Computerized Psycho-social Intervention for Anxiety Disorders

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a short, computerized intervention can reduce anxiety in children by targeting their sensitivity to making mistakes. Researchers aim to measure two types of brain activity (ERN and balance N1) to determine if they change after the intervention. The study involves children aged 9-12 with anxiety disorders such as generalized anxiety disorder, social anxiety disorder, or obsessive-compulsive disorder, who can stand unaided for 15 minutes. Half of the participants will receive the active intervention (a psycho-social, computerized intervention targeting error sensitivity), while the other half will engage in a different computerized activity. The findings could guide new methods for treating and preventing anxiety in children. As an unphased trial, this study offers a unique opportunity for children to contribute to pioneering research that could shape future anxiety treatments.

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 prior data suggests that this computerized psycho-social intervention is safe for children with anxiety disorders?

Research shows that the computerized program designed to help with sensitivity to mistakes is generally well-tolerated. Previous studies have examined its effects on anxiety and its ability to reduce a brain signal linked to anxiety. These studies have not identified any major side effects, suggesting it is safe to use.

The program is brief, lasting only 45 minutes, which reduces the chance of negative reactions. Although specific safety numbers are not available, the program is non-invasive and computer-based, typically presenting a lower risk compared to more intense treatments. While further research could provide additional details, current evidence supports its safety in humans, particularly in children with anxiety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for anxiety disorders that often involve medication or face-to-face therapy, this computerized psycho-social intervention is unique because it specifically targets error sensitivity through a digital platform. This approach could offer a more personalized and accessible treatment option, enabling individuals to engage with therapy at their own pace and convenience. Researchers are excited about this intervention because it not only reduces barriers to accessing care but also harnesses technology to potentially enhance the effectiveness of managing anxiety symptoms in a novel way.

What evidence suggests that this trial's treatments could be effective for anxiety disorders?

Research shows that a short, computer-based program can help reduce a brain signal called error-related negativity (ERN), linked to anxiety disorders. In this trial, participants in the intervention arm will receive a psycho-social, computerized intervention targeting error sensitivity, aiming to lower ERN levels. People with anxiety often have higher ERN levels, even before developing the disorder. By lowering the ERN, this program may help manage anxiety symptoms. Early results suggest that this approach might also influence another brain signal called balance N1, related to anxiety and balance problems. The connection between these brain signals suggests that this treatment could help manage anxiety in children. ^{1 2 3 4 6}

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.

Severe psychopathology (e.g., bipolar disorder, psychosis, thought disorder, neurological disease, severe or extreme suicide risk)

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

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. link.springer.com link.springer.com/article/10.3758/s13415-019-00760-w

A brief, computerized intervention targeting error sensitivity ... Results will potentially provide further evidence linking the psychological construct of error sensitivity to the ERN, as well as provide a ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31820417/

A brief, computerized intervention targeting error sensitivity ... However, none of these approaches directly target the psychological constructs linked to an increased ERN (e.g., error sensitivity). ... Anxiety Disorders / ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05503017?cond=NCT05503017&rank=1

Computerized Intervention Targeting the Error-Related ... Behavioral : Psycho-social, computerized intervention targeting error sensitivity ... Anxiety Disorders. Generalized Anxiety Disorder. Phobia, Social.

4. researchgate.net researchgate.net/publication/337848576_A_brief_computerized_intervention_targeting_error_sensitivity_reduces_the_error-related_negativity

(PDF) A brief, computerized intervention targeting error ... Despite growing evidence that an elevated error-related negativity (ERN) is a risk marker for anxiety, it is unclear what psychological construct underlies this ...

5. ctv.veeva.com ctv.veeva.com/study/computerized-intervention-targeting-the-error-related-negativity-and-balance-n1-in-anxious-children

Computerized Intervention Targeting the Error-Related ... Social Anxiety Disorder. Anxiety Disorders. Treatments. Behavioral: Psycho-social, computerized intervention targeting error sensitivity.

6. sciencedirect.com sciencedirect.com/science/article/pii/S0165032722014136

Randomized controlled trial of computerized approach ... ... computerized approach/avoidance training in social anxiety disorder: Neural and symptom outcomes ... target of first-line psychosocial treatments.