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Anxiety Disorders clinical trials

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NCT ID: NCT05493865 Not yet recruiting - Depression, Anxiety Clinical Trials

Parent-Child Single-Session Growth Mindset Intervention on Adolescent Depression and Anxiety Problems

Start date: September 1, 2024
Phase: N/A
Study type: Interventional

Depression and anxiety are common mental health problems among adolescents worldwide. In Hong Kong, one in every four secondary school students reports clinical-level depression or anxiety symptoms. Extant research has found that a fixed mindset on intelligence and emotions and failure-is-debilitating belief are closely related to more depression and anxiety symptoms, hopelessness, and suicidality. At the same time, recent research also points to the importance of parental mindset. Parents are the primary social support of adolescents; parental belief systems can strongly influence children's affect, behaviour, and mental health. However, the effects of parent-child mindset interventions on a child's internalising problems have not yet been empirically examined. As emerging evidence has shown the promise of single-session interventions in reducing and preventing youth internalising problems, this project develops and examines a parent and child single-session intervention on mindsets of intelligence, failure, and emotion (PC-SMILE) - to tackle depression and anxiety in young people and promote parental well-being. Using a three-arm randomised controlled trial, the proposed study will examine the effectiveness of PC-SMILE on reducing depression and anxiety symptoms among children, enhancing well-being and parent-child relationships. A total of 549 parent-child dyads will be recruited from six secondary schools and randomly assigned to either the PC-SMILE intervention group, the C-SMILE intervention group, or the no-intervention waitlist control group. The intervention is approximately 45 minutes in length. In the PC-SMILE group, both parent and child will receive intervention, and their mental health and family relationship will be assessed at three time points: baseline before intervention (T1), within two weeks post-intervention (T2), and three months post-intervention (T3). In the C-SMILE group, only the child will undergo intervention, while both the child and parent will be required to complete the repeated assessments. A pilot test (n = 9) has supported the feasibility and acceptability of the PC-SMILE intervention. We hypothesise that compared to the waitlist control group, the PC-SMILE intervention group and C-SMILE group will significantly improve child depression and anxiety (primary outcome) and significantly improve secondary outcomes, including children's academic self-efficacy, hopelessness, psychological well-being, and parent-child interactions and relationships, and PC-SMILE group is more effective than C-SMILE group. The intention-to-treat principle and linear-regression-based maximum likelihood multi-level models will be used for data analysis. As of May 2024, we enrolled 75 students and their parents in the study. This study will not only provide evidence on parent-child growth mindset intervention for adolescent internalising problems but can also serve as a scalable and accessible intervention for improving the well-being of young people and their parents.

NCT ID: NCT05490199 Not yet recruiting - Clinical trials for Functional Impairment

Brief Enhanced Anxiety Sensitivity Treatment

Start date: October 1, 2022
Phase: N/A
Study type: Interventional

This pilot study trial will test the acceptability, feasibility, and usability of a brief enhanced anxiety sensitivity treatment to reduce anxiety sensitivity and functional impairment in Veterans.

NCT ID: NCT05488418 Not yet recruiting - Clinical trials for Depressive Disorder, Major

Clinical Study of Biomarkers of Stress Resilience: Role of ELK1 and GPR56

GeBra-clin
Start date: September 1, 2022
Phase: N/A
Study type: Interventional

70% of Europeans will be exposed to a potentially traumatic event (PTE). Following this experience, people are likely to develop various psychiatric disorders such as post-traumatic stress disorder (PTSD) or a major depressive episode (MDE). However, not all subjects have the same risk to develop a pathology, and resilience capacities, which depend on multiple factors are difficult to predict. Currently, there are no objective tools to stratify exposed subjects according to their risk of developing pathological responses to stress, which leads to difficulties in allocating means of prevention and treatment. Recently, new biological hypotheses explaining vulnerability/resilience to stress and depression, implicating the GPR56 and ELK1 genes, have been described. Previous studies have shown that evaluation of the vulnerability risk can be obtained from clinical, cognitive, biological or brain imaging variables, but no study has integrated these different approaches. Therefore, the project presented here aims at integrating behavioral, biological and neuroimaging data to predict the development of psychiatric disease. In this study, a prospective cohort of 255 violent trauma victims will be set up in 3 French cities for a period of 2 years. Eligible subjects will be included in the month following PTE and will be followed longitudinally for 12 months. Evaluations at 1, 3, 6 and 12 months will be performed, during which the subject will complete various clinical and cognitive tests. A blood sample will be collected at each visit to study biological processes including the regulation of genetic and epigenetic expression, in particular the expression of the GPR56 and ELK1 genes in the blood. For eligible subjects a brain MRI will be proposed at the first visit. We hypothesize that the genetic expression of ELK1 and GPR56 is predictive of the development of psychiatric pathologies at 6 and 12 months post-PTE. The ambition of this project is also to highlight the importance of a multimodal approach integrating a triad of markers (behavioral, biological and neuroimaging) to test this hypothesis.

