Trial Summary
What is the purpose of this trial?The goal of this study is to test a web-based psychoeducational resource for adolescents with central disorders of hypersomnolence and their families. The investigators hope to assess the website's usability, acceptability, and feasibility, as well as its potential effect on social relationship health.
Participants will be asked to review the content of the psychoeducational websites. The participants will then provide feedback on the website, as well as the adolescent's social relationships and social health before and after reviewing the website through online surveys.
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications.
What safety data exists for the psychoeducational resource for sleeping disorders?The existing research highlights a general lack of comprehensive adverse event monitoring in behavioral health interventions, including psychoeducational resources. While adverse event monitoring is standard in clinical trials for medications, it is less integrated into trials for behavioral interventions. The need for expanded monitoring is emphasized to better inform participants of potential risks. However, specific safety data for the psychoeducational resource for sleeping disorders is not directly addressed in the provided research.3891415
Is the web-based psychoeducational resource a promising treatment for sleeping disorders?Yes, the web-based psychoeducational resource is promising because it can improve sleep habits, reduce the time it takes to fall asleep, and increase overall sleep duration. It is also cost-effective and can be as effective as treatments involving direct contact with a therapist.1571013
What data supports the idea that Psychoeducational Resource for Sleeping Disorders (also known as: Web-based psychoeducational resource) is an effective treatment?The available research shows that psychoeducational interventions, including web-based resources, can be effective for psychiatric disorders. For example, a study on a web-based intervention for schizophrenia reported positive outcomes, suggesting that similar approaches could be beneficial for sleeping disorders. Additionally, psychoeducation has been shown to improve patients' understanding and management of their conditions, which can lead to better treatment compliance and quality of life. While specific data on sleeping disorders is not provided, the success in other areas indicates potential effectiveness.2461112
Eligibility Criteria
This trial is for adolescents aged 10-19 with narcolepsy type 1 or type 2, or idiopathic hypersomnia, and their parents. Participants must speak English fluently and be interested in improving social health for those with central disorders of hypersomnolence.Inclusion Criteria
I am between 10-19 years old, or I am the parent of an adolescent in this age range.
I am a teenager diagnosed with narcolepsy or idiopathic hypersomnia.
Treatment Details
The study is testing a web-based psychoeducational resource designed to help teenagers with excessive sleepiness disorders and their families. It aims to evaluate the website's user-friendliness, acceptance, practicality, and its impact on the teens' social relationships.
1Treatment groups
Experimental Treatment
Group I: Web-based psychoeducational ResourceExperimental Treatment1 Intervention
Eligible families will be provided with website access instructions. Parents and children will be instructed to review the materials separately. The intervention will provide each person with individualized action items to be discussed as a family. It is anticipated that reviewing all of the psychoeducational materials will take the parent/child approximately one hour, resulting in a total intervention burden of two hours for the family. Participants will be encouraged to return to the website as often as needed to review content. For the purposes of this project, they will be instructed to review all intervention materials within one month of receiving the website access instructions.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Boston Children's HospitalBoston, MA
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Who is running the clinical trial?
Boston Children's HospitalLead Sponsor
American Academy of Sleep MedicineCollaborator
References
The treatment of insomnia through mass media, the results of a televised behavioral training programme. [2019]An important trend in behavioral medicine is a psycho-educational approach to health problems. A training course aimed at the treatment of sleep disorders has been developed using the following basic principles: (1) a symptomatic approach, (2) emphasis on information on sleep and sleep disorders, (3) self-management, and (4) interventions based on behaviour therapeutic principles that are further developed for the treatment of sleep disorders. Because the results of courses used in primary health care were encouraging, a similar training course of eight programmes was broadcasted by the Dutch educational radio and television station Teleac. About 200,000 people viewed the course, 23,000 of whom ordered the course material. The results of the training course were assessed from a sample (N = 325) by means of a sleep diary in a pre-test, post-test and a follow-up condition. In addition, several questionnaires were used to collect information on personality factors and on physical and psychological complaints. The training produced an estimated decrease in sleep latency of 25 minutes. The duration of sleep increased by nearly 40 minutes. Of the people using hypnotic drugs 40% ceased their use after the course. The training course broadcasted by Teleac is found to be an effective means of improving sleeping behaviour. The results of the course are comparable with interventions that use direct therapist-client contact, suggesting that the presence of a therapist in this approach may not be of crucial importance. The decrease in the use of hypnotics makes the approach cost-effective.
