Obsessive Compulsive DisorderSC-CBTNCT01981317
Stepped Care Cognitive Behavioral Therapy for Pediatric Obsessive Compulsive Disorder
A study testing Stepped Care Cognitive Behavioral Therapy and Cognitive Behavioral Therapy in people with Obsessive Compulsive Disorder and Stepped Care Cognitive Behavioral Therapy, run by University of South Florida at 1 site in United States.
Trial summary
The purpose of this research study is to determine how well children with OCD can be helped using therapy that requires less clinic visits. The investigators are testing a Stepped-Care Cognitive Behavioral Therapy (SC-CBT) approach in which children receive a full course of parent-led, therapist-guided treatment for… Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Obsessive Compulsive Disorder, Stepped Care Cognitive Behavioral Therapy
- What is being tested?
- Stepped Care Cognitive Behavioral Therapy and Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Oct 2018
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Outpatient youth with obsessive-compulsive disorder between the ages 8-17 years.
- A Children's Yale-Brown Obsessive-Compulsive Scale score ≥ 16
- Child has a Full Scale IQ ≥ 80 as assessed on the WASI
- English speaking
Who cannot join
- Past adequate CBT with E/RP trial
- Initiation of antidepressant medication within 12 weeks before study enrollment, or an antipsychotic/mood stabilizer medication 6 weeks before study enrollment, or a stimulant/anxiolytic or alpha 2 agonist 4 weeks before study enrollment
- Established Treatment changes: Any change in dose of an established psychotropic medication (e.g., antidepressants) within 8 weeks before study enrollment (4 weeks for antipsychotic, mood stabilizer, alpha 2 agonist; 2 weeks for stimulant/anxiolytic). Alternative medications must be stable for 4 weeks prior to baseline. Any medications must remain stable during treatment; downward adjustments due to side effects may be acceptable with PI approval.
- Active child suicidality assessed by all available information (e.g., KSADS-PL, CDI).
- DSM-IV conduct disorder, autism, mental retardation, bipolar, schizophrenia/schizoaffective disorders; or substance abuse in past 6 months; or co-primary eating disorder; using all available information.
- Another behavioral/emotional problem or psychiatric disorder is considered to be more problematic than OCD.
- Non-English speaking.
- WASI-IQ SS <80.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Rothman Center for Pediatric Neuropsychiatry
St. Petersburg, Florida, 33701
About this study
The purpose of this research study is to determine how well children with OCD can be helped using therapy that requires less clinic visits. The investigators are testing a Stepped-Care Cognitive Behavioral Therapy (SC-CBT) approach in which children receive a full course of parent-led, therapist-guided treatment for OCD. The goal is to see if therapy can be done in fewer visits to the clinic. Children receiving SC-CBT will start with Step One, which includes three therapy sessions over six weeks. Those who do not get better in Step One will "STEP UP" to Step Two which involves coming in to meet with a therapist for the remaining sessions. Youth receiving SC-CBT will be compared to youth receiving standard CBT in the clinic through this study. It is expected that Stepped Care will be an acceptable, cost-effect, and feasible treatment with outcomes similar to standard CBT.
Read the detailed description
Below is a summary of assessment and interventions as part of the study (separated by condition). Two thirds will receive SC-CBT, one-third standard CBT (determined at random following the initial phone screen).
- Phone Screen (with parent)
- Informed Consent and Initial Assessment
- Randomization to either SC-CBT or Standard CBT
- Treatment Phase (either 1 or 2 determined at random following 'C')
- SC-CBT Children who are randomized into SC-CBT will receive Step One:
- 3-in-office sessions - 1 hour each (over 6 weeks)
- 6 weekly phone calls (15 minutes or less)
- Post assessment (at the end of the 6 weeks)
- 3-month follow up Children are "stepped up" to Step Two of SC-CBT if we determine more therapy is needed (following the post assessment). Step Two is a continuation of therapy and will include:
- 9-in-office weekly sessions - 1 hour each (over 9 weeks)
- Post assessment (after session 9)
- 3-month follow up OR
- Standard CBT
Children who are randomized into the standard CBT group will receive:
- 12-in-office weekly sessions - 1 hour each (over 12 weeks)
- Midpoint Assessment (after 6 weeks)
- Post assessment (at the end of the 12 weeks)
- 3-month follow up
- Being tested
- Stepped Care Cognitive Behavioral Therapy, Cognitive Behavioral Therapy
- Keywords
- Obsessive Compulsive Disorder, Cognitive Behavioral Therapy, Stepped Care CBT, Exposure and Response Prevention, Psychotherapy, Counseling
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stepped Care Cognitive Behavioral TherapyBehavioural
Cognitive Behavioral TherapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Stepped Care CBT | Experimental | All participants in this arm receive Step One which includes 3-in-office sessions lasting 1 hour each over 6 weeks and 6 weekly phone calls lasting 15 minutes or less. The in-office sessions are devoted to psychoeducation, cognitive therapy, and hierarchy development. These sessions will include all procedures of the standard therapist-delivered CBT but will be parent-led, therapist guided; thus, the parent is delivering evidence-based strategies with clinician guidance.
