Obsessive-Compulsive DisorderNCT03672565
SMART ERP for the Behavioral Treatment of Youth With Obsessive Compulsive Disorder (OCD)
A study testing Phase One: Standardized Brief Intensive ERP, Phase Two: Flexible Patient Driven Intensive ERP and Follow-Up Phase: Booster Calls in people with Obsessive-Compulsive Disorder, run by University of British Columbia at 1 site in Canada.
Trial summary
This randomized pilot study examines a graduated behavioral treatment approach for youth with obsessive compulsive disorder. Youth will be randomized to receive treatment in the community or at the hospital. In the first stage, youth receive an intro session and two 3-hour ERP sessions. Read more about this study
- Who is it for?
- Ages 7 to 19 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Phase One: Standardized Brief Intensive ERP, Phase Two: Flexible Patient Driven Intensive ERP and Follow-Up Phase: Booster Calls
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2018to 27 Aug 2021
- 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 7 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Be between the ages of 7 - 19 years
- Have a primary diagnosis of OCD
- Have a score of equal to, or greater than, 16 on the Children's Yale - Brown Obsessive Compulsive Scale
- Be, and have a parent/guardian, willing to participate in treatment
- Be stable on psychotropic medication as demonstrated by at least 10 weeks since first initiation of an serotonin reuptake inhibitor (SRI) and 4 weeks since initiation of any other psychotropic medications as well as 4 weeks since any dose adjustment of any psychotropic medications.
- Have sufficient English capabilities to complete questionnaires
- Live within the Greater Vancouver Area (within approximately 60 minutes drive of BC Children's Hospital)
Who cannot join
- Meet diagnostic criteria for bipolar disorder, psychosis, intellectual disability, substance dependence/abuse, or autism spectrum disorder (> level 1 impairment)
- Demonstrate alternate psychiatric symptoms of a more pressing nature than the OCD symptoms (e.g. suicidal intent in the context of comorbid depression)
- Youth or parents refusing to engage in treatment
- Initiation of an antidepressant within 10 weeks or an alternate psychotropic medication within 4 weeks or adjusted dosage within 4 weeks
- Family lives outside of the Greater Vancouver Area (longer than 60 minutes drive of BC Children's Hospital)
Trial locations and contacts
1 site in 1 country.
Canada1 site
BC Children's Hospital Research Institute
Vancouver, British Columbia
About this study
Official title: Flexibly Dosed Intensive Exposure and Response Prevention as a Means to Maximize Outcomes for Youth With Obsessive Compulsive Disorder
This randomized pilot study examines a graduated behavioral treatment approach for youth with obsessive compulsive disorder. Youth will be randomized to receive treatment in the community or at the hospital. In the first stage, youth receive an intro session and two 3-hour ERP sessions. Youth will be assessed for OCD recovery. Recovered youth enter follow-up. Still affected youth enter the second stage, where they will can select to receive up to four additional ERP sessions (one per week). In follow-up, youth will receive three 30 minute weekly calls and will be reassessed at 1- and 6-months following treatment.
Read the detailed description
Obsessive compulsive disorder (OCD) is a highly debilitating psychiatric disorder that affects many youth. Despite strong empirical support that exposure and response prevention (ERP) is an efficacious and tolerable treatment of pediatric OCD including when presented in intensive formats, most individuals simply do not access or receive this treatment.
The dissemination of efficient interventions is of high public health priority, and graduated, or stepped care, models may be the answer. However, initial interventions within a graduated approach must be appropriate for the severity of the condition, given that unnecessary delays to an optimal dose may result in escalating burden on families and ultimately health services. Indeed, low intensity online CBT and self-help have so far had limited efficacy with less than one third of patients deemed responsive to treatment.