An evaluation model for psychoeducational interventions using interactive multimedia. [2019]A review of published evaluations of psychoeducational interventions using interactive digital multimedia shows that evaluations typically address only some of the areas that collectively would constitute a comprehensive evaluation. There appears to be a need for an accepted standard for these evaluations, based on a general evaluation model that encompasses all relevant aspects of development, efficacy and use of multimedia interventions. A comprehensive model is proposed which includes special features of multimedia interventions that lead to unique evaluation requirements. The model integrates relevant aspects of program evaluation and clinical trials models in order to provide a unique model that includes all the evaluation domains relevant to digital multimedia interventions. These include evaluation of intervention theory, intervention design strategies, the formative process, intervention efficacy (process and outcome) and contextual issues such as evaluability assessment, reporting and stakeholder issues. The application of individual components of the model is illustrated with reference to problems in the evaluation literature on a particular type of digital multimedia intervention, electroencephalographic biofeedback for Attention-Deficit/Hyperactivity Disorder. The model should be useful for researchers planning evaluations of digital multimedia interventions, especially in the psychoeducational domain. This paper provides a theoretical and evidential background for the evaluation model, and includes a checklist and flowchart for the planning and conduct of the evaluation.
Comparison of increasingly detailed elicitation methods for the assessment of adverse events in pediatric psychopharmacology. [2007]To improve the gathering of adverse events (AEs) in pediatric psychopharmacology by examining the value and acceptability of increasingly detailed elicitation methods.
Computer-based education for patients with psychosis. [2016]To evaluate the use of a computer-delivered psycho-education programme which tries to improve patients' knowledge and understanding of psychosis.
Clinical psychology training in sleep and sleep disorders. [2021]There is growing evidence to suggest that clinical psychologists would benefit from more training in sleep and sleep disorders. Sleep disturbances are commonly comorbid with mental health disorders and this relationship is often bidirectional. In addition, psychologists have become integral members of multidisciplinary sleep medicine teams and there are not enough qualified psychologists to meet the clinical demand. The purpose of this study was to evaluate the current education on sleep and sleep disorders provided to clinical psychology predoctoral students and interns. Directors of graduate programs and internships (N=212) completed a brief online survey on sleep education in their program. Only 6% of programs offers formal didactic courses in sleep, with 31% of programs offering training in the treatment of sleep disorders. There are few programs with sleep faculty (16%), and most reported that their institutions were ineffective in providing sleep education. Thirty-nine percent of training directors reported they would implement a standard curriculum on sleep, if available. The findings from this study suggest that more opportunities are needed for trainees in clinical psychology to gain didactic and clinical experience with sleep and sleep disorders.
Web-based psychoeducational intervention for persons with schizophrenia and their supporters: one-year outcomes. [2022]This study examined the use of a uniquely designed Web site and home computers to deliver online multifamily psychoeducational therapy to persons with schizophrenia and their informal supports (family and friends). Web site usage and outcome benefits are reported.
Sleep health education in pediatric community settings: rationale and practical suggestions for incorporating healthy sleep education into pediatric practice. [2022]This article offers practical ways to incorporate healthy sleep education into pediatric practice and discusses key questions, barriers, and strategies associated with such efforts. The rationale for incorporating healthy sleep education in pediatric practice settings is presented, and desirable features of sleep education programs that may be implemented in pediatric practice are identified. Potential barriers are reviewed and strategies offered to overcome these barriers, such as developing resources applicable to healthy sleep education and practical information for pediatricians. Key factors regarding effectiveness of such interventional programs and key points relevant to successful healthy sleep education in pediatric practice are highlighted.
The use of Enhancing Quality Use of Medication Self-Reported Questionniare (EQUIM-SRQ) among mental health consumers: a pilot study. [2015]To assess the applicability, interpretability and potential limitations of an adverse event screening questionnaire (the Enhancing Quality Use of Medication Self-Reported Questionnaire [EQUIM-SRQ]) in an Australian mental health outpatient population.
The need for expanded monitoring of adverse events in behavioral health clinical trials. [2012]Monitoring for possible adverse events is ethically required by Institutional Review Boards and Good Clinical Practice guidelines for all human research involving the delivery of treatment interventions in a clinical trial. The monitoring of adverse events is a well-established and routine practice for contemporary clinical trials involving medications and medical devices. However, these same guidelines have not been fully integrated into clinical trials involving the use of behavioral health interventions and psychotherapy. Most behavioral health clinical trials limit adverse event monitoring to serious adverse events such as suicide attempts, completed suicides, and psychiatric hospitalizations. Other possible "side effects" of psychotherapy, such as temporary increases in anxiety, are often considered a normal part of therapy and are therefore not documented as possible adverse events. This manuscript reviews a variety of reasons for the limited adverse event monitoring in behavioral health clinical trials and highlights the importance of incorporating expanded adverse event monitoring into future behavioral health clinical trials. Without understanding the nature and prevalence of adverse events, patients cannot be informed adequately of the possible risks and benefits of behavioral interventions prior to engaging in treatment.
