Computerized Psycho-social Intervention for Anxiety Disorders
Recruiting in Palo Alto (17 mi)
+1 other location
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Florida State University
Disqualifiers: Depression, ADHD, Severe psychopathology, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Anxiety disorders are the most common form of psychopathology, and frequently begin in childhood, resulting in lifelong impairment. Increased brain activity after making mistakes, as reflected by the error-related negativity (ERN), is observed in people with anxiety disorders, even before disorder onset. The ERN is therefore of great interest as a potentially modifiable risk factor for anxiety. However, methodological issues can make the ERN difficult to measure.
Increased brain activity in response to a balance disturbance, as reflected by the balance N1, resembles the ERN, but does not share its methodological issues. The investigators' preliminary data demonstrate that the balance N1 and the ERN are associated in amplitude in adults, suggesting they may depend on the same brain processes. The balance N1 has never been investigated in individuals with anxiety disorders, but it increases in amplitude within individuals under anxiety-inducing environmental contexts. Further, balance and anxiety are related in terms of brain anatomy, daily behavior, disorder presentation, and response to treatment.
The present investigation will measure the ERN and the balance N1 in children (ages 9-12) with anxiety disorders, and further, how these brain activity measures change in response to a brief, 45-minute, computerized psychosocial intervention that was developed to reduce reactivity to errors, and has been shown to reduce the ERN. The investigators will recruit approximately 80 children with anxiety disorders, half of whom will be randomly assigned to the active intervention condition. The other half will be assigned to an active control condition, consisting of a different 45-minute computerized presentation. Participants assigned to the control condition can access the computerized intervention after participation in the study.
The purpose of this investigation is to test the hypothesis that the balance N1 and the ERN will be reduced to a similar extent after the intervention, to demonstrate that these brain responses arise from shared brain processes. Transfer of the effect of the psycho-social intervention to the balance N1 would provide insight into prior work demonstrating that balance training can alleviate anxiety in young children, and well-documented benefits of psychotherapy to balance disorders. Collectively, these data may guide the development of multidisciplinary interventions for the prevention and treatment of anxiety disorders in children.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment for anxiety disorders?
Research shows that computer-based psychological interventions can be effective, especially for mild to moderate cases of anxiety and depression. Additionally, computer-assisted cognitive-behavioral therapy (CBT) has been successful in treating anxiety in children, suggesting that similar computerized approaches could be beneficial for adults as well.
12345Is the computerized psycho-social intervention for anxiety disorders safe for humans?
There is limited information on the safety of computerized psycho-social interventions, as most studies focus on medical treatments. However, monitoring for adverse events (unintended negative effects) is important, and while serious events are tracked, minor side effects like temporary anxiety increases are often not documented.
46789How is the Computerized Psycho-social Intervention for Anxiety Disorders different from other treatments?
This treatment is unique because it uses a computer-based approach to specifically target error sensitivity, which is a novel focus compared to traditional therapies. It offers a cost-effective and accessible way to deliver psycho-social interventions, making it easier for people to receive treatment from home.
13101112Eligibility Criteria
This trial is for English-speaking children aged 9-12 with an anxiety disorder such as generalized anxiety, social anxiety, or OCD. They must be able to stand unassisted for 15 minutes. Children with severe psychopathology, recent head injuries, significant medical conditions or disabilities that affect standing are excluded.Inclusion Criteria
My child speaks English.
I can stand for 15 minutes without help.
I have been diagnosed with an anxiety disorder.
Exclusion Criteria
I have been diagnosed with depression or ADHD.
I do not have an English-speaking primary caregiver to accompany my child to lab visits.
I have a condition or disability that prevents me from standing.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Intervention
Participants undergo a 45-minute computerized psychosocial intervention to reduce reactivity to errors
1 hour
1 visit (in-person)
Control
Participants in the control group receive a different 45-minute computerized presentation
1 hour
1 visit (in-person)
Follow-up
Participants are monitored for changes in ERN and balance N1 after the intervention
1 hour
1 visit (in-person)
Participant Groups
The study tests a computerized intervention designed to reduce error sensitivity in anxious children by measuring changes in brain activity related to errors (ERN) and balance disturbances (balance N1). Half of the participants will receive this intervention while the other half will get a control computerized presentation on healthy lifestyle choices.
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Group II: Control ConditionActive Control1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
RADLAB at Innovation ParkTallahassee, FL
FSU Psychology BuildingTallahassee, FL
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Who Is Running the Clinical Trial?
Florida State UniversityLead Sponsor
National Institute of Mental Health (NIMH)Collaborator
References
Manage Your Life Online: A Web-Based Randomized Controlled Trial Evaluating the Effectiveness of a Problem-Solving Intervention in a Student Sample. [2019]Evidence for the efficacy of computer-based psychological interventions is growing. A number of such interventions have been found to be effective, especially for mild to moderate cases. They largely rely on psychoeducation and 'homework tasks', and are specific to certain diagnoses (e.g. depression).
Improving the efficiency of psychological treatment using outcome feedback technology. [2018]This study evaluated the impact of applying computerized outcome feedback (OF) technology in a stepped care psychological service offering low and high intensity therapies for depression and anxiety.