In contrast, brief intensive ERP is likely an efficient and effective alternative to flexibly dosing the level of intervention to the participant's needs. In fact, a recent pilot study (n = 10) providing two 3-hour ERP sessions to youth with OCD observed 60% post-treatment, and 70% 6-month follow-up, remission rates among participants. Extending on this study's findings, by utilizing more conservative remission criteria and providing access to additional doses of intensive ERP to youth not yet achieving remission, holds promise in identifying the level of services utilized by families to achieve meaningful treatment outcomes.
Above and beyond the use of a graduated dose model, many questions remain regarding optimal implementation methods for the behavioral treatment of pediatric OCD. In particular, the impact of treatment setting (i.e. community versus clinic) on response has not been systematically studied within this population. Given increased setting relevance and opportunity for in vivo learning, community exposures may be expected to be more effective; however, as they are associated with additional challenges (e.g., transportation time), their contribution to improvement needs to be directly verified and weighed against these costs.
Therefore, the present study seeks to determine the feasibility of implementing a sequential, multiple assignment, randomized trial (SMART) for the behavioral treatment of youth with OCD. The study focuses on evaluating the benefits from a minimum initial dose of intensive exposure and response prevention (ERP) as well as the demand for, and benefits from, additional ERP sessions by still-affected OCD families. In addition, via randomization, the study examines the influence of treatment setting (community vs hospital) on response. Primary outcomes include the impact of treatment on symptom severity and other relevant clinical outcomes (e.g., quality of life, youth- and family-functioning) as well as patient decisions/treatment utilization. Participant perspectives on study/treatment procedures (e.g., acceptability, optimal components) as well as cost-effectiveness (e.g., travel expenses, staff time, service utilization) will also be recorded.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Phase One: Standardized Brief Intensive ERP, Phase Two: Flexible Patient Driven Intensive ERP, Follow-Up Phase: Booster Calls
- Keywords
- Exposure and Response prevention ERP, Cognitive-behavioural therapy, Pediatric OCD, Childhood-onset OCD
- 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.
Phase One: Standardized Brief Intensive ERPBehavioural
Participants will be randomized to receive ERP sessions at the hospital or at relevant community locations. In the introductory session, participants will be provided with psychoeducation about OCD and the treatment model, will develop a list of potential exposures, and will attempt initial exposure and response prevention (ERP) exercises. The session will end with an assignment of ERP homework. In the seven days following the introductory session, youth and parents will receive two 3-hour sessions, separated by a three day break. The sessions will begin with a brief review of homework completion and success. Following this, with parent observation, the clinician will guide the youth through escalating ERP exercises. The session will end with ERP homework planning. Other evidence-based treatment strategies (e.g., addressing motivation, discussing parental accommodations) may be implemented as deemed necessary by the clinician in order to encourage effective engagement in ERP exercises.
Phase Two: Flexible Patient Driven Intensive ERPBehavioural
Families will have the opportunity to access up to four additional once/week 3-hour intensive ERP sessions.
Three days prior to each additional ERP session (sessions 3-6), families will be prompted to fill out online forms and decide how to proceed with treatment for that week with the following options:
- They may select that they would like to receive and complete the next ERP session, and up to four 3-hour ERP sessions during Phase Two. Completion of all four ERP session will automatically end Phase Two.
- They may opt to delay receiving a treatment session by one week for any reason. Families will be allowed to take a week off up to two times during Phase Two. If both weeks off are utilized, at the next decision point families must either opt to complete an ERP Session or end their participation in Phase Two.
- They may select to end their participation in Phase Two at any decision point and for any reason (e.g., don't perceive it as helpful, have improved substantially).
