Exposure Therapy for Child Anxiety

(IMPACT Trial)

Overseen By Jennifer Freeman, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Bradley Hospital

Must not be taking: Psychotropic medication

Disqualifiers: Thought disorder, Psychotic symptoms, Conduct disorder, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 24 weeks

379 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

There is strong evidence that cognitive behavioral therapy (CBT) with exposure is the preferred treatment for youth with anxiety disorders, but outpatient services that provide this type of treatment are limited. Even for those who do have access to anxiety-specific treatment, a traditional outpatient model of treatment delivery may not be suitable. Among the numerous logistical barriers to treatment access and response is the inability to generalize treatment tools to settings outside of the office. Patient-centered (home-based or telehealth; patient-centered telehealth closed as of 5/1/21) treatment models that target symptoms in the context in which they occur could be more effective, efficient, and accessible for families. The present study aims to compare the efficacy, efficiency, and feasibility of patient centered home-based CBT and patient centered telehealth CBT with a traditional office-based model of care. The question proposed, including proposed outcomes, have been generated and developed by a group of hospital, payer, patient and family stakeholders who will also contribute to the iterative process of protocol revision. The investigators anticipate 379 anxious youth to be randomized to receive outpatient treatment using telehealth (patient-centered telehealth closed as of 5/1/21), home-based services, or treatment as usual using a traditional outpatient model. Results of this study are expected to provide evidence for the efficacy and efficiency of patient-centered treatment, as well as increase treatment access and family engagement in the treatment process.

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

The trial does not specify if you must stop taking your current medications. However, if you are on psychotropic medication, it must be stable to participate.

What safety data exists for exposure therapy for child anxiety?

The provided research primarily focuses on prolonged exposure therapy (PE) for PTSD in adults, particularly in military personnel and female assault victims. While these studies highlight PE as an effective treatment, they also mention concerns about potential symptom worsening, which may deter clinicians from using it. However, specific safety data for exposure therapy in child anxiety is not directly addressed in these studies. ^{1 2 3 4 5}

Is Exposure Therapy a promising treatment for child anxiety?

Yes, Exposure Therapy is a promising treatment for child anxiety. It is a well-established method that helps people face their fears in a safe way, which can reduce anxiety over time. This approach has been shown to be effective in treating anxiety and stress-related issues. ^{1 2 3 5 6}

What data supports the idea that Exposure Therapy for Child Anxiety is an effective treatment?

The available research shows that Exposure Therapy, especially when combined with parent coaching, leads to significant improvements in children with anxiety disorders. One study found that children who received parent-coached exposure therapy showed greater improvement compared to those who received traditional cognitive behavioral therapy. This improvement was maintained even after three months, suggesting that Exposure Therapy can be more effective and require fewer sessions. Additionally, another study highlighted that community therapists who used exposure-focused treatment protocols increased their use of evidence-based treatment, although the quality of exposure needs to be improved for better outcomes. Compared to psychoanalytic therapy, which showed moderate improvements, Exposure Therapy appears to offer more immediate and significant benefits for treating child anxiety. ^{7 8 9 10 11}

Who Is on the Research Team?

Jennifer Freeman, PhD

Principal Investigator

Warren Alpert Medical School of Brown University

Are You a Good Fit for This Trial?

This trial is for children and teens aged 5-18 with anxiety or OCD, who need outpatient care. They must have had symptoms for at least 3 months and a stable parent or guardian to participate in treatment. It's not for those with certain psychiatric disorders, unstable medication use, acute suicidality, or other concurrent psychotherapy.

Inclusion Criteria

You have a responsible and stable parent or guardian who can be involved in your treatment.

I have been diagnosed with anxiety or OCD as my main health issue.

I need medical care but can go home after.

Exclusion Criteria

I am starting treatment for another major mental health condition.

You have symptoms of severe confusion or seeing or hearing things that aren't real.

You have a conduct disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cognitive behavioral therapy (CBT) for anxiety and OCD through different delivery models: patient-centered home-based, patient-centered telehealth, and provider-centered office-based.

24 weeks

4 visits per month (combination of in-person and telehealth)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Exposure Therapy

Trial Overview The study tests how well cognitive behavioral therapy (CBT) with exposure works when done at home or via telehealth compared to the traditional office-based approach. The goal is to see which method helps youth with anxiety more effectively and makes treatment easier to access.

How Is the Trial Designed?