Children are then "stepped up" to Step Two of SC-CBT if it is determined that more therapy is needed following the post assessment. Step Two is a continuation of therapy and will include 9 additional in-office weekly session lasting 1 hour each over 9 weeks. These sessions will be therapist-led and are devoted to exposure and response prevention. Receives: Behavioral: Stepped Care Cognitive Behavioral Therapy |
| Standard CBT | Active comparator | All patients in this arm will receive 12 sessions of therapy over 12 weeks using the evidence-based cognitive behavioral therapy protocol in POTS (2004). Sessions 1-3 do not include exposures and are devoted to psychoeducation, cognitive therapy, and hierarchy development. Sessions 4-12 involve exposure and response prevention exercises specific to each youth. Receives: Behavioral: Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Yale-Brown Obsessive-Compulsive Scale
The Children's Yale-Brown Obsessive-Compulsive Scale is a psychometrically sound clinician-rated interview assessing OCD symptom severity.
Measured: 12 weeks
Clinical Global Impression Improvement Scale
The CGI-I is a widely used 7-point clinician rating of clinical improvement.
Measured: 12 weeks
Secondary outcomes (1)
Clinical Global Impression Severity Scale
The CGI-S is a widely used 7-point clinician rating of clinical severity.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionMar 2017
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive Compulsive DisorderStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Obsessive Compulsive Foundation
- Responsible party
- Sponsor
- Investigators
- Adam Lewin, Ph.D., Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01981317
- Sponsor's protocol ID
- IOCDF2013
- Acronym
- SC-CBT
- Status last verified
- Oct 2018
- First submitted
- 4 Nov 2013
- Last updated
- 20 Mar 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stepped Care Cognitive Behavioral Therapy for Pediatric Obsessive Compulsive Disorder
- ClinicalTrials.gov ID
- NCT01981317
- Acronym / sponsor ID
- SC-CBT / IOCDF2013
- Keywords
- Obsessive Compulsive Disorder, Cognitive Behavioral Therapy, Stepped Care CBT, Exposure and Response Prevention, Psychotherapy, Counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- Obsessive Compulsive Foundation
- Study start
- Oct 2013
- Primary completion
- Mar 2017 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 11 Nov 2013 (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.
The purpose of this research study is to determine how well children with OCD can be helped using therapy that requires less clinic visits. The investigators are testing a Stepped-Care Cognitive Behavioral Therapy (SC-CBT) approach in which children receive a full course of parent-led, therapist-guided treatment for OCD. The goal is to see if therapy can be done in fewer visits to the clinic. Children receiving SC-CBT will start with Step One, which includes three therapy sessions over six weeks. Those who do not get better in Step One will "STEP UP" to Step Two which involves coming in to meet with a therapist for the remaining sessions. Youth receiving SC-CBT will be compared to youth receiving standard CBT in the clinic through this study. It is expected that Stepped Care will be an acceptable, cost-effect, and feasible treatment with outcomes similar to standard CBT.
Detailed description
Below is a summary of assessment and interventions as part of the study (separated by condition). Two thirds will receive SC-CBT, one-third standard CBT (determined at random following the initial phone screen).