Follow-Up Phase: Booster CallsBehavioural
Upon achieving remission at any remission assessment or completion of remission assessment five, youth will enter the follow-up phase. Youth will receive three weekly 30 minute post-treatment booster phone calls. Calls will focus on homework completion, ERP planning, and relapse prevention skills.
| Study group | Role | What they receive |
|---|---|---|
| Hospital setting | Active comparator | ERPs may be conducted in various settings on hospital grounds (e.g., cafeteria, hallways) but will not be conducted off property. Receives: Behavioral: Phase One: Standardized Brief Intensive ERP; Behavioral: Phase Two: Flexible Patient Driven Intensive ERP; Behavioral: Follow-Up Phase: Booster Calls |
| Community setting | Active comparator | Community ERP sessions will be conducted locations deemed most relevant to the child's symptom presentation such as in the home or at other community locations (e.g., church, downtown). Receives: Behavioral: Phase One: Standardized Brief Intensive ERP; Behavioral: Phase Two: Flexible Patient Driven Intensive ERP; Behavioral: Follow-Up Phase: Booster Calls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in OCD symptom severity (i.e., percentage of youth achieving remission) following Treatment Phase One both within and between treatment settings (hospital vs. community)
OCD symptom severity is measured with Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS), a clinician-rated scale of 10 items, each rated from 0 (no symptoms) to 4 (extreme symptoms), scores are summed to give a maximum score of 40. Higher scores indicate worse symptomatology. Youth will be identified as in remission if they are rated as having a total score of 11 (out of 40) or lower on the CY-BOCS at post-treatment assessment 1.
Measured: Baseline Assessment (Week1/Day1), Post-treatment Assessment 1 (Week3/Day14)
Change in OCD symptom severity between pre- and post-treatment for both treatment phases both within and between treatment settings
OCD symptom severity is measured with Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS), a clinician-rated scale of 10 items, each rated from 0 (no symptoms) to 4 (extreme symptoms), scores are summed to give a maximum score of 40. Higher scores indicate worse symptomatology.
Phase one pre- and post-treatment is assessed at Baseline assessment (BA) and PA1 while phase two pre- and post-treatment is assessed at Treatment Decision Point (TDP) and Post-treatment assessment 2 (PA2).
Measured: Phase 1: BA (Week1/Day1), PA1 (Week3/Day14) | Phase 2: TDP (weeks4-9/days18,25,32,39,46,53), PA2 (Week4-10/Day21,28,35,42,49,or60)
Number of sessions utilized by families used within treatment phase two both within and between treatment settings
Following treatment phase one, families will decide between the following options at Treatment Decision Points (TDP):
- The family may select that they would like to receive and complete the next ERP session and can select to receive up to four additional 3-hour ERP sessions during Treatment Phase Two.
- The family may opt to delay receiving a treatment session by one week for any reason (e.g., prior engagement/holiday, additional time to evaluate symptoms). Families will be allowed to take a week off up to two times during Treatment Phase Two.
- The family may select to end their participation in Treatment Phase Two at any decision point and for any reason (e.g., don't perceive it as helpful, have improved substantially, have already utilized two weeks off and do not wish to have an additional session).
Measured: TDP (Weeks4-9/Day18,25,32,39,46,or53)
Secondary outcomes (2)
Patient satisfaction and treatment tolerability
Participant perspectives on study/treatment procedures (e.g., acceptability, optimal components) is measured with:
- Treatment Expectancy Question (Clinician-, parent- and youth-rated forms)
- Treatment Perspectives Form (Parent- and youth-rated)
Measured: Treatment expectancy at Baseline Assessment; treatment perspectives at one-month follow-up following treatment completion
Cost-effectiveness
Different aspects of cost-effectiveness will be examined (e.g., travel expenses, staff time, service utilization).
A cost-utility analysis will be conducted to examine cost-benefit ratios between conditions and for the program as a whole.