Group I: patient-centered telehealth CBT Experimental Treatment 1 Intervention

60 minute telehealth exposure therapy with a PhD psychologist once per month and a 90 minute telehealth CBT with a mobile exposure coach three times per month for a total of four visits per month (once per week). Patient-centered telehealth was closed when the recruitment goal was met in May 2021.

Group II: patient-centered home CBT Experimental Treatment 1 Intervention

60 minute office-based exposure therapy with a PhD psychologist once per month and a 90 minute community-based CBT with a mobile exposure coach three times per month for a total of four visits per month (once per week)

Group III: Provider-centered Active Control 1 Intervention

60 minute office-based exposure therapy with a PhD psychologist four times per month (once per week)

Exposure Therapy is already approved in United States for the following indications:

Approved in United States as Prolonged Exposure Therapy for:

• Posttraumatic Stress Disorder (PTSD)

Who Is Running the Clinical Trial?

Bradley Hospital

Lead Sponsor

Trials

22

Recruited

1,900+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Brown University

Collaborator

Trials

480

Recruited

724,000+

Published Research Related to This Trial

Long-term follow-up (8 to 13 years post-treatment) of 67 participants showed that exposure-based cognitive behavioral therapy (CBT) for phobic and anxiety disorders in children and adolescents resulted in sustained remission of targeted anxiety symptoms into young adulthood.

The study found that both group and individual treatment approaches yielded similar long-term benefits, indicating that the effectiveness of exposure-based CBT extends beyond initial treatment, helping to maintain mental health during critical developmental years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral treatment for childhood anxiety disorders: long-term effects on anxiety and secondary disorders in young adulthood. Saavedra, LM., Silverman, WK., Morgan-Lopez, AA., et al.[2021]

In a preliminary trial with 14 children aged 7 to 14, both cognitive behavioral therapy (CBT) and parent-coached exposure therapy were found to be safe and effective for treating childhood anxiety disorders, with significant improvements observed in both groups.

Parent-coached exposure therapy showed greater effectiveness than traditional CBT, with moderate to large effect sizes for most measures, and it required fewer appointments while maintaining its benefits over a three-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility of improving CBT for childhood anxiety disorders through a dismantling study. Whiteside, SP., Ale, CM., Young, B., et al.[2018]

A brief training using the Anxiety Coach application helped 17 community therapists become more open to and use exposure therapy techniques with 32 youth aged 8-18, indicating that technology-assisted training can enhance therapists' willingness to adopt evidence-based practices.

Despite the increased use of exposure therapy, the study found no significant improvement in patient symptoms, suggesting that simply increasing the quantity of exposure is not enough; the quality and intensity of the exposure techniques used also need to be addressed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Technology to Promote Therapist Use of Exposure Therapy for Childhood Anxiety Disorders: A Randomized Pilot Study. Whiteside, SPH., Biggs, BK., Ollendick, TH., et al.[2023]

In a study involving 86 children and adolescents undergoing psychoanalytic psychotherapy, moderate improvements in anxiety symptoms were reported at the end of treatment, with effects becoming more pronounced at a 1-year follow-up.

Long-term psychoanalytic therapy was found to be effective in reducing anxiety pathology and enhancing quality of life, showing that the benefits of treatment are stable over time, even when compared to a wait-list control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effectiveness of Psychoanalytic Psychotherapy for Children and Adolescents with Severe Anxiety Psychopathology in a Naturalistic Treatment Setting]. Weitkamp, K., Daniels, JK., Baumeister-Duru, A., et al.[2019]

The SmartCAT mobile health platform, designed to support brief cognitive behavioral therapy (BCBT) for child anxiety, was found to be feasible and well-received by both therapists and youth participants in a pilot study involving nine children aged 9-14.

Participants rated the SmartCAT app as highly usable, completing an average of 5.36 skills coach entries per session, suggesting that integrating mobile technology can enhance engagement and practice of CBT skills in real-life situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The SmartCAT: an m-health platform for ecological momentary intervention in child anxiety treatment. Pramana, G., Parmanto, B., Kendall, PC., et al.[2022]

Prolonged Exposure (PE) therapy is a safe and effective treatment for PTSD, with a study of 361 female assault survivors showing no reliable worsening of PTSD symptoms and low rates of depression worsening among those who received PE.

