Anxiety, SocialNCT04790864
An Online Large-group One-session Treatment for Public Speaking Anxiety
A study testing Online large-group one-session treatment with post-treatment exercise targeting expectancy violation in people with Anxiety, Social, run by Ruhr University of Bochum at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Social
- What is being tested?
- Online large-group one-session treatment with post-treatment exercise targeting expectancy violation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2021to 4 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Not having the appropriate technical equipment for participation in a videoconference
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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).
Read the detailed description
Comprising both groups, the investigators expect a reduction in public speaking anxiety. This effect should be present comparing pre-treatment anxiety to the anxiety reported at the assessment points directly after treatment, one month after treatment and six months after treatment. The change in reported anxiety between the two assessment time points before treatment is used as a control condition as there is no waitlist control group that is assessed but not treated. The reduction in public speaking anxiety is expected to be larger when comparing the assessments before and after treatment than in the control period before treatment. Furthermore, the investigators hypothesize participants to benefit from the intervention in terms of other constructs, namely socially phobic cognitions and fear of negative evaluation.
Besides the hypotheses regarding general efficacy of the intervention, the investigators expect the reduction in public speaking anxiety in the EV group to be larger than in the BASIC group. This superiority of the EV condition should be present at the assessment points directly after treatment, one month after treatment and six months after treatment.
The sample under investigation will be a sample of anxious individuals recruited from the community. All participants can attain the intervention for free and there is no payment for participation. On a website created for the project, interested parties can receive information on the project and can self-screen their public speaking anxiety and generalized social anxiety. Participation is recommended if public speaking anxiety is high and if general social phobia is low. After registration for the study, participants are asked to fill out a survey through a link sent to them via e-mail. This survey comprises all outcome measures. The same procedure is carried out two days before, one day after, one month after and six months after treatment.
The target sample size is 100 participants. The decision for that number is not based on power calculations as there was no study before that conducted an online large-group one-session intervention for the treatment of public speaking anxiety and therefore effect size estimates would be random. Instead, the target sample size can be ascribed to organizational purposes.
In terms of the general efficacy hypothesis, the primary outcome measure will be analyzed with a repeated measures ANOVA covering the assessment time points after registration, two days before and one month after treatment.
For all other outcome measures, the investigators will use a rmANOVA comprising all five assessment time points, i.e. after registration, two days before the intervention, one day after the intervention, one month after the intervention and six months after the intervention. Furthermore, there will be paired comparisons between the public speaking anxiety scores at each of the assessment time points.
These analyses will be conducted not only for public speaking anxiety but also for social phobic cognitions, fear of negative evaluation and other psychological constructs such as positive mental health.
Regarding the expectancy violation hypothesis, the primary outcome measure will be analyzed with a 2x3 repeated measures ANOVA. For all other outcome measures, the investigators will use 2x5 between-within repeated measures ANOVAs (rmANOVA) to analyze the results. The first factor is a between-subjects factor that comprises the two groups BASIC and EV. The second factor is a within-subjects factor reflecting the five assessment time points after registration for the study, two days before the intervention, one day after the intervention, one month after the intervention and six months after the intervention. This analysis will be conducted for public speaking anxiety, social phobic cognitions and fear of negative evaluation. Moreover, there will be paired comparisons between the two groups for each of the assessment time points.
- Conditions
- Anxiety, Social
- Being tested
- Online large-group one-session treatment with post-treatment exercise targeting expectancy violation, Online large-group one-session treatment with post-treatment control exercise
- Keywords
- large-group treatment, one-session treatment, online intervention, public speaking anxiety, expectancy violation
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online large-group one-session treatment with post-treatment exercise targeting expectancy violationBehavioural
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 control exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Online large-group one-session treatment with post-treatment exercise targeting expectancy violation | Experimental | Not described Receives: 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 | Not described Receives: Behavioral: Online large-group one-session treatment with post-treatment control exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
10 items, 6-point Likert scale (0 - 5), large change in a negative direction means better outcome
Measured: 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)
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
Measured: 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)
5 items, 4-point Likert scale (1 - 4), large change in a negative direction means better outcome
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start1 Jan 2021
- Primary completion1 May 2021
- Study completion4 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety, SocialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Svenja Schaumburg, Ruhr University of Bochum
- Investigators
- Svenja Schaumburg, M. Sc., Principal investigator, Ruhr University of Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04790864
- Sponsor's protocol ID
- 684
- Status last verified
- Apr 2022
- First submitted
- 5 Mar 2021
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04790864
- Acronym / sponsor ID
- 684
- Conditions
- Anxiety, Social
- Keywords
- large-group treatment, one-session treatment, online intervention, public speaking anxiety, expectancy violation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 4 Oct 2021 (actual)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Comprising both groups, the investigators expect a reduction in public speaking anxiety. This effect should be present comparing pre-treatment anxiety to the anxiety reported at the assessment points directly after treatment, one month after treatment and six months after treatment. The change in reported anxiety between the two assessment time points before treatment is used as a control condition as there is no waitlist control group that is assessed but not treated. The reduction in public speaking anxiety is expected to be larger when comparing the assessments before and after treatment than in the control period before treatment. Furthermore, the investigators hypothesize participants to benefit from the intervention in terms of other constructs, namely socially phobic cognitions and fear of negative evaluation.
