Computerized Cognitive Behavioral Therapy for Childhood Anxiety in Community Health Centers
Condition: Generalized Anxiety Disorder; Social Phobia; Separation Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social; Anxiety, Separation
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will examine the efficacy of a computerized cognitive behavioral therapy (CCBT)
      program for children with anxiety disorders in community health centers. The first phase of
      the study will offer insight into the feasibility of providing this intervention in community
      health centers, while the second phase will compare CCBT to treatment as usual.
    

Detailed description: 
      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.
    

Intervention name(s): Computerized Cognitive Behavioral Therapy; Treatment as usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Those who choose to participate will be enrolled in the 14 week study (18 weeks for phase II). They will required to attend 3 assessments - pre-treatment (week 0), mid-treatment (week 8), and post-treatment (week 14) (and a 4th assessment for a 1 month Follow-up for Phase II at week 18). This group will follow the CCBT protocol (Camp Cope-A-lot), which is the computer-assisted intervention for anxious children being examined in this study. The first 6 levels of this program are skill building levels to be completed by the user in his/her own home. The remaining 6 levels are completed with the therapist and consist of exposure tasks and rehearsal geared toward each child.; Those who choose to participate will be enrolled in the 14 week study (18 weeks for phase II). They will required to attend 3 assessments - pre-treatment (week 0), mid-treatment (week 8), and post-treatment (week 14) (and a 4th assessment for a 1 month Follow-up for Phase II at week 18). Those in this group will not receive the CCBT, and instead will undergo therapy for their anxiety as they usually would, whether by using medication or working with a therapist.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: childhood anxiety disorders; cognitive behavioral therapy; CBT; Generalized Anxiety Disorder; Social Phobia; Separation Anxiety Disorder; Psychotherapy; Counseling; Social Anxiety Disorder