A Phase 3 interventional study of Computerized Cognitive Behavioral Therapy and Treatment as usual in Generalized Anxiety Disorder, Social Phobia and Separation Anxiety Disorder, sponsored by University of South Florida. Completed at 4 sites in United States. Open to participants aged 7 Years to 13 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-18.
Sponsored by University of South Florida · Phase 3, Interventional, and Treatment
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.
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.
517 studies on the registry are indexed under Generalized Anxiety Disorder; 124 are open to participants now.
This study's enrollment of 100 is above the median of 83 across 439 interventional studies indexed under Generalized Anxiety Disorder.
Browse Generalized Anxiety Disorder studies →University of South Florida is the lead sponsor of 340 studies on the registry; 65 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: Computerized Cognitive Behavioral Therapy
Behavioral: Treatment as usual
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.
PARS
Pediatric Anxiety Rating Scale (PARS)- The PARS (RUPP, 2002) is a clinician-rated scale assessing anxiety symptoms and the associated severity and impairment in children over the past week. The scale score ranges from 0 to 30 with higher scores reflecting worse anxiety. The score, ranging from 0-30 represents a total score by summing all 6 items (which have item response options ranking from 0 to 5 each).
Time frame: 14 Weeks
ADIS-C/P Clinical Severity Rating
Anxiety Disorders Interview Schedule for DSM-IV: Child and Parent Versions (ADIS-IV-C/P)- The ADIS-IV-C/P (Silverman \& Albano, 1996) is a clinician-administered, semi-structured interview that assesses for the presence and severity of DSM-IV anxiety disorders as well as Dysthymia and Major Depression, ADHD, Conduct Disorder, and Oppositional-Defiant Disorder. Excellent psychometric properties have been reported (e.g., Wood et al., 2002). The Clinical Severity Rating score is a one item metric reflecting the severity of the anxiety diagnosis. This is rated by the clinician based on their interview with the patient and parent, together with their judgment. The Rating ranges from 0 to 8 with higher scores reflecting worse anxiety.
Time frame: 14 weeks
| Milestone | Computerized Cognitive Behavioral Therapy | Treatment as Usual |
|---|---|---|
| Started | 49 | 51 |
| Completed | 45 | 47 |
| Not completed | 4 | 4 |
| Withdrew: Lost to follow-up | 4 | 4 |
Pediatric Anxiety Rating Scale (PARS)- The PARS (RUPP, 2002) is a clinician-rated scale assessing anxiety symptoms and the associated severity and impairment in children over the past week. The scale score ranges from 0 to 30 with higher scores reflecting worse anxiety. The score, ranging from 0-30 represents a total score by summing all 6 items (which have item response options ranking from 0 to 5 each).
| units on a scale | Computerized Cognitive Behavioral Therapy | Treatment as Usual |
|---|---|---|
| PARS | 11.4 ± 5.2 | 14.7 ± 4.9 |
Anxiety Disorders Interview Schedule for DSM-IV: Child and Parent Versions (ADIS-IV-C/P)- The ADIS-IV-C/P (Silverman \& Albano, 1996) is a clinician-administered, semi-structured interview that assesses for the presence and severity of DSM-IV anxiety disorders as well as Dysthymia and Major Depression, ADHD, Conduct Disorder, and Oppositional-Defiant Disorder. Excellent psychometric properties have been reported (e.g., Wood et al., 2002). The Clinical Severity Rating score is a one item metric reflecting the severity of the anxiety diagnosis. This is rated by the clinician based on their interview with the patient and parent, together with their judgment. The Rating ranges from 0 to 8 with higher scores reflecting worse anxiety.
| units on a scale | Computerized Cognitive Behavioral Therapy | Treatment as Usual |
|---|---|---|
| ADIS-C/P Clinical Severity Rating | 3 ± 1.3 | 4 ± 1.4 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Computerized Cognitive Behavioral Therapy | 0/49 (0%) | 0/49 (0%) | 0/49 (0%) |
| Treatment as Usual | 0/51 (0%) | 0/51 (0%) | 0/51 (0%) |
| Age, Categorical(Participants) | Computerized Cognitive Behavioral Therapy | Treatment as Usual | Total |
|---|---|---|---|
| <=18 years | 49 | 51 | 100 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Computerized Cognitive Behavioral Therapy | Treatment as Usual | Total |
|---|---|---|---|
| Mean | 9.4 ± 1.8 | 10.2 ± 1.8 | 9.82 ± 1.8 |
| Sex: Female, Male(Participants) | Computerized Cognitive Behavioral Therapy | Treatment as Usual | Total |
|---|---|---|---|
| Female | 23 | 21 | 44 |
| Male | 26 | 30 | 56 |
| Race (NIH/OMB)(Participants) | Computerized Cognitive Behavioral Therapy | Treatment as Usual | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 1 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 7 | 11 |
| White | 43 | 41 | 84 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 2 | 2 |
| Region of Enrollment(participants) | Computerized Cognitive Behavioral Therapy | Treatment as Usual | Total |
|---|---|---|---|
| United States | 49 | 51 | 100 |
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Generalized Anxiety Disorder →