Internet-Based Cognitive Behavioral Therapy for Anxiety in Autism

Overseen By Eric Storch, Ph.D.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Must not be taking: Psychotropic, Stimulant

Disqualifiers: Bipolar, Psychotic disorder, Intellectual disability, others

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

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods of delivering internet-based cognitive-behavioral therapy (CBT) led by parents for youth with anxiety and Autism Spectrum Disorder (ASD). The study compares the effectiveness of weekly therapist support through emails alone versus emails plus video calls. It seeks to determine which method more effectively reduces anxiety symptoms. This trial targets children aged 7-15 in Texas with ASD and anxiety or obsessive-compulsive disorder (OCD) as their primary issues, with a parent or guardian willing to participate. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance therapy delivery for youth with ASD and anxiety.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications, but you cannot start a new psychotropic medication within 4 weeks or a stimulant/psychoactive medication within 2 weeks before joining.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that internet-based cognitive behavioral therapy (iCBT) is generally easy for people to handle. Patients reported high satisfaction with iCBT-E and did not experience significant increases in anxiety or other negative effects. Serious negative outcomes were rare, occurring in about 5.8% of cases, indicating that most people did not see their symptoms worsen.

Research found that adding video guidance to iCBT-EV improved well-being and skills without adding extra risk. Some people faced challenges with technology and scheduling, but these did not affect safety.

Overall, both iCBT-E and iCBT-EV appear safe for treating anxiety. Most people manage these treatments well, and serious side effects are uncommon. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer a fresh approach to managing anxiety in youth with Autism Spectrum Disorder (ASD). Unlike traditional face-to-face cognitive-behavioral therapy (CBT), these treatments are internet-based and parent-led, making them more accessible and potentially less intimidating for families. The iCBT-Email (iCBT-E) option uses weekly emails from a therapist, providing guidance and support, whereas the iCBT-Email and Videoconferencing (iCBT-EV) option includes both emails and six video calls, offering a more interactive and personalized experience. This flexibility allows families to choose a level of engagement that suits their needs, potentially improving adherence and outcomes.

What evidence suggests that this trial's treatments could be effective for youth with anxiety and ASD?

Research shows that online cognitive behavioral therapy (iCBT) can effectively treat anxiety. Studies have found that iCBT often costs less than traditional group therapy for anxiety. In this trial, participants will receive either the email-based version (iCBT-E), proven effective with proper client monitoring, or the version that includes both emails and video calls (iCBT-EV). Research suggests that iCBT-EV works well for various mental health issues, including anxiety, and adding video calls might provide extra support, potentially enhancing the therapy's effectiveness. Overall, iCBT is considered an accessible and effective way to treat anxiety. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

Inclusion Criteria

You are between the ages of 7-15 years at consent/assent.

The child has been diagnosed with Autism spectrum disorder (ASD).

One parent/guardian is able and willing to participate.

Exclusion Criteria

The child has been diagnosed with bipolar disorder, psychotic disorder, or intellectual disability.

The child is currently having very serious thoughts about hurting themselves or others, or they are hurting themselves and need medical help.

The child is currently receiving therapy for anxiety.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pilot Intervention

Initial testing of the internet-based, parent-led cognitive-behavioral therapy (iCBT) for anxiety in children with ASD

4 weeks

Randomized Controlled Phase

Participants receive either iCBT-E or iCBT-EV over 12 weeks, with therapist support via email or email and videoconferencing

12 weeks

Weekly email support, 6 video calls for iCBT-EV group

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• iCBT-E
• iCBT-EV

How Is the Trial Designed?

Group I: iCBT-Email (iCBT-E) Experimental Treatment 1 Intervention

Parents will receive a weekly email from a therapist over the 12 weeks of treatment.

Group II: iCBT-Email and Videoconferencing (iCBT-EV) Active Control 1 Intervention

Parents will receive a weekly email and six 30-minute supportive video calls with a therapist over the 12 weeks of treatment.

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6084818/

Content of client emails in internet-delivered cognitive ... While some research suggests that both forms of ICBT can be effective when using well-designed interventions combined with monitoring of client ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9683746/

The Effectiveness of Internet-Based Cognitive Behavioral ... The purpose of this study was to compare the effectiveness of internet-based cognitive behavioral therapy (iCBT) for depression, to that of treatment as usual ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2214782919300831

Negative effects associated with internet-delivered ... 61.5% of ICBT clients in the sample (n = 59/80) reported experiencing at least one negative effect during treatment.

4. oxfordre.com oxfordre.com/psychology/oso/viewentry/10.1093$002facrefore$002f9780190236557.001.0001$002facrefore-9780190236557-e-332?p=emailA/bOPC2JTOrz6&d=/10.1093/acrefore/9780190236557.001.0001/acrefore-9780190236557-e-332

A Systematic Meta-Review of Internet-Based Cognitive ... For ICBT vs intervention (group CBT): 3 comparisons for anxiety: ICBT more cost-effective than group CBT in all comparisons. Studies varied in ...

5. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2020.00838/full

Effectiveness and Cost-Effectiveness of Internet-Based ... The present study aims to investigate clinical effectiveness and cost-effectiveness of an internet-based CBT-I program Sleepsy in comparison with care as usual ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2214782914000256

The impact of telephone versus e-mail therapist guidance ... Therapist guidance by telephone does not appear to differ from therapist guidance by e-mail in iCBT for depression, although further research featuring larger ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6190066/

Is self-guided internet-based cognitive behavioural therapy ... Self-guided iCBT had low clinically significant deterioration rates (5.8%) and resulted in lower risk of clinically significant deterioration compared with ...

8. formative.jmir.org formative.jmir.org/2022/2/e33374

An Internet-Based Cognitive Behavioral Therapy Program for ... This study aims to evaluate the usability of Tranquility—a novel iCBT program for anxiety—and its fidelity to CBT principles ...