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NCT06661460
The goal of this study is to develop a new internet-delivered cognitive behavioral therapy (ICBT) intervention for youths with anxiety disorders based on the best current knowledge about effective cognitive behavioral therapy for the target group, refine the intervention in collaboration with patient and public representatives, and conduct a preliminary evaluation of the treatment effects in an open clinical trial. The primary objective of the study is: 1\. To evaluate the preliminary efficacy of a newly developed ICBT intervention for children and adolescents with anxiety disorders in reducing anxiety severity, as measured by the Pediatric Anxiety Rating Scale (PARS). Secondary objectives of the study are: 1. To examine the preliminary efficacy (PARS) of the ICBT intervention at 3 months post-treatment. 2. To examine how youths with anxiety disorders, their caregivers, therapists, and healthcare leadership experience the ICBT intervention. 3. To examine factors (e.g., age, type of anxiety disorder, presence of depressive symptoms, experiences of ICBT) that predict treatment outcome. 4. To examine how the ICBT intervention can be improved (e.g., treatment content and technical delivery) for future use. Participants will: * Undergo ICBT treatment for anxiety disorders during 12 weeks * Complete questionnaires at multiple time points throughout the study * Participate in follow-ups post-treatment and 3 months post-treatment * A selection of participants will also be invited to focus group interviews with the aim to generate ideas on how the intervention may be improved for future use
NCT06958887
Title Is the Betwixt application effective and acceptable in improving emotion regulation for an adult clinical population? Short title Betwixt: Effective/acceptable clinical population emotion regulation? Chief Investigator Jacob Andrews Aims A: Evaluate the effectiveness of the Betwixt intervention on emotion regulation, self-compassion, and cognitive reappraisal in a clinical population. B: Investigate whether changes in processes targeted by Betwixt result in improvements in clinical outcomes. C: Explore the acceptability, and putative processes of Betwixt within a clinical context. Trial configuration Single Case Experimental Design (SCED) series and acceptability and change interviews Setting Lincolnshire Partnership Foundation Trust Sample size estimate Minimum of three cases recommended Number of participants Eight (with replacement participants if they do not contribute sufficient data to the intervention phase) Eligibility criteria Inclusion criteria for IAPT services: Adult, on the waiting list for the service, experiencing an anxiety disorder or depression, own a mobile phone, and comfortable using a phone for an extended period. Able to give informed consent. Exclusion criteria: Insufficient English reading ability and not available for the length of the intervention. Description of interventions The intervention is an interactive game called Betwixt, which is delivered to participants via an app. Betwixt is a theory-driven app with foundations in emotion regulation, cognitive behavioural therapy, and mindfulness. Each participant will have access to the app for four weeks and will be asked to use it every two days. Duration of study Overall: 24 months Per participant: Seven weeks Outcome measures CER-Q, DERS-SF, GAD-2, GAD-7, PHQ-2, PHQ-9, SCS, SWEMWBS and WSAS Analytical methods Structured visual analysis; Kendall's Tau-U; Reliable Change and Clinically Significant Change analysis; Simulation Modelling Analysis; and Framework Analysis.