Cognitive Behavioral Therapy for Anxiety and Depression in Autism

Overseen By Eric A Storch, Ph.D.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Must not be taking: Psychotropics, Stimulants, Benzodiazepines

Disqualifiers: Psychotic disorder, Conduct disorder, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of transdiagnostic cognitive behavioral therapy for autistic youth experiencing anxiety or depression. The trial compares this therapy to usual treatments to determine which is more effective. It targets children aged 12-17 with autism who have significant anxiety or depression symptoms and reside in Texas. The goal is to help these children manage their symptoms more effectively. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could enhance treatment options for autistic youth.

Do I have to stop taking my current medications for the trial?

If your child is taking psychotropic medications, they must have been on a stable dose for at least 6 weeks (or 2 weeks for stimulants/benzodiazepines) before starting the trial. If they recently started these medications, they may need to wait before participating.

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

Research shows that transdiagnostic cognitive behavioral therapy (CBT) is generally easy for people to handle. Studies have found that this therapy is safe for children and teenagers, even those with complex needs like autism, anxiety, or depression. For instance, in one study with 197 young participants, those who received this therapy attended an average of 11 sessions, indicating they could participate without major issues.

Feedback on the therapy's practicality and acceptance has been positive, showing that most participants find the sessions manageable and helpful. Although specific data on negative effects is lacking, the absence of reported problems in these studies suggests that serious safety concerns are unlikely.

Overall, transdiagnostic CBT seems to be a safe option for young people dealing with anxiety and depression, especially those on the autism spectrum. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Transdiagnostic Cognitive Behavioral Therapy (CBT) for anxiety and depression in autism because it offers a tailored approach that addresses multiple conditions simultaneously, unlike traditional therapies that often focus on one specific disorder. This therapy adapts CBT techniques to be more flexible and applicable across various emotional and behavioral issues, which is particularly valuable for individuals with autism who may experience overlapping symptoms. By providing a more inclusive and adaptable framework, this treatment has the potential to be more effective and efficient, offering improvements in both anxiety and depression with a single therapeutic approach.

What evidence suggests that transdiagnostic cognitive behavioral therapy might be an effective treatment for anxiety and depression in autism?

Research has shown that transdiagnostic cognitive behavioral therapy (CBT) effectively reduces anxiety and depression in young people. In this trial, some participants will receive transdiagnostic CBT, which studies indicate reduces anxiety symptoms more effectively than standard treatments. This therapy teaches skills to manage stress and negative thoughts, improving mood and coping abilities. It has been particularly helpful for children and teens with anxiety disorders, offering promise for autistic youth who often face similar challenges. Early findings suggest that transdiagnostic CBT can address multiple issues simultaneously, making it a flexible treatment option. Other participants in this trial will receive treatment as usual, serving as an active comparator. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for autistic adolescents aged 12-17 with significant anxiety and/or depression, based in Texas. They must have a diagnosis of autism confirmed by specific assessments and primary issues with anxiety or depression. A parent must participate, no current psychotherapy for these conditions, stable medication use, and sufficient English skills are required.

Inclusion Criteria

The child meets criteria for autism spectrum disorder using evidence-based assessment approaches (e.g., Autism Diagnostic Observation Schedule-Second Edition; Childhood Autism Rating Scale-Second Edition)

Anxiety/depressive disorder is the primary presenting problem as determined by administration of the Mini International Neuropsychiatric Interview

One parent/guardian is able and willing to participate

Exclusion Criteria

The child has limited verbal communication abilities

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

My child urgently needs help for severe thoughts of harming themselves or others.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pilot Intervention

Pilot intervention involving 12 adolescent-caregiver dyads to refine the treatment model and assessment measures

4-6 weeks

Randomized Controlled Trial

Randomized trial involving 100 adolescent-caregiver dyads to evaluate the clinical efficacy of the treatment

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transdiagnostic Cognitive Behavioral Therapy

Trial Overview The study is examining the impact of transdiagnostic cognitive behavioral therapy (CBT) on autistic youth with anxiety or depression compared to usual treatment methods. It aims to see if this tailored CBT approach can effectively reduce symptoms across both conditions.

How Is the Trial Designed?

Group I: Transdiagnostic cognitive behavioral therapy Experimental Treatment 1 Intervention

Group II: Treatment as usual Active Control 1 Intervention

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

Approved in United States as Cognitive Behavioral Therapy for:

• Post-Traumatic Stress Disorder (PTSD)
• Anxiety Disorders

Approved in European Union as Cognitive Behavioral Therapy for:

• Post-Traumatic Stress Disorder (PTSD)
• Anxiety Disorders
• Depression

Approved in Canada as Cognitive Behavioral Therapy for:

• Post-Traumatic Stress Disorder (PTSD)
• Anxiety Disorders

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Texas Higher Education Coordinating Board

Collaborator

Texas Higher Education Coordinating Board

Collaborator

Trials

4

Recruited

390+

Published Research Related to This Trial

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]

Transdiagnostic cognitive behavioral therapy (CBT) protocols have been developed to streamline treatment for affective disorders by combining overlapping components from various disorder-specific CBT approaches, potentially reducing the number of protocols needed.

