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Svenja Schaumburg, M. Sc.

    Ruhr University of Bochum

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants are not aware that there are two different post-treatment exercises and are not informed that the aim of the EV condition is to promote expectancy violation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator (Research Fellow / PhD Student)

Study Record Dates

First Submitted

March 5, 2021

First Posted

March 10, 2021

Study Start

January 1, 2021

Primary Completion

May 1, 2021

Study Completion

October 4, 2021

Last Updated

April 27, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

It is planned to make individual participant data available on publication of the associated study results, via a publically-available data repository such as Open Science Framework. Data made available will be the research data reported in the publication, with the exception of any data that could compromise participant anonymity.

Locations