AnxietyBCBT-PCNCT01147614

Brief Cognitive Behavioral Therapy (CBT) for Pediatric Anxiety and Depression in Primary Care

A study testing Brief Cognitive Behavioral Therapy (BCBT) and Specialty mental health care referral (SMHC) in people with Anxiety and Depression, run by San Diego State University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine whether a brief (12 week) psychological treatment program, based in primary care, can help youths struggling with anxiety and/or depression. This brief cognitive behavioral therapy program will be compared to enhanced referral to specialty mental health care. Read more about this study

Who is it for?: Ages 8 to 16 years
Conditions the study is for: Anxiety, Depression
What is being tested?: Brief Cognitive Behavioral Therapy (BCBT) and Specialty mental health care referral (SMHC)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 185 participants
Where: 2 sitesUnited States
Study dates: Sep 2010to Apr 2016
Phase: Interventional
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 8 to 16 years
All sexes
No healthy volunteers
Child

Who may be able to join

meet full or probable diagnostic criteria for Separation Anxiety Disorder, Generalized Anxiety Disorder, Social Phobia, Major Depression, Dysthymic Disorder, or Minor Depression
age 8.0 to 16.9
live with legal, consenting guardian for at least 6 months

Who cannot join

youths requiring alternate intervention (e.g., youths with bipolar disorder, psychosis, active suicidal ideation with plan, PTSD, substance dependence, current physical or sexual abuse, or mental retardation
suffer from serious or unstable physical illness (e.g., uncontrolled diabetes)
currently in active, alternate intervention for anxiety or depression (e.g., antidepressant use)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Western Psychiatric Institute and Clinics
Pittsburgh, Pennsylvania, 15213
San Diego State University
San Diego, California, 92120

Other trials in United States

About this study

Official title: Brief CBT for Pediatric Anxiety and Depression in Primary Care

Read the detailed description

Mood and anxiety disorders in childhood and adolescence are disabling, distressing, and prevalent and produce added costs to health systems. This two-site randomized controlled trial will test the effects of a brief cognitive behavioral therapy (BCBT) protocol (8-12 sessions) in a large sample (N=210) of children and adolescents (age 8-16) presenting with anxiety and/or depression in primary care. Clinical and cost-effectiveness of BCBT will be compared to a plausible public health alternative - enhanced referral to specialty mental health care (SMHC). This investigation is noteworthy in adopting a deployment-focused model and testing this intervention early in its development within a real world context (primary care) and against a plausible public health comparison condition (SMHC) relevant for future treatment dissemination.

Conditions: Anxiety, Depression
Being tested: Brief Cognitive Behavioral Therapy (BCBT), Specialty mental health care referral (SMHC)
Keywords: Child, adolescent, anxiety, depression, internalizing, cognitive behavioral therapy, pediatric primary care
Medical subject headings: Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Brief Cognitive Behavioral Therapy (BCBT)Behavioural
Also called BCBT
BCBT: 8-12 sessions over 16 weeks of cognitive-behavioral therapy administered by Master's-level clinicians in primary care setting
Specialty mental health care referral (SMHC)Behavioural
Also called SMHC
SMHC: specialty mental health care referrals provided

Study groups in NCT01147614
Study group	Role	What they receive
specialty mental health care referral	Active comparator	Not described Receives: Behavioral: Specialty mental health care referral (SMHC)
Brief Cognitive Behavioral Therapy	Experimental	Not described Receives: Behavioral: Brief Cognitive Behavioral Therapy (BCBT)

What is being measured

The primary outcome is the main question the study is designed to answer.

Clinical Global Impression
Measured: measured at baseline (week 0)
Clinical Global Impression
Measured: measured at post-treatment (week 16)
Clinical Global Impression
Measured: measured at 8 month follow-up (week 32)

Secondary outcomes (9)

Pediatric Anxiety Rating Scale
Measured: measured at baseline (week 0)
Children's Depression Rating Scale - Revised
Measured: measured at baseline (week 0)
Health Utilities Index
This measure will aid in cost-effectiveness analyses.
Measured: measured at baseline (week 0)
Pediatric Anxiety Rating Scale
Measured: measured at post-treatment (week 16)
Pediatric Anxiety Rating Scale
Measured: measured at 8 month follow-up (week 32)
Children's Depression Rating Scale - Revised
Measured: measured at post-treatment (week 16)
Children's Depression Rating Scale - Revised
Measured: measured at 8 month follow-up (week 32)
Health Utilities Index
This measure will aid in cost-effectiveness analyses.
Measured: measured at post-treatment (week 16)
Health Utilities Index
This measure will aid in cost-effectiveness analyses.
Measured: measured at 8 month follow-up (week 32)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2010Apr 2016