Measured: After study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start1 Oct 2018
- Primary completion27 Aug 2021
- Study completion27 Aug 2021
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 Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Michael Smith Foundation for Health Research
- Responsible party
- Principal investigator, Evelyn Stewart, MD, University of British Columbia
- Investigators
- Evelyn S. Stewart, MD, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03672565
- Sponsor's protocol ID
- H18-01654
- Status last verified
- Sep 2021
- First submitted
- 11 Sep 2018
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Selles RR, Naqqash Z, Best JR, Franco-Yamin D, Qiu ST, Ferreira JS, Deng X, Hannesdottir DK, Oberth C, Belschner L, Negreiros J, Farrell LJ, Stewart SE. Effects of Treatment Setting on Outcomes of Flexibly-Dosed Intensive Cognitive Behavioral Therapy for Pediatric OCD: A Randomized Controlled Pilot Trial. Front Psychiatry. 2021 May 17;12:669494. doi: 10.3389/fpsyt.2021.669494. eCollection 2021.
PubMed 34079488
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flexibly Dosed Intensive Exposure and Response Prevention as a Means to Maximize Outcomes for Youth With Obsessive Compulsive Disorder
- ClinicalTrials.gov ID
- NCT03672565
- Acronym / sponsor ID
- H18-01654
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Exposure and Response prevention ERP, Cognitive-behavioural therapy, Pediatric OCD, Childhood-onset OCD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Michael Smith Foundation for Health Research
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 27 Aug 2021 (actual)
- Study completion
- 27 Aug 2021 (actual)
- First posted
- 14 Sep 2018 (actual)
- 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 randomized pilot study examines a graduated behavioral treatment approach for youth with obsessive compulsive disorder. Youth will be randomized to receive treatment in the community or at the hospital. In the first stage, youth receive an intro session and two 3-hour ERP sessions. Youth will be assessed for OCD recovery. Recovered youth enter follow-up. Still affected youth enter the second stage, where they will can select to receive up to four additional ERP sessions (one per week). In follow-up, youth will receive three 30 minute weekly calls and will be reassessed at 1- and 6-months following treatment.
Detailed description
Obsessive compulsive disorder (OCD) is a highly debilitating psychiatric disorder that affects many youth. Despite strong empirical support that exposure and response prevention (ERP) is an efficacious and tolerable treatment of pediatric OCD including when presented in intensive formats, most individuals simply do not access or receive this treatment.
The dissemination of efficient interventions is of high public health priority, and graduated, or stepped care, models may be the answer. However, initial interventions within a graduated approach must be appropriate for the severity of the condition, given that unnecessary delays to an optimal dose may result in escalating burden on families and ultimately health services. Indeed, low intensity online CBT and self-help have so far had limited efficacy with less than one third of patients deemed responsive to treatment.
In contrast, brief intensive ERP is likely an efficient and effective alternative to flexibly dosing the level of intervention to the participant's needs. In fact, a recent pilot study (n = 10) providing two 3-hour ERP sessions to youth with OCD observed 60% post-treatment, and 70% 6-month follow-up, remission rates among participants. Extending on this study's findings, by utilizing more conservative remission criteria and providing access to additional doses of intensive ERP to youth not yet achieving remission, holds promise in identifying the level of services utilized by families to achieve meaningful treatment outcomes.
Above and beyond the use of a graduated dose model, many questions remain regarding optimal implementation methods for the behavioral treatment of pediatric OCD. In particular, the impact of treatment setting (i.e. community versus clinic) on response has not been systematically studied within this population. Given increased setting relevance and opportunity for in vivo learning, community exposures may be expected to be more effective; however, as they are associated with additional challenges (e.g., transportation time), their contribution to improvement needs to be directly verified and weighed against these costs.
