Clinical trial NCT01416805: Computerized Cognitive Behavioral Therapy for Childhood Anxiety in Community Health Centers
Official title: Utilizing Health Information Technology to Improve Health Care Quality: Implementation of a Computerized Cognitive Behavioral Therapy Protocol for Childhood Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Generalized Anxiety Disorder
Social Phobia
Separation Anxiety Disorder
Keywords: childhood anxiety disorders
cognitive behavioral therapy
CBT
Generalized Anxiety Disorder
Social Phobia
Separation Anxiety Disorder
Psychotherapy
Counseling
Social Anxiety Disorder
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: Access Behavioral Health
name: Henderson Behavioral Health
name: Directions for Mental Health
First posted: 2011-08-15
Enrollment: 100
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: PARS
timeFrame: 14 Weeks
Secondary outcomes:
measure: ADIS-C/P Clinical Severity Rating
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Clearwater
country: United States
facility: Directions for Mental Health
state: Florida
city: Fort Lauderdale
country: United States
facility: Henderson Behavioral Health
state: Florida
city: Pensacola
country: United States
facility: Access Behavioral Health
state: Florida
city: Tampa
country: United States
facility: Eric Storch
state: Florida
Study officials:
affiliation: University of South Florida
name: Eric A Storch, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Storch EA, Salloum A, King MA, Crawford EA, Andel R, McBride NM, Lewin AB. A RANDOMIZED CONTROLLED TRIAL IN COMMUNITY MENTAL HEALTH CENTERS OF COMPUTER-ASSISTED COGNITIVE BEHAVIORAL THERAPY VERSUS TREATMENT AS USUAL FOR CHILDREN WITH ANXIETY. Depress Anxiety. 2015 Nov;32(11):843-52. doi: 10.1002/da.22399. Epub 2015 Sep 14.