Anxiety, Social Clinical Trial
Official title:
Speaking Out Against Anxiety: Feasibility and Efficacy of an Online Large-group One-session Treatment for Public Speaking Anxiety and the Role of Expectancy Violation
NCT number | NCT04790864 |
Other study ID # | 684 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 1, 2021 |
Est. completion date | October 4, 2021 |
Verified date | April 2022 |
Source | Ruhr University of Bochum |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 60 |
Est. completion date | October 4, 2021 |
Est. primary completion date | May 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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) Exclusion Criteria: - Not having the appropriate technical equipment for participation in a videoconference |
Country | Name | City | State |
---|---|---|---|
Germany | Ruhr-University of Bochum | Bochum |
Lead Sponsor | Collaborator |
---|---|
Ruhr University of Bochum |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | change on positive mental health scale (german version; Lukat, Margraf, Lutz, van der Feld, & Becker, 2015) | 9 items, 4-point Likert scale (1 - 4), large change in a positive direction means better outcome | 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 | change on generalized self efficacy scale (german version; Schwarzer & Jerusalem, 1999) | 10 items, 4-point Likert scale (1 - 4), large change in a positive direction means better outcome | two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention | |
Other | change on satisfaction with life scale (german version; Glaesmer, Grande, Braehler, & Roth, 2011) | 5 items, 7-point Likert scale (1 - 7), large change in a positive direction means better outcome | two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention | |
Other | change on self-efficacy in presentation and moderation skills scale, presentation subscale (german version; Ringeisen, Rohrmann, Bürgermeister, & Tibubos, 2019) | 8 items, 5-point Likert scale (1 - 5), large change in a positive direction means better outcome | two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention | |
Other | change on Rosenberg self-esteem scale - revised (german version; Collani & Herzberg, 2003) | 10 items, 4-point Likert scale (1 - 4), large change in a positive direction means better outcome | two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention | |
Other | change on depression anxiety stress scale (DASS-21; german version; Nilges & Essau, 2015) | 21 items, 4-point Likert scale (0 - 3), 3 subscales that are analyzed separately (depression, anxiety, stress), large change in a negative direction means better outcome | two days before the intervention, one month after the intervention, six months after the intervention | |
Primary | 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 | 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 | 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 | |
Secondary | change on social cognitions questionnaire (german version; Stangier, Heidenreich, Ehlers, & Clark, 1996) | 22 items, two questions regarding each item; 1st: frequency of thoughts, 5-point Likert scale (1 - 5), large change in a negative direction means better outcome; 2nd: degree of confidence, that the content of the cognition is correct, 0-100, large change in a negative direction means better outcome | 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 | |
Secondary | change on fear of negative evaluation scale short form (german version; Kemper, Lutz, & Neuser, 2011) | 5 items, 4-point Likert scale (1 - 4), large change in a negative direction means better outcome | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05868135 -
Effects and Cost-effectiveness of e-Meistring - a Guided Internet-delivered Psychological Treatment
|
||
Recruiting |
NCT04598230 -
Partners in Caring for Anxious Youth
|
Phase 3 |