- Phone Screen (with parent)
- Informed Consent and Initial Assessment
- Randomization to either SC-CBT or Standard CBT
- Treatment Phase (either 1 or 2 determined at random following 'C')
- SC-CBT Children who are randomized into SC-CBT will receive Step One:
- 3-in-office sessions - 1 hour each (over 6 weeks)
- 6 weekly phone calls (15 minutes or less)
- Post assessment (at the end of the 6 weeks)
- 3-month follow up Children are "stepped up" to Step Two of SC-CBT if we determine more therapy is needed (following the post assessment). Step Two is a continuation of therapy and will include:
- 9-in-office weekly sessions - 1 hour each (over 9 weeks)
- Post assessment (after session 9)
- 3-month follow up OR
- Standard CBT
Children who are randomized into the standard CBT group will receive:
- 12-in-office weekly sessions - 1 hour each (over 12 weeks)
- Midpoint Assessment (after 6 weeks)
- Post assessment (at the end of the 12 weeks)
- 3-month follow up
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stepped Care CBT | Experimental | Behavioral: Stepped Care Cognitive Behavioral TherapyAll participants in this arm receive Step One which includes 3-in-office sessions lasting 1 hour each over 6 weeks and 6 weekly phone calls lasting 15 minutes or less. The in-office sessions are devoted to psychoeducation, cognitive therapy, and hierarchy development. These sessions will include all procedures of the standard therapist-delivered CBT but will be parent-led, therapist guided; thus, the parent is delivering evidence-based strategies with clinician guidance. Children are then "stepped up" to Step Two of SC-CBT if it is determined that more therapy is needed following the post assessment. Step Two is a continuation of therapy and will include 9 additional in-office weekly session lasting 1 hour each over 9 weeks. These sessions will be therapist-led and are devoted to exposure and response prevention. |
| Standard CBT | Active comparator | Behavioral: Cognitive Behavioral TherapyAll patients in this arm will receive 12 sessions of therapy over 12 weeks using the evidence-based cognitive behavioral therapy protocol in POTS (2004). Sessions 1-3 do not include exposures and are devoted to psychoeducation, cognitive therapy, and hierarchy development. Sessions 4-12 involve exposure and response prevention exercises specific to each youth. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Outpatient youth with obsessive-compulsive disorder between the ages 8-17 years.
- A Children's Yale-Brown Obsessive-Compulsive Scale score ≥ 16
- Child has a Full Scale IQ ≥ 80 as assessed on the WASI
- English speaking
Key exclusion criteria (8 listed)
- Past adequate CBT with E/RP trial
- Initiation of antidepressant medication within 12 weeks before study enrollment, or an antipsychotic/mood stabilizer medication 6 weeks before study enrollment, or a stimulant/anxiolytic or alpha 2 agonist 4 weeks before study enrollment
- Established Treatment changes: Any change in dose of an established psychotropic medication (e.g., antidepressants) within 8 weeks before study enrollment (4 weeks for antipsychotic, mood stabilizer, alpha 2 agonist; 2 weeks for stimulant/anxiolytic). Alternative medications must be stable for 4 weeks prior to baseline. Any medications must remain stable during treatment; downward adjustments due to side effects may be acceptable with PI approval.
- Active child suicidality assessed by all available information (e.g., KSADS-PL, CDI).
- DSM-IV conduct disorder, autism, mental retardation, bipolar, schizophrenia/schizoaffective disorders; or substance abuse in past 6 months; or co-primary eating disorder; using all available information.
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 |
|---|---|---|
| Stepped Care Cognitive Behavioral Therapy | Behavioural | Stepped Care CBT |
| Cognitive Behavioral Therapy | Behavioural | Standard CBT |
Primary outcome
Children's Yale-Brown Obsessive-Compulsive Scale
Time frame: 12 weeks
The Children's Yale-Brown Obsessive-Compulsive Scale is a psychometrically sound clinician-rated interview assessing OCD symptom severity.
Clinical Global Impression Improvement Scale
Time frame: 12 weeks
The CGI-I is a widely used 7-point clinician rating of clinical improvement.
1 secondary outcome
Clinical Global Impression Severity Scale
Time frame: 12 weeks
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 20 Mar 2019.
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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.
Adam Lewin, Ph.D. principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stepped Care Cognitive Behavioral Therapy and Cognitive Behavioral Therapy in people with Obsessive Compulsive Disorder and Stepped Care Cognitive Behavioral Therapy, run by University of South Florida 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 4 inclusion and 8 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 20 Mar 2019. 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.
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?
Children's Yale-Brown Obsessive-Compulsive Scale (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 20 Mar 2019.