Cognitive Behavioral Therapy for Anxiety in Autism

Recruiting at 2 trial locations

Overseen By Eric Storch, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Disqualifiers: Psychotic disorder, Severe suicidal ideation, Concurrent psychotherapy, others

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 14

Duration: 14 weeks

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

If your child is taking psychotropic medication, they can continue as long as the dosage has been stable for the past 4 weeks (or 2 weeks for stimulants or benzodiazepines). If not, you may need to wait until the dosage is stable before joining the trial.

What data supports the effectiveness of this treatment for anxiety in autism?

Research shows that cognitive-behavioral therapy (CBT) is effective for treating various anxiety disorders, including generalized anxiety disorder and social anxiety disorder. CBT helps by changing negative thought patterns and behaviors, leading to long-term improvements in anxiety and depression. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy (CBT) safe for humans?

Cognitive Behavioral Therapy (CBT) and related therapies like Mindfulness-Based Stress Reduction (MBSR) and Acceptance-Based Behavioral Therapies (ABBT) are generally considered safe for humans, as they are widely used and studied for various anxiety disorders and other conditions. ^{6 7 8 9 10}

How is Cognitive Behavioral Therapy (CBT) unique for treating anxiety in autism?

Cognitive Behavioral Therapy (CBT) is unique for treating anxiety in autism because it can be tailored to the specific needs of individuals with autism spectrum disorder (ASD), often involving parental involvement to enhance effectiveness. Unlike some other treatments, CBT focuses on changing thought patterns and behaviors, and it has shown moderate success in reducing anxiety symptoms in children with high-functioning ASD. ^{11 12 13 14 15}

What is the purpose of this trial?

Anxiety is very common in autistic youth. Recently, an intervention has been created by the investigators to target these symptoms in autistic youth in a community setting. The purpose of this study is to determine the feasibility of implementing this treatment in community care centers.

Eligibility Criteria

This trial is for autistic youth aged 7-17 with an official diagnosis and significant anxiety symptoms, as confirmed by specific assessments. Participants must have a verbal IQ over 70, live in Texas or Pennsylvania, and be able to understand English/Spanish. A parent/guardian must participate. Those on stable psychotropic meds may join; however, those with psychotic disorders or severe suicidal tendencies cannot.

Inclusion Criteria

A parent/guardian must be available and willing to engage in the therapy sessions and assessment of the study.

I am a teenager with high anxiety levels, as shown by my test scores.

The child has been determined to be suitable for the intervention focus, based on a structured psychiatric diagnostic interview (the Mini International Neuropsychiatric Interview) conducted by an independent evaluator supervised by an experienced psychologist and indicating that anxiety is the main concern.

Exclusion Criteria

My child has been diagnosed with a psychotic disorder.

My child has been on a stable dose of their mental health medication for at least 4 weeks.

My child currently has severe thoughts of harming themselves or others, needing medical help.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cognitive behavioral therapy adapted for autistic youth with anxiety, including exposure components, approximately once a week for 14 weeks

14 weeks

14 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

• Cognitive Behavioral Therapy

Trial Overview The study tests the effectiveness of a community-based Cognitive Behavioral Therapy (CBT) program tailored for autistic youth against the usual treatment methods. It aims to see if this specialized CBT can be feasibly implemented in community care centers to help manage anxiety.

Participant Groups

Group I: Cognitive Behavioral Therapy Active Control 1 Intervention

Participants will receive cognitive behavioral therapy that has been adapted for autistic youth with anxiety. These sessions will also include components of exposure. Participants will receive therapy around once a week for 14 weeks.

Group II: Treatment as Usual Placebo Group 1 Intervention

Participants will complete treatment as usual. They will be referred to other community resources, including skills training. Additionally, participants may begin or end therapy and/or medication.

Cognitive Behavioral Therapy is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Cognitive Behavioral Therapy for:

• Anxiety disorders
• Depressive disorders
• Eating disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)

Approved in United States as Cognitive Behavioral Therapy for:

• Anxiety disorders
• Depressive disorders
• Eating disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)
• Substance use disorders

Approved in Canada as Cognitive Behavioral Therapy for:

• Anxiety disorders
• Depressive disorders
• Eating disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

Findings from Research

Cognitive-behavioral therapy (CBT) is recognized as a leading and effective treatment for various anxiety disorders, targeting harmful thoughts and behaviors that contribute to anxiety.

