Computerized Psycho-social Intervention for Anxiety Disorders

Recruiting at 1 trial location

Overseen By Norman B Schmidt, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Florida State University

Disqualifiers: Depression, ADHD, Severe psychopathology, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

80 Participants Needed

What You Need to Know Before You Apply

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.

Is 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. ^{1 2 3 4 5}

How 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. ^{6 7 8 9 10}

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. ^{5 8 10 11 12}

Who Is on the Research Team?

Norman B Schmidt, PhD

Principal Investigator

Florida State University

Are You a Good Fit for This Trial?

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

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Psycho-social, computerized intervention targeting error sensitivity

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Group II: Control Condition Active Control 1 Intervention

Who Is Running the Clinical Trial?

Florida State University

Lead Sponsor

Trials

234

Recruited

41,100+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

The web-based program Manage Your Life Online (MYLO) was tested in a randomized controlled trial with 213 healthy volunteers and showed improvements in problem distress, anxiety, and depression, but was not more effective than the control program ELIZA.

Participants rated MYLO as significantly more helpful than ELIZA, indicating its acceptability, although the lack of a no-treatment control means we cannot rule out the possibility of spontaneous recovery influencing the results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Manage Your Life Online: A Web-Based Randomized Controlled Trial Evaluating the Effectiveness of a Problem-Solving Intervention in a Student Sample. Bird, T., Mansell, W., Wright, J., et al.[2019]

The study involving 594 patients showed that implementing computerized outcome feedback (OF) technology in therapy for depression and anxiety did not significantly change clinical outcomes, as measured by PHQ-9 and GAD-7 scores, compared to traditional methods.

However, the use of OF led to a significant reduction in the average duration and cost of treatment, suggesting that OF can enhance the efficiency of stepped care psychological services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving the efficiency of psychological treatment using outcome feedback technology. Delgadillo, J., Overend, K., Lucock, M., et al.[2018]

Cognitive-behavioral therapy (CBT) is effective for treating anxiety in children, and researchers are developing computer-assisted versions to make this treatment more accessible and cost-effective for youth aged 7-12.

Programs like Camp-Cope-A-Lot and CBT4CBT demonstrate promising results in using technology to deliver CBT, enhancing the dissemination of effective treatments for child anxiety in community settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computers and psychosocial treatment for child anxiety: recent advances and ongoing efforts. Kendall, PC., Khanna, MS., Edson, A., et al.[2019]

A single-session, computer-delivered cognitive bias modification for interpretation biases (CBM-I) significantly reduced anxiety sensitivity (AS) by 62% immediately after the intervention, with a 64% reduction maintained one month later.

Participants in the active treatment group experienced fewer panic responses during a physiological challenge, indicating that the intervention not only reduced AS but also improved coping mechanisms related to anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and randomized trial evaluation of a novel computer-delivered anxiety sensitivity intervention. Capron, DW., Schmidt, NB.[2018]

Computer-assisted behavioral treatments have the potential to revolutionize mental health care by making effective therapies accessible to individuals who might not otherwise receive psychiatric help.

While there is promise in these therapies, it is crucial to rigorously evaluate their efficacy and safety before widespread dissemination to ensure that their benefits are not overstated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-assisted therapy in psychiatry: be brave-it's a new world. Carroll, KM., Rounsaville, BJ.[2022]

The REACH II program, a multi-site trial focused on caregivers of Alzheimer's patients, highlighted the need for tailored safety monitoring and adverse event reporting protocols in psychosocial and behavioral intervention studies, as existing guidelines primarily address medical interventions.

The study identified unique challenges in defining and classifying adverse events, as well as establishing resolution criteria, emphasizing the variability in safety monitoring practices across psychosocial trials and the necessity for standardized protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Data and safety monitoring in social behavioral intervention trials: the REACH II experience. Czaja, SJ., Schulz, R., Belle, SH., et al.[2022]

In a systematic review of 117 studies on psychosocial interventions for childhood mental disorders, only 31% monitored adverse events, highlighting a significant gap in safety reporting.

