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Anxiety, Social clinical trials

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NCT ID: NCT05868135 Recruiting - Panic Disorder Clinical Trials

Effects and Cost-effectiveness of e-Meistring - a Guided Internet-delivered Psychological Treatment

Start date: September 9, 2021
Phase:
Study type: Observational

The goal of this observational multicentre study is to address the effectiveness and cost-effectiveness of providing a therapist guided internet based cognitive behavioural therapy (ICBT) for common mental disorders in a routine healthcare setting. Main research questions is 1) What is the effectiveness of guided internet based treatment for moderate depression, panic disorder and social anxiety disorder across clinics in routine care? 2) What is the cost-effectiveness of guided internet based treatment for moderate depression, panic disorder and social anxiety disorder across clinics? 3) Who benefits from guided internet-delivered treatment? 4) What are the predictors of drop-out from guided internet based treatment? 5) To what extent does user experiences of guided internet based treatment influence adherence and effectiveness? Participants will receive up to nine guided ICBT sessions (modules) and answer questionnaires covering symptoms severity, health related quality of life, work and social ability, user satisfaction and medication. All questionnaires are part of the standard patient follow up routines in the four treatment locations participating in the study. Analytical approach is to compare locations/clinics and subgroups of patients.

NCT ID: NCT04790864 Completed - Anxiety, Social Clinical Trials

An Online Large-group One-session Treatment for Public Speaking Anxiety

Start date: January 1, 2021
Phase: N/A
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).

NCT ID: NCT04598230 Recruiting - Anxiety, Separation Clinical Trials

Partners in Caring for Anxious Youth

PCAY
Start date: February 9, 2021
Phase: Phase 3
Study type: Interventional

Pediatric onset anxiety disorders (generalized anxiety, social anxiety, separation anxiety) are highly prevalent, and if untreated, are impairing into adolescence and adulthood. In the largest comparative efficacy study remission occurred in about 65% of children and adolescents treated with a combination of a selective serotonin reuptake inhibitors (SSRI) and cognitive behavioral therapy (CBT). In contrast, CBT without an SSRI achieved remission in 35% of children at 3 months and 45% at 6 months-a 30% and 20% difference, respectively. Despite the difference in remission rates, CBT alone is the preferred treatment of most patients and families. Lack of awareness of the significant difference in remission rates and concerns about medication side effects may drive patient and family preference even though SSRIs have a positive safety profile. Critiques of CBT in the above study suggest that CBT was not as effective as it could be due to short treatment duration, restricted family involvement and limited exposure sessions. Would the combination of CBT and an SSRI still be superior to CBT only, if CBT was of longer duration, and included more family involvement and exposure sessions? In the Partners in Care for Anxious Youth (PCAY) study, children and adolescents with an anxiety disorder ages 7-17 years followed in pediatric primary care clinics affiliated with three institution: Lurie Children's Hospital of Chicago, University of California Los Angeles and University of Cincinnati will be randomized to one of two treatment arms; either CBT only or CBT combined with an SSRI (either fluoxetine, sertraline, or escitalopram). CBT in PCAY will be 6 months in duration and include more family involvement, and more exposure opportunities than past trials. The 6-month acute treatment phase will be followed by 6 months of followup. The primary outcome will be anxiety symptom remission and reduction in impairment over 6 and 12-months.