Computerized Cognitive Behavioral Therapy for Childhood Anxiety in Community Health Centers

Childhood anxiety disorders are quite common and associated with significant psychosocial
impairment and distress. Offering equivalent efficacy to pharmacotherapy without the common
side effect profile, cognitive behavioral therapy (CBT) is a first line treatment for anxiety
disorders in youth. However, dissemination of CBT to community settings is very limited.
Effective treatment via traditional CBT often necessitates that the patient travel to a
center that specializes in this treatment, and cost can prove an impediment to those of lower
socioeconomic status, in particular. As well, differing theoretical approaches and training
result in a minority of children with anxiety receiving evidence-based CBT. Accordingly,
there is a great need for more widely accessible practices. As such, we are proposing a two
phase trial that evaluates the feasibility of implementing a patient-centered intervention in
community mental health centers, followed by an efficacy trial. In Phase I, an open trial of
computerized CBT (CCBT) will be completed that focuses on feasibility issues of providing
this intervention in community mental health centers. Thereafter, we will complete a
randomized controlled trial comparing CCBT to treatment as usual (TAU) in Phase II. The open
trial will recruit 18 youth ages 7 to 13 years, with the purpose of testing both practicality
and management of an already developed CCBT protocol (Kendall & Khanna, 2008). The outcome
trial will recruit 110 youth, with the purpose of measuring the efficacy of the CCBT protocol
in front-line settings. Significantly greater symptom reductions in the CCBT group as
compared to the TAU group would provide critical evidence for the inclusion of CCBT as a
treatment option for anxious youth without immediate access to such in-person care. While
this study will be coordinated by the University of South Florida Rothman Center for
Neuropsychiatry team who is located at All Children's Hospital (USF/ACH), recruitment will
take place at three community mental health centers throughout Florida that serve families of
lower socioeconomic status. Primary outcomes will be assessed by an independent evaluator,
and will include change in anxiety symptom severity; response rates; and remission rates.
CCBT will follow the Kendall and Khanna (2008) manual with appropriate integrity checks. The
implications of this study are significant, as computerized CBT may enable widespread
dissemination of efficacious therapy for anxiety disorders among youth.

Inclusion Criteria:

- Outpatient boys and girls with an anxiety disorder (see below) aged 7-13 years.

- Meets DSM-IV criteria for a diagnosis of one of the following anxiety disorders:
separation anxiety disorder (SAD), generalized anxiety disorder (GAD), or social
phobia.

- Minimum score of 14 on the PARS Severity Scale.

- The child has a Full Scale IQ greater than 80 as assessed on the Wechsler Abbreviated
Scale of Intelligence.

- Have home access to a computer with internet connection.

Exclusion Criteria:

- Receiving concurrent psychotherapy or other counseling services.

- New Treatments: Initiation of an antidepressant within 12 weeks before study
enrollment or an antipsychotic 6 weeks before study enrollment. No new alternative
medications, nutritionals or therapeutic diets within 6 weeks of study enrollment.
However, pharmacological interventions may be initiated or added if the child is
randomized to the Treatment as Usual arm in Phase II.

- Established Treatment changes: Any change in established psychotropic medication
(e.g., antidepressants, anxiolytics) within 8 weeks before study enrollment (6 weeks
for antipsychotic). Alternative medications that might have behavioral effects must be
stable for 6 weeks prior to the study baseline assessment. Any medications that the
child is on must remain stable during treatment unless s/he is randomized to the
Treatment as Usual arm in Phase II.

- (a) Current clinically significant suicidality or (b) individuals who have engaged in
suicidal behaviors within 6 months.

- Lifetime DSM-IV bipolar disorder, schizophrenia, or schizoaffective disorder.

- Unwillingness of parents to make the commitment to accompany their children for study
visits/assessments.

- Presence of a significant and/or unstable medical illness which might lead to
hospitalization during the study.