Generalized Anxiety DisorderPhase 3NCT01416805
Computerized Cognitive Behavioral Therapy for Childhood Anxiety in Community Health Centers
A Phase 3 study testing Computerized Cognitive Behavioral Therapy and Treatment as usual in people with Generalized Anxiety Disorder and Social Phobia, run by University of South Florida at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Generalized Anxiety Disorder, Social Phobia, Separation Anxiety Disorder
- What is being tested?
- Computerized Cognitive Behavioral Therapy and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesUnited States
- Study dates
- Aug 2011to Dec 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Directions for Mental Health
Clearwater, Florida
Henderson Behavioral Health
Fort Lauderdale, Florida
Access Behavioral Health
Pensacola, Florida
Eric Storch
Tampa, Florida, 33629
About this study
Official title: Utilizing Health Information Technology to Improve Health Care Quality: Implementation of a Computerized Cognitive Behavioral Therapy Protocol for Childhood Anxiety
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.
Read the 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.
- Being tested
- Computerized Cognitive Behavioral Therapy, Treatment as usual
- Keywords
- childhood anxiety disorders, cognitive behavioral therapy, CBT, Generalized Anxiety Disorder, Social Phobia, Separation Anxiety Disorder, Psychotherapy, Counseling, Social Anxiety Disorder
- Medical subject headings
- Generalized Anxiety Disorder, Phobia, Social, Anxiety, Separation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized Cognitive Behavioral TherapyBehavioural
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.
Treatment as usualBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Computerized Cognitive Behavioral Therapy | Experimental | Not described Receives: Behavioral: Computerized Cognitive Behavioral Therapy |
| Treatment as Usual | Active comparator | Not described Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 14 Weeks
Secondary outcomes (1)
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.
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Access Behavioral Health, Henderson Behavioral Health, Directions for Mental Health
- Responsible party
- Sponsor
- Investigators
- Eric A Storch, Ph.D., Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01416805
- Sponsor's protocol ID
- 1R18HS018665
- Status last verified
- Mar 2019
- First submitted
- 11 Aug 2011
- Last updated
- 18 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Smarason O, Guzick AG, Goodman WK, Salloum A, Storch EA. Predictors and Moderators of Treatment Outcomes for Anxious Children Randomized to Computer-Assisted Cognitive Behavioral Therapy or Standard Community Care. J Child Adolesc Psychopharmacol. 2023 Oct;33(8):316-324. doi: 10.1089/cap.2023.0019.
PubMed 37861988Storch 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.
PubMed 26366886
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing Health Information Technology to Improve Health Care Quality: Implementation of a Computerized Cognitive Behavioral Therapy Protocol for Childhood Anxiety
- ClinicalTrials.gov ID
- NCT01416805
- Acronym / sponsor ID
- 1R18HS018665
- Keywords
- childhood anxiety disorders, cognitive behavioral therapy, CBT, Generalized Anxiety Disorder, Social Phobia, Separation Anxiety Disorder, Psychotherapy, Counseling
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- Access Behavioral Health, Henderson Behavioral Health, Directions for Mental Health
- Study start
- Aug 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 15 Aug 2011 (estimated)
- Results
- Posted 18 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computerized Cognitive Behavioral Therapy | Experimental | Behavioral: Computerized Cognitive Behavioral Therapy |
| Treatment as Usual | Active comparator | Behavioral: Treatment as usual |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computerized Cognitive Behavioral TherapyThose 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. | Behavioural | Computerized Cognitive Behavioral Therapy |
| Treatment as usualThose 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. | Behavioural | Treatment as Usual |
Primary outcome
PARS
Time frame: 14 Weeks
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).
1 secondary outcome
ADIS-C/P Clinical Severity Rating
Time frame: 14 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37861988Smarason O, Guzick AG, Goodman WK, Salloum A, Storch EA. Predictors and Moderators of Treatment Outcomes for Anxious Children Randomized to Computer-Assisted Cognitive Behavioral Therapy or Standard Community Care. J Child Adolesc Psychopharmacol. 2023 Oct;33(8):316-324. doi: 10.1089/cap.2023.0019.
- Derived from this study: PubMed 26366886Storch 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric A Storch, Ph.D. principal investigator
University of South Florida
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Computerized Cognitive Behavioral Therapy and Treatment as usual in people with Generalized Anxiety Disorder and Social Phobia, run by University of South Florida at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PARS (time frame: 14 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01416805, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2019.