Online Cognitive Behavioral Therapy for Autism and Anxiety

(LUNA-A Trial)

Overseen By Jolie Held, BA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Must not be taking: Antidepressants, Stimulants, Benzodiazepines, Antipsychotics

Disqualifiers: Psychotic disorder, Conduct disorder, others

Compensation: Varies

Number of Visits: 7

Duration: 12 weeks

139 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to make therapy for anxiety more accessible to autistic adolescents through an online approach. It compares traditional in-person cognitive behavioral therapy (CBT) with an internet-based version called LUNA-Adolescent. The trial seeks participants living in Texas who have autism, experience significant anxiety, and can communicate verbally. Parents or guardians must also be willing to participate alongside the child. The goal is to determine if online therapy can effectively assist those who have difficulty accessing in-person treatment.

As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could enhance therapy accessibility for others in the future.

Will I have to stop taking my current medications?

The trial requires that participants do not start new antidepressant medications within 12 weeks of assessment (4 weeks for stimulants/benzodiazepines/antipsychotics) and do not change the dosage of psychotropic medications within 4 weeks of assessment (2 weeks for stimulants/benzodiazepines/antipsychotics).

What prior data suggests that internet-delivered cognitive-behavioral therapy is safe for autistic adolescents with anxiety?

Research has shown that online Cognitive Behavioral Therapy (CBT) is a well-accepted treatment for autistic children and teens with anxiety. In earlier studies, families participated in a 12-week online CBT program designed for autistic kids aged 7 to 15. The findings indicated that this method was safe for participants, with very few reports of negative effects, suggesting it is generally a safe option.

This online format aims to make CBT more accessible, especially for families who find it hard to attend in-person sessions. The program includes weekly treatment lessons, video calls with therapists, and email check-ins, offering full support without needing to leave home. Overall, online CBT has shown promise in safely helping autistic young people manage anxiety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the online cognitive behavioral therapy (CBT) for autism and anxiety, particularly the LUNA-Adolescent protocol, because it offers a unique internet-based approach to treatment. Unlike traditional in-person CBT sessions, this method provides flexibility and accessibility with 12 weekly online modules, bi-weekly telehealth visits, and regular email check-ins. This online delivery can be particularly beneficial for autistic adolescents who may find in-person sessions challenging or overwhelming. Additionally, the integration of technology allows for a more personalized and consistent support system, potentially leading to better engagement and outcomes for participants.

What evidence suggests that internet-delivered cognitive-behavioral therapy is effective for anxiety in autistic adolescents?

Research has shown that online Cognitive Behavioral Therapy (CBT) can reduce anxiety in autistic young people. Studies have found both email and video call versions of this therapy effective. In this trial, participants in the LUNA-Adolescent group will receive internet-based CBT, which includes structured online lessons and regular video call sessions. This program has been tested and showed promise in managing anxiety in autistic teenagers. Overall, these findings suggest that online CBT can be a practical and effective way to manage anxiety in this group. ^{1 2 3 6 7}

Who Is on the Research Team?

Eric Storch, PhD

Principal Investigator

Baylor College of Medicine

Are You a Good Fit for This Trial?

This trial is for adolescents with Autism Spectrum Disorder who also experience anxiety. It's designed to help those who have trouble accessing traditional in-person therapy due to costs, location, or a lack of trained providers.

Inclusion Criteria

Participants are located in Texas

The participant has an IQ above 69, based on the KBIT-2, another valid test or clinician judgement (e.g., a previous assessment conducted, and report shared with study team)

My child is between 11 and 17 years old.

Exclusion Criteria

My child is currently in therapy for social skills or anxiety.

My child started new depression medication recently or during therapy.

My child has been diagnosed with a psychotic or conduct disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive internet-based cognitive behavioral therapy (LUNA-Adolescent) or standard-care CBT for 12 weeks

12 weeks

6 bi-weekly telehealth visits, email check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 month follow-up assessment

What Are the Treatments Tested in This Trial?

Interventions

• Internet-delivered Cognitive-Behavioral Therapy

Trial Overview The study tests an internet-delivered Cognitive-Behavioral Therapy (CBT) program called LUNA-Adolescent against the usual treatment methods. The aim is to see if this online program can effectively reduce anxiety in autistic youth.

How Is the Trial Designed?

Group I: LUNA-Adolescent Active Control 1 Intervention

Dyads in the Learning to Understand and Navigate Anxiety-Adolescent (LUNA-Adolescent) group will receive internet-based cognitive behavioral therapy (LUNA-Adolescent), which includes 12 weekly treatment modules, 6 bi-weekly, 30-minutes telehealth visits, and email check-ins.

Group II: Treatment as Usual Placebo Group 1 Intervention

Dyads in the standard-care cognitive behavioral therapy (CBT) group will receive 12 weekly sessions of transdiagnostic CBT for anxiety in autistic youth.