Therefore, the present study seeks to determine the feasibility of implementing a sequential, multiple assignment, randomized trial (SMART) for the behavioral treatment of youth with OCD. The study focuses on evaluating the benefits from a minimum initial dose of intensive exposure and response prevention (ERP) as well as the demand for, and benefits from, additional ERP sessions by still-affected OCD families. In addition, via randomization, the study examines the influence of treatment setting (community vs hospital) on response. Primary outcomes include the impact of treatment on symptom severity and other relevant clinical outcomes (e.g., quality of life, youth- and family-functioning) as well as patient decisions/treatment utilization. Participant perspectives on study/treatment procedures (e.g., acceptability, optimal components) as well as cost-effectiveness (e.g., travel expenses, staff time, service utilization) will also be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hospital setting | Active comparator | Behavioral: Phase One: Standardized Brief Intensive ERP, Behavioral: Phase Two: Flexible Patient Driven Intensive ERP, Behavioral: Follow-Up Phase: Booster CallsERPs may be conducted in various settings on hospital grounds (e.g., cafeteria, hallways) but will not be conducted off property. |
| Community setting | Active comparator | Behavioral: Phase One: Standardized Brief Intensive ERP, Behavioral: Phase Two: Flexible Patient Driven Intensive ERP, Behavioral: Follow-Up Phase: Booster CallsCommunity ERP sessions will be conducted locations deemed most relevant to the child's symptom presentation such as in the home or at other community locations (e.g., church, downtown). |
Who may qualify
- Ages
- 7 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Be between the ages of 7 - 19 years
- Have a primary diagnosis of OCD
- Have a score of equal to, or greater than, 16 on the Children's Yale - Brown Obsessive Compulsive Scale
- Be, and have a parent/guardian, willing to participate in treatment
- Be stable on psychotropic medication as demonstrated by at least 10 weeks since first initiation of an serotonin reuptake inhibitor (SRI) and 4 weeks since initiation of any other psychotropic medications as well as 4 weeks since any dose adjustment of any psychotropic medications.
Key exclusion criteria (5 listed)
- Meet diagnostic criteria for bipolar disorder, psychosis, intellectual disability, substance dependence/abuse, or autism spectrum disorder (> level 1 impairment)
- Demonstrate alternate psychiatric symptoms of a more pressing nature than the OCD symptoms (e.g. suicidal intent in the context of comorbid depression)
- Youth or parents refusing to engage in treatment
- Initiation of an antidepressant within 10 weeks or an alternate psychotropic medication within 4 weeks or adjusted dosage within 4 weeks
- Family lives outside of the Greater Vancouver Area (longer than 60 minutes drive of BC Children's Hospital)
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 |
|---|---|---|
| Phase One: Standardized Brief Intensive ERPParticipants will be randomized to receive ERP sessions at the hospital or at relevant community locations. In the introductory session, participants will be provided with psychoeducation about OCD and the treatment model, will develop a list of potential exposures, and will attempt initial exposure and response prevention (ERP) exercises. The session will end with an assignment of ERP homework. In the seven days following the introductory session, youth and parents will receive two 3-hour sessions, separated by a three day break. The sessions will begin with a brief review of homework completion and success. Following this, with parent observation, the clinician will guide the youth through escalating ERP exercises. The session will end with ERP homework planning. Other evidence-based treatment strategies (e.g., addressing motivation, discussing parental accommodations) may be implemented as deemed necessary by the clinician in order to encourage effective engagement in ERP exercises. | Behavioural | Community setting, Hospital setting |
| Phase Two: Flexible Patient Driven Intensive ERPFamilies will have the opportunity to access up to four additional once/week 3-hour intensive ERP sessions. Three days prior to each additional ERP session (sessions 3-6), families will be prompted to fill out online forms and decide how to proceed with treatment for that week with the following options: * They may select that they would like to receive and complete the next ERP session, and up to four 3-hour ERP sessions during Phase Two. Completion of all four ERP session will automatically end Phase Two. * They may opt to delay receiving a treatment session by one week for any reason. Families will be allowed to take a week off up to two times during Phase Two. If both weeks off are utilized, at the next decision point families must either opt to complete an ERP Session or end their participation in Phase Two. * They may select to end their participation in Phase Two at any decision point and for any reason (e.g., don't perceive it as helpful, have improved substantially). | Behavioural | Community setting, Hospital setting |
| Follow-Up Phase: Booster CallsUpon achieving remission at any remission assessment or completion of remission assessment five, youth will enter the follow-up phase. Youth will receive three weekly 30 minute post-treatment booster phone calls. Calls will focus on homework completion, ERP planning, and relapse prevention skills. | Behavioural | Community setting, Hospital setting |
Primary outcome
Change in OCD symptom severity (i.e., percentage of youth achieving remission) following Treatment Phase One both within and between treatment settings (hospital vs. community)
Time frame: Baseline Assessment (Week1/Day1), Post-treatment Assessment 1 (Week3/Day14)
OCD symptom severity is measured with Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS), a clinician-rated scale of 10 items, each rated from 0 (no symptoms) to 4 (extreme symptoms), scores are summed to give a maximum score of 40. Higher scores indicate worse symptomatology. Youth will be identified as in remission if they are rated as having a total score of 11 (out of 40) or lower on the CY-BOCS at post-treatment assessment 1.