First posted22 Jun 2010 (estimated)
Study startSep 2010
Primary completionApr 2016
Study completionApr 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for AnxietyStudies of the same condition, open and under way.
More trials run by San Diego State UniversityThe 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 185 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01147614
Sponsor's protocol ID: 7887933
Other IDs: 5R01MH084935
Acronym: BCBT-PC
Status last verified: Apr 2016
First submitted: 17 Jun 2010
Last updated: 14 Apr 2016
Results posted: No
Data monitoring committee: Yes

Publications

Weersing VR, Gonzalez A, Campo JV, Lucas AN. Brief behavioral therapy for pediatric anxiety and depression: Piloting an integrated treatment approach. Cognitive and Behavioral Practice 15: 126-139, 2008.
Baca SA, Goger P, Glaser D, Rozenman M, Gonzalez A, Dickerson JF, Lynch FL, Porta G, Brent DA, Weersing VR. Reduction in avoidance mediates effects of brief behavioral therapy for pediatric anxiety and depression. Behav Res Ther. 2023 May;164:104290. doi: 10.1016/j.brat.2023.104290. Epub 2023 Mar 8.
PubMed 36965232
Schwartz KTG, Kado-Walton M, Dickerson JF, Rozenman M, Brent DA, Porta G, Lynch FL, Gonzalez A, Weersing VR. Brief Behavioral Therapy for Anxiety and Depression in Pediatric Primary Care: Breadth of Intervention Impact. J Am Acad Child Adolesc Psychiatry. 2023 Feb;62(2):230-243. doi: 10.1016/j.jaac.2022.08.007. Epub 2022 Aug 24.
PubMed 36030033
Brent DA, Porta G, Rozenman MS, Gonzalez A, Schwartz KTG, Lynch FL, Dickerson JF, Iyengar S, Weersing VR. Brief Behavioral Therapy for Pediatric Anxiety and Depression in Primary Care: A Follow-up. J Am Acad Child Adolesc Psychiatry. 2020 Jul;59(7):856-867. doi: 10.1016/j.jaac.2019.06.009. Epub 2019 Jul 3.
PubMed 31278996
Weersing VR, Brent DA, Rozenman MS, Gonzalez A, Jeffreys M, Dickerson JF, Lynch FL, Porta G, Iyengar S. Brief Behavioral Therapy for Pediatric Anxiety and Depression in Primary Care: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Jun 1;74(6):571-578. doi: 10.1001/jamapsychiatry.2017.0429.
PubMed 28423145

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Brief CBT for Pediatric Anxiety and Depression in Primary Care
ClinicalTrials.gov ID: NCT01147614
Acronym / sponsor ID: BCBT-PC / 7887933
Conditions: Anxiety, Depression
Keywords: Child, adolescent, anxiety, depression, internalizing, cognitive behavioral therapy, pediatric primary care
Study type: Interventional
Recruitment status: Completed
Enrolment: 185 participants (actual)
Lead sponsor: San Diego State UniversityUniversity, hospital or other
Collaborators: University of Pittsburgh, Kaiser Permanente, National Institute of Mental Health (NIMH)
Study start: Sep 2010
Primary completion: Apr 2016 (actual)
Study completion: Apr 2016 (actual)
First posted: 22 Jun 2010 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
specialty mental health care referral	Active comparator	Behavioral: Specialty mental health care referral (SMHC)
Brief Cognitive Behavioral Therapy	Experimental	Behavioral: Brief Cognitive Behavioral Therapy (BCBT)

Who may qualify

Ages: 8 to 16 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

meet full or probable diagnostic criteria for Separation Anxiety Disorder, Generalized Anxiety Disorder, Social Phobia, Major Depression, Dysthymic Disorder, or Minor Depression
age 8.0 to 16.9
live with legal, consenting guardian for at least 6 months

