Post-Traumatic Stress DisorderNCT00614068
Effectiveness of Trauma-Focused Cognitive Behavioral Therapy in Treating Children With Post-Traumatic Stress Disorder
A study testing Trauma-focused cognitive behavioral therapy (TF-CBT) and Treatment as usual (TAU) in people with Post-Traumatic Stress Disorder, run by Icahn School of Medicine at Mount Sinai at 8 sites in United States.
Trial summary
This study will compare the effectiveness of trauma-focused cognitive behavioral therapy versus standard care in treating children with post-traumatic stress disorder. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- Trauma-focused cognitive behavioral therapy (TF-CBT) and Treatment as usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 8 sitesUnited States
- Study dates
- Jan 2007to Feb 2009
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Seeking services at Jewish Board of Family and Children's Services outpatient clinics
- Meets DSM-IV criteria for PTSD
- Stable on medication for 1 month before study entry
- English-speaking
Who cannot join
- Active suicidality or anyone whose life circumstances might be considered peri-traumatic (e.g., active current abuse)
- Uncontrolled psychosis
- Severe mental retardation or severe brain damage
- Severe language comprehension barriers
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Jewish Board of Family and Children's Services (Yeshiva Chanoch Lenaar)
New York, New York, 10019
Jewish Board of Family and Children's Services (Staten Island)
New York, New York, 10314
Jewish Board of Family and Children's Services (Beatman)
New York, New York, 10463
Jewish Board of Family and Children's Services (Pelham)
New York, New York, 10467
Jewish Board of Family and Children's Services (BoroPark)
New York, New York, 11219
Jewish Board of Family and Children's Services (Break-Free Adolescent Services)
New York, New York, 11223
Jewish Board of Family and Children's Services (South Brooklyn)
New York, New York, 11223
Jewish Board of Family and Children's Services (Pride)
New York, New York, 11362
About this study
Official title: Creating a Collaborative Field Research Organization
This study will compare the effectiveness of trauma-focused cognitive behavioral therapy versus standard care in treating children with post-traumatic stress disorder.
Read the detailed description
Each year approximately 5 million children in the United States are exposed to some form of traumatic event, and nearly 40% of these children will go on to develop post-traumatic stress disorder (PTSD). There are a number of traumatic events that have been shown to cause PTSD in children, including natural disaster, physical or sexual abuse, loss of a loved one, and witnessing an act of violence. Children with PTSD may experience persistent generalized fear and anxiety, recurrent nightmares, mood swings, withdrawal, and depression. If left untreated, PTSD can cause serious distress for those affected, resulting in emotional, academic, and social problems. Trauma-focused cognitive behavioral therapy (TF-CBT), a form of psychotherapy that focuses on trauma, may be the most effective means of improving PTSD screening and treatment in community-based mental health services. Although TF-CBT has shown success in treating children with PTSD in the research setting, its use in community clinics remains limited. This study will compare the effectiveness of TF-CBT versus treatment as usual (TAU) in treating children with PTSD in community clinics. The study will also develop a community collaboration between a community mental health agency and an academic institution, both in New York City, to address childhood trauma and PTSD and to enhance research in community clinics.
Participation in this study will last about 3 months. Potential parent and child participants will first undergo initial assessments, which will include interviews and questionnaires concerning symptoms of PTSD. Eligible participants will then be assigned randomly to receive TF-CBT or TAU. Participants in both groups will attend 12 sessions over 3 months. TF-CBT sessions will include trauma-focused treatment and will teach participants behavioral management and coping skills to overcome their PTSD. TAU sessions will include routine community clinic care and will not involve a trauma-focused treatment component. Upon completion of treatment, participants will complete repeat interviews and questionnaires.
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- Trauma-focused cognitive behavioral therapy (TF-CBT), Treatment as usual (TAU)
- Keywords
- Treatment, PTSD
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma-focused cognitive behavioral therapy (TF-CBT)Behavioural
TF-CBT sessions will include trauma-focused treatment and will teach participants behavioral management and coping skills to overcome their PTSD.