Computers and psychosocial treatment for child anxiety: recent advances and ongoing efforts. [2019]Building on the empirical data supporting the efficacy of cognitive-behavioral therapy (CBT) for child anxiety, researchers are working on the development and evaluation of cost-effective and transportable CBT approaches. Related to this, a widely endorsed goal is to disseminate evidence-based treatments from research settings to community settings. Computer-assisted treatments have emerged as a means to provide cost-effective and efficient service to an increased number of anxious youth for whom a CBT treatment would be otherwise unavailable. We offer a rationale for the development and evaluation of computer-assisted psychosocial treatments for anxiety in youth, offer illustrative advances made in this area, and describe our efforts in using computers to enhance dissemination of CBT for child anxiety. Specifically, our illustrations include a description of (a) Camp-Cope-A-Lot (CCAL), a computer-assisted CBT for the treatment of anxiety disorders in youth ages 7-12, and (b) CBT4CBT: Computer-based training in CBT for anxious youth. Findings from evaluations of these programs are summarized, and further advances are proposed and discussed.
Development and randomized trial evaluation of a novel computer-delivered anxiety sensitivity intervention. [2018]Anxiety disorders contribute substantially to the overall public health burden of psychopathology. Anxiety sensitivity (AS), a fear of anxiety related sensations, is one of the few known malleable risk factors for anxiety pathology. Previous AS reduction treatments have utilized highly trained clinicians. A completely-computerized AS treatment would reduce costs and increase dissemination possibilities. Cognitive bias modification for interpretation biases (CBM-I) interventions have shown clinically significant reductions in anxiety symptoms. Another emerging literature focused on learning has shown context-shifting tasks can greatly increase learning without adding logistical burden to an intervention. The current study evaluated a CBM-I for AS that utilized a context-shifting task to deliver twice the treatment dose of extant interventions.
Computer-assisted therapy in psychiatry: be brave-it's a new world. [2022]The capacity to deliver some forms of behavioral treatment via computers may prove to be a small revolution in the delivery of mental health care. Although early research on the efficacy of these approaches has yielded mixed results, this new strategy offers tremendous potential to provide empirically supported therapies to many individuals who would never access psychiatric care, to extend the time and expertise of clinicians, and to offer improved care and monitoring. However, the great promise of computer-assisted therapies may be diminished if their benefits are overstated or if they are broadly released or disseminated before being carefully evaluated using the same methodologic standards that are requirements for evaluating clinician-delivered therapies. In this article, we review the current status of empiric support for computer-assisted therapies, advocating for enhanced rigor to identify those that are most effective, as well as the need to more thoroughly assess possible adverse effects, recognizing that even a modestly effective computer-assisted intervention could have enormous impact.
Data and safety monitoring in social behavioral intervention trials: the REACH II experience. [2022]Psychosocial and behavioral interventions trials targeting a broad range of complex social and behavioral problems such as smoking, obesity and family caregiving have proliferated in the past 30 years. At the same time the use of Data and Safety Monitoring Boards (DSMBs) to monitor the progress and quality of intervention trials and the safety of study participants has increased substantially. Most of the existing literature and guidelines for safety monitoring and reporting of adverse events focuses on medical interventions. Consequently, there is little guidance for investigators conducting social and behavior trials.
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.
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.
Editorial: Primum non nocere - are adverse events accurately reported in studies on psychological interventions for children? [2023]Adverse Events (AEs) are defined as any unfavorable and unintended sign or symptom, that may occur during or after receipt of any intervention. The principle of non-maleficence requires careful consideration to ensure that existing or new psychological interventions are not harmful before they can be considered beneficial. In this context, the safety of psychological interventions, including the possible occurrence of AEs, is increasingly important for patients, families, and clinicians. The evaluation of AEs is crucial to obtain a complete understanding of the risk/benefit balance of psychological interventions. There is a need for researchers and clinicians to assess and report AEs comprehensively and in a coordinated manner. It is necessary to have more accurate data on the recording of AEs in protocols to enhance transparency and consistency, as well as to improve practice. Finally, and to facilitate this process, there is a need for standards for data collection.
Computer-supported cognitive behavioral treatment of anxiety disorders. [2018]This article reviews the empirical literature pertaining to the use of computer-supported cognitive-behavioral treatment of anxiety disorders, including palmtop computers, virtual reality exposure therapy, and personal computer software programs. The advantages and disadvantages unique to each type of technology are described. The review concludes with a discussion of ethical issues, barriers to the use of technology by clinicians, and suggestions for a process by which scientists and practitioners can conceptualize how technology can advance our understanding of anxiety and our dissemination of effective treatments.
Internet-delivered attention bias modification training in individuals with social anxiety disorder--a double blind randomized controlled trial. [2021]Computerized cognitive bias modification for social anxiety disorder has in several well conducted trials shown great promise with as many as 72% no longer fulfilling diagnostic criteria after a 4 week training program. To test if the same program can be transferred from a clinical setting to an internet delivered home based treatment the authors conducted a randomized, double-blind placebo-controlled trial.
Treating Childhood Social Anxiety Disorder With Virtual Environments and Serious Games: A Randomized Trial. [2022]Disseminating efficacious psychological treatments remains a challenge for researchers and clinicians. In the case of social anxiety disorder (SAD), Social Effectiveness Therapy for Children (SET-C) has been demonstrated as an efficacious intervention, but elements of the protocol, such as peer generalization sessions, remain challenging to conduct in typical clinical settings. To address this need, we developed an artificially intelligent, web-based application, Pegasys-VR™, designed to replace peer generalization sessions and enhance homework compliance. The feasibility of Pegasys-VR™ was tested in a randomized controlled trial in comparison to SET-C. The results indicated that both programs were equally efficacious in decreasing anxiety and improving social skill in social encounters. Sixty-three percent (63%) of children treated with SET-C and 60% treated with Pegasys-VR™ did not meet diagnostic criteria for SAD at posttreatment. Pegasys-VR™ is a feasible, efficacious, and dissemination-friendly element of a comprehensive treatment program for social anxiety disorder in children.