Participants receiving PE and other active treatments demonstrated significant improvements in PTSD and depression compared to those on a waitlist, highlighting the importance of treatment in preventing symptom deterioration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primum non nocere (first do no harm): symptom worsening and improvement in female assault victims after prolonged exposure for PTSD. Jayawickreme, N., Cahill, SP., Riggs, DS., et al.[2014]

A study involving 160 active-duty military personnel with PTSD found that 60-minute prolonged exposure (PE) therapy sessions are just as effective as the standard 90-minute sessions, making treatment more accessible in settings that typically use shorter appointment times.

Both the Clinician Administered PTSD Scale (CAPS-5) and the PTSD Checklist (PCL-5) showed that the efficacy of 60-minute sessions was noninferior to 90-minute sessions, suggesting that shorter sessions can be effectively implemented without compromising treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of 90-min versus 60-min sessions of prolonged exposure for PTSD: A randomized controlled trial in active-duty military personnel. Foa, EB., Bredemeier, K., Acierno, R., et al.[2022]

Providers who received post-workshop consultation after a 4-day prolonged exposure therapy (PE) training reported significantly higher self-efficacy and used more components of PE, leading to better treatment delivery.

Patients treated by providers with post-workshop consultation experienced faster reductions in PTSD symptoms and lower severity at follow-up assessments, indicating that ongoing support for providers can enhance patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of a prolonged exposure workshop with and without consultation on provider and patient outcomes: a randomized implementation trial. Foa, EB., McLean, CP., Brown, LA., et al.[2022]

Participants in a study of web-based prolonged exposure therapy (Web-PE) for PTSD reported positive experiences, highlighting the flexibility of online therapy as a significant benefit, despite initial skepticism about its effectiveness.

The study, involving 29 active duty military personnel and veterans, indicated that while self-motivation was crucial for engagement, participants appreciated the support from therapists and suggested improvements for the program, pointing to favorable perceptions of Web-PE overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceptions and experiences of web-prolonged exposure for posttraumatic stress disorder: A mixed-methods study. McLean, CP., Miller, ML., Dondanville, KA., et al.[2022]

Prolonged exposure therapy (PE) is recognized as the most scientifically validated treatment for post-traumatic stress disorder (PTSD), outperforming various pharmacological and psychotherapeutic options.

The therapy includes both imaginal and in vivo exposure techniques, and the paper discusses its effectiveness and dissemination specifically in Japan, highlighting its importance in treating chronic PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prolonged Exposure Therapy for Post-traumatic Stress Disorder]. Asukai, N.[2018]

The READY online toolkit for exposure therapy was accessed by 1,731 unique users and had 13,543 page views in its first three years, indicating some level of interest among clinicians.

Despite the initial usage, the impact of READY was limited due to low return visits by users, suggesting that while online resources can support exposure therapy, further refinements are needed to enhance their effectiveness and utility for clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Implementation Outcomes of a Free Online Toolkit to Support Exposure Therapy Implementation for Youth. Becker-Haimes, EM., Wislocki, K., Schriger, SH., et al.[2023]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Cognitive behavioral treatment for childhood anxiety disorders: long-term effects on anxiety and secondary disorders in young adulthood. [2021]

2. England pubmed.ncbi.nlm.nih.gov

The feasibility of improving CBT for childhood anxiety disorders through a dismantling study. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Using Technology to Promote Therapist Use of Exposure Therapy for Childhood Anxiety Disorders: A Randomized Pilot Study. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

[Effectiveness of Psychoanalytic Psychotherapy for Children and Adolescents with Severe Anxiety Psychopathology in a Naturalistic Treatment Setting]. [2019]

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

The SmartCAT: an m-health platform for ecological momentary intervention in child anxiety treatment. [2022]

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

Primum non nocere (first do no harm): symptom worsening and improvement in female assault victims after prolonged exposure for PTSD. [2014]

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

The efficacy of 90-min versus 60-min sessions of prolonged exposure for PTSD: A randomized controlled trial in active-duty military personnel. [2022]

8. England pubmed.ncbi.nlm.nih.gov

The effects of a prolonged exposure workshop with and without consultation on provider and patient outcomes: a randomized implementation trial. [2022]

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

Perceptions and experiences of web-prolonged exposure for posttraumatic stress disorder: A mixed-methods study. [2022]

10. Japan pubmed.ncbi.nlm.nih.gov

[Prolonged Exposure Therapy for Post-traumatic Stress Disorder]. [2018]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Preliminary Implementation Outcomes of a Free Online Toolkit to Support Exposure Therapy Implementation for Youth. [2023]