The article discusses both common and unique elements of different CBT protocols tailored for specific anxiety disorders, and it also highlights recent strategies aimed at improving the effectiveness of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-Behavioral Treatments for Anxiety and Stress-Related Disorders. Curtiss, JE., Levine, DS., Ander, I., et al.[2022]

Cognitive-behavioral therapy (CBT) is effective in treating generalized anxiety disorders, showing significant clinical improvements in anxiety and depression compared to no treatment and other control conditions, based on a review of 13 controlled clinical trials.

CBT not only has low dropout rates but also maintains long-term improvements, demonstrating the largest effect sizes compared to other therapies, indicating its strong efficacy as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychotherapy for generalized anxiety disorder. Borkovec, TD., Ruscio, AM.[2022]

Cognitive-behavioral therapy (CBT) is consistently more effective than waiting-list and placebo control groups for treating generalized anxiety disorder, panic disorder, and social phobia, indicating its strong efficacy as a treatment option.

Cognitive changes during CBT are strong predictors of treatment outcomes, suggesting that the therapeutic approach can lead to significant improvements in anxiety disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive therapy of anxiety disorders. Chambless, DL., Gillis, MM.[2019]

Anxiety UK's psychological therapy service demonstrated high effectiveness, with recovery and improvement rates surpassing NHS IAPT targets among 957 clients who completed therapy between April 2019 and March 2020.

Cognitive behavioral therapy (CBT) was found to be the most effective method for reducing anxiety, and the results showed that attending more therapy sessions led to greater improvements in both anxiety and depression scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of Anxiety UK's psychological therapy service outcomes. Tham, SG., Lidbetter, N., Pedley, R., et al.[2022]

Cognitive-behavioral therapy (CBT) is shown to be both efficacious and effective for treating various anxiety disorders, including PTSD, OCD, and generalized anxiety disorder, based on a comprehensive review of existing research.

To improve treatment outcomes, future research should focus on dismantling studies to identify which specific CBT techniques are most beneficial for different patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for anxiety disorders: an update on the empirical evidence. Kaczkurkin, AN., Foa, EB.[2018]

In a study of 108 participants with social anxiety disorder, cognitive-behavioral group therapy (CBGT) was found to be more effective than mindfulness-based stress reduction (MBSR) for individuals with higher levels of anger suppression, leading to greater reductions in social anxiety.

Conversely, higher anger expression was linked to less reduction in social anxiety during MBSR, suggesting that individuals with SAD who struggle with anger might benefit more from CBGT than MBSR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The moderating effects of anger suppression and anger expression on cognitive behavioral group therapy and mindfulness-based stress reduction among individuals with social anxiety disorder. Kuo, JR., Zeifman, RJ., Morrison, AS., et al.[2021]

Cognitive-behavioral therapy (CBT) is based on scientific experimentation rather than just theories, making it a unique and evidence-based approach to treatment.

Recent research at the University of Minnesota has integrated new neuroscientific findings with CBT, potentially enhancing its effectiveness and understanding in therapeutic practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of cognitive-behavioral therapy in the University of Minnesota's outpatient psychiatry clinic. Kushner, MG.[2018]

Mindfulness-based cognitive therapy (MBCT) showed significant reductions in anxiety and depressive symptoms in a small group of 11 participants with generalized anxiety disorder (GAD), suggesting it may be an effective treatment option.

The study highlights the potential of MBCT to enhance mindful awareness in everyday life, indicating its broader benefits beyond just symptom reduction, and calls for future randomized clinical trials to further evaluate its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy for generalized anxiety disorder. Evans, S., Ferrando, S., Findler, M., et al.[2022]

Acceptance-based behavioral therapies (ABBTs) effectively target anxiety disorders by focusing on reducing reactivity and experiential avoidance, using mindfulness and acceptance strategies to promote engagement in meaningful activities.

Future research should include more randomized control trials comparing ABBTs to other treatments, investigate the mechanisms behind their effectiveness, and explore their applicability to diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness and acceptance-based behavioral therapies for anxiety disorders. Roemer, L., Williston, SK., Eustis, EH., et al.[2021]

In a randomized clinical trial involving 18 women with generalized anxiety disorder (GAD), Acceptance-based behavior therapy (ABBT) significantly reduced the severity of GAD symptoms and improved quality of life compared to a control group that did not receive psychotherapy.

While ABBT led to a decrease in worry severity, this change was not statistically significant when compared to the control group, indicating that while ABBT is effective for symptom relief, its impact on worry may require further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of acceptance-based behavior therapy on severity of symptoms, worry and quality of life in women with generalized anxiety disorder. Zargar, F., Asgharnejad Farid, AA., Atef-Vahid, MK., et al.[2021]

Cognitive Behaviour Therapy (CBT) has been shown to be an effective treatment for anxiety in individuals with Asperger's syndrome, based on a review of nine studies.