Key exclusion criteria (3 listed)

youths requiring alternate intervention (e.g., youths with bipolar disorder, psychosis, active suicidal ideation with plan, PTSD, substance dependence, current physical or sexual abuse, or mental retardation
suffer from serious or unstable physical illness (e.g., uncontrolled diabetes)
currently in active, alternate intervention for anxiety or depression (e.g., antidepressant use)

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
Brief Cognitive Behavioral Therapy (BCBT)Also: BCBTBCBT: 8-12 sessions over 16 weeks of cognitive-behavioral therapy administered by Master's-level clinicians in primary care setting	Behavioural	Brief Cognitive Behavioral Therapy
Specialty mental health care referral (SMHC)Also: SMHCSMHC: specialty mental health care referrals provided	Behavioural	specialty mental health care referral

Primary outcome

Clinical Global Impression
Time frame: measured at baseline (week 0)
Clinical Global Impression
Time frame: measured at post-treatment (week 16)
Clinical Global Impression
Time frame: measured at 8 month follow-up (week 32)

9 secondary outcomes

Pediatric Anxiety Rating Scale
Time frame: measured at baseline (week 0)
Children's Depression Rating Scale - Revised
Time frame: measured at baseline (week 0)
Health Utilities Index
Time frame: measured at baseline (week 0)
Pediatric Anxiety Rating Scale
Time frame: measured at post-treatment (week 16)
Pediatric Anxiety Rating Scale
Time frame: measured at 8 month follow-up (week 32)
Children's Depression Rating Scale - Revised
Time frame: measured at post-treatment (week 16)
Children's Depression Rating Scale - Revised
Time frame: measured at 8 month follow-up (week 32)
Health Utilities Index
Time frame: measured at post-treatment (week 16)
Health Utilities Index
Time frame: measured at 8 month follow-up (week 32)

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 14 Apr 2016.
BackgroundWeersing VR, Gonzalez A, Campo JV, Lucas AN. Brief behavioral therapy for pediatric anxiety and depression: Piloting an integrated treatment approach. Cognitive and Behavioral Practice 15: 126-139, 2008.
Derived from this study: PubMed 36965232Baca SA, Goger P, Glaser D, Rozenman M, Gonzalez A, Dickerson JF, Lynch FL, Porta G, Brent DA, Weersing VR. Reduction in avoidance mediates effects of brief behavioral therapy for pediatric anxiety and depression. Behav Res Ther. 2023 May;164:104290. doi: 10.1016/j.brat.2023.104290. Epub 2023 Mar 8.
Derived from this study: PubMed 36030033Schwartz KTG, Kado-Walton M, Dickerson JF, Rozenman M, Brent DA, Porta G, Lynch FL, Gonzalez A, Weersing VR. Brief Behavioral Therapy for Anxiety and Depression in Pediatric Primary Care: Breadth of Intervention Impact. J Am Acad Child Adolesc Psychiatry. 2023 Feb;62(2):230-243. doi: 10.1016/j.jaac.2022.08.007. Epub 2022 Aug 24.
Derived from this study: PubMed 31278996Brent DA, Porta G, Rozenman MS, Gonzalez A, Schwartz KTG, Lynch FL, Dickerson JF, Iyengar S, Weersing VR. Brief Behavioral Therapy for Pediatric Anxiety and Depression in Primary Care: A Follow-up. J Am Acad Child Adolesc Psychiatry. 2020 Jul;59(7):856-867. doi: 10.1016/j.jaac.2019.06.009. Epub 2019 Jul 3.
Derived from this study: PubMed 28423145Weersing VR, Brent DA, Rozenman MS, Gonzalez A, Jeffreys M, Dickerson JF, Lynch FL, Porta G, Iyengar S. Brief Behavioral Therapy for Pediatric Anxiety and Depression in Primary Care: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Jun 1;74(6):571-578. doi: 10.1001/jamapsychiatry.2017.0429.
Click here for more information about this study: Brief CBT for Pediatric Anxiety and Depression in Primary CareLink 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

San Diego State University

David A Brent, M.D. principal investigator

Western Psychiatric Institute and Clinics

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 3 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 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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.

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?

Clinical Global Impression (time frame: measured at baseline (week 0)). The study lists 3 primary outcomes in all. 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 NCT01147614, which also lists 5 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 14 Apr 2016.