Besides the hypotheses regarding general efficacy of the intervention, the investigators expect the reduction in public speaking anxiety in the EV group to be larger than in the BASIC group. This superiority of the EV condition should be present at the assessment points directly after treatment, one month after treatment and six months after treatment.
The sample under investigation will be a sample of anxious individuals recruited from the community. All participants can attain the intervention for free and there is no payment for participation. On a website created for the project, interested parties can receive information on the project and can self-screen their public speaking anxiety and generalized social anxiety. Participation is recommended if public speaking anxiety is high and if general social phobia is low. After registration for the study, participants are asked to fill out a survey through a link sent to them via e-mail. This survey comprises all outcome measures. The same procedure is carried out two days before, one day after, one month after and six months after treatment.
The target sample size is 100 participants. The decision for that number is not based on power calculations as there was no study before that conducted an online large-group one-session intervention for the treatment of public speaking anxiety and therefore effect size estimates would be random. Instead, the target sample size can be ascribed to organizational purposes.
In terms of the general efficacy hypothesis, the primary outcome measure will be analyzed with a repeated measures ANOVA covering the assessment time points after registration, two days before and one month after treatment.
For all other outcome measures, the investigators will use a rmANOVA comprising all five assessment time points, i.e. after registration, two days before the intervention, one day after the intervention, one month after the intervention and six months after the intervention. Furthermore, there will be paired comparisons between the public speaking anxiety scores at each of the assessment time points.
These analyses will be conducted not only for public speaking anxiety but also for social phobic cognitions, fear of negative evaluation and other psychological constructs such as positive mental health.
Regarding the expectancy violation hypothesis, the primary outcome measure will be analyzed with a 2x3 repeated measures ANOVA. For all other outcome measures, the investigators will use 2x5 between-within repeated measures ANOVAs (rmANOVA) to analyze the results. The first factor is a between-subjects factor that comprises the two groups BASIC and EV. The second factor is a within-subjects factor reflecting the five assessment time points after registration for the study, two days before the intervention, one day after the intervention, one month after the intervention and six months after the intervention. This analysis will be conducted for public speaking anxiety, social phobic cognitions and fear of negative evaluation. Moreover, there will be paired comparisons between the two groups for each of the assessment time points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- Not having the appropriate technical equipment for participation in a videoconference
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online large-group one-session treatment with post-treatment exercise targeting expectancy violationThe 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. | Behavioural | Online large-group one-session treatment with post-treatment exercise targeting expectancy violation |
| Online large-group one-session treatment with post-treatment control exerciseThe 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. | Behavioural | Online large-group one-session treatment with post-treatment control exercise |
Primary outcome
change on self statements during public speaking scale (german version; Hofmann & Heinrichs, 2001)
Time frame: 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]
10 items, 6-point Likert scale (0 - 5), large change in a negative direction means better outcome
3 secondary outcomes
change on self statements during public speaking scale (german version; Hofmann & Heinrichs, 2001)
Time frame: 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)
Time frame: 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)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Anxiety, Social
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Bonding Before Birth: A mHealth Intervention for First-time Expectant Couples
Anxiety, Pregnancy
Recruiting
Comprehensive Assessment of Rehabilitation Experience Using the SAFE Scale
Caregiver Anxiety, Acquired Brain Injury
Not yet recruiting
Online Study on the Impact of a Self-Help Tool for Social Anxiety
Social Anxiety
Active, not recruiting
Targeting Social Function in Anxiety and Eating Disorders
Eating Disorders, Anorexia Nervosa
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Svenja Schaumburg, M. Sc. principal investigator
Ruhr University of Bochum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online large-group one-session treatment with post-treatment exercise targeting expectancy violation in people with Anxiety, Social, run by Ruhr University of Bochum at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change on self statements during public speaking scale (german version; Hofmann & Heinrichs, 2001) (time frame: 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]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.