NCT ID: NCT05453981 Not yet recruiting - Anxiety Clinical Trials

A Pilot RCT on the Efficacy of TranS-C Intervention on Anxiety Symptoms

Start date: September 1, 2022
Phase: N/A
Study type: Interventional

This study will examine whether the Transdiagnostic Sleep and Circadian Intervention (TranS-C; Harvey & Buysse, 2017) can improve sleep and circadian functioning and reduce disorder-focused symptoms in patients with anxiety symptoms. Sleep disturbance is highly comorbid with GAD (Dolsen et al., 2014). TranS-C, targeting common sleep disturbances in disorders, has improved disorder-focused symptoms and sleep and circadian functioning in patients with Severe mental illness (SMI). Nonetheless, no study examined TranS-C's efficacy on GAD patients specifically. Hence, this study will be a pilot study that examines the efficacy of TranS-C on people with anxiety symptoms by comparing with a care-as-usual control group (CAU). Around 80 Hong Kong residents aged 18 or above, with a GAD-7 score 10 or above and at least 1 sleep or circadian problem will be recruited. Eligible participants will be randomized to the TranS-C group or CAU group in a 1:1 ratio. The TranS-C group will receive 2-hour group-based TranS-C intervention delivered by clinical psychology trainees for 6 weeks under the supervision of a clinical psychologist. Both groups will complete a set of questionnaires at baseline, immediate post-treatment and 12-week follow-up. They will also complete sleep diaries throughout as homework. The outcome measures include mood, sleep, quality of life etc. This study will test whether theTranS-C intervention apparoach can be considered as a treatment for people with anxiety symptoms and sleep problems.

NCT ID: NCT05442099 Not yet recruiting - Anxiety State Clinical Trials

The Effect of Iso-Principal Based Music Playlists on Anxiety

Start date: August 15, 2022
Phase: N/A
Study type: Interventional

Chronic anxiety is a growing psychological challenge worldwide and at pre-clinical levels, can be disabling. Some research suggests music may reduce anxiety symptoms as effectively as anti-anxiety drugs without the adverse side effects. The iso principle suggests that the effectiveness of music interventions for mood management can be maximized by commencing a session with music that matches an individual's current emotional state and then gradually moving toward their desired emotional state. Our previous work demonstrated that a playlist generated by a music recommendation system that uses the iso-principal, along with music informatics, auditory beat stimulation, and reinforcement learning can reduce somatic and cognitive anxiety. However, it is unknown whether music playlists based on the iso-principal alone can reduce anxiety. In this study, the investigators wish to examine whether music playlists (~30 min long) based on the iso-principal (neutral to calm) will reduce anxiety after anxiety induction compared to a calm music playlist. The investigators hypothesize that the iso-principal playlist will have greater state anxiety reduction compared to the calm playlist.

NCT ID: NCT05442086 Not yet recruiting - Anxiety State Clinical Trials

Music and ABS as a Potential Anxiety Intervention

Start date: August 15, 2022
Phase: N/A
Study type: Interventional

Anxiety is a growing problem and has been steadily increasing, particularly in the adolescent and young adult populations in the past 24 years. Music and auditory beat stimulation (ABS) in the theta frequency range (4-7 Hz) are sound-based anxiety treatments that have been investigated in prior studies with subjective measures of anxiety. Here, the anxiety-reducing potential of calm music combined with theta ABS will be examined in a large sample of participants with objective psychophysiological measures (heart rate variability and EEG), stress hormone measures (salivary cortisol) along with subjective measures (STICSA state). Participants with moderate trait anxiety (n = 100) will be randomly assigned to a single 24-minute session of sound-based treatment: combined (music & ABS), or pink noise (control). Pre- and post-intervention heart rate variability and EEG band power (alpha, beta, delta, and theta bands), along with somatic and cognitive state anxiety measures (STICSA State) will be collected along with trait anxiety (STICSA Trait), and musical preferences (Short Test of Music Preferences). Our hypothesis is that the music & ABS condition will have significantly higher EEG theta band activity and heart rate variability compared to the pink noise control condition. The investigators also expect to see significantly reduces higher state anxiety reduction in the music & ABS condition compared to the pink noise control condition. Participants with moderate trait anxiety (n = 100) will be randomly assigned to a single 24-minute session of sound-based treatment: combined (music & ABS), or pink noise (control). Pre- and post-intervention heart rate variability and EEG band power (alpha, beta, delta, and theta bands), along with somatic and cognitive state anxiety measures (STICSA State) will be collected along with trait anxiety (STICSA Trait), and musical preferences (Short Test of Music Preferences). The investigators predict that the music & ABS condition will have significantly increased power in the theta and alpha bands, higher heart rate variability, higher state anxiety reduction, and lower salivary cortisol levels compared to the pink noise control condition.