Among the studies that did monitor adverse events, there was a lack of consistency in how these events were defined and assessed, with only 11% evaluating the causes of the events, which is crucial for understanding the risks associated with these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review. Lodewyk, K., Bagnell, A., Courtney, DB., et al.[2023]

Current clinical trials for behavioral health interventions often do not monitor adverse events as thoroughly as those for medications and medical devices, focusing mainly on serious incidents like suicide attempts and hospitalizations.

There is a need for expanded monitoring of adverse events in psychotherapy trials to better inform patients about potential risks, including temporary increases in anxiety, which are often overlooked but can impact treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The need for expanded monitoring of adverse events in behavioral health clinical trials. Peterson, AL., Roache, JD., Raj, J., et al.[2012]

The safety of psychological interventions is critical, as adverse events (AEs) can occur and must be carefully evaluated to ensure that these interventions do not cause harm before being deemed beneficial.

There is a pressing need for standardized protocols for assessing and reporting AEs in psychological interventions to improve transparency, consistency, and ultimately enhance clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial: Primum non nocere - are adverse events accurately reported in studies on psychological interventions for children? Purgato, M., Cortese, S.[2023]

The review highlights various computer-supported cognitive-behavioral treatments for anxiety disorders, including palmtop computers, virtual reality exposure therapy, and personal computer software, each with unique advantages and disadvantages.

It emphasizes the need for ethical considerations and addresses barriers that clinicians face in using technology, suggesting a collaborative approach to enhance the understanding and treatment of anxiety disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-supported cognitive behavioral treatment of anxiety disorders. Anderson, P., Jacobs, C., Rothbaum, BO.[2018]

In a randomized trial with 79 participants, a computerized cognitive bias modification program aimed at reducing social anxiety did not show significant differences in outcomes between the active training and placebo groups, despite improvements in anxiety and quality of life over time.

The study suggests that the current format of the attention bias modification program may require adjustments before it can be effectively delivered as an internet-based treatment for social anxiety disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-delivered attention bias modification training in individuals with social anxiety disorder--a double blind randomized controlled trial. Carlbring, P., Apelstrand, M., Sehlin, H., et al.[2021]

A web-based application called Pegasys-VR™ was developed to replace challenging peer generalization sessions in Social Effectiveness Therapy for Children (SET-C) and was found to be equally effective in reducing anxiety and improving social skills in children with social anxiety disorder (SAD).

In a randomized controlled trial, 63% of children treated with SET-C and 60% treated with Pegasys-VR™ no longer met the diagnostic criteria for SAD after treatment, demonstrating the efficacy and feasibility of this innovative approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating Childhood Social Anxiety Disorder With Virtual Environments and Serious Games: A Randomized Trial. Beidel, DC., Tuerk, PW., Spitalnick, J., et al.[2022]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Manage Your Life Online: A Web-Based Randomized Controlled Trial Evaluating the Effectiveness of a Problem-Solving Intervention in a Student Sample. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Improving the efficiency of psychological treatment using outcome feedback technology. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Computers and psychosocial treatment for child anxiety: recent advances and ongoing efforts. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Development and randomized trial evaluation of a novel computer-delivered anxiety sensitivity intervention. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Computer-assisted therapy in psychiatry: be brave-it's a new world. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Data and safety monitoring in social behavioral intervention trials: the REACH II experience. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

The need for expanded monitoring of adverse events in behavioral health clinical trials. [2012]

9. England pubmed.ncbi.nlm.nih.gov

Editorial: Primum non nocere - are adverse events accurately reported in studies on psychological interventions for children? [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Computer-supported cognitive behavioral treatment of anxiety disorders. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Internet-delivered attention bias modification training in individuals with social anxiety disorder--a double blind randomized controlled trial. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Treating Childhood Social Anxiety Disorder With Virtual Environments and Serious Games: A Randomized Trial. [2022]