Change in OCD symptom severity between pre- and post-treatment for both treatment phases both within and between treatment settings
Time frame: Phase 1: BA (Week1/Day1), PA1 (Week3/Day14) | Phase 2: TDP (weeks4-9/days18,25,32,39,46,53), PA2 (Week4-10/Day21,28,35,42,49,or60)
OCD symptom severity is measured with Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS), a clinician-rated scale of 10 items, each rated from 0 (no symptoms) to 4 (extreme symptoms), scores are summed to give a maximum score of 40. Higher scores indicate worse symptomatology. Phase one pre- and post-treatment is assessed at Baseline assessment (BA) and PA1 while phase two pre- and post-treatment is assessed at Treatment Decision Point (TDP) and Post-treatment assessment 2 (PA2).
Number of sessions utilized by families used within treatment phase two both within and between treatment settings
Time frame: TDP (Weeks4-9/Day18,25,32,39,46,or53)
Following treatment phase one, families will decide between the following options at Treatment Decision Points (TDP): A) The family may select that they would like to receive and complete the next ERP session and can select to receive up to four additional 3-hour ERP sessions during Treatment Phase Two. B) The family may opt to delay receiving a treatment session by one week for any reason (e.g., prior engagement/holiday, additional time to evaluate symptoms). Families will be allowed to take a week off up to two times during Treatment Phase Two. C) The family may select to end their participation in Treatment Phase Two at any decision point and for any reason (e.g., don't perceive it as helpful, have improved substantially, have already utilized two weeks off and do not wish to have an additional session).
2 secondary outcomes
Patient satisfaction and treatment tolerability
Time frame: Treatment expectancy at Baseline Assessment; treatment perspectives at one-month follow-up following treatment completion
Cost-effectiveness
Time frame: After study completion
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 Sep 2021.
- Derived from this study: PubMed 34079488Selles RR, Naqqash Z, Best JR, Franco-Yamin D, Qiu ST, Ferreira JS, Deng X, Hannesdottir DK, Oberth C, Belschner L, Negreiros J, Farrell LJ, Stewart SE. Effects of Treatment Setting on Outcomes of Flexibly-Dosed Intensive Cognitive Behavioral Therapy for Pediatric OCD: A Randomized Controlled Pilot Trial. Front Psychiatry. 2021 May 17;12:669494. doi: 10.3389/fpsyt.2021.669494. eCollection 2021.
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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.
Evelyn S. Stewart, MD principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phase One: Standardized Brief Intensive ERP, Phase Two: Flexible Patient Driven Intensive ERP and Follow-Up Phase: Booster Calls in people with Obsessive-Compulsive Disorder, run by University of British Columbia at 1 site in Canada.
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 7 inclusion and 5 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 Sep 2021. 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 Canada. 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?
Change in OCD symptom severity (i.e., percentage of youth achieving remission) following Treatment Phase One both within and between treatment settings (hospital vs. community) (time frame: Baseline Assessment (Week1/Day1), Post-treatment Assessment 1 (Week3/Day14)). 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 NCT03672565, 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 Sep 2021.