There is limited data on the effectiveness of CBT for other sub-types of autism spectrum disorders (ASD), indicating a need for further research to explore its efficacy across the spectrum and to understand the mechanisms behind its success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of anxiety in autism spectrum disorders using cognitive behaviour therapy: A systematic review. Lang, R., Regester, A., Lauderdale, S., et al.[2022]

Cognitive Behavioral Therapy (CBT) is effective in reducing anxiety symptoms in children with Autism Spectrum Disorder (ASD), showing a moderate effect size of -0.66 based on a meta-analysis of 23 studies.

Involving parents in the treatment process significantly enhances the effectiveness of CBT, with a larger effect size of -0.85 compared to child-only treatments, which had a smaller effect size of -0.34.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Cognitive Behavioral Therapy for Reducing Anxiety in Children with High Functioning ASD: A Systematic Review and Meta-Analysis. Perihan, C., Burke, M., Bowman-Perrott, L., et al.[2020]

Clinicians who participated in Workshop training conditions showed significantly increased knowledge of cognitive-behavioral therapy (CBT) and delivered the Facing Your Fears program with higher fidelity compared to those trained via a Manual, indicating that interactive training methods may enhance the quality of therapy delivery.

Despite the differences in training methods, all clinicians effectively reduced anxiety symptoms in children with autism spectrum disorder (ASD), suggesting that the Facing Your Fears program can be successfully implemented across various training formats.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training clinicians to deliver group CBT to manage anxiety in youth with ASD: Results of a multisite trial. Reaven, J., Moody, EJ., Grofer Klinger, L., et al.[2019]

Cognitive-behavioral therapy (CBT) has shown significant efficacy in reducing anxiety in children and adolescents with high-functioning autism spectrum disorder (ASD), with effect sizes of 1.19 for clinician ratings and 1.21 for parent ratings based on a review of eight studies involving 469 participants.

The results indicate that both parent and clinician assessments are effective in measuring the impact of CBT on anxiety, while self-reported anxiety showed a moderate effect size of 0.68, suggesting that further studies are needed to explore CBT's effectiveness against more controlled conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for anxiety in children with high-functioning autism: a meta-analysis. Sukhodolsky, DG., Bloch, MH., Panza, KE., et al.[2022]

The review identified two probably efficacious cognitive-behavioral therapy (CBT) programs for treating anxiety disorders in children and youth with autism spectrum disorders (ASD), but no well-established programs were found.

The study highlights the need for further research to refine and establish the efficacy of CBT formats specifically designed for ASD populations, as current evidence shows variability in effectiveness among different program types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on the effectiveness of psychotherapy for anxiety disorders in children and adolescents with ASD. Hunsche, MC., Kerns, CM.[2020]

References

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

Cognitive-Behavioral Treatments for Anxiety and Stress-Related Disorders. [2022]

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

Psychotherapy for generalized anxiety disorder. [2022]

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

Cognitive therapy of anxiety disorders. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

An evaluation of Anxiety UK's psychological therapy service outcomes. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for anxiety disorders: an update on the empirical evidence. [2018]

6. Netherlands pubmed.ncbi.nlm.nih.gov

The moderating effects of anger suppression and anger expression on cognitive behavioral group therapy and mindfulness-based stress reduction among individuals with social anxiety disorder. [2021]

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

The use of cognitive-behavioral therapy in the University of Minnesota's outpatient psychiatry clinic. [2018]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy for generalized anxiety disorder. [2022]

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

Mindfulness and acceptance-based behavioral therapies for anxiety disorders. [2021]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of acceptance-based behavior therapy on severity of symptoms, worry and quality of life in women with generalized anxiety disorder. [2021]

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

Treatment of anxiety in autism spectrum disorders using cognitive behaviour therapy: A systematic review. [2022]

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

Effects of Cognitive Behavioral Therapy for Reducing Anxiety in Children with High Functioning ASD: A Systematic Review and Meta-Analysis. [2020]

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

Training clinicians to deliver group CBT to manage anxiety in youth with ASD: Results of a multisite trial. [2019]

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

Cognitive-behavioral therapy for anxiety in children with high-functioning autism: a meta-analysis. [2022]

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

Update on the effectiveness of psychotherapy for anxiety disorders in children and adolescents with ASD. [2020]