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Published Research Related to This Trial

A pilot study involving 33 families tested a telehealth intervention for anxiety in youth with autism spectrum disorders, showing strong acceptability and excellent fidelity to the original in-person program.

Preliminary results indicated improvements in youth anxiety symptoms and parent competence over time, suggesting that telehealth could be a promising method for delivering effective interventions, although further research is needed to enhance usability and evaluate efficacy more rigorously.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth delivery of cognitive-behavioral intervention to youth with autism spectrum disorder and anxiety: A pilot study. Hepburn, SL., Blakeley-Smith, A., Wolff, B., et al.[2018]

Up to 50% of autistic individuals experience anxiety, highlighting the need for effective interventions; this study is testing a novel app-based therapy called 'Molehill Mountain' designed specifically for autistic people to help manage anxiety.

The ongoing pilot trial aims to enroll about 100 participants aged 16 and older, assessing the app's feasibility and acceptability while using established anxiety measurement tools, with the goal of informing future larger randomized-controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Molehill Mountain feasibility study: Protocol for a non-randomised pilot trial of a novel app-based anxiety intervention for autistic people. Oakley, B., Boatman, C., Doswell, S., et al.[2023]

The Facing Your Fears-Adolescent Version (FYF-A) program, a modified cognitive behavior therapy (CBT) for adolescents with high-functioning autism spectrum disorders, showed significant reductions in anxiety severity and interference after treatment in a study of 24 participants aged 13-18.

Nearly 46% of participants met criteria for a positive treatment response on their primary anxiety diagnosis post-intervention, with low anxiety levels maintained at a 3-month follow-up, indicating the potential effectiveness of this tailored CBT approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facing your fears in adolescence: cognitive-behavioral therapy for high-functioning autism spectrum disorders and anxiety. Reaven, J., Blakeley-Smith, A., Leuthe, E., et al.[2022]

A pilot study involving nine children with autism spectrum disorder (ASD) evaluated a parent-led online cognitive-behavioral therapy (CBT) program, which was found to be acceptable and feasible for families despite some technical issues.

The program showed preliminary efficacy with significant reductions in youth anxiety as measured by clinicians, although parents did not report similar reductions, indicating a need for further investigation into the program's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Telehealth Delivery of Group Parent-Led Cognitive-Behavioral Therapy During COVID-19: A Pilot Study. Byrne, G., Vickers, L., Ni Longphuirt, E., et al.[2022]

Cognitive-behavioral therapy (CBT) effectively reduces anxiety symptoms in adolescents with Autism Spectrum Disorders (ASD), with some reduction maintained one year after treatment, based on a study of 22 participants aged 12-17.

Higher severity of ASD was linked to better treatment responses, suggesting that more severe cases may benefit more from CBT, which is encouraging for long-term management of anxiety in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Verbal Ability and Severity of Autism on Anxiety in Adolescents With ASD: One-Year Follow-Up After Cognitive Behavioral Therapy. White, SW., Schry, AR., Miyazaki, Y., et al.[2021]

The BRAVE Self-Help program, an internet-based cognitive behavioral therapy (iCBT) for children and adolescents with anxiety, showed significant reductions in anxiety symptoms, with 57.7% of participants completing nine sessions achieving recovery to nonelevated anxiety levels.

Participants reported moderate satisfaction with the program, and those who completed six or more sessions experienced a substantial average improvement in anxiety scores, indicating that iCBT can be a feasible and effective first-step intervention for young people.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Large-Scale Dissemination of Internet-Based Cognitive Behavioral Therapy for Youth Anxiety: Feasibility and Acceptability Study. March, S., Spence, SH., Donovan, CL., et al.[2023]

A feasibility study involving six adolescents with anxiety disorders showed that a translated version of the ICBT program 'Chilled Out' was generally well-received, with five participants completing the 12-week program and expressing satisfaction with it.

Preliminary results indicated significant improvements in anxiety severity, with a standardized mean difference of d = 1.54 from pre- to post-treatment, suggesting that this ICBT program could be an effective intervention for Danish youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-based cognitive behavioral therapy for adolescents with anxiety disorders: A feasibility study. Stjerneklar, S., Hougaard, E., Nielsen, AD., et al.[2023]

A pilot study involving 14 patients with generalized anxiety disorder (GAD) showed that internet-delivered acceptance-based behavior therapy led to significant improvements in anxiety levels, with a large effect size of Cohen's d = 2.14 at post-treatment.

The majority of participants completed all treatment modules, and high client satisfaction ratings suggest that this form of therapy is well-received, indicating its potential as a promising new treatment for GAD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-delivered acceptance-based behavior therapy for generalized anxiety disorder: A pilot study. Dahlin, M., Ryberg, M., Vernmark, K., et al.[2022]

A randomized controlled trial involving 93 children aged 8-12 with anxiety disorders showed that internet-delivered cognitive behavior therapy (ICBT) significantly reduced anxiety symptoms, with a large effect size (Cohen's d = 1.66) reported by clinicians after 10 weeks of treatment.