These newer transdiagnostic treatments, such as group CBT for anxiety and the unified protocol for emotional disorders, aim to address multiple symptoms and comorbidities simultaneously, making CBT more accessible and cost-effective for both providers and patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Movement towards transdiagnostic psychotherapeutic practices for the affective disorders. Gros, DF., Allan, NP., Szafranski, DD.[2018]

Group transdiagnostic behavior therapy (TBT) was found to be feasible and effective for youths aged 16-19 with anxiety disorders, showing significant improvements in anxiety symptoms after 12 sessions.

While TBT led to moderate reductions in anxiety and stress, the effects on depression and overall impairment were less reliable, suggesting that further research with larger samples is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Findings for Group Transdiagnostic Behavior Therapy for Affective Disorders Among Youths. Gros, DF., Merrifield, C., Hewitt, J., et al.[2022]

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]

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]

Transdiagnostic cognitive-behavioral therapy (CBT) is an adaptable treatment that can effectively address a variety of anxiety and emotional disorders, potentially improving accessibility for patients.

Clinical trials and meta-analyses indicate that transdiagnostic CBT is as effective as traditional CBT, and may be particularly beneficial for individuals with multiple anxiety and emotional disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transdiagnostic Therapy. Norton, PJ., Roberge, P.[2018]

In a study involving 231 participants with anxiety disorders, combining transdiagnostic group cognitive-behavioral therapy (tCBT) with treatment-as-usual (TAU) significantly reduced anxiety symptoms compared to TAU alone, as measured by the Beck Anxiety Inventory and clinician severity ratings.

The results showed a substantial effect size (Cohen's d = 0.76 for BAI and 0.79 for ADIS-5), indicating that tCBT is an effective addition to standard care for improving anxiety disorder symptoms in community mental health settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group transdiagnostic cognitive-behavior therapy for anxiety disorders: a pragmatic randomized clinical trial. Roberge, P., Provencher, MD., Gaboury, I., et al.[2022]

Clinicians are significantly more likely to intend to use cognitive-behavioral therapy (CBT) for non-autistic adults compared to autistic adults, indicating a gap in treatment accessibility for autistic individuals.

The most important factor influencing clinicians' intentions to provide CBT to autistic adults is their attitudes towards this treatment, suggesting that improving clinician attitudes could enhance the adoption of CBT for autistic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors Influencing the Use of Cognitive-Behavioral Therapy with Autistic Adults: A Survey of Community Mental Health Clinicians. Maddox, BB., Crabbe, SR., Fishman, JM., et al.[2023]

A study involving 49 children with Autism Spectrum Disorder (ASD) showed that Cognitive Behavioural Therapy (CBT) significantly reduced anxiety, with 30% of participants free from their primary anxiety diagnoses after treatment.

While there were no significant differences in primary outcomes between the treatment and waitlist groups, secondary outcomes indicated meaningful improvements, suggesting that CBT is a feasible and potentially effective intervention for anxiety in children with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group Based Cognitive Behavioural Therapy for Anxiety in Children with Autism Spectrum Disorder: A Randomised Controlled Trial in a General Child Psychiatric Hospital Setting. Kilburn, TR., Sørensen, MJ., Thastum, M., et al.[2023]

In a study of 148 autistic youth aged 7-13 with anxiety disorders, the exposure phase of cognitive-behavioral therapy (CBT) led to significantly faster symptom reduction compared to the cognitive and psychoeducation phases, highlighting the effectiveness of exposure techniques in treating anxiety.

The findings suggest that cognitive strategies alone may slow down symptom improvement, indicating that therapists should prioritize moving quickly to exposure practices to enhance treatment efficacy for autistic youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Change during cognitive and exposure phases of cognitive-behavioral therapy for autistic youth with anxiety disorders. Guzick, AG., Schneider, SC., Kendall, PC., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05738967

Transdiagnostic Behavioral Therapy for Anxiety and ... About 1 in 54 adolescents are estimated to be on the autism spectrum, with over half suffering from anxiety or depressive disorders.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7758821/

Effectiveness of Transdiagnostic Cognitive-Behavioral ... Evidence suggests that cognitive-behavioral therapies (CBTs) are effective for the indicated prevention and treatment of childhood anxiety,4,5, ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0272735825001096

Together and beyond: A systematic review on ... Efficacy of transdiagnostic cognitive-behavioral group therapy for anxiety disorders and headache in adolescents. Journal of Anxiety Disorders, 46 (2017), pp ...

4. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2022.741039/full

Transdiagnostic Cognitive-Behavioral Therapy for ... Linear mixed models indicated that a significantly greater reduction in anxiety symptoms was evident in the UP group by comparison to the EUC group (GAD-7, p ...

5. acamh.onlinelibrary.wiley.com acamh.onlinelibrary.wiley.com/doi/10.1111/jcpp.12915

A randomized waitlist‐controlled trial of cognitive behavior ... The purpose of the present study was to examine the efficacy of a manualized and individually delivered 10-session, transdiagnostic CBT intervention.

6. sciencedirect.com sciencedirect.com/science/article/pii/S1077722925000434

Development and Pilot Testing of Transdiagnostic ... Although trials comparing transdiagnostic CBT to disorder-specific protocols have yielded inconsistent results favoring transdiagnostic CBT in ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6220772/

A randomized waitlist‐controlled trial of cognitive behavior ... The purpose of the present study was to examine the efficacy of a manualized and individually delivered 10-session, transdiagnostic CBT intervention.