Treatment as usual (TAU)Behavioural
TAU outpatient sessions will include routine community care and nontrauma-focused therapy.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Participants will receive 12 sessions of trauma-focused cognitive behavioral therapy over 3 months. Receives: Behavioral: Trauma-focused cognitive behavioral therapy (TF-CBT) |
| B | Active comparator | Participants will receive 12 sessions of treatment as usual over 3 months. Receives: Behavioral: Treatment as usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
University of California Los Angeles- Post-Traumatic Stress Disorder (UCLA-PTSD) Reaction Index
Measured: Measured at baseline and Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startJan 2007
- Primary completionDec 2008
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Claude M. Chemtob, PhD, Principal investigator, Icahn School of Medicine at Mount SinaiRohini Luthra, PhD, Study director, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00614068
- Sponsor's protocol ID
- GCO 00-0996
- Other IDs
- R24MH063910, DSIR SE-CE
- Status last verified
- Apr 2015
- First submitted
- 11 Feb 2008
- Last updated
- 6 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creating a Collaborative Field Research Organization
- ClinicalTrials.gov ID
- NCT00614068
- Acronym / sponsor ID
- GCO 00-0996
- Conditions
- Post-Traumatic Stress Disorder
- Keywords
- Treatment, PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jan 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 13 Feb 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 study will compare the effectiveness of trauma-focused cognitive behavioral therapy versus standard care in treating children with post-traumatic stress disorder.
Detailed description
Each year approximately 5 million children in the United States are exposed to some form of traumatic event, and nearly 40% of these children will go on to develop post-traumatic stress disorder (PTSD). There are a number of traumatic events that have been shown to cause PTSD in children, including natural disaster, physical or sexual abuse, loss of a loved one, and witnessing an act of violence. Children with PTSD may experience persistent generalized fear and anxiety, recurrent nightmares, mood swings, withdrawal, and depression. If left untreated, PTSD can cause serious distress for those affected, resulting in emotional, academic, and social problems. Trauma-focused cognitive behavioral therapy (TF-CBT), a form of psychotherapy that focuses on trauma, may be the most effective means of improving PTSD screening and treatment in community-based mental health services. Although TF-CBT has shown success in treating children with PTSD in the research setting, its use in community clinics remains limited. This study will compare the effectiveness of TF-CBT versus treatment as usual (TAU) in treating children with PTSD in community clinics. The study will also develop a community collaboration between a community mental health agency and an academic institution, both in New York City, to address childhood trauma and PTSD and to enhance research in community clinics.
Participation in this study will last about 3 months. Potential parent and child participants will first undergo initial assessments, which will include interviews and questionnaires concerning symptoms of PTSD. Eligible participants will then be assigned randomly to receive TF-CBT or TAU. Participants in both groups will attend 12 sessions over 3 months. TF-CBT sessions will include trauma-focused treatment and will teach participants behavioral management and coping skills to overcome their PTSD. TAU sessions will include routine community clinic care and will not involve a trauma-focused treatment component. Upon completion of treatment, participants will complete repeat interviews and questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Behavioral: Trauma-focused cognitive behavioral therapy (TF-CBT)Participants will receive 12 sessions of trauma-focused cognitive behavioral therapy over 3 months. |
| B | Active comparator | Behavioral: Treatment as usual (TAU)Participants will receive 12 sessions of treatment as usual over 3 months. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Seeking services at Jewish Board of Family and Children's Services outpatient clinics
- Meets DSM-IV criteria for PTSD
- Stable on medication for 1 month before study entry
- English-speaking
Key exclusion criteria (4 listed)
- Active suicidality or anyone whose life circumstances might be considered peri-traumatic (e.g., active current abuse)
- Uncontrolled psychosis
- Severe mental retardation or severe brain damage
- Severe language comprehension barriers
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 |
|---|---|---|
| Trauma-focused cognitive behavioral therapy (TF-CBT)TF-CBT sessions will include trauma-focused treatment and will teach participants behavioral management and coping skills to overcome their PTSD. | Behavioural | A |
| Treatment as usual (TAU)TAU outpatient sessions will include routine community care and nontrauma-focused therapy. | Behavioural | B |
Primary outcome
University of California Los Angeles- Post-Traumatic Stress Disorder (UCLA-PTSD) Reaction Index
Time frame: Measured at baseline and Month 3
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 6 Apr 2015.
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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.
Claude M. Chemtob, PhD principal investigator
Icahn School of Medicine at Mount Sinai
Rohini Luthra, PhD study director
Icahn School of Medicine at Mount Sinai
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trauma-focused cognitive behavioral therapy (TF-CBT) and Treatment as usual (TAU) in people with Post-Traumatic Stress Disorder, run by Icahn School of Medicine at Mount Sinai at 8 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 4 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 6 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
University of California Los Angeles- Post-Traumatic Stress Disorder (UCLA-PTSD) Reaction Index (time frame: Measured at baseline and Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2015.