At the three-month follow-up, 50% of children in the ICBT group no longer met the criteria for their principal anxiety diagnosis, indicating that ICBT can lead to lasting improvements in anxiety management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-delivered cognitive behavioural therapy for children with anxiety disorders: A randomised controlled trial. Vigerland, S., Ljótsson, B., Thulin, U., et al.[2022]

The pilot study involving 94 adolescents aged 13 to 17 showed that the Internet-based cognitive behavioral therapy program, Breathe, was moderately satisfactory, with 90% of participants finding it easy to use and understand.

However, retention rates were low, with only 28% of the Breathe group completing the program, indicating that adjustments are needed to improve participant engagement and reduce barriers to completing the therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Internet-Based Cognitive Behavioral Program for Adolescents With Anxiety: Pilot Randomized Controlled Trial. O'Connor, K., Bagnell, A., McGrath, P., et al.[2020]

A study involving 31 early adolescents with high-functioning autism and anxiety showed that those receiving a personalized cognitive-behavioral therapy (CBT) protocol had significantly better outcomes than those receiving treatment as usual (TAU).

Out of the participants, 11 of 16 in the CBT group were treatment responders, and these improvements were maintained one month after treatment, highlighting the efficacy of CBT for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of cognitive-behavioral therapy versus treatment as usual for adolescents with autism spectrum disorders and comorbid anxiety. Storch, EA., Lewin, AB., Collier, AB., et al.[2018]

Citalopram and buspirone showed some improvement in treating anxiety in youth with autism spectrum disorders (ASD), while fluvoxamine did not demonstrate efficacy.

Cognitive behavioral therapy (CBT) was found to have moderate efficacy for anxiety disorders in high-functioning youth with ASD, but most studies were short-term and involved small sample sizes, highlighting the need for larger, long-term trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of treatments for anxiety in youth with autism spectrum disorders. Vasa, RA., Carroll, LM., Nozzolillo, AA., et al.[2022]

A study involving six adolescents and young adults with high-functioning autism showed that an adapted cognitive-behavioral therapy (CBT) protocol effectively reduced anxiety symptoms and improved adaptive functioning, with improvements maintained at a one-month follow-up.

While clinician-rated measures indicated significant reductions in anxiety severity, parent- and self-reported anxiety showed mixed results, suggesting that spontaneous changes during the baseline period may have influenced these ratings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of anxiety in older adolescents and young adults with autism spectrum disorders: A pilot study. Ehrenreich-May, J., Simpson, G., Stewart, LM., et al.[2021]

A modified Cognitive Behavioral Therapy (CBT) program for adolescents with autism spectrum disorders (ASD) significantly reduced anxiety symptoms, with 79% of participants showing positive treatment responses compared to only 28.6% in the waitlist group.

The CBT program also positively impacted autism symptom severity according to parent reports, indicating that the treatment was effective not only for anxiety but also for some aspects of autism, although further modifications to the program may be needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for early adolescents with autism spectrum disorders and clinical anxiety: a randomized, controlled trial. Wood, JJ., Ehrenreich-May, J., Alessandri, M., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39368459/

Internet-based, parent-led cognitive behavioral therapy for ... This study tested two versions of parent-led, Internet-delivered cognitive behavioral therapy for anxiety among autistic youth; one that provided weekly email ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0005796724001669

A randomized trial comparing email vs. telehealth support Email and telehealth-supported, parent-led iCBT both appear to be effective treatments for autistic youth with anxiety disorders that require reduced therapist ...

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Internet-delivered Cognitive-Behavioral Therapy for ... Specifically, this project will evaluate the efficacy and cost effectiveness of LUNA-Adolescent compared to standard-care CBT for anxiety. Overall, this study ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9997671/

Development and pilot testing of internet-delivered, family ... A 12-week family-based, Internet-delivered cognitive behavioral therapy (iCBT) program for 7–15 year-old autistic youth with anxiety and/or OCD was developed

5. bcm.edu bcm.edu/healthcare/clinical-trials/h-55617

Internet-Delivered Cognitive Behavioral Therapy for ... Baylor College of Medicine is conducting a study providing anxiety treatment designed to fit the needs of autistic children (aged 11-17).

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03247075

Study Details | NCT03247075 | Internet-delivered CBT vs ... The primary objective of this study is to test the efficacy of internet-delivered CBT (ICBT) for youth (10 - 17 years) with social anxiety disorder.

7. nature.com nature.com/articles/s41598-025-88779-7

Virtual delivery of group-based cognitive behavioral ... Virtual delivery of FYF is feasible and effective for treating elevated anxiety in autistic children/youth and may improve access.