DepressionPhase 2NCT00669526
Clinical and Cost Effectiveness of Brief Cognitive-Behavioral Therapy (CBT) for Pediatric Internalizing Disorders
A Phase 2 study testing BCBT and SMHC referral in people with Depression and Anxiety, run by Robert Wood Johnson Foundation at 1 site in United States.
Trial summary
This project assesses the clinical and cost effectiveness of brief cognitive-behavioral therapy (CBT) for depressed (ages 11-17) and anxious (ages 8-17) youths seen for services in pediatric primary care. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- BCBT and SMHC referral
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Apr 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ages 11 to 17 years
- Meet diagnostic criteria for Major Depression, Dysthymia, or Minor Depression
- Live with a legal guardian
- Ages 7 to 17 years
- Meet full or probable (missing one, non-core symptom) diagnostic criteria for Separation Anxiety Disorder, Generalized Anxiety Disorder, Social Phobia, or Specific Phobia
- Live with a legal guardian
Who cannot join
- Require treatment other than brief CBT (namely, youths with bipolar disorder, psychosis, active suicidal ideation with plan, post-traumatic stress disorder, substance dependence, or mental retardation
- Experience of recent physical or sexual maltreatment
- Serious or unstable physical illness
- Current participation in an alternate, active intervention for the target condition of interest
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Clinical and Cost Effectiveness of Brief CBT for Pediatric Internalizing Disorders
This project assesses the clinical and cost effectiveness of brief cognitive-behavioral therapy (CBT) for depressed (ages 11-17) and anxious (ages 8-17) youths seen for services in pediatric primary care. This study is designed to compare the impact of brief CBT delivered on-site in pediatric primary care to referral to specialty mental health care (SMHC), as well as obtain an estimate of the total costs of the CBT protocols for depression and anxiety and the cost-effectiveness of the protocols compared to referral to and utilization of SMHC services.
- Conditions
- Depression, Anxiety
- Being tested
- BCBT, SMHC referral
- Keywords
- anxiety, depression, Major Depressive Disorder, child, adolescent, CBT, Cognitive-Behavioral Therapy, primary care
- Medical subject headings
- Depression, Anxiety Disorders, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCBTBehavioural
Also called CBT, Cognitive-Behavioral Therapy
Brief Cognitive Behavioral Therapy. This BCBT protocol consists of up to 8 CBT sessions to be conducted over a maximum of 12 weeks.
SMHC referralBehavioural
Referral to local Speciality Mental Health Care. Families were referred to local mental health care providers, and could freely choose any treatment or combination of treatments offered (e.g., anti-depressant medication, individual psychotherapy, family psychotherapy, etc.).
| Study group | Role | What they receive |
|---|---|---|
| SMHC referral | Active comparator | Referral to local Specialty Mental Health Care Services Receives: Behavioral: SMHC referral |
| BCBT | Experimental | Brief Cognitive Behavioral Therapy Receives: Behavioral: BCBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Global Impressions - Improvement (CGI-I)
Measured: weeks 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2008 (estimated)
- Study startOct 2004
- Primary completionMar 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert Wood Johnson Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), William T. Grant Foundation
- Investigators
- V. Robin Weersing, Ph.D., Principal investigator, SDSU/UCSD Joint Doctoral Program in Clinical Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00669526
- Sponsor's protocol ID
- 051653
- Status last verified
- Apr 2008
- First submitted
- 28 Apr 2008
- Last updated
- 30 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Weersing, V. R., Gonzalez, A., Campo, J. V., & Lucas, A. N. Brief Behavioral Therapy for Pediatric Anxiety and Depression: Piloting an Integrated Treatment Approach. Cognitive and Behavioral Practice (in press), 2008.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Cost Effectiveness of Brief CBT for Pediatric Internalizing Disorders
- ClinicalTrials.gov ID
- NCT00669526
- Acronym / sponsor ID
- 051653
- Conditions
- Depression, Anxiety
- Keywords
- anxiety, depression, Major Depressive Disorder, child, adolescent, CBT, Cognitive-Behavioral Therapy, primary care
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Robert Wood Johnson FoundationUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), William T. Grant Foundation
- Study start
- Oct 2004
- Primary completion
- Mar 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 30 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project assesses the clinical and cost effectiveness of brief cognitive-behavioral therapy (CBT) for depressed (ages 11-17) and anxious (ages 8-17) youths seen for services in pediatric primary care. This study is designed to compare the impact of brief CBT delivered on-site in pediatric primary care to referral to specialty mental health care (SMHC), as well as obtain an estimate of the total costs of the CBT protocols for depression and anxiety and the cost-effectiveness of the protocols compared to referral to and utilization of SMHC services.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMHC referral | Active comparator | Behavioral: SMHC referralReferral to local Specialty Mental Health Care Services |
| BCBT | Experimental | Behavioral: BCBTBrief Cognitive Behavioral Therapy |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Ages 11 to 17 years
- Meet diagnostic criteria for Major Depression, Dysthymia, or Minor Depression
- Live with a legal guardian
- Ages 7 to 17 years
- Meet full or probable (missing one, non-core symptom) diagnostic criteria for Separation Anxiety Disorder, Generalized Anxiety Disorder, Social Phobia, or Specific Phobia
Key exclusion criteria (4 listed)
- Require treatment other than brief CBT (namely, youths with bipolar disorder, psychosis, active suicidal ideation with plan, post-traumatic stress disorder, substance dependence, or mental retardation
- Experience of recent physical or sexual maltreatment
- Serious or unstable physical illness
- Current participation in an alternate, active intervention for the target condition of interest
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 |
|---|---|---|
| BCBTAlso: CBT, Cognitive-Behavioral TherapyBrief Cognitive Behavioral Therapy. This BCBT protocol consists of up to 8 CBT sessions to be conducted over a maximum of 12 weeks. | Behavioural | BCBT |
| SMHC referralReferral to local Speciality Mental Health Care. Families were referred to local mental health care providers, and could freely choose any treatment or combination of treatments offered (e.g., anti-depressant medication, individual psychotherapy, family psychotherapy, etc.). | Behavioural | SMHC referral |
Primary outcome
Clinician Global Impressions - Improvement (CGI-I)
Time frame: weeks 12 and 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2008.
- BackgroundWeersing, V. R., Gonzalez, A., Campo, J. V., & Lucas, A. N. Brief Behavioral Therapy for Pediatric Anxiety and Depression: Piloting an Integrated Treatment Approach. Cognitive and Behavioral Practice (in press), 2008.
- The National Institute of Mental Health (NIMH) is the largest scientific organization in the world dedicated to research focused on the understanding, treatment, and prevention of mental disorders and the promotion of mental health.Link provided by the sponsor.
- The Robert Wood Johnson Foundation (RWJF) focuses on the pressing health and health care issues facing our country.Link provided by the sponsor.
- William T. Grant Foundation's mission focuses on improving the lives of youth ages 8 to 25 in the United States. We accomplish this by providing grants primarily for high-quality empirical studies.Link provided by the sponsor.
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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.
V. Robin Weersing, Ph.D. principal investigator
SDSU/UCSD Joint Doctoral Program in Clinical Psychology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BCBT and SMHC referral in people with Depression and Anxiety, run by Robert Wood Johnson Foundation at 1 site 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 6 inclusion and 4 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 30 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinician Global Impressions - Improvement (CGI-I) (time frame: weeks 12 and 24). 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 NCT00669526, which also lists 1 linked publication.
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 30 Apr 2008.