A "Sleep 101" Program for College Students Improves Sleep Hygiene Knowledge and Reduces Maladaptive Beliefs about Sleep. [2022]Sensitizing young adults about sleep hygiene knowledge and helpful sleep attitudes may have the potential to instill long-lasting healthy sleep practices. Towards these ends, evaluation of psychoeducational program "Sleep 101" tailored to college students was undertaken. Following two weeks of sleep-log recordings, participants were randomly assigned to a Sleep 101 (experimental) condition or a sleep monitoring (control) condition. The Sleep 101 condition was comprised of two 90-minute workshops aimed to educate students about healthy sleep practices, helpful thoughts about sleep, and ways to improve sleep. The sleep monitoring group received a sleep hygiene handout and completed sleep logs for the study duration. Sleep 101 participants endorsed fewer maladaptive beliefs and attitudes about sleep, increased sleep hygiene knowledge, and reduced sleep onset latency compared to the sleep monitoring participants. Brief psychoeducational courses may be a cost-effective way to alleviate current, and/or prevent future, sleep problems in young adults.
[Education care in patients with psychiatric disorders in France: Psychoeducation or therapeutic patient education?] [2019]Psychoeducation and therapeutic patient education can be effectively included in treatments for patients with psychiatric disorders. These two effective educational therapies have the common purpose of improving disorder-related morbidity, compliance with treatment and patients' quality of life. While they have different methods of application, both teach patients to play an active role in their own care. However, it is still critical to combine them for care of patients with psychiatric and addiction disorders in a manner that allows for specificity. To do this, the differences between psychoeducation and therapeutic patient education must be considered, and their potential for the management of patients with psychiatric and addiction disorders must be determined.
Bridging the Gap Between Individualized Inpatient Safety Planning and Postdischarge Efficacy. [2023]Implementation of programs that increase both psychiatric patient education and their involvement in treatment programming can lead to positive outcomes postdischarge. Patients involved in programs focusing on skills, recovery, and that are individualized show a reduction in symptoms as well as an increase in engagement, treatment, and recovery posthospitalization.
Examining the Utility of a Sleep Resource in Transdiagnostic Internet-Delivered Cognitive Behavior Therapy: An Observational Study. [2022]Patients seeking transdiagnostic internet-delivered cognitive behavior therapy (T-ICBT) for anxiety or depression often have sleep difficulties. A brief resource that includes sleep psychoeducation and strategies for improving sleep (e.g., stimulus control and sleep restriction) may address comorbid insomnia without the need for an insomnia-specific ICBT course. This observational study explored patient use and feedback of a brief sleep resource available to all patients (n = 763) enrolled in an 8-week T-ICBT course. Overall, 30.1% of patients (n = 230) reviewed the resource and were older, more engaged with the ICBT course (i.e., more likely to complete the program, more logins, and greater number of days enrolled in the course) and had higher pretreatment insomnia symptoms than those who did not review the resource. Resource reviewers did not report larger improvements in symptoms of insomnia than non-reviewers, even among patients with clinical levels of insomnia, and average insomnia levels remained above the clinical cutoff at posttreatment. While patients were satisfied with the resource and it was beneficial to some patients, more research is needed to further explore how it may be integrated into T-ICBT and how therapists can encourage the use of the resource among patients who may benefit from the resource.
Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review. [2023]Adverse event monitoring in studies of psychotherapy is crucial to clinical decision-making, particularly for weighing of benefits and harms of treatment approaches. In this systematic review, we identified how adverse events are defined, measured, and reported in studies of psychosocial interventions for children with mental disorders.
Developing a research tool to detect iatrogenic adverse events in psychiatric health care by involving service users and health professionals. [2023]Most health professionals working in psychiatric care will experience adverse events (AE) such as service user suicide or violence, during their career Norway lacks measures to capture potential iatrogenic injuries, such as risk assessment measures, to evaluate patient records for AEs in both inpatient and outpatient psychiatric clinics in hospitals WHAT THE PAPER ADDS TO EXISTING KNOWLEDGE: We have described an approach to the validation of a research tool between different national contexts; a process that went beyond language translation We have incorporated the understanding of health professionals and service users; to bring together the lifeworld of the patient with the professional definition of AEs, triggers and risk areas of AEs in a psychiatric context. The service users' experiences resulted in modifications to the tool.