NCT ID: NCT05420883 Not yet recruiting - Acupressure Clinical Trials

The Effect of Acupressure and Halogen Light Stimulation on Nonstress Testing and Pregnant Anxiety

Start date: June 15, 2022
Phase: N/A
Study type: Interventional

Fetal death accounts for approximately half of perinatal death. Fetal health should be evaluated in order to identify fetuses at risk of intrauterine death and to prevent perinatal morbidity and mortality. The Nonstress test, which is used to evaluate fetal health, is an important issue as it provides health professionals with information about fetal health. The research was planned as a randomized controlled trial to examine the effect of acupressure and halogen light stimulation on nonstress testing and anxiety of the pregnant woman. The research is planned to be conducted in the nonstress test room of the Obstetrics and Gynecology outpatient clinic of Samsun Training and Research Hospital Gynecology and Childhood Diseases Hospital between May 2021 and June 2023. The sample size of the study was calculated by power analysis (G*Power 3.1.9.2 program was used) and a total of 120 pregnant women were found. In order to increase the analysis power of the research, the number of samples was increased by 20% and it was decided to have at least 144 pregnant women (acupressure group: 48; halogen light group: 48 and control group: 48) for the study. The data of the study will be collected with the Pregnant Identification Form, the Nonstress Test Follow-up Form and the State Anxiety Scale. The data of the study will be evaluated using the SPSS 24 deviation, median and minimum-maximum values will be given. Chi-square test, Student t test, ANOVA test for those with normal distribution, Mann-Whitney U and Kruskal Wallis tests for those who are not.

NCT ID: NCT05398016 Not yet recruiting - Anxiety Clinical Trials

Task Sharing for Anxiety

Start date: April 2023
Phase: N/A
Study type: Interventional

This single-arm pilot clinical trial will evaluate the feasibility, acceptability, and engagement of target mechanism, and preliminary impact of a low-intensity behavioral intervention for mild-to-moderate anxiety disorders. Treatment will delivered by trained lay counselors (n = 5) to patient participants (n = 15).

NCT ID: NCT05384483 Not yet recruiting - Clinical trials for Social Anxiety Disorder

Cariprazine Versus Placebo for Social Anxiety Disorder

Start date: July 15, 2022
Phase: Phase 4
Study type: Interventional

The proposed study is a 12 week double-blind, placebo-controlled trial to examine the efficacy, safety, and tolerability of Vraylar® (cariprazine) in the treatment of patients with Social Anxiety Disorder (SAD), as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5). Subjects will be randomized to one of two treatment arms (placebo or Vraylar® 1.5 mg/day) in a 1:1 ratio. The study will be done at a single clinical research site.

NCT ID: NCT05292612 Not yet recruiting - Clinical trials for Social Anxiety Disorder

CvC-SAD (Clinician vs Coach)Self-help Versions in a RCT

Start date: May 1, 2023
Phase: N/A
Study type: Interventional

Background: Social Anxiety Disorder (SAD) is a common mental problem, where people experience severe and disabling anxiety about social situations and interactions. It is highly prevalent world-wide and in Hong Kong, causing significant suffering/distress. While evidence-based interventions exist, e.g., cognitive behavioural therapy (CBT), there will be not enough trained therapists to meet the treatment demand so that the majority of the SAD patients receive no treatment. Internet-based therapies may offer a solution, given that they deliver treatment more cost-efficiently by requiring lesser therapist time so that more patients can be treated with the same therapist resources. One UK internet-based CBT protocol for SAD, iCBT(C&W), shows high efficacy and efficiency in initial UK and Hong Kong trials with Englishspeaking patients. Objectives: 1. To develop and confirm the efficacy of a Chinese-language version of iCBT(C&W), administered by clinical psychologists in standard therapist-guided format. 2. To develop an even more cost-efficient new self-help format with some minimal 'coaching' performed by trained psychology bachelor-level graduates - its efficacy expected as 'noninferior' to that of the therapist-guided format. Overall design: Three-arm parallel group randomised controlled noninferiority trial: Standard therapist-guided iCT-SAD vs. Guided self-help iCT-SAD vs. Waitlist Method: The iCBT(C&W) protocol will be translated into Chinese. Approximately 110 Chinese adults with SAD will be recruited in Hong Kong and randomised into one of two treatment conditions, therapist-guided versus self-help. The treatment lasts 14 weeks. The primary outcome measure will be Liebowitz Social Anxiety Scale (self-report version).