Improving Access to Child Anxiety Treatment (IMPACT)

B

Bradley Hospital

Status

Enrolling

Conditions

Social Anxiety
Obsessive-Compulsive Disorder
Pediatric Disorder
Selective Mutism
Anxiety
Anxiety Disorders
Separation Anxiety
OCD
Panic Disorder
Generalized Anxiety Disorder
Social Anxiety Disorder
Agoraphobia
Generalized Anxiety
Phobia

Treatments

Behavioral: Exposure Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03528109
IHS-2017C1-6400

Details and patient eligibility

About

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.

Full description

Anxiety disorders are a significant public health problem that cause suffering for youth and their families, derail normal childhood development, and when left untreated persist into adulthood with high societal costs. Cognitive Behavioral Treatment (CBT) including exposure therapy is the treatment of choice, yet multiple barriers limit access to care. Even for families with access to care, traditional provider-centered (office based) treatment presents challenges and can limit effectiveness for many youth and families. Home- and Community-based exposure therapy is efficacious for patients who previously did not improve with provider-centered services, and input from family stakeholders suggests that treatment in these settings is an optimal match for their needs. Patient-centered models involving home visits and provider teams have consistently demonstrated increased treatment accessibility and engagement. However, there has been no comprehensive comparison of exposure delivered by patient-centered teams using home visits versus by provider-centered office visits alone for childhood anxiety. The absence of comparative effectiveness research (CER) data impedes targeted use of patient centered versus traditional outpatient treatment and would better allocate limited resources, provide the best quality care, and help patients and families make educated decisions about their treatment choices. Telehealth has strong evidence for effectiveness for youth with anxiety and OCD when delivered by a licensed provider, with treatment responder rates ranging from 73-82% (Carpenter, et al., 2018; Comer et al., 2017; Storch et al., 2011). Although traditional telehealth treatments can address barriers associated with in-person treatment, it has yet to be leveraged to increase service capacity. The overall goal of this proposal is to compare two models of service delivery, patient-centered delivery (utilizing novel deployment of personnel both in-home and via telehealth, patient-centered telehealth closed as of 5/1/21) vs. traditional provider-centered delivery, of CBT in youth ages 5-18 receiving exposure therapy for anxiety. A total of 379 children will be treated, with 166 (or 167) children randomly assigned to provider-centered, 166 (or 167) assigned to patient-centered in-home, and 46 assigned to patient-centered telehealth treatment conditions. The patient-centered telehealth condition was added in 2020 in response the COVID-19 global pandemic and closed when the recruitment goal was reached in May 2021. Telehealth treatment models are a necessary health system adaptation in the current health crisis, but also may improve access to care post pandemic. We hope including telehealth as a comparator in our service delivery compared effectiveness trial will be highly informative and relevant for the future mental healthcare landscape. A trained independent evaluator (IE) blind to condition will measure patient and family treatment engagement, anxiety symptoms/severity, and functional impairment at baseline, during active treatment at weeks 6, 12, 18, and 24, and 3- and 6-month follow-up after acute treatment. The primary aims are to compare the relative effectiveness of patient-centered vs. provider-centered treatment for: 1) improving family treatment engagement/satisfaction, 2) reducing anxiety symptoms, and 3) reducing associated disability (quality of life and functional impairment). Secondary outcomes are to understand moderators of treatment response including: severity of illness, caregiver burden/family accommodation, and barriers to treatment access and to explore group differences in time course of response, durability of treatment gains, provider volume/capacity and efficiency in patient centered versus provider centered treatment.

Enrollment

379 estimated patients

Sex

All

Ages

5 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • age 5-18 inclusive
  • primary or co-primary DSM-V diagnosis of anxiety or OCD
  • symptom duration of at least 3 months
  • outpatient care needed
  • presence of a stable parent, or guardian, who can participate in treatment

Exclusion criteria

  • other primary or co-primary psychiatric disorder which requires initiation of other active current treatment
  • documented mental retardation
  • thought disorder or psychotic symptoms
  • conduct disorder
  • acute suicidality
  • concurrent psychotherapy
  • chronic medical illness that would preclude their active participation in treatment
  • treatment with psychotropic medication that is not stable

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

379 participants in 3 patient groups

patient-centered home CBT
Experimental group
Description:
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)
Treatment:
Behavioral: Exposure Therapy
Provider-centered
Active Comparator group
Description:
60 minute office-based exposure therapy with a PhD psychologist four times per month (once per week)
Treatment:
Behavioral: Exposure Therapy
patient-centered telehealth CBT
Experimental group
Description:
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.
Treatment:
Behavioral: Exposure Therapy

Trial contacts and locations

1

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Central trial contact

Jennifer Freeman, PhD; Kate Sheehan, BS

Data sourced from